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KEYTRUDA® (pembrolizumab) plus chemotherapy significantly improved overall survival versus chemotherapy alone as first-line treatment for unresectable advanced pleural mesothelioma

In Phase 3 CCTG IND.227/KEYNOTE-483 trial, KEYTRUDA plus chemotherapy also demonstrated statistically significant improvements in PFS and ORR compared to chemotherapy alone

 

RAHWAY, N.J. & KINGSTON, Ontario — (BUSINESS WIRE) — $MRK #MRK — Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and the Canadian Cancer Trials Group (CCTG) today announced results from the Phase 3 CCTG IND.227/KEYNOTE-483 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, plus chemotherapy as first-line treatment for patients with unresectable advanced pleural mesothelioma. At the final analysis of the study, KEYTRUDA plus chemotherapy significantly improved overall survival (OS), reducing the risk of death by 21% (HR=0.79 [95% CI, 0.64-0.98]; two-sided p value=0.0324), with a median OS of 17.3 months (95% CI, 14.4-21.3) versus 16.1 months (95% CI, 13.1-18.2) for chemotherapy alone. These late-breaking data are being presented today during an oral abstract session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (abstract #LBA8505) and are being discussed with regulatory authorities worldwide.

“Patients with pleural mesothelioma are usually diagnosed at an advanced stage, when the five year survival rate is only 12% and curative surgery is not an option,” said Dr. Lesley Seymour, Director of the Investigational New Drug program at CCTG, and Senior Investigator for IND.227. “The addition of pembrolizumab to platinum-pemetrexed in our study resulted in significantly improved overall survival, progression-free survival and objective response rates compared to platinum-pemetrexed alone, regardless of PD-L1 expression. This regimen represents a potential new treatment option for patients with advanced pleural mesothelioma.”

 

“These results support the potential of KEYTRUDA plus chemotherapy as a new first-line option for patients with advanced pleural mesothelioma, who currently have limited treatment options,” said Dr. Gregory Lubiniecki, Vice President, Global Clinical Development, Merck Research Laboratories. “These data demonstrate our commitment to improving outcomes for patients with different types of thoracic cancer through our expansive clinical development program and research evaluating KEYTRUDA in new, difficult-to-treat tumors.”

 

Study design and additional data from IND.227/KEYNOTE-483

IND.227/KEYNOTE-483 is a randomized, open-label Phase 2/3 trial (ClinicalTrials.gov, NCT02784171) sponsored and conducted by CCTG in collaboration with National Cancer Institute of Naples (NCIN) and Intergroupe Francophone de Cancérologie Thoracique (IFCT). Merck provided KEYTRUDA and support for the trial. The trial evaluated KEYTRUDA plus chemotherapy versus chemotherapy alone for the treatment of patients with unresected advanced pleural mesothelioma. The primary endpoint of the study is OS, and secondary endpoints include progression-free survival (PFS) and objective response rate (ORR) as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) modified for mesothelioma, safety and quality of life. The Phase 3 part of the trial enrolled 440 patients who were randomized to receive:

 

  • KEYTRUDA (200 mg intravenously [IV] every three weeks [Q3W] for up to 35 cycles) plus pemetrexed (500 mg/m2 Q3W for six cycles) and cisplatin (75 mg/m2 Q3W for six cycles; carboplatin substitution [AUC 5-6 Q3W for six cycles] was permitted), or
  • Pemetrexed and cisplatin (carboplatin substitution was permitted) alone.

 

PFS was also significantly improved for KEYTRUDA plus chemotherapy compared to chemotherapy alone (HR=0.80 [95%CI, 0.65-0.99], two-sided p value = 0.0372; median PFS 7.13 months versus 7.16 months respectively). At 12 months, the estimated PFS rate was 26% for KEYTRUDA plus chemotherapy versus 17% for chemotherapy alone. The ORR was significantly higher for KEYTRUDA plus chemotherapy versus chemotherapy alone (62% versus 38%, p<0.0001).

 

The safety profile of KEYTRUDA plus chemotherapy in this study was consistent with previously reported studies. Adverse events related to study treatment of grade 3 or 4 occurred in 27% of patients in the KEYTRUDA plus chemotherapy arm, and 15% of patients on the chemotherapy-alone arm. The most common grade ≥3 adverse events in the KEYTRUDA arm were fatigue (7%), nausea (5%) and febrile neutropenia (5%); the corresponding values for the chemotherapy arm were 6%, 1% and 1%. KEYTRUDA-related adverse events resulting in discontinuation of KEYTRUDA occurred in 16% of patients receiving KEYTRUDA plus chemotherapy.

 

About mesothelioma

Mesothelioma is a type of cancer that starts in the linings of certain parts of the body, including the chest, abdomen, heart and testicles. Worldwide, it is estimated there were more than 30,000 new cases of mesothelioma diagnosed and more than 26,000 deaths from the disease in 2020. Pleural mesothelioma, which develops in the lining of the lungs, is the most common form of mesothelioma, accounting for about 75% of all cases. Pleural mesothelioma often progresses rapidly, and the five-year survival rate is only 12%. Although incidence of mesothelioma has gradually declined in the U.S., continued use of and exposure to asbestos around the world has resulted in increasing global rates of this aggressive disease.

 

About the Canadian Cancer Trials Group

The Canadian Cancer Trials Group (CCTG) is a cancer clinical trials research cooperative that develops, conducts and analyses phase I-III trials to test anti-cancer and supportive therapies at over 85 hospitals and cancer centres across Canada and internationally. From their operations centre at Queen’s University, CCTG has supported more than 600 trials enrolling 100,000 patients from 40 countries on 6 continents through a global network of 20,000 investigators and clinical trial staff. CCTG is a national program of the Canadian Cancer Society (CCS) and their aim is to improve survival and quality of life for all people with cancer. CCTG IND.227 was supported by a grant from CCS (707213). For further information, please visit the CCTG website: www.cctg.ca.

 

About KEYTRUDA® (pembrolizumab) injection, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

 

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

 

Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:

  • stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
  • metastatic.

 

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

 

KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 cm), II, or IIIA NSCLC.

 

See additional selected indications for KEYTRUDA in the U.S. after the Selected Important Safety Information

 

Selected Important Safety Information for KEYTRUDA

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the PD-1 or the PD-L1, blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

 

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

 

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

 

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

 

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

 

Pneumonitis occurred in 41 (7%) patients, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. In adult patients who received adjuvant therapy for NSCLC, patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.

 

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

 

Hepatotoxicity and Immune-Mediated Hepatitis

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

 

KEYTRUDA With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event.

 

Immune-Mediated Endocrinopathies

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

 

Hypophysitis

KEYTRUDA can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Hypophysitis occurred in 0.6% (17/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.2%) reactions. Systemic corticosteroids were required in 94% (16/17) of patients; of these, the majority remained on systemic corticosteroids. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

 

Thyroid Disorders

KEYTRUDA can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Withhold or permanently discontinue KEYTRUDA depending on severity. Thyroiditis occurred in 0.6% (16/2799) of patients receiving KEYTRUDA, including Grade 2 (0.3%). None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients.

 

Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). It led to permanent discontinuation of KEYTRUDA in <0.1% (2) and withholding in 0.3% (7) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Hypothyroidism occurred in 8% (237/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (6.2%). It led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.5% (14) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. The majority of patients with hypothyroidism required long-term thyroid hormone replacement. The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC, occurring in 16% of patients receiving KEYTRUDA as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism. The incidence of new or worsening hyperthyroidism was higher in 580 patients with resected NSCLC, occurring in 11% of patients receiving KEYTRUDA as a single agent as adjuvant treatment, including Grade 3 (0.2%) hyperthyroidism. The incidence of new or worsening hypothyroidism was higher in 580 patients with resected NSCLC, occurring in 22% of patients receiving KEYTRUDA as a single agent as adjuvant treatment (KEYNOTE-091), including Grade 3 (0.3%) hypothyroidism.

 

Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis

Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Withhold KEYTRUDA depending on severity. Type 1 DM occurred in 0.2% (6/2799) of patients receiving KEYTRUDA. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement.

 

Immune-Mediated Nephritis With Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.1%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 89% (8/9) of patients. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Nephritis resolved in 56% of the 9 patients.

 

Immune-Mediated Dermatologic Adverse Reactions

KEYTRUDA can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with anti–PD-1/PD-L1 treatments. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. Withhold or permanently discontinue KEYTRUDA depending on severity. Immune-mediated dermatologic adverse reactions occurred in 1.4% (38/2799) of patients receiving KEYTRUDA, including Grade 3 (1%) and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 40% (15/38) of patients. These reactions led to permanent discontinuation in 0.1% (2) and withholding of KEYTRUDA in 0.6% (16) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 6% had recurrence. The reactions resolved in 79% of the 38 patients.

 

Other Immune-Mediated Adverse Reactions

The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other anti–PD-1/PD-L1 treatments. Severe or fatal cases have been reported for some of these adverse reactions. Cardiac/Vascular: Myocarditis, pericarditis, vasculitis; Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; Ocular: Uveitis, iritis and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: Pancreatitis, to include increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis (and associated sequelae, including renal failure), arthritis (1.5%), polymyalgia rheumatica; Endocrine: Hypoparathyroidism; Hematologic/Immune: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection.

 

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. Monitor for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. For Grade 3 or Grade 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

 

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after anti–PD-1/PD-L1 treatments. Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute and chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause).

Contacts

Media Contacts:

Julie Cunningham

(617) 519-6264

Sienna Choi

(908) 873-4311

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Damini Chokshi

(732) 594-1577

CCTG Media Contacts:

Lisa Callahan

CCTG Communications Leader

lcallahan@ctg.queensu.ca
(343) 363-7158

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Merck’s KEYTRUDA® (pembrolizumab) plus chemotherapy before surgery and continued as a single agent after surgery reduced the risk of event-free survival events by 42% versus pre-operative chemotherapy in resectable stage II, IIIA or IIIB NSCLC

Based on a subgroup analysis, improvement in event-free survival (EFS) with the KEYTRUDA-based regimen was consistent across all PD-L1 expression subgroups, histology and stage

 

Exploratory subgroup analysis showed a reduction in EFS events with the KEYTRUDA perioperative regimen for patients with or without pathological complete response (pCR) compared with the chemotherapy-placebo regimen

 

KEYNOTE-671 is the eighth positive pivotal study evaluating a KEYTRUDA-based regimen in earlier stages of cancer and the seventh positive pivotal study in lung cancer

 

RAHWAY, N.J. — (BUSINESS WIRE) — Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive results from the pivotal Phase 3 KEYNOTE-671 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, as a perioperative treatment regimen, which includes treatment before surgery (neoadjuvant) and after surgery (adjuvant), for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer (NSCLC). After a median follow-up of 25.2 months, neoadjuvant KEYTRUDA plus chemotherapy followed by resection and adjuvant single-agent KEYTRUDA significantly improved EFS, reducing the risk of disease recurrence, progression or death by 42% (HR=0.58 [95% CI, 0.46-0.72]; p<0.00001) for patients with resectable stage II, IIIA or IIIB NSCLC versus neoadjuvant placebo plus chemotherapy followed by adjuvant placebo. For patients who received the KEYTRUDA-based regimen, median EFS was not reached (95% CI, 34.1-NR) versus 17 months (95% CI, 14.3-22) for patients who received chemotherapy alone.

The trial is continuing to allow for additional follow-up of overall survival (OS), the other dual primary endpoint. A favorable trend in OS was observed for the KEYTRUDA regimen versus pre-operative chemotherapy (HR 0.73 [95% CI, 0.54-0.99]; p=0.02124); with only 177 events, these OS data are not mature and did not reach statistical significance at the time of this interim analysis. The safety profile of the KEYTRUDA regimen was consistent with the safety profile in earlier stages and metastatic NSCLC, with no new safety concerns identified. These results are being presented today during a clinical science symposium, The Promise of Neoadjuvant Immunotherapy Across Solid Tumors, at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (abstract #LBA100) and are also being simultaneously published in the New England Journal of Medicine.

 

In a subgroup analysis, improvement in EFS with the KEYTRUDA regimen was consistent across PD-L1 expression subgroups, histology and stage. Treatment with the KEYTRUDA-based regimen reduced the risk of EFS events regardless of PD-L1 expression versus the chemotherapy-placebo regimen (tumor proportion score [TPS] ≥50% [n=266] HR=0.42 [95% CI, 0.28-0.65]; TPS 1-49% [n=242] HR=0.51 [95% CI, 0.34-0.75]; TPS <1% [n=289] HR=0.77 [95% CI, 0.55-1.07]). The KEYTRUDA-based regimen also improved EFS compared with the chemotherapy-placebo regimen regardless of histology (nonsquamous [n=453] HR=0.58 [95% CI, 0.43-0.78]; squamous [n=344] HR=0.57 [95% CI, 0.41-0.77]) and stage (stage II [n=239] HR=0.65 [95% CI, 0.42-1.01]; stage IIIA [n=442] HR=0.54 [95% CI, 0.41-0.72]; stage IIIB [n=116] HR=0.52 [95% CI, 0.31-0.88]).

 

While achieving pCR is a predictor of better outcomes, an exploratory subgroup analysis showed the reduction in EFS events with the KEYTRUDA perioperative regimen was observed for patients with or without pCR (with pCR: HR=0.33 [95% CI, 0.09-1.22]; without pCR: HR=0.69 [95% CI, 0.55-0.86]).

 

“Historically, more than half of people with earlier stages of non-small cell lung cancer that has been surgically removed will experience recurrence,” said Dr. Heather Wakelee, thoracic medical oncologist and professor of medicine at Stanford Medicine, president of the International Association for the Study of Lung Cancer and principal investigator for KEYNOTE-671. “Results showed that a pembrolizumab-based regimen before and after surgery significantly reduced the risk of recurrence, progression or death by 42 percent versus pre-operative chemotherapy, regardless of PD-L1 expression and with or without a pathological complete response. These event-free survival data are very encouraging and support the potential of this perioperative approach for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer.”

 

“These compelling new results build on previous studies of KEYTRUDA in earlier stages of disease across certain types of cancer, including non-small cell lung cancer,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “KEYNOTE-671 demonstrated statistically significant and clinically meaningful improvements in event-free survival for patients with stage II, IIIA or IIIB non-small cell lung cancer treated with the KEYTRUDA perioperative regimen compared with chemotherapy and surgery alone. We are working with the FDA and other global authorities to bring this new option to patients as quickly as possible.”

 

“These results are meaningful for the community of thoracic surgeons given the need for additional treatment options that can improve event-free survival for patients with resectable stage II, IIIA or IIIB non-small cell lung cancer,” said Dr. Jonathan Spicer, associate professor of surgery, McGill University, attending surgeon, division of thoracic and upper gastrointestinal surgery, Montreal General Hospital, McGill University Health Centre and KEYNOTE-671 investigator. “Notably, the results showed that the KEYTRUDA-based perioperative regimen did not impact the opportunity for a complete resection and improvements were seen regardless of if they achieved a pathological complete response or not.”

 

Merck previously announced that, based on these results, the U.S. Food and Drug Administration (FDA) has accepted a new supplemental Biologics License Application (sBLA) for KEYTRUDA for the treatment of patients with resectable stage II, IIIA, or IIIB (T3-4N2) NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment. The FDA has set a Prescription Drug User Fee Act, or target action, date of Oct. 16, 2023.

 

 

In addition to KEYNOTE-671, seven other pivotal trials evaluating a KEYTRUDA-based regimen in patients with earlier stages of cancer met their primary endpoint(s). These trials included: KEYNOTE-057 in Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer; KEYNOTE-629 in cutaneous squamous cell carcinoma; KEYNOTE-716 in stage IIB and IIC melanoma; KEYNOTE-054 in stage III melanoma; KEYNOTE-091 in stage IB, II or IIIA NSCLC; KEYNOTE-564 in renal cell carcinoma; and KEYNOTE-522 in triple-negative breast cancer.

 

The seven positive pivotal studies in lung cancer include: KEYNOTE-189, KEYNOTE-407, KEYNOTE-042, KEYNOTE-024, KEYNOTE-010, KEYNOTE-091 and KEYNOTE-671.

 

Merck has an extensive clinical development program in lung cancer and is advancing multiple registration-enabling studies, with research directed at earlier stages of disease and novel combinations. Key studies in earlier stages of NSCLC and small cell lung cancer (SCLC) include KEYNOTE-671, KEYNOTE-091, KEYNOTE-867, KEYLYNK-012, KEYVIBE-006 and KEYLYNK-013.

 

As announced, data spanning more than 25 different types of cancer are being presented from Merck’s broad oncology portfolio and investigational pipeline at the 2023 ASCO Annual Meeting. A compendium of Merck’s presentations and posters is available here.

 

Study design and additional data from KEYNOTE-671

KEYNOTE-671 is a randomized, double-blind Phase 3 trial (ClinicalTrials.gov, NCT03425643) evaluating neoadjuvant KEYTRUDA plus chemotherapy, followed by resection and adjuvant KEYTRUDA as a single agent, versus placebo plus neoadjuvant chemotherapy, followed by resection and adjuvant placebo, in patients with resectable stage II, IIIA or IIIB (T3-4N2) NSCLC. The trial’s dual primary endpoints are EFS and OS. Key secondary endpoints include pCR and major pathological response (mPR). The study enrolled 797 patients who were randomly assigned (1:1) to receive either:

 

  • KEYTRUDA (200 mg intravenously [IV] every three weeks [Q3W] for up to four cycles) plus chemotherapy (cisplatin [75 mg/m2, IV; given on Day 1 of each cycle] and either gemcitabine [1000 mg/m2, IV; given on Days 1 and 8 of each cycle or pemetrexed [500 mg/m2, IV; given on Day 1 of each cycle]) as neoadjuvant therapy prior to surgery, followed by KEYTRUDA (200 mg IV Q3W for up to 13 cycles) as adjuvant therapy post-surgery (n=397) for up to 13 cycles, or;
  • Placebo (saline IV Q3W for up to four cycles) plus chemotherapy (cisplatin [75 mg/m2, IV; given on Day 1 of each cycle] and either gemcitabine [1000 mg/m2, IV; given on Days 1 and 8 of each cycle] or pemetrexed [500 mg/m2, IV; given on Day 1 of each cycle]) as neoadjuvant therapy prior to surgery, followed by placebo (saline IV Q3W for up to 13 cycles) as adjuvant therapy post-surgery (n=400) for up to 13 cycles.

 

As previously announced, KEYNOTE-671 met the dual primary endpoint of EFS at the first interim analysis. At two years, 62.4% of patients treated with the KEYTRUDA regimen were alive and did not experience an EFS event compared to 40.6% of patients treated with the chemotherapy-placebo regimen.

 

The KEYTRUDA-based perioperative treatment regimen also demonstrated statistically significant and clinically meaningful improvements in key secondary endpoints of pCR and mPR. In the study, 18.1% of patients treated with the KEYTRUDA plus chemotherapy regimen achieved pCR versus 4% of patients treated with pre-operative chemotherapy (difference: 14.2% (95% CI: 10.1-18.7); p<0.00001). Additionally, treatment with the KEYTRUDA plus chemotherapy regimen resulted in a 30.2% mPR rate, meaning 10% or less or their tumor cells remained after receiving perioperative treatment, versus 11% with chemotherapy alone (difference: 19.2% [95% CI: 13.9-24.7]; p<0.00001).

 

Among patients treated with pre-operative KEYTRUDA plus chemotherapy, 80.6% underwent definitive surgery compared to 75.5% who received chemotherapy alone. Of these patients, 92% and 84% had a complete resection (R0 resection), respectively.

 

Treatment-related adverse events (TRAEs) occurred in 96.7% of patients receiving the KEYTRUDA regimen (n=396) and 95% of patients receiving the chemotherapy-placebo regimen (n=399); Grade 3-5 TRAEs occurred in 44.9% versus 37.3%, respectively. Treatment-related adverse events led to discontinuation of all study treatment in 12.6% of patients treated with the KEYTRUDA regimen and 5.3% treated with the chemotherapy-placebo regimen. Treatment-related adverse events led to death in 1.0% of patients receiving the KEYTRUDA regimen (n=4) and 0.8% of patients receiving the chemotherapy-placebo regimen (n=3). No new safety concerns were identified.

 

Immune-mediated adverse events (AEs) and infusion reactions of any grade occurred in 25.3% of patients receiving the KEYTRUDA regimen and 10.5% of patients receiving the chemotherapy-placebo regimen. Grade 3-5 immune-mediated AEs and infusion reactions occurred in 5.8% versus 1.5%, respectively. The most common of these events (occurring in ≥10% of patients) was hypothyroidism (11.1%) in patients receiving the KEYTRUDA regimen. Immune-mediated AEs and infusion reactions led to death in 0.3% of patients receiving the KEYTRUDA regimen (n=1) and no patients receiving the chemotherapy-placebo regimen. Immune-mediated AEs and infusion reactions that led to discontinuation of all study treatment occurred in 5.1% of patients receiving the KEYTRUDA regimen and 0.8% of patients receiving the chemotherapy-placebo regimen.

 

About lung cancer

Lung cancer is the leading cause of cancer death worldwide. In 2020 alone, there were more than 2.2 million new cases and 1.8 million deaths from lung cancer globally. Non-small cell lung cancer is the most common type of lung cancer, accounting for about 81% of all cases. In the U.S., the overall five-year survival rate for patients diagnosed with lung cancer is 25%, which is a 21% improvement over the last five years. Improved survival rates are due, in part, to reduction in smoking, advances in diagnostic and surgical procedures, as well as the introduction of new therapies. However, screening, early detection and improving treatment rates remain an important unmet need, as 44% of lung cancer cases are not found until they are advanced. Only 5.8% of people in the U.S. who are eligible were screened for lung cancer in 2021.

 

About Merck’s research in lung cancer

Merck is advancing research aimed at transforming the way lung cancer is treated, with a goal of improving outcomes for patients affected by this deadly disease. Through nearly 200 clinical trials evaluating more than 36,000 patients around the world, Merck is at the forefront of lung cancer research. In NSCLC, KEYTRUDA has five approved U.S. indications (see indications below) and is approved for advanced disease in more than 95 countries. Among Merck’s research efforts are trials focused on evaluating KEYTRUDA in earlier stages of lung cancer as well as identifying new combinations and coformulations with KEYTRUDA.

 

About Merck’s early-stage cancer clinical program

Finding cancer at an earlier stage may give patients a greater chance of long-term survival. Many cancers are considered most treatable and potentially curable in their earliest stage of disease. Building on the strong understanding of the role of KEYTRUDA in later-stage cancers, Merck is studying KEYTRUDA in earlier disease states, with approximately 20 ongoing registrational studies across multiple types of cancer.

 

About KEYTRUDA® (pembrolizumab) injection, 100 mg

KEYTRUDA is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

 

Merck has the industry’s largest immuno-oncology clinical research program. There are currently more than 1,600 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient’s likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

 

Selected KEYTRUDA® (pembrolizumab) Indications in the U.S.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) ≥1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is:

  • stage III where patients are not candidates for surgical resection or definitive chemoradiation, or
  • metastatic.

 

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

 

KEYTRUDA, as a single agent, is indicated as adjuvant treatment following resection and platinum-based chemotherapy for adult patients with stage IB (T2a ≥4 cm), II, or IIIA NSCLC.

 

See additional selected indications for KEYTRUDA in the U.S. after the Selected Important Safety Information

 

Selected Important Safety Information for KEYTRUDA

 

Severe and Fatal Immune-Mediated Adverse Reactions

KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the PD-1 or the PD-L1, blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, can affect more than one body system simultaneously, and can occur at any time after starting treatment or after discontinuation of treatment. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

 

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Early identification and management are essential to ensure safe use of anti–PD-1/PD-L1 treatments. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. For patients with TNBC treated with KEYTRUDA in the neoadjuvant setting, monitor blood cortisol at baseline, prior to surgery, and as clinically indicated. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

 

Withhold or permanently discontinue KEYTRUDA depending on severity of the immune-mediated adverse reaction. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose adverse reactions are not controlled with corticosteroid therapy.

 

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis. The incidence is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Systemic corticosteroids were required in 67% (63/94) of patients. Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Pneumonitis resolved in 59% of the 94 patients.

 

Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis rates were similar in patients with and without prior thoracic radiation. Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients. Of the patients who developed pneumonitis, 42% interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution.

 

Pneumonitis occurred in 7% (41/580) of adult patients with resected NSCLC who received KEYTRUDA as a single agent for adjuvant treatment of NSCLC, including fatal (0.2%), Grade 4 (0.3%), and Grade 3 (1%) adverse reactions. Patients received high-dose corticosteroids for a median duration of 10 days (range: 1 day to 2.3 months). Pneumonitis led to discontinuation of KEYTRUDA in 26 (4.5%) of patients. Of the patients who developed pneumonitis, 54% interrupted KEYTRUDA, 63% discontinued KEYTRUDA, and 71% had resolution.

 

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis, which may present with diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Systemic corticosteroids were required in 69% (33/48); additional immunosuppressant therapy was required in 4.2% of patients. Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Colitis resolved in 85% of the 48 patients.

 

Hepatotoxicity and Immune-Mediated Hepatitis

 

KEYTRUDA as a Single Agent

KEYTRUDA can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.4%), and Grade 2 (0.1%) reactions. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, none had recurrence. Hepatitis resolved in 79% of the 19 patients.

 

KEYTRUDA With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased alanine aminotransferase (ALT) (20%) and increased aspartate aminotransferase (AST) (13%) were seen at a higher frequency compared to KEYTRUDA alone. Fifty-nine percent of the patients with increased ALT received systemic corticosteroids. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. All patients with a recurrence of ALT ≥3 ULN subsequently recovered from the event.

 

Immune-Mediated Endocrinopathies

 

Adrenal Insufficiency

KEYTRUDA can cause primary or secondary adrenal insufficiency. For Grade 2 or higher, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold KEYTRUDA depending on severity. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.

Contacts

Media:

Julie Cunningham

(617) 519-6264

Nikki Sullivan

(718) 644-0730

Investor:

Peter Dannenbaum

(732) 594-1579

Damini Chokshi

(732) 594-1577

Read full story here

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Generational Group to sponsor amateur golf standout Anna Davis

Davis is a rising star among female amateur golfers and the agreement expands Generational’s brand sponsorships with key figures in the world of golf

 

DALLAS — (BUSINESS WIRE) — Generational Group, a leading investment banking firm for middle market, privately held businesses is pleased to announce that it has signed an NIL (Name, Image, and Likeness) sponsorship agreement with amateur golfer Anna Davis.


Davis, a left-hander who is currently ranked 5th in the world women’s amateur golf rankings, exploded onto the national spotlight in April 2022 when, at 16 years old, she won the Augusta National Women’s Amateur, the youngest champion in the Tournament’s history. That win qualified Davis for three majors and four additional LPGA Tour events. Davis played extremely well in those additional events, making the cut five of seven times.

 

Davis and Generational Group share the same Core Values and commitment to excellence and hard work. The Generational team looks forward to her joining its other Brand Ambassadors, Jack Nicklaus, Justin Leonard and Mito Pereira.

 

Davis, from Spring Valley, California will have a busy 2023 summer schedule. This week, starting June 1 through June 4, she will play in the LPGA’s Mizuho America’s Open at Liberty National Golf Club in Jersey City, New Jersey. This will mark the first time that Liberty National will host an LPGA event. Showcasing the stars of today along with the future of the game, the LPGA players will compete with 24 top-ranked junior girls, creating an unprecedented week of education and opportunity to inspire the next generation of LPGA Tour players.

 

Following her appearance at the Mizuho America’s Open, Davis will play in the U.S. Women’s Open at Pebble Beach, California, from July 6 through July 9. It marks the first time in Pebble Beach history that the greatest players in the game will compete for the 2023 U.S. Women’s Open. Following the US Women’s Open, she will likely represent The United States in the Junior Ryder Cup and Junior Solheim Cup overseas.

 

Davis qualified for this year’s U.S. Women’s Open winning the 36 hole qualifier at the Valencia (California) Country Club with a 2-under total of 142. Davis, who represented the United States in the 2021 Junior Solheim and Junior Ryder Cups, won the Girls Junior Invitational at Sage Valley earlier this year as well as the Girls Junior Orange Bowl.

 

In November 2022, Davis announced that she had verbally committed to playing collegiate golf at Auburn University.

 

Ryan Binkley, President and CEO of Generational Group stated, “It is a real pleasure to be working with Anna and to watch her compete against the best in women’s golf this year. We look forward to seeing her game develop and are pleased to be associated with someone with her talent, dedication, and drive for excellence.”

 

Binkley added, “Generational is proud to invest in the future of women’s golf and we are thankful for the opportunity to team with Anna for her future development. We recognize that amateur golf is expensive, and we are privileged to share in Anna’s growth.”

 

About Generational Group

Generational Equity, Generational Capital Markets (member FINRA/SIPC), Generational Wealth Advisors, Generational Consulting Group and DealForce are part of Generational Group, which is headquartered in Dallas, Texas.

 

With more than 350 professionals located throughout 16 offices in North America, the companies help business owners release the wealth of their business by providing growth consulting, merger, acquisition, and wealth management services. The Generational suite of advisory services includes strategic growth consulting, exit planning education, business valuation, value enhancement strategies, M&A services, and wealth management.

 

The M&A Advisor named Generational Equity Investment Banking Firm of the Year three years in a row, Valuation Firm of the Year in 2020, and North American Investment Bank of the Year in 2022 as well as Consulting Firm of the Year. For more information, visit https://www.genequityco.com/ or the Generational Equity press room.

Contacts

Carl Doerksen

972-342-0968

cdoerksen@generational.com

or

Jim Rocco

PRCG | Sports
212-683-8100

jrocco@prcg.com

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Northern Trust appoints Michael J. Bracci President of East Florida and Mid-Atlantic Regions

CHICAGO — (BUSINESS WIRE) — #wealthmanagement — Northern Trust has expanded the role of Michael J. Bracci to President of the East Florida and Mid-Atlantic Regions. Bracci, who has been President of the East Florida Region since 2003, will now lead the strategic direction and execution of the Wealth Management business of both the East Florida and Mid-Atlantic Regions, including Atlanta, Philadelphia and Washington, D.C.


Bracci, who joined Northern Trust in 1993, is a leader in investment management, trust and fiduciary management, financial planning and private banking. Prior to becoming President, he served as the Regional Senior Banking Officer for the Palm Beach Martin Region, and as Managing Director of the North Palm Beach office.

 

“For many years, Mike has delivered proven leadership, shown an unwavering dedication to client service and developed a strong track record for creating advice-driven solutions,” said Glenda G. Pedroso, President of the East Region for Northern Trust Wealth Management. “I am delighted he will be taking on this expanded role as President of both the Mid-Atlantic and East Florida Regions.”

 

Bracci earned a Bachelor of Arts in Economics from Tulane University and has more than 30 years of experience in the banking and finance industry. He began his career in the management training program at a large Southeast regional commercial bank and subsequently led a regional commercial banking team.

 

He is a member of the Board of Trustees for the Raymond F. Kravis Center for the Performing Arts and previously served as the Chair of the Board of Trustees. He also serves on the board of the Nicklaus Children’s Healthcare Foundation and has been Chair of the Board’s Executive Committee since 2005.

 

In 2021, Bracci was named to the Board of the Community Foundation for Palm Beach and Martin Counties. He is the current chair of the Investment Committee, past Treasurer of the Board and past Chair of the Finance Committee.

 

Northern Trust Wealth Management offers holistic wealth management services for affluent individuals and families, family offices, foundations and endowments, and privately held businesses. It is recognized for its innovative technology, service excellence and depth of expertise, with $368.3 billion in assets under management as of March 31, 2023. The Northern Trust Company is an Equal Housing Lender. Member FDIC.

 

About Northern Trust

Northern Trust Corporation (Nasdaq: NTRS) is a leading provider of wealth management, asset servicing, asset management and banking to corporations, institutions, affluent families and individuals. Founded in Chicago in 1889, Northern Trust has a global presence with offices in 25 U.S. states and Washington, D.C., and across 23 locations in Canada, Europe, the Middle East and the Asia-Pacific region. As of March 31, 2023, Northern Trust had assets under custody/administration of US$14.2 trillion, and assets under management of US$1.3 trillion. For more than 130 years, Northern Trust has earned distinction as an industry leader for exceptional service, financial expertise, integrity and innovation. Visit us on northerntrust.com. Follow us on Twitter @NorthernTrust or Northern Trust Corporation on LinkedIn.

 

Northern Trust Corporation, Head Office: 50 South La Salle Street, Chicago, Illinois 60603 U.S.A., incorporated with limited liability in the U.S. Global legal and regulatory information can be found at https://www.northerntrust.com/terms-and-conditions.

Contacts

Karen Mellen

773-860-8110

kem6@ntrs.com
http://www.northerntrust.com

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AM Best to host briefing on cyber insurance trends, impact of AI and evolving threats

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance — AM Best will host an analytical briefing on trends and challenges in the cyber insurance market, including the rise of artificial intelligence and the return of ransomware attacks, at 11 a.m. (EDT) on Tuesday, June 13, 2023.

During the event, titled, “Cyber: Moderating Pricing, Cautious Underwriting, Even as Risks Resurface,” the panel, made up of AM Best analysts and industry experts, will discuss the market’s performance in 2022 and key market indicators, such as pricing, capacity and reinsurance conditions. Other topics include cyber war exclusions and recent developments in risk modeling, as well as how AI is being harnessed not only by underwriters in the segment, but also by more-sophisticated cyber criminals.

 

The panel includes:

  • Shawn Ram, head of insurance, Coalition, Inc.;
  • Matthew Silley, cyber reinsurance broker, Lockton Re;
  • Sridhar Manyem, senior director, industry research and analytics, AM Best; and
  • Christopher Graham, senior industry analyst, industry research and analytics, AM Best;

Attendees can submit questions during registration or by emailing conferenceinformation@ambest.com. The event will be streamed in video and audio formats, and playback will be available shortly after the event.

 

To find out more about the webinar or to register, please visit http://www.ambest.com/conferences/Cyber2023/index.html.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2023 by A.M. Best Rating Services, Inc. and/or its affiliates.

ALL RIGHTS RESERVED.

Contacts

Christopher Sharkey
Associate Director, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 439 2200, ext. 5098
al.slavin@ambest.com

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AM Best announces winner of 2023 Student Challenge

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best has announced that Hannah Youngblood from Florida State University is the winner of AM Best’s 2023 Student Challenge for her proposal to create a telemedicine platform for prescriptions that would address the issue of inadequate insurance coverage and high prescription costs.

 

The nationwide competition tasked risk management and insurance students with creating innovative solutions for insurance risks. In addition to Youngblood, six students from University of Wisconsin—Madison were finalists in the competition, which was open to undergraduate and graduate students, who were invited to submit as individuals or in teams of two.

 

With her telemedicine platform, Youngblood aims to save lives by improving access to prescriptions and reducing the 125,000 annual deaths due to poor prescription access. It would educate, inform and compare, providing a reliable, affordable and accessible solution for prescription management.

 

“Existing applications like Optum, CVS, Walgreens, GoodRx and Mark Cuban’s Cost Plus could be integrated into this platform to provide users with a one-stop solution for finding the best prescription prices,” Youngblood explained. “By consolidating these services, the platform would benefit the 43% of inadequately insured Americans and the 66% of Americans with prescriptions.”

 

Potential platform expansions could include prescription reminders, an informational drug database, a medical care provider database and partnerships for discounts on certain drugs.

 

AM Best’s 2023 Student Challenge is sponsored by the AM Best Foundation, which financially supports charitable organizations that encourage education and thought leadership in insurance and risk management.

 

“The innovative ideas proposed by these students show a bright future for the insurance industry,” said Lee McDonald, group vice president of AM Best – Information Services.

 

To view interviews with Youngblood, as well as the other finalists, please visit AM Best’s 2023 Student Challenge landing page.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2023 by A.M. Best Company, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Lee McDonald
Group Vice President
AM Best – Information Services
+1 908-882-2102
lee.mcdonald@ambest.com

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New Jersey American Water completes acquisition of Egg Harbor City water and sewer systems

First acquisition in the State completed via the Water Infrastructure Protection Act adds more than 3,000 new customer connections for company and provides rate protection for residents

 

CAMDEN, N.J. — (BUSINESS WIRE) — New Jersey American Water announced today it has completed its acquisition of the water and wastewater systems of Egg Harbor City, N.J. for $21.8 million.

 

The sale of these systems, which serve approximately 3,000 customer connections combined, follows the approval of the New Jersey Department of Community Affairs and the New Jersey Board of Public Utilities, and is the first in the state of New Jersey to be completed through the Water Infrastructure Protection Act (WIPA).

 

The state’s WIPA legislation was signed into law in 2015. It permits the sale or lease of municipally owned water or wastewater systems that meet certain criteria. The New Jersey Department of Environmental Protection certified the city’s request to pursue the sale through the WIPA path in April 2019.

 

“This is a historic moment for New Jersey communities that simply do not have the resources or capabilities to adequately or efficiently maintain their own water and wastewater systems,” said New Jersey Assembly Majority Leader and WIPA sponsor Louis D. Greenwald.

 

“When my fellow legislators and I passed WIPA, our goal was to help struggling municipalities find alternatives to meet their needs by providing capital investment, expertise and financial assistance. It is incredibly gratifying to see Egg Harbor City be able to take advantage of this program to get the system upgrades they need in order to better service the community.”

 

Under the agreement, New Jersey American Water will invest $14 million in the first 10 years to make needed upgrades to the city’s water and wastewater systems, including $9 million in the first five years, while keeping rates stable for customers. Some of these projects include construction of an emergency interconnection with the New Jersey American Water regional system for resiliency, water and sewer main replacements, valve and hydrant replacements and wastewater pump station improvements.

 

“This agreement provides tremendous benefits for our residents. The sale of our city’s water and wastewater systems to New Jersey American Water will provide nearly $22 million to help the city pay off existing debt while leaving additional money to assist in other areas of the city’s budget. Additionally, the company is committed to investing $14 million into much-needed system improvements. All told, this means better infrastructure, stable water rates and millions in funds for the city, none of which would be possible without the sale of the systems,” said Egg Harbor City Mayor Lisa Jiampetti.

 

“We are ready to provide the residents of Egg Harbor City with reliable water and wastewater services, as we do for over 190 municipalities across the state,” said Mark McDonough, president of New Jersey American Water.

 

“Our plan includes rebuilding and modernizing the town’s water and wastewater infrastructure for continued quality and increased reliability while stabilizing rates and providing excellent customer service. Additionally, three of the city’s water and wastewater employees are joining our local operations team starting today.”

 

Customers will begin receiving information from New Jersey American Water within the next week to facilitate a smooth transition. Egg Harbor City residents will be able to take advantage of the company’s customer service benefits, including online account management and billing information, as well as its H20 Help to Others program for qualifying customers needing help paying their water and sewer bills. A dedicated webpage has also been created at www.newjerseyamwater.com/eggharborcity.

 

About New Jersey American Water

New Jersey American Water, a subsidiary of American Water (NYSE: AWK), is the largest investor-owned water utility in the state, providing high-quality and reliable water and/or wastewater services to approximately 2.8 million people. For more information, visit www.newjerseyamwater.com and follow New Jersey American Water on Twitter and Facebook.

 

About American Water

With a history dating back to 1886, American Water is the largest and most geographically diverse U.S. publicly traded water and wastewater utility company. The company employs approximately 6,500 dedicated professionals who provide regulated and regulated-like drinking water and wastewater services to an estimated 14 million people in 24 states. American Water provides safe, clean, affordable and reliable water services to our customers to help keep their lives flowing. For more information, visit amwater.com and diversityataw.com. Follow American Water on Twitter, Facebook and LinkedIn.

Contacts

Denise Venuti Free

Sr. Director, Communications & External Affairs

New Jersey American Water

856-955-4874

Denise.Free@amwater.com

Chelsea Kulp

Sr. Manager, Government & External Affairs

New Jersey American Water

856-745-1861

Chelsea.Kulp@amwater.com

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AJGA unveils renamed Liberty National ACE Grant following donation by Paul & Phyllis Fireman Charitable Foundation

12-year agreement announced ahead of inaugural Mizuho Americas Open hosted by Michelle Wie West at Liberty National Golf Club in Jersey City, NJ

Donation is latest milestone in Fireman family’s continued support for junior golf initiatives totaling more than $12 million

 

 

JERSEY CITY, N.J. — (BUSINESS WIRE) — The American Junior Golf Association today announced its Achieving Competitive Excellence (ACE) Grant has been formally rebranded as the Liberty National ACE Grant as part of a 12-year agreement between the organization and the prestigious Liberty National Golf Club in Jersey City, NJ.

 

The renaming follows a donation to the AJGA by the Paul & Phyllis Fireman Charitable Foundation, which has made a comprehensive effort to support transformational change in communities across the country in its mission to grow and make the sport more accessible, totaling more than $12 million in contributions to youth golf initiatives over many years.

The ACE Grant provides financial assistance to young men and women who aspire to earn a college golf scholarship through competitive golf. It was founded in 2003 by the AJGA to help provide opportunities to players who have the skills but not the means to play a national junior golf schedule. Since its inception, the program has reimbursed over $6 million to junior golfers who have gone on to earn over $15 million in college scholarships.

 

This rebrand will provide the AJGA the resources to create additional opportunities for junior golfers, growing the game and making it even more impactful for years to come.

 

The announcement comes the week of the inaugural Mizuho Americas Open, hosted by golf icon Michelle Wie West, adding the LPGA Tour to the list of world-class tournaments which have taken place at Liberty National. The club will concurrently host an AJGA Invitational which will provide the opportunity for 24 female junior golfers on the American Junior Golf Association Tour to compete for an individual title in front of the iconic Manhattan skyline adjacent to the course. Following the conclusion of the tournament, the inaugural Liberty National ACE Grant Cup fundraising event will take place at the course on Monday, June 5.

 

“We are extremely proud and honored to support future generations of golfers through the AJGA and this reimagined Liberty National ACE Grant,” said Paul Fireman, former CEO of Reebok and co-founder of Liberty National Golf Club.

 

“The impact of the ACE Grant cannot be understated, as some of golf’s biggest stars were able to achieve their dreams because of the program, and we look forward to its evolution and upward trajectory beginning with this week’s Mizuho Americas Open at Liberty National,” said Dan Fireman, co-Founder and President, Liberty National Golf Club.

 

“We are honored to partner with the Fireman family to create the Liberty National ACE Grant which provides financial aid to juniors who have the talent to compete at a national level, but not the financial resources,” AJGA Executive Director Stephen Hamblin said. “The Fireman family continues to be a leading benefactor in their support of golf at every level. We couldn’t be more thrilled to become part of the giving legacy of the Fireman family.”

 

“Like so many of the sport’s biggest stars, the ACE Grant has empowered me to pursue my dreams of becoming a professional player,” said Rose Zhang, the most decorated player in amateur women’s golf history who will be making her professional debut at the Mizuho Americas Open. “The AJGA and Paul & Phyllis Fireman Charitable Foundation have done so much to support generations of young golfers and I’m excited to see the impact the Liberty National ACE Grant will have in the future, as well as the inaugural Liberty National ACE Grant Cup event on June 5.”

 

The Paul & Phyllis Fireman Charitable Foundation brings entrepreneurial vision and resources to support transformational change in communities where the family lives and works. Among the number of key partnerships the organization has includes Liberty Science Center, SciTech Scity, One Family, Inc., Team Walker, The Hurley Family Foundation, Team Impact and Ron Burton Training Village.

 

About American Junior Golf Association

The American Junior Golf Association is a 501(c)(3) nonprofit organization dedicated to the overall growth and development of young men and women who aspire to earn college golf scholarships through competitive junior golf.

 

The AJGA provides valuable exposure for college golf scholarships, and has an annual junior membership (boys and girls, ages 12-19) of more than 7,900 members from 50 states and 51 foreign countries. Through initiatives like the Achieving Competitive Excellence (ACE) Grant, a financial assistance program, and Leadership Links, a service-oriented platform that teaches juniors charitable-giving skills, the AJGA fosters the growth of golf’s next generation.

 

TaylorMade and adidas are the AJGA’s National Sponsors, supporting the AJGA for more than 25 years. TaylorMade has served as the Official Ball of the AJGA since 2016. adidas has been the Official Apparel and Footwear of the AJGA since 2017. Rolex, in its fourth decade of AJGA sponsorship, became the inaugural AJGA Premier Partner in 2004.

 

AJGA alumni have risen to the top of amateur, collegiate and professional golf. Former AJGA juniors have compiled more than 1,000 victories on the PGA and LPGA Tours. AJGA alumni include Patrick Cantlay, Billy Horschel, Collin Morikawa, Scottie Scheffler, Jordan Spieth, Justin Thomas, Tiger Woods, Paula Creamer, Jessica Korda, Nelly Korda, Cristie Kerr, Stacy Lewis, Inbee Park and Lexi Thompson.

 

About Liberty National Golf Club

One of the world’s most iconic golf locales, Liberty National Golf Club is located along the Hudson River in Jersey City, NJ, with striking views of the Statue of Liberty, Ellis Island and Manhattan skyline. Liberty National fittingly opened on July 4, 2006, and is guided by the vision and leadership of former Reebok Founder, Chairman & CEO Paul Fireman and his son Dan Fireman, managing partner of Fireman Capital Partners. Designed by US Open Champion Tom Kite and esteemed golf course mastermind Bob Cupp, Liberty National is kept in tournament ready playing condition. Liberty National hosted The Presidents Cup in 2017 as well as multiple PGA TOUR FedExCup Playoff events.

 

For more information about Liberty National Golf Club, visit www.libertynationalgc.com

Contacts

Matthew_Jordan@dkcnews.com

Categories
Business Lifestyle Regulations & Security

AM Best assigns credit ratings to Somerset Reinsurance Company

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best has assigned a Financial Strength Rating (FSR) of A- (Excellent) and a Long-Term Issuer Credit Rating (Long-Term ICR) of “a-” (Excellent) to Somerset Reinsurance Company (SRC) (Orlando, FL). The outlook assigned to these Credit Ratings (ratings) is stable.

 

The ratings reflect SRC’s balance sheet strength, which AM Best assesses as strong, as well as its adequate operating performance, neutral business profile and appropriate enterprise risk management.

 

SRC is a startup reinsurance company; however, this subsidiary of Somerset Reinsurance Ltd (Somerset Re Ltd.) (Bermuda) is expected to rely on its parent for services as it expands its business profile. To manage its business growth and regulatory capital requirements, SRC is expected to receive capital support over its planned growth period as needed. That planned growth is moderately aggressive in the early years of expansion, where the company is expected to seek reinsurance opportunities for products on the low to moderate risk continuum. The management team has deep industry expertise and is expected to leverage its use of direct channels, brokers and strategic partners to garner its new business opportunities and its U.S. domicile should open up more domestic-sourced business in its target market.

 

The ratings are also afforded one notch of lift off of Somerset Re Ltd. The addition of SRC adds the Somerset Re Group brand flexibility to conduct business in the U.S. insurance market. AM Best also expects SRC’s operating capabilities to be fully integrated for non-underwriting activities and co-sourced with Somerset Re Ltd. for external functions as well.

 

The stable outlooks reflect AM Best’s expectation that SRC will build upon its projected planned growth of reinsurance solutions to its targeted market, while prudently managing its assets and liabilities, as well as its risk-based capital as business is added.

 

This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper use of Best’s Credit Ratings, Best’s Performance Assessments, Best’s Preliminary Credit Assessments and AM Best press releases, please view Guide to Proper Use of Best’s Ratings & Assessments.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

 

Copyright © 2023 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Wayne Kaminski
Senior Financial Analyst
+1 908 439 2200, ext. 5061
wayne.kaminski@ambest.com

Christopher Sharkey
Associate Director, Public Relations
+1 908 439 2200, ext. 5159
christopher.sharkey@ambest.com

Michael Porcelli
Senior Director
+1 908 439 2200, ext. 5548
michael.porcelli@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 439 2200, ext. 5098
al.slavin@ambest.com

Categories
Economics Healthcare Regulations & Security

Hagens Berman: Settlement worth in excess of $500 million reached in insulin pricing class-action lawsuit

Attorneys representing individuals living with diabetes announce class-action settlement bringing four years of insulin at a reduced price to those who pay out-of-pocket, among other benefits

 

NEWARK, N.J. — (BUSINESS WIRE) — $LLY #T1 — Attorneys at Hagens Berman and Carella Byrne Cecchi Olstein Brody & Agnello today announced a settlement with insulin-maker Eli Lilly worth more than $500 million, culminating a class-action lawsuit on behalf of insulin purchasers alleging systematic overpricing of insulin.

 

“This settlement will bring immense, forward-looking relief, especially for those who are underinsured or paying with co-insurance – those most in need of assistance paying for the medications they need to live,” said Steve Berman, managing partner and co-founder of Hagens Berman and court-appointed co-lead counsel representing insulin purchasers in the lawsuit. “Those paying out-of-pocket for insulin will receive four years of insulin at a reduced price under the settlement.”

 

“Our experts calculate this will save these consumers $500 million in payments for their insulin over the four-year period,” Berman added.

 

Hagens Berman and Carella Byrne filed the first-of-its-kind lawsuit in 2017 in the U.S. District Court for the District of New Jersey. The class action details several accounts from patients resorting to extreme measures to survive rising insulin prices, including starving themselves to control their blood sugar levels, intentionally slipping into diabetic ketoacidosis to receive insulin samples from hospital emergency rooms, under-dosing insulin, and taking expired insulin.

 

“We are incredibly pleased to culminate this important case and over six years of hard-fought litigation on behalf of millions of individuals who rely on insulin every day,” said James Cecchi of Carella Byne, co-lead counsel representing the class. “We believe this settlement will have a positive impact on the daily lives of millions of Americans living with diabetes.”

 

Benefits Under the Insulin Pricing Settlement

The settlement for insulin purchasers includes immense benefits for those most harmed by prohibitively high prices – cash payers, as well as the underinsured and those paying through co-insurance.

 

  • Forward-Looking Benefits: Eli Lilly will provide comprehensive affordability solutions to insulin purchasers through a four-year plan that stipulates no one will pay more than $35 out-of-pocket monthly for insulin.
  • Settlement Funds: For those not eligible for the first tier of relief, a $13.5 million settlement fund will be established for the class. If any amount remains unclaimed, remaining funds will be redistributed to claimants, so that funds are rightfully delivered to the class, for up to three times their claimed losses.According to settlement documents, “Eligible Settlement Claimants can receive cash payments based on their purchases of Lilly Insulin Products during the Settlement Class Period to be calculated based on a formula set by Plaintiffs and the approved plan of allocation.”

 

The process for submitting a settlement claim is designed to be as simple and convenient as possible, and the settlement claim form will be available on the settlement website and can be submitted electronically once the settlement has been approved by the court.

 

Immediately following preliminary approval of the settlement agreement, plaintiffs plan to serve subpoenas on the six largest pharmacy benefit manufacturers and seven largest national retail pharmacy chains in the United States to obtain transactional data. Settlement documents state that most settlement claims will be verifiable through this transactional data without requiring class members to submit documentation.

 

Class members will also be notified directly based on this available information, and additional targeted ads will be used to ensure all eligible are aware and notified of their benefits.

 

The class includes anyone in the U.S. who paid any portion of the purchase price for any Lilly Insulin Product, for themselves or on behalf of any family member or dependent, no matter how they paid for it, since Jan. 1, 2009, to the date of entry of the final approval order of the settlement. The settlement references a list price, Average Wholesale Price, and Wholesale Acquisition Cost or Price. Insulin purchased exclusively through Medicaid is excluded.

 

During the lawsuit’s six years, the parties saw multiple rounds of motion to dismiss briefing, three amended complaints and extensive discovery, including more than 60 depositions of plaintiffs and defendants’ employees.

 

Read more about the law firm’s class-action lawsuit against insulin makers.

 

About Hagens Berman

Hagens Berman is a global plaintiffs’ rights complex litigation law firm with a tenacious drive for achieving real results for those harmed by corporate negligence and fraud. Since its founding in 1993, the firm’s determination has earned it numerous national accolades, awards and titles of “Most Feared Plaintiff’s Firm,” MVPs and Trailblazers of class-action law. More about the law firm and its successes can be found at www.hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.

 

About Carella Byne

Carella Byrne is one of the leading law firms in the New Jersey – New York metropolitan area, serving a diverse clientele ranging from small businesses to Fortune 500 corporations. Carella Byrne has led – or been part of the leadership team – in many of the nation’s most complex and important consumer class actions affecting consumer rights. More about the law firm and its successes can be found at www.carellabyrne.com.

Contacts

Ash Klann

pr@hbsslaw.com
206-268-9363