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US FDA approves Bristol Myers Squibb and 2seventy bio’s Abecma for triple-class exposed relapsed or refractory multiple myeloma after two prior lines of therapy

Abecma tripled progression-free survival compared tostandard regimens in the Phase 3 KarMMa-3 trial, with a 51% reduction in risk of disease progression or death and a well-established safety profile

Expanded approval brings this personalized CAR T cell therapy to more patients with relapsed or refractory multiple myeloma earlier in their treatment journey as a one-time infusion offering meaningful treatment-free intervals when responding to therapy

Abecma is now approved in the U.S., Japan, Switzerland and the EU for earlier use for triple-class exposed relapsed and/or refractory multiple myeloma, underscoring BMS’ commitment to delivering Abecma globally, with consistently high manufacturing success rates and continuous increases in capacity

PRINCETON, N.J., & CAMBRIDGE, Mass. — (BUSINESS WIRE) — $BMY #CART — Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) have announced that on April 4, 2024, the U.S. Food and Drug Administration (FDA) approved Abecma^®(idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody, based on results from the KarMMa-3 trial.

This approval expands Abecma’s indication, making it available in earlier lines to patients who have relapsed or become refractory after exposure to these three main classes of treatment (triple-class exposed), after two prior lines of therapy. Abecma is administered as a one-time infusion, with a new recommended dose range of 300 to 510 x 10⁶ CAR-positive T cells. Please see the Important Safety Information section below, including Boxed WARNINGS for Abecma regarding Cytokine Release Syndrome, Neurologic Toxicities, Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome, Prolonged Cytopenia, and Secondary Hematological Malignancies.

“Abecma has demonstrated a progression-free survival benefit three times that of standard regimens in relapsed or refractory multiple myeloma, and we are now bringing the promise of cell therapy to patients earlier in their treatment journey,” said Bryan Campbell, senior vice president, Head of Commercial, Cell Therapy, Bristol Myers Squibb. “This approval underpins our commitment to addressing the unmet needs of more patients living with multiple myeloma by improving upon the current treatment paradigm, and we remain steadfast in our pursuit of innovation and advancing cell therapy research to deliver potentially transformative therapies.”

“We are extremely pleased that Abecma will be available to many more patients in the U.S.,” said Chip Baird, chief executive officer, 2seventy bio. “This approval represents another important milestone for patients, for Abecma, and for 2seventy bio as we remain committed to increasing treatment options and working to improve outcomes for patients living with multiple myeloma.”

Despite advances in treatment, multiple myeloma remains an incurable disease characterized by periods of remission and relapse. In early lines of treatment, regimens consisting of combinations of IMiDs, PIs, and anti-CD38 monoclonal antibodies are often used to help manage the disease. Unfortunately, as many patients go on to relapse and/or become refractory to these classes of therapy, more patients are becoming triple-class exposed earlier in their treatment journey. There are limited options for these patients, and triple-class exposed relapsed and/or refractory multiple myeloma is associated with poor outcomes and a median progression-free survival (PFS) of three to five months. In this patient population with high unmet need, Abecma has demonstrated clinically meaningful and statistically significant improvements in PFS (95% CI: 13.3 months vs. 4.4 months [HR: 0.49; p<0.0001]). In addition, Abecma exhibited a well-established safety profile with mostly low-grade cytokine release syndrome and neurotoxicity. No cases of Parkinsonism were reported in the study.

“The results of the KarMMa-3 study are remarkable, especially given the historic outcomes with standard regimens for these patients with relapsed or refractory disease,” said Al-Ola A. Abdallah, M.D., University of Kansas, Clinical Associate Professor, Clinical Director, Hematologic Malignancies and Cellular Therapeutics and chair of U.S. Myeloma Innovations Research Collaborative. “With this approval, these patients now have an opportunity to be treated at an earlier line of therapy with a potentially transformative therapy that offers significantly improved progression-free survival for this difficult-to-treat disease that has had no established treatment approach.”

To support this approval and future expansions, Bristol Myers Squibb has made continuous investments to increase manufacturing capacity and has shown a consistently high manufacturing success rate of 94% for Abecma in the commercial setting.

Abecma was recently approved in Japan, Switzerland and the European Union for adult patients with triple-class exposed relapsed and/or refractory multiple myeloma after two prior lines of therapy, making it the only CAR T cell therapy available globally for earlier lines of therapy for patients with triple-class exposed relapsed and/or refractory multiple myeloma. Abecma is also currently approved in Great Britain and Israel for adult patients with triple-class exposed relapsed and refractory multiple myeloma after three or more prior lines of therapy.

KarMMa-3 Pivotal Trial Results

The KarMMa-3 trial is a pivotal, Phase 3, open-label, global, randomized, controlled trial evaluating Abecma compared to standard regimens in patients with relapsed and refractory multiple myeloma who have received two to four prior lines of treatment, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and were refractory to the last treatment regimen, with 94% of patients with disease refractory to prior treatment with daratumumab. KarMMa-3 is the only Phase 3 trial to evaluate a CAR T cell therapy in a patient population consisting entirely of triple-class exposed relapsed and refractory multiple myeloma patients. The trial’s patient-centric design allowed for crossover from standard regimens to Abecma upon confirmed disease progression. At the time of the final progression-free survival (PFS) analysis, more than half (56%) of patients in the standard regimens arm crossed over to receive Abecma as a subsequent therapy.

In the study, 254 patients were randomized to receive Abecma and 132 were randomized to receive standard regimens that consisted of combinations that included daratumumab, pomalidomide, and dexamethasone (DPd), daratumumab, bortezomib, and dexamethasone (DVd), ixazomib, lenalidomide, and dexamethasone (IRd), carfilzomib and dexamethasone (Kd) or elotuzumab, pomalidomide and dexamethasone (EPd) chosen based on their most recent treatment regimen and investigator discretion. In the Abecma arm, pretreatment consisted of leukapheresis and optional bridging therapy. The choice to use bridging therapy was at the discretion of the investigator.

At an estimated median duration of follow-up of 15.9 months at the primary PFS analysis, Abecma more than tripled the primary endpoint of PFS compared with standard regimens, with a median PFS of 13.3 months (95% CI: 11.8-16.1) vs. 4.4 months (95% CI: 3.4-5.9), respectively (HR:0.49; 95% CI: 0.38-0.64; p<0.0001), representing a 51% reduction in the risk of disease progression or death with Abecma. Abecma also showed a significant improvement in overall response rates (p<0.0001) with the majority (71%) of patients treated with Abecma achieving a response, and 39% achieving a complete or stringent complete response. In comparison, less than half of patients (42%) who received standard regimens achieved a response, with 5% experiencing a complete response or stringent complete response. Responses were durable with Abecma, with a median duration of response of 14.8 months (95% CI: 12.0-18.6). In those patients who derived a complete response or better, median duration of response was 20 months (95% CI: 15.8-24.3).

Abecma has exhibited a well-established and consistent safety profile with mostly low-grade cytokine release syndrome (CRS) and neurotoxicity. Among patients who received Abecma in the KarMMa and KarMMa-3 studies (n=349), any grade CRS occurred in 89% of patients, including Grade >3 CRS in 7% of patients, and three cases (0.9%) of Grade 5 CRS reported. The median time to onset of CRS was 1 day (range: 1-27 days), and the median duration of CRS was 5 days (range: 1-63 days). Any grade neurotoxicity occurred in 40% of patients treated with Abecma in the KarMMa and KarMMa-3 studies, including Grade 3 neurotoxicity in 4% of patients, and two cases (0.6%) of Grade 4 neurotoxicity reported. At the safety update for KarMMa-3, one case of Grade 5 neurotoxicity was reported. The median time to onset of neurotoxicity was 2 days (range: 1-148 days), and the median duration of neurotoxicity was 8 days (range: 1-720 days).

About Abecma

Abecma is a CAR T cell therapy that recognizes and binds to BCMA on the surface of multiple myeloma cells leading to CAR T cell proliferation, cytokine secretion, and subsequent cytolytic killing of BCMA-expressing cells. Abecma is being jointly developed and commercialized in the U.S. as part of a Co-Development, Co-Promotion, and Profit Share Agreement between Bristol Myers Squibb and 2seventy bio.

This approval further underscores Bristol Myers Squibb’s deep knowledge and experience in cell therapy science and continued clinical advancements for multiple myeloma patients. The companies’ broad clinical development program for Abecma includes ongoing and planned clinical studies (KarMMa-2, KarMMa-3, KarMMa-9) for patients with multiple myeloma. For more information visit clinicaltrials.gov.

U.S. Important Safety Information

BOXED WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED CYTOPENIA and SECONDARY HEMATOLOGICAL MALIGNANCIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.
Neurologic Toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed.
Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or neurologic toxicities.
Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA.
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA
ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS.

Warnings and Precautions:

Early Death: In KarMMa-3, a randomized (2:1), controlled trial, a higher proportion of patients experienced death within 9 months after randomization in the ABECMA arm (45/254; 18%) compared to the standard regimens arm (15/132; 11%). Early deaths occurred in 8% (20/254) and 0% prior to ABECMA infusion and standard regimen administration, respectively, and 10% (25/254) and 11% (15/132) after ABECMA infusion and standard regimen administration, respectively. Out of the 20 deaths that occurred prior to ABECMA infusion, 15 occurred from disease progression, 3 occurred from adverse events and 2 occurred from unknown causes. Out of the 25 deaths that occurred after ABECMA infusion, 10 occurred from disease progression, 11 occurred from adverse events, and 4 occurred from unknown causes.

Cytokine Release Syndrome (CRS): CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA. Among patients receiving ABECMA for relapsed refractory multiple myeloma in the KarMMa and KarMMa-3 studies (N=349), CRS occurred in 89% (310/349), including ≥ Grade 3 CRS (Lee grading system) in 7% (23/349) of patients and Grade 5 CRS in 0.9% (3/349) of patients. The median time-to-onset of CRS, any grade, was 1 day (range: 1 to 27 days), and the median duration of CRS was 5 days (range: 1 to 63 days). In the pooled studies, the rate of ≥Grade 3 CRS was 10% (7/71) for patients treated in dose range of 460 to 510 x 10⁶ CAR-positive T cells and 5.4% (13/241) for patients treated in dose range of 300 to 460 x 10⁶ CAR-positive T cells.

The most common manifestations of CRS (greater than or equal to 10%) included pyrexia (87%), hypotension (30%), tachycardia (26%), chills (19%), hypoxia (16%). Grade 3 or higher events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, ARDS, atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, coagulopathy, renal failure, multiple organ dysfunction syndrome and HLH/MAS.

Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.

Of the 349 patients who received ABECMA in clinical trials, 226 (65%) patients received tocilizumab; 39% (135/349) received a single dose, while 26% (91/349) received more than 1 dose of tocilizumab. Overall, 24% (82/349) of patients received at least 1 dose of corticosteroids for treatment of CRS. Almost all patients who received corticosteroids for CRS also received tocilizumab. For patients treated in dose range of 460 to 510 x 10⁶ CAR-positive T cells, 76% (54/71) of patients received tocilizumab and 35% (25/71) received at least 1 dose of corticosteroids for treatment of CRS. For patients treated in dose range of 300 to 460 x 10⁶ CAR-positive T cells, 63% (152/241) of patients received tocilizumab and 20% (49/241) received at least 1 dose of corticosteroid for treatment of CRS.

Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs or symptoms of CRS and monitor patients for signs or symptoms of CRS for at least 4 weeks after ABECMA infusion. At the first sign of CRS, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated. Ensure that a minimum of 2 doses of tocilizumab are available prior to infusion of ABECMA. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.

Neurologic Toxicities: Neurologic toxicities, including immune-effector cell-associated neurotoxicity (ICANS), which may be severe or life- threatening, occurred concurrently with CRS, after CRS resolution, or in the absence of CRS following treatment with ABECMA.

In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, CAR T cell-associated neurotoxicity occurred in 40% (139/349), including Grade 3 in 4% (14/349) and Grade 4 in 0.6% (2/349) of patients. The median time to onset of neurotoxicity was 2 days (range: 1 to 148 days). The median duration of CAR T cell-associated neurotoxicity was 8 days (range: 1 to 720 days) in all patients including those with ongoing neurologic events at the time of death or data cut off. CAR T cell-associated neurotoxicity resolved in 123 of 139 (88%) patients and median time to resolution was 5 days (range: 1 to 245 days). One-hundred and thirty four out of 349 (38%) patients with neurotoxicity had CRS. The onset of neurotoxicity during CRS was observed in 93 patients, before the onset of CRS in 12 patients, and after the CRS event in 29 patients. The rate of Grade 3 or 4 CAR T cell-associated neurotoxicity was 5.6% (4/71) and 3.7% (9/241) for patients treated in dose range of 460 to 510 x 10⁶ CAR-positive T cells and 300 to 460 x 10⁶ CAR-positive T cells, respectively. The most frequent (greater than or equal to 5%) manifestations of CAR T cell-associated neurotoxicity include encephalopathy (21%), headache (15%), dizziness (8%), delirium (6%), and tremor (6%).

At the safety update for KarMMa-3 study, one patient developed fatal neurotoxicity 43 days after ABECMA. In KarMMa, one patient had ongoing Grade 2 neurotoxicity at the time of death. Two patients had ongoing Grade 1 tremor at the time of data cutoff.

Cerebral edema has been associated with ABECMA in a patient in another study in multiple myeloma. Grade 3 myelitis and Grade 3 parkinsonism have occurred after treatment with ABECMA in another study in multiple myeloma.

Monitor patients at least daily for 7 days following ABECMA infusion at the REMS-certified healthcare facility for signs or symptoms of neurologic toxicities and monitor patients for signs or symptoms of neurologic toxicities for at least 4 weeks after ABECMA infusion and treat promptly. Rule out other causes of neurologic symptoms. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. Counsel patients to seek immediate medical attention should signs or symptoms occur at any time.

Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, HLH/MAS occurred in 2.9% (10/349) of patients. All events of HLH/MAS had onset within 10 days of receiving ABECMA, with a median onset of 6.5 days (range: 4 to 10 days) and occurred in the setting of ongoing or worsening CRS. Five patients with HLH/MAS had overlapping neurotoxicity. The manifestations of HLH/MAS include hypotension, hypoxia, multiple organ dysfunction, renal dysfunction and cytopenia.

In KarMMa-3, one patient had Grade 5, two patients had Grade 4 and two patients had Grade 3 HLH/MAS. The patient with Grade 5 HLH/MAS also had Grade 5 candida sepsis and Grade 5 CRS. In another patient who died due to stroke, the Grade 4 HLH/MAS had resolved prior to death. Two cases of Grade 3 and one case of Grade 4 HLH/MAS had resolved.

In KarMMa, one patient treated in the 300 x 10⁶ CAR-positive T cells dose cohort developed fatal multi-organ HLH/MAS with CRS. In another patient with fatal bronchopulmonary aspergillosis, HLH/MAS was contributory to the fatal outcome. Three cases of Grade 2 HLH/MAS resolved.

HLH/MAS is a potentially life-threatening condition with a high mortality rate if not recognized early and treated. Treatment of HLH/MAS should be administered per institutional guidelines.

ABECMA REMS: Due to the risk of CRS and neurologic toxicities, ABECMA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the ABECMA REMS. Further information is available at www.AbecmaREMS.com or contact Bristol-Myers Squibb at 1-866-340-7332.

Hypersensitivity Reactions: Allergic reactions may occur with the infusion of ABECMA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) in ABECMA.

Infections: ABECMA should not be administered to patients with active infections or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after ABECMA infusion.

In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, infections (all grades) occurred in 61% of patients. Grade 3 or 4 infections occurred in 21% of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 7%, bacterial infections in 4.3%, and fungal infections in 1.4% of patients. Overall, 15 patients had Grade 5 infections (4.3%); 8 patients (2.3%) with infections of pathogen unspecified, 3 patients (0.9%) with fungal infections, 3 patients (0.9%) with viral infections, and 1 patient (0.3%) with bacterial infection.

Monitor patients for signs and symptoms of infection before and after ABECMA infusion and treat appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to standard institutional guidelines.

Febrile neutropenia was observed in 38% (133/349) of patients after ABECMA infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

Viral Reactivation: Cytomegalovirus (CMV) infection resulting in pneumonia and death has occurred following ABECMA administration. Monitor and treat for CMV reactivation in accordance with clinical guidelines. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against plasma cells. Perform screening for CMV, HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice.

Prolonged Cytopenias: In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, 40% of patients (139/349) experienced prolonged Grade 3 or 4 neutropenia and 42% (145/349) experienced prolonged Grade 3 or 4 thrombocytopenia that had not resolved by Month 1 following ABECMA infusion. In 89% (123/139) of patients who recovered from Grade 3 or 4 neutropenia after Month 1, the median time to recovery from ABECMA infusion was 1.9 months. In 76% (110/145) of patients who recovered from Grade 3 or 4 thrombocytopenia, the median time to recovery was 1.9 months. Five patients underwent stem cell therapy for hematopoietic reconstitution due to prolonged cytopenia. The rate of Grade 3 or 4 thrombocytopenia was 62% (44/71) and 56% (135/241) for patients treated in dose range of 460 to 510 x 10⁶ CAR-positive T cells and 300 to 460 x 10⁶ CAR-positive T cells, respectively.

Monitor blood counts prior to and after ABECMA infusion. Manage cytopenia with myeloid growth factor and blood product transfusion support according to local institutional guidelines.

Hypogammaglobulinemia: In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, hypogammaglobulinemia was reported as an adverse event in 13% (46/349) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 37% (130/349) of patients treated with ABECMA.

Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in 45% (158/349) of patients treated with ABECMA. Forty-one percent of patients received intravenous immunoglobulin (IVIG) post-ABECMA for serum IgG <400 mg/dL.

Monitor immunoglobulin levels after treatment with ABECMA and administer IVIG for IgG <400 mg/dl. Manage appropriately per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.

Use of Live Vaccines: The safety of immunization with live viral vaccines during or after ABECMA treatment has not been studied.

Contacts

Bristol Myers Squibb

Media Inquiries:
media@bms.com

Investors:
investor.relations@bms.com

2seventy bio

Investors:

Elizabeth Pingpank

860-463-0469

elizabeth.pingpank@2seventybio.com

Media:

Jenn Snyder

617-448-0281

jenn.snyder@2seventybio.com

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AM Best to participate and exhibit at RIMS’ 2024 RISKWORLD Conference

Post author By Michelle Dryden
Post date April 4, 2024
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OLDWICK, N.J. — (BUSINESS WIRE) — #insurance—AM Best will participate and exhibit at RISKWORLD—the RIMS 2024 Annual Conference and Exhibition—with sessions that will focus on reinsurance market conditions, cyber risks, artificial intelligence, stress testing and workers’ compensation. The risk management event takes place May 5-8 at the San Diego Convention Center, in San Diego, Calif.

On May 6, at 1:55 p.m. (PST), Dawn Walker, associate director, AM Best, will give a presentation titled, “Improving Conditions for Reinsurers and the Implications.” Walker also will give a presentation at 2 p.m. (PST) on May 7 titled, “Workers’ Compensation: Are Favorable Frequency Trends Sustainable?” Walker joined AM Best in 2022 and is part of its Strategy and Communications department; she has more than 15 years of insurance industry and risk management experience.

Sridhar Manyem, senior director, AM Best, will also deliver a pair of presentations at the conference. The first titled, “Cyber Insurance: Moderating Prices and Cautious Underwriting Even as Cyber Risks Resurface,” will be held at 9:55 a.m. (PST) on May 7. His second presentation will take place at 10:30 a.m. (PST) on May 8 and is titled, “AI in Insurance: Risks and Opportunities.” Manyem is the head of AM Best’s industry research team and oversees publishing of the company’s perspectives on topical issues.

Maura McGuigan, managing director, AM Best, will give a presentation titled, “The Critical Function of Effective Stress Testing,” at 3:30 p.m. (PST) on May 7. McGuigan is the head of credit rating criteria at AM Best, and responsible for the testing and review of its credit rating methodology criteria, models and tools, and economic and country risk.

In addition, AM Best will exhibit at booth No. 1636 at the conference. Visitors to the AM Best booth can learn about the rating agency, its role in the insurance industry and the resources it offers to insurance professionals, including Best’s Credit Ratings, insurance data and analysis resources and financial data products, and Best’s Performance Assessment for Delegated Underwriting Authority Enterprises (DUAEs).

A Best’s Performance Assessment is an industry-first tool providing an objective, independent opinion of a DUAE’s ability to perform services on behalf of carriers. DUAEs such as MGAs and MGUs, have become an important part of the insurance value chain, with premiums having doubled globally over the last decade.

In addition, AMBest TV will provide video coverage of the conference. For daily reports, panel discussions and executive interviews, visit https://www.ambest.tv/rims24 during the event or look for the RIMS-related playlist under the “Event Coverage 2024” tab at https://www.ambest.tv.

RIMS is an industry association of risk professionals, with its 80 chapters more than 200,000 risk practitioners and business leaders from over 75 countries. To view the official agenda and learn more about RISKWORLD, please visit the event overview.

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.

Contacts

Christopher Sharkey
Associate Director, Public Relations
+1 908 882 2310
christopher.sharkey@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 882 2318
al.slavin@ambest.com

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AM Best assigns credit ratings to Amherst Specialty Insurance Company

Post author By Michelle Dryden
Post date April 4, 2024
No Comments on AM Best assigns credit ratings to Amherst Specialty Insurance Company

OLDWICK, N.J. — (BUSINESS WIRE) — #insurance — AM Best has assigned a Financial Strength Rating of A- (Excellent) and a Long-Term Issuer Credit Rating of “a-” (Excellent) to Amherst Specialty Insurance Company (Amherst Specialty) (Addison, Texas). The outlook assigned to these Credit Ratings (ratings) is stable.

The ratings reflect Amherst Specialty’s balance sheet strength, which AM Best assesses as very strong, as well as its adequate operating performance, limited business profile and appropriate enterprise risk management (ERM).

Amherst Specialty was founded in December 2023 as a Texas-domiciled surplus insurance carrier. It is classified under the Financial Size Category of VIII. The company is a subsidiary of the ultimate parent, RTC Financial Group, LLC (RTC), and received a Certificate of Authority to transact insurance business in the state on Dec. 15, 2023. RTC is also the parent of Risk Theory Holdings (Risk Theory). Risk Theory began underwriting in 2013 and has grown to nearly 250 employees offering multiple programs focused on the specialty market. Amherst Specialty will become the primary excess and surplus insurance paper to write all new and renewal policies of Risk Theory programs.

The balance sheet strength assessment is driven by AM Best’s expectation that Amherst Specialty will maintain the strongest level of risk-adjusted capitalization, as measured by Best’s Capital Adequacy Ratio (BCAR), over the five-year start-up period. Additionally, the balance sheet further reflects Amherst Specialty’s conservative investment strategy and overall liquidity profile. Partially offsetting these factors is the company’s limited financial flexibility on a stand-alone basis. However, Amherst Specialty’s risk-adjusted capitalization has been supported by credit facilities obtained by its ultimate parent, highlighting the overall financial strength of the organization.

AM Best assesses Amherst Specialty’s operating performance as adequate based on the company’s primary business programs, which have been in place at Risk Theory, an affiliated managing general agency platform, and are expected to generate positive results over Amherst Specialty’s business plan. AM Best assesses the company’s business profile as limited given the start-up nature of the company and strong competition in the surplus lines industry. However, management has extensive experience operating the primary business programs, which offsets some of the execution risk involved. AM Best assesses Amherst Specialty’s ERM capabilities as appropriate, supported by an ERM framework with clear identification of risks, tolerances, and reporting requirements. Additionally, management will utilize strong reinsurance programs to preserve the capital base adequately.

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.

Contacts

Cristian Sieira
Financial Analyst
+1 908 882 2315
cristian.sieira@ambest.com

Rosemarie Mirabella
Director
+1 908 882 2125
rosemarie.mirabella@ambest.com

Christopher Sharkey

Associate Director, Public Relations

+1 908 882 2310
christopher.sharkey@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 882 2318
al.slavin@ambest.com

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AM Best to host webinar on the growing impact of secondary insurance perils

Post author By Michelle Dryden
Post date April 2, 2024
No Comments on AM Best to host webinar on the growing impact of secondary insurance perils

OLDWICK, N.J. — (BUSINESS WIRE) — AM Best will host a complimentary webinar, titled, “From Convective Storms to Flood: The Growing Impact of Secondary Insurance Perils,” on April 23, 2024, at 2 p.m. EDT.

While natural catastrophes such as hurricanes and earthquakes grab all the headlines, secondary perils including flood, convective storms and wildfires lurk in the shadows, posing significant threats to businesses and individuals alike.

In a one-hour webinar sponsored by Munich Re U.S., an expert panel will unravel the complexities of secondary perils (also known as non-peak perils), exploring their nature, impact, and mitigation strategies. Register now.

Key points to be covered:

Defining secondary insurance perils: Discover what constitutes secondary perils and how they differ from primary risks.
Identifying secondary perils: Explore a range of secondary perils commonly encountered.
Impact on insurance coverage: Understand how secondary perils can impact insurance coverage and claims processes.
Mitigation strategies: Learn proactive approaches to mitigate the risks posed by secondary perils and safeguard your assets.
Lessons learned: Gain valuable insights from real-world examples illustrating the consequences of overlooking secondary perils.

Panelists:

Tehya Duckworth, senior vice president, /property underwriting manager, Munich Re U.S.;
Joe Bonanno, senior vice president/excess and surplus, property underwriting manager – Northeast and Midwest, Munich Re Specialty Insurance; and
Sean Kevelighan, chief executive officer, Insurance Information Institute.

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

Contacts

Lee McDonald
Senior Vice President, Publication & News Services
+1 908 882 2102
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AM Best affirms Credit Ratings of NiSource Insurance Corporation, Inc.

Post author By Michelle Dryden
Post date March 31, 2024
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OLDWICK, N.J. — (BUSINESS WIRE) — AM Best has affirmed the Financial Strength Rating of A (Excellent) and the Long-Term Issuer Credit Rating of “a” (Excellent) of NiSource Insurance Corporation, Inc. (NICI) (Salt Lake City, UT). The outlook of these Credit Ratings (ratings) is stable.

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

NICI maintains the strongest level of risk-adjusted capitalization, as measured by Best’s Capital Adequacy Ratio (BCAR). A conservative reserving philosophy is evident through the company’s reported favorable reserves development in each of the past 10 years. The balance sheet assessment also considers the company’s ample liquidity measures, and maintaining low underwriting leverage, in addition to having no debt.

The strong operating performance assessment is supported by favorable combined and operating ratios that outperforms AM Best’s commercial casualty composite. NICI’s strong operational results reflect loss ratios trending favorably, and a low underwriting expense structure that stems from the inherent benefits of being a single-parent captive for NiSource Inc. (NiSource). Through its niche captive orientation, risk management expertise and conservative underwriting criteria, NICI has generated favorable results at levels generally equal to or better than its industry peers, organically growing its surplus by three-fold in the past 10 years.

NICI is a single-parent captive insurer wholly owned by NiSource, providing all-risk property, workers’ compensation, excess general and automobile liability, medical stop-loss, long-term disability, group life insurance and punitive damage coverage for the parent and its affiliates. AM Best has taken a balanced view of NICI’s overall business profile, which albeit limited in scope, maintains inherent advantages as a single-parent captive with immediate access to business and resources along with the broader financial wherewithal of its ultimate parent. NICI plays a critical role in NiSource’s overall ERM framework, supporting its objectives through insuring key risks of the parent, ultimately supporting NiSource’s financing needs.

The stable outlooks for NICI reflect the company’s sustained profitability, adherence to maintaining capital at the appropriate risk-adjusted levels and its measured and prudent approach in insuring its parent’s exposure. Positive rating action may occur due to a sustained trend of improvement in the company’s overall balance sheet strength that supports a higher assessment level. Conversely, negative rating actions could occur from a decline in the company’s operating performance, an increase in underwriting leverage or an outsized loss event that triggers a sudden decline in risk-adjust capitalization. In addition, negative rating action could occur due to financial issues resulting in rating pressure on the ultimate parent that could impact NiSource’s ratings.

AM Best remains the leading rating agency of alternative risk transfer entities, with more than 200 such vehicles rated in the United States and throughout the world. For current Best’s Credit Ratings and independent data on the captive and alternative risk transfer insurance market, please visit www.ambest.com/captive.

Contacts

Chul Lee
Senior Financial Analyst
+1 908 882 2005
chul.lee@ambest.com

Christopher Sharkey
Associate Director, Public Relations
+1 908 882 2310
christopher.sharkey@ambest.com

Fred Eslami
Associate Director
+1 908 882 1759
fred.eslami@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 882 2318

al.slavin@ambest.com

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AM Best affirms Credit Ratings of Coalition Insurance Company

Post author By Michelle Dryden
Post date March 31, 2024
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OLDWICK, N.J. — (BUSINESS WIRE) — #insurance — AM Best has affirmed the Financial Strength Rating of A- (Excellent) and the Long-Term Issuer Credit Rating of “a-” (Excellent) of Coalition Insurance Company (CIC) (New York, NY). The outlook of these Credit Ratings (ratings) is stable.

The ratings reflect CIC’s balance sheet strength, which AM Best assesses as very strong, as well as its adequate operating performance, limited business profile and appropriate enterprise risk management (ERM).

CIC’s balance sheet strength is supported by the strongest level of risk-adjusted capitalization, as measured by Best’s Capital Adequacy Ratio (BCAR), surplus growth, conservative loss reserves and low underwriting leverage produced in the first nine months of operation and its five-year pro forma.

CIC’s adequate operating performance is largely based on CIC scaling its book of business through its affiliate, Coalition Insurance Solutions, Inc. (CIS) and the ability to execute on the company’s strategic business plan, including, pro forma operating results over the next five years. Cyber insurance is one of the fastest growing lines of business, and between business and management projects the business to expand rapidly with sustained premium growth for the company over the next five-year period.

CIC’s business profile assessment of limited reflects its position as a new company writing cyber insurance. The company is licensed and operating in all 50 states and the District of Columbia and is currently providing coverage for cyber liability and technology errors & omissions. CIS has relationships with a broad base of insurance brokers, which has access to the company’s proprietary system to quote, rate and bind policies. CIC’s management team includes diverse backgrounds with extensive experience in insurance, engineering & product, cybersecurity and software development. CIC partners with its brokers and insureds to educate and remediate vulnerabilities identified in their systems.

CIC’s ERM is considered appropriate for its risk profile, overall underwriting, risk management, remediation response and circular and continuous underwriting. CIC understands the risk, reviews vulnerabilities and manages risks within its risk appetite and risk tolerances. CIC is dependent on its parent for most of its risk management resources and decision-making as it works to develop its own framework over time.

Contacts

Kourtnie Beckwith
Senior Financial Analyst
+1 908 882 1649
kourtnie.beckwith@ambest.com

Christopher Sharkey
Associate Director, Public Relations
+1 908 882 2310
christopher.sharkey@ambest.com

Fred Eslami
Associate Director
+1 908 882 1759
fred.eslami@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 882 2318
al.slavin@ambest.com

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Lesbian law firm owner ensures ‘reproductive freedom’ for all-female staff

Post author By Editor
Post date March 30, 2024
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— Owner contributes $430K for IVF treatments amidst court controversy

WEST HARTFORD, Conn. –– According to the Centers for Disease Control and Prevention (CDC), one in five couples in the U.S. struggles with some form of infertility.

— Photo: Attorney Brooke Goff, founder and owner of Goff Law Group in Connecticut, is helping her employees start a family by offering a bonus health benefit by pledging $43oK for coverage of infertility treatments. From left: Attorney Brooke Goff, her wife Angeline Ioannou, and their children: 11-year-old Grayson and 5-month-old Victoria, who were conceived via IVF and IUI, are a refreshing example of the modern family. — Credit: Goff Law Group

The biggest roadblock for most of them to start on the path of parenthood is the high cost of fertility treatments. To ease that financial burden and help those seeking to start a family achieve success, Brooke Goff, founder and president of Goff Law Group in Connecticut, has pledged $430K to offset the massive expense of the fertility process.

The enhanced benefit is a hot topic given the recent Alabama Supreme Court ruling on “fetal personhoods” and the uncertain future of the procedure.

“I knew at a young age that I wanted to have a family, yet I also knew that as a gay woman, I would need some assistance from science,” said Attorney Brooke Goff, owner of Goff Law Group, a personal injury law firm in Connecticut.

“In vitro fertilization fulfilled my desire to carry a child and experience the beautiful journey of pregnancy, something every woman should be entitled to, if she so desires, regardless of her sexuality.”

That’s why in 2022, Attorney Goff began researching viable solutions and was told that only larger global companies, not small businesses, would even consider fertility health coverage.

“I was taken aback that more small businesses do not invest in their employees across the board- with family planning and creation,” she adds.

“Employees are the lifeblood of any company and if a business owner wants continued success and profitability, he or she should be investing in their employees’ family – both present and future.”

Undeterred, Attorney Goff eventually partnered with Carrot, a third-party health benefit company, and absorbed the entire near half-a-million-dollar cost of implementing the program. Specifics of Goff Law Group’s comprehensive IVF program include:

mental health counseling as related to the infertility process
individual infertility journey design and implementation
access to over 800 clinics throughout the United States
discount coverage for infertility care including but not limited to IVF, IUI, surrogacy, adoption, preservation of embryos, genetic testing, and medications related to infertility
coverage for after birth lactation services, overnight doulas, and women’s behavioral health as related to postpartum

“It has always been my belief that every woman deserves the right to have a family and unfortunately, it is easier for some than others,” said Attorney Goff.

“When infertility comes into the mix, it adds unplanned costs to the family and a lot of anxiety and uncertainty. Hence, it is important to offer a benefit with full-spectrum physical and mental health care.”

Attorney Goff explains that although some health insurance plans cover run-of-the-mill infertility treatments, they may have certain requirements as a result of strict state mandates such as 12 months of unsuccessful attempts to become pregnant and other limitations based on the age of the woman.

She further notes that health insurance typically does not cover surrogacy, adoption, egg harvesting, donor eggs, or donor sperm. “I wanted to provide something better to my employees alternative to the minimal health insurance coverages currently on the market,” Attorney Goff adds.

Regarding the recent Alabama legislation that allows couples undergoing IVF to sue a fertility clinic for lost or damaged embryos under the state’s wrongful death law, Attorney Goff explains that the ruling takes away pregnancy options and freedoms from potential parents who desperately desire a biological family. She believes that couples who are having infertility issues will now be deterred in using IVF intervention due to the risk of criminalization if their embryos are not used or disposed of properly.

“The ruling is making a lot of assumptions as to what might happen in that an embryo is a promise of pregnancy not an actual pregnancy,” said Attorney Goff. “The ruling should be appealed and overturned so as not to limit a family’s ability to conceive and reproduce. This is not a woman issue — it’s a family issue.”

When asked if she has any concerns about her female employees becoming mothers and its residual impact on her firm’s bottom line due to them being out of the office for sick days, Attorney Goff notes that she prefers hiring working mothers because they do the same amount of work in eight hours that others often do in twelve since they have learned excellent time management and organization skills, patience, and compassion while raising a family — all essential traits in operating a legal business. Goff Law Group is currently the largest women-owned and operated personal injury law firm in the state and is predominately made up of a female staff.

“Everyone has their own parenting journey and I want to open all of the doors for my employees to select one that universally meets their medical history, sexual preference and financial situation,” concludes Attorney Goff. “Doing my part to give my employees hope and direction in creating a family is something I take very seriously — and so should everyone else.”

About Attorney Brooke Goff

Attorney Brooke Goff is the founder and president of Goff Law Group, the largest woman-owned and operated personal injury law firm in Connecticut, comprised of 12 experienced female attorneys with various litigation backgrounds and skillsets. The firm’s foundation is built on its aggressive, no-nonsense tactics, free consultations, direct attorney access and a 99% resolution result rate. Arguably the most public openly female gay lawyer in the region, Attorney Goff has been named one of the Top 10 Most Influential People in Legal Services for 2024 and has earned the Super Lawyer Rising Star Award for the past seven years. Attorney Goff is a sought-after speaker at numerous elementary, middle, and high schools, as well as colleges and universities about the importance of education and pursuing one’s dreams. She is an inspiration for girls and a strong advocate for women to live their authentic lives. Visit www.gofflawgroup.net for more information.

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‘Red vs. Blue’ final season releases as feature-length movie after Rooster Teeth shutdown by Warner Bros. Discovery

Post author By Editor
Post date March 29, 2024
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The battling factions of “Red vs. Blue” are getting one last adventure — in which they must team up to fight a common enemy — that will soon available on a screen near you, even though Rooster Teeth is closing its doors.

“Red vs. Blue: Restoration,” the 19th and final season of Rooster Teeth’s groundbreaking comedy sci-fi series, will be available starting May 7 in its entirety as an 87-minute feature-length film by Warner Bros. Discovery Home Entertainment.

The movie will be available on May 7 to purchase for $14.99 from Amazon Prime Video, Apple TV, Google Play, Vudu and other electronic sell-through outlets, and available May 21 to rent digitally for $4.99.

WBDHE also released a teaser trailer of the forthcoming movie (watch below). Per the official synopsis: “When the universe’s greatest villain returns in a terrifying new form, old adversaries, the Reds and Blues of Blood Gulch, will have to set aside their differences to save the galaxy one last time.”

The move comes in the wake of the decision by Warner Bros. Discovery — Rooster Teeth’s most recent corporate parent — earlier this month to shut down the money-losing entertainment division, throwing RT’s employees and contributors out of work. WBD is looking to sell the catalog and intellectual property rights to “Red vs. Blue,” along with a handful of other popular Rooster Teeth productions like “RWBY” and “Gen:Lock.”

For the final chapter of “Red vs. Blue,” series co-creator and RT co-founder Burnie Burns returned after a four-year hiatus to pen the script, reuniting with director Matt Hullum to bring closure to the narrative that has spanned more than two decades.

“I’m thrilled to return for ‘Red vs. Blue: Restoration’ and to conclude this incredible 21-year journey with our longtime fans,” Burns said in a statement. Hullum added: “Red vs. Blue has been a cornerstone of Rooster Teeth’s legacy, and we’re immensely proud of what we’ve accomplished together.”

“Red vs. Blue” is set in the universe of Xbox’s Halo game franchise, in which two teams, Red and Blue, engage in a perpetual conflict in a desolate canyon. Led by the bumbling Sarge and the cynical Church, the soldiers navigate absurd situations and misunderstandings with a mix of humor and sci-fi elements.

The show debuted in 2003, before YouTube launched. “Red vs. Blue,” in addition to establishing a popular digitally distributed entertainment franchise before the streaming revolution, was innovative in using machinima to create animations using video game engines. “Red vs. Blue: Restoration” was produced with Epic Games’ Unreal Engine.

— Variety

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AM Best assigns Credit Ratings to Emerald Bay Specialty Insurance Company

Post author By Michelle Dryden
Post date March 29, 2024
No Comments on AM Best assigns Credit Ratings to Emerald Bay Specialty Insurance Company

OLDWICK, N.J.–(BUSINESS WIRE)–#insurance—AM Best has assigned a Financial Strength Rating of A- (Excellent) and a Long-Term Issuer Credit Rating of “a-” (Excellent) to Emerald Bay Specialty Insurance Company (EBSIC) (Tucson, AZ). The outlook assigned to these Credit Ratings (ratings) is stable.

The ratings reflect EBSIC’s balance sheet strength, which AM Best assesses as very strong, as well as its adequate operating performance, limited business profile and appropriate enterprise risk management (ERM).

EBSIC is an Arizona-domiciled hybrid fronting company operating in the surplus lines market throughout the United States. As such, the company’s strategy involves maintaining a significant risk position in the programs it writes. EBSIC’s ultimate parent is Emerald Bay Risk Solutions, LLC (Emerald Bay) and Emerald Bay will be owned primarily by Bain Capital Insurance (BCI).

EBSIC’s balance sheet strength assessment is driven by the company’s risk-adjusted capitalization, as measured by Best’s Capital Adequacy Ratio (BCAR), which is expected to be in the strongest range throughout the company’s initial five-year business plan. The balance sheet strength is underpinned further by a conservative investment profile and the backing of BCI. BCI has committed significant equity into the company to support the start-up operations and has assisted EBSIC’s ultimate parent, Emerald Bay, in sourcing a term loan credit facility as part of the initial funding of EBSIC.

AM Best assesses EBSIC’s operating performance as adequate as the company’s underwriting guidelines are anticipated to produce profitable operating results over the intermediate term. Additionally, the company’s initial portfolio will include third-party programs where management has developed deep expertise through previous collaborations. AM Best assesses EBSIC’s business profile as limited given the start-up nature of the company’s operations. However, AM Best notes that management has a strong track record of operating in the insurance and fronting markets, which reduces execution risk. AM Best assesses EBSIC’s ERM framework as appropriate with clear strategic objectives well aligned with the company’s risk appetite. Moreover, there is a robust risk monitoring and governance structure in place to ensure accountability and oversight throughout the organization.

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.

Contacts

Cristian Sieira
Financial Analyst
+1 908 882 2315
cristian.sieira@ambest.com

Christopher Sharkey
Associate Director, Public Relations
+1 908 882 2310
christopher.sharkey@ambest.com

Greg Williams
Senior Director
+1 908 882 2434
greg.williams@ambest.com

Al Slavin
Senior Public Relations Specialist
+1 908 882 2318
al.slavin@ambest.com

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