Author: Michelle Dryden

AMSTERDAM — (BUSINESS WIRE) — #insurance — Rising interest rates, widening spreads and volatile equity markets have contributed to significant unrealised losses in European insurers’ balance sheets, according to analysts at insurance credit rating agency AM Best.

In a new Best’s Commentary, “Adverse Economic Environment Driving Significant Unrealised Losses in Insurers’ Investment Portfolios,” analysts monitoring European insurers’ mid-year 2022 results state that it is becoming increasingly apparent that large unrealised losses have been incurred on their investment portfolios. They attribute these losses to the combined effects of rising interest rates, widening credit spreads and volatile market performance, which have led to a decrease in the market values of investments.

 

Going forward, AM Best will continue to monitor the impact of the current economic environment on insurers and provide further commentary as deemed appropriate.

 

To access a complimentary copy of this commentary, please visit http://www3.ambest.com/bestweek/purchase.asp?record_code=322703.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specialising 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 © 2022 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Pierre Tournier
Associate Director, Analytics
+31 20 308 5423
pierre.tournier@ambest.com

Tim Prince
Director, Analytics
+44 20 7397 0320
timothy.prince@ambest.com

Richard Banks
Director, Industry Research – EMEA
+44 20 7397 0322
richard.banks@ambest.com

Edem Kuenyehia
Director, Market Development & Communications – EMEA & AP
+44 20 7397 0280
edem.kuenyehia@ambest.com

• Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy

 

TOKYO & BASKING RIDGE, N.J. — (BUSINESS WIRE) — Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) ENHERTU^® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

 

The approval was granted under the FDA’s Real-Time Oncology Review (RTOR) program following the recent Priority Review and Breakthrough Therapy Designation of ENHERTU in the U.S. in this setting. The expanded approval for ENHERTU in the U.S. enables its use across a wide spectrum of HER2 expression, including patients with HER2 low disease.

 

The approval by the U.S. Food and Drug Administration (FDA) was based on positive results from the DESTINY-Breast04 phase 3 trial of previously treated patients with HER2 low metastatic breast cancer. In the trial, ENHERTU demonstrated a 49% reduction in the risk of disease progression or death versus physician’s choice of chemotherapy in patients with HER2 low metastatic breast cancer with hormone receptor (HR) positive disease (hazard ratio [HR] = 0.51; 95% confidence interval [CI]: 0.40-0.64; p<0.0001). A median progression-free survival (PFS) of 10.1 months (95% CI: 9.5-11.5) was seen in patients treated with ENHERTU compared to 5.4 months (95% CI: 4.4-7.1) with chemotherapy, as assessed by blinded independent central review (BICR). Results also showed a 36% reduction in the risk of death with ENHERTU compared to chemotherapy in patients with HR positive disease (HR=0.64; 95% CI: 0.48-0.86; p=0.0028) with a median overall survival (OS) of 23.9 months with ENHERTU (95% CI: 20.8-24.8) versus 17.5 months with chemotherapy (95% CI: 15.2-22.4).

 

In the overall trial population of patients with HER2 low metastatic breast cancer with HR positive or HR negative disease and across levels of HER2 expression (both IHC 1+ and IHC 2+/ISH-) a similar 50% reduction in the risk of disease progression or death was observed between ENHERTU and chemotherapy (HR=0.50; 95% CI: 0.40-0.63; p<0.0001), with a median PFS of 9.9 months (95% CI: 9.0-11.3) for ENHERTU versus 5.1 months (95% CI: 4.2-6.8) in those treated with chemotherapy, as assessed by BICR. A median OS of 23.4 months (95% CI: 20.0-24.8) was seen in patients treated with ENHERTU versus 16.8 months (95% CI: 14.5-20.0) in those treated with chemotherapy (HR=0.64; 95% CI: 0.49-0.84; p=0.001).

 

“Approximately half of all patients with breast cancer have tumors that are HER2 low, which have previously been classified as HER2 negative and have not had effective treatment options with HER2 targeted medicines,” said Shanu Modi, MD, medical oncologist, Memorial Sloan Kettering Cancer Center and principal investigator for the trial. “Based on the promising results of the DESTINY-Breast04 trial, clinicians are starting to differentiate levels of HER2 expression and redefine how metastatic breast cancer is classified with a distinct HER2 low patient population that may be eligible for trastuzumab deruxtecan.”

 

Additional results from the DESTINY-Breast04 trial showed that in patients with HR positive disease, the confirmed objective response rate (ORR) more than tripled in the ENHERTU arm versus the chemotherapy arm (52.9% [n=175; 95% CI: 47.3-58.4] versus 16.6% [n=27; 95% CI: 11.2-23.2], respectively). Twelve (3.6%) complete responses (CR) and 164 (49.5%) partial responses (PR) were observed in patients with HR positive disease treated with ENHERTU compared to one (0.6%) CR and 26 (16%) PRs in those treated with chemotherapy. Median duration of response was 10.7 months for ENHERTU versus 6.8 months for chemotherapy.

 

In the overall trial population, confirmed ORR more than tripled in the ENHERTU arm (52.3% [n=195; 95% CI: 47.1-57.4]) versus those treated with chemotherapy (16.3% [n=30; 95% CI: 11.3-22.5]). Thirteen (3.5%) CRs and 183 (49.1%) PRs were observed in patients treated with ENHERTU compared to two (1.1%) CRs and 28 (15.2%) PRs in those treated with chemotherapy. Median duration of response was 10.7 months for ENHERTU versus 6.8 months for chemotherapy.

 

ENHERTU is approved with Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and Embryo-Fetal toxicity. The safety of ENHERTU was evaluated in 371 patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who received at least one dose of ENHERTU 5.4 mg/kg in the DESTINY-Breast04 trial. The most common adverse reactions (frequency ≥20%), including laboratory abnormalities, were nausea, decreased white blood cell count, decreased hemoglobin, decreased neutrophil count, decreased lymphocyte count, fatigue, decreased platelet count, alopecia, vomiting, increased aspartate aminotransferase, increased alanine aminotransferase, constipation, increased blood alkaline phosphatase, decreased appetite, musculoskeletal pain, diarrhea and hypokalemia. Overall, 12% of patients had confirmed ILD or pneumonitis related to treatment as determined by an independent adjudication committee. The majority of ILD events were primarily low grade, with five grade 3 (1.3%) and no grade 4 events reported. Fatalities due to adverse reactions occurred in 4% of patients including ILD/pneumonitis (three patients); sepsis (two patients); and ischemic colitis, disseminated intravascular coagulation, dyspnea, febrile neutropenia, general physical health deterioration, pleural effusion and respiratory failure.

 

“Today’s FDA approval marks a monumental moment in breast cancer treatment as ENHERTU is the first-ever HER2 directed medicine to be approved for the treatment of patients with HER2 low metastatic breast cancer,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. “With the groundbreaking survival benefit seen in the DESTINY-Breast04 trial, this milestone confirms the importance of targeting lower levels of HER2 expression in the treatment of metastatic breast cancer and we are thrilled that we can now offer ENHERTU to even more patients.”

 

“The rapid approval of ENHERTU in HER2 low metastatic breast cancer by the FDA underscores the urgency to bring this transformational medicine to patients as quickly as possible,” said Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca. “Patients with HER2 low tumors, who are identified through existing HER2 testing methods, will now have the opportunity to be treated based upon their HER2 status.”

 

Based on the DESTINY-Breast04 data, fam-trastuzumab deruxtecan-nxki (ENHERTU) was added to the NCCN Clinical Practical Guidelines in Oncology (NCCN Guidelines^®) in June 2022 as the Category 1 preferred regimen for patients with tumors that are HER2 IHC 1+ or 2+ and ISH negative who have received at least one prior line of chemotherapy for metastatic disease and, if tumor is HR+, are refractory to endocrine therapy.¹

 

As part of Project Orbis, ENHERTU also is under regulatory review for the same indication by the Australian Therapeutic Goods Administration, Brazilian Health Regulatory Agency (ANVISA), Health Canada and Switzerland’s Swissmedic.

 

Daiichi Sankyo and AstraZeneca are committed to ensuring that patients in the U.S. who are prescribed ENHERTU can access the medication and receive necessary financial support. Provider and patient support, reimbursement and distribution for ENHERTU in the U.S. will be accessible by visiting www.ENHERTU4U.com or calling 1-833-ENHERTU (1-833-364-3788).

 

Please visit www.ENHERTU.com for full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

 

Financial Considerations

Following approval in the U.S., an amount of $200 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment for an indication for ENHERTU in patients with HER2 low metastatic breast cancer who were previously treated with one or two lines of chemotherapy.

 

Sales of ENHERTU in the U.S. are recognized by Daiichi Sankyo. For further details on the financial arrangements, please consult the collaboration agreement from March 2019.

 

About DESTINY-Breast04

DESTINY-Breast04 is a global, randomized, open-label, pivotal phase 3 trial evaluating the efficacy and safety of ENHERTU (5.4 mg/kg) versus physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, paclitaxel or nab-paclitaxel) in patients with HR positive or HR negative, HER2 low unresectable and/or metastatic breast cancer previously treated with one or two prior lines of chemotherapy. Patients were randomized 2:1 to receive either ENHERTU or chemotherapy.

 

The primary endpoint of DESTINY-Breast04 is PFS in patients with HR positive disease based on BICR. Key secondary endpoints include PFS based on BICR in all randomized patients (HR positive and HR negative disease), OS in patients with HR positive disease and OS in all randomized patients (HR positive and HR negative disease). Other secondary endpoints include PFS based on investigator assessment, objective response rate based on BICR and on investigator assessment, duration of response based on BICR and safety. DESTINY-Breast04 enrolled 557 patients at multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

 

About Breast Cancer and HER2 Expression

Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide and in the U.S.^2,3 More than two million patients with breast cancer were diagnosed in 2020 with nearly 685,000 deaths globally.² In the U.S., more than 290,000 patients are expected to be diagnosed in 2022, with more than 43,000 deaths.⁴ Approximately one in five patients with breast cancer are considered HER2 positive.⁵

 

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including breast, gastric, lung and colorectal cancers, and is one of many biomarkers expressed in breast cancer tumors.⁶

 

HER2 expression is currently determined by an IHC test which estimates the amount of HER2 protein on a cancer cell, and/or an ISH test, which counts the copies of the HER2 gene in cancer cells.^6,7 HER2 tests provide IHC and ISH scores across the full HER2 spectrum and are routinely used to determine appropriate treatment options for patients with metastatic breast cancer. HER2 positive cancers are currently defined as HER2 expression measured as IHC 3+ or IHC 2+/ISH+, and HER2 negative cancers are defined as HER2 expression measured as IHC 0, IHC 1+ or IHC 2+/ISH-.⁶ However, approximately half of all breast cancers are HER2 low, defined as a HER2 score of IHC1+ or IHC 2+/ISH-.^8,9,10 HER2 low occurs in both HR positive and HR negative disease.¹¹

 

Previously, patients with HR positive metastatic breast cancer and HER2 low disease had limited effective treatment options following progression on endocrine (hormone) therapy.^9,12 Additionally, few targeted options were available for those with HR negative disease.¹³ Now with the approval of ENHERTU, patients with HER2 low tumors may be eligible for HER2 directed therapy.

 

About ENHERTU

ENHERTU^® (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, ENHERTU is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. ENHERTU consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

 

ENHERTU (5.4 mg/kg) is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received a (or one or more) prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy, based on the results from the DESTINY-Breast03 trial. ENHERTU also is approved in several countries for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens based on the results from the DESTINY-Breast01 trial.

 

ENHERTU (5.4 mg/kg) is approved in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 low (immunohistochemistry (IHC) 1+ or IHC 2+/in-situ hybridization (ISH)-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy, based on the results of the DESTINY-Breast04 trial.

 

ENHERTU (6.4 mg/kg) is approved in several countries for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.

 

ENHERTU is approved in the U.S. with Boxed WARNINGS for Interstitial Lung Disease and Embryo-Fetal Toxicity. For more information, please see the accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

 

About the ENHERTU Clinical Development Program

A comprehensive global development program is underway evaluating the efficacy and safety of ENHERTU monotherapy across multiple HER2 targetable cancers including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, also are underway.

 

Regulatory applications for ENHERTU in breast, gastric and non-small cell lung cancers are currently under review in several countries based on the DESTINY-Breast01, DESTINY-Breast03, DESTINY-Breast04, DESTINY-Gastric01, DESTINY-Gastric02 and DESTINY-Lung01 trials, respectively.

 

About the Daiichi Sankyo and AstraZeneca Collaboration

Daiichi Sankyo Company, Limited (referred to as Daiichi Sankyo) and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU in March 2019 and datopotamab deruxtecan (Dato-DXd) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and datopotamab deruxtecan.

 

Important Safety Information

Indications

ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

• Unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either:
  • In the metastatic setting, or
  • In the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy

• Unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy

• Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen

 

WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY

Interstitial lung disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms. Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception.

 

Contraindications

None.

Warnings and Precautions

Interstitial Lung Disease / Pneumonitis

Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in ≤28 days from date of onset, maintain dose. If resolved in >28 days from date of onset, reduce dose one level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate systemic corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks.

 

Metastatic Breast Cancer and HER2-Mutant Solid Tumors (5.4 mg/kg)

In patients with metastatic breast cancer and other solid tumors treated with ENHERTU 5.4 mg/kg, ILD occurred in 12% of patients. Fatal outcomes due to ILD and/or pneumonitis occurred in 1.0% of patients treated with ENHERTU. Median time to first onset was 5 months (range: 0.9 to 23).

 

Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)

In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients. Median time to first onset was 2.8 months (range: 1.2 to 21.0).

 

Neutropenia

Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU. Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] <1.0 to 0.5 x 10⁹/L), interrupt ENHERTU until resolved to Grade 2 or less, then maintain dose. For Grade 4 neutropenia (ANC <0.5 x 10⁹/L), interrupt ENHERTU until resolved to Grade 2 or less, then reduce dose by one level. For febrile neutropenia (ANC <1.0 x 10⁹/L and temperature >38.3º C or a sustained temperature of ≥38º C for more than 1 hour), interrupt ENHERTU until resolved, then reduce dose by one level.

 

Metastatic Breast Cancer and HER2-Mutant Solid Tumors (5.4 mg/kg)

In patients with metastatic breast cancer and other solid tumors treated with ENHERTU 5.4 mg/kg, a decrease in neutrophil count was reported in 65% of patients. Sixteen percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 22 days (range: 2 to 664). Febrile neutropenia was reported in 1.1% of patients.

 

Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)

In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, a decrease in neutrophil count was reported in 72% of patients. Fifty-one percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 16 days (range: 4 to 187). Febrile neutropenia was reported in 4.8% of patients.

 

Left Ventricular Dysfunction

Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including ENHERTU. Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage LVEF decrease through treatment interruption. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is <10%, continue treatment with ENHERTU and repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and absolute decrease from baseline is 10-20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF has not recovered to within 10% from baseline, permanently discontinue ENHERTU. If LVEF recovers to within 10% from baseline, resume treatment with ENHERTU at the same dose. When LVEF is <40% or absolute decrease from baseline is >20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of <40% or absolute decrease from baseline of >20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment.

 

Metastatic Breast Cancer and HER2-Mutant Solid Tumors (5.4 mg/kg)

In patients with metastatic breast cancer and other solid tumors treated with ENHERTU 5.4 mg/kg, LVEF decrease was reported in 3.6% of patients, of which 0.4% were Grade 3.

 

Locally Advanced or Metastatic Gastric Cancer (6.4 mg/kg)

In patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, no clinical adverse events of heart failure were reported; however, on echocardiography, 8% were found to have asymptomatic Grade 2 decrease in LVEF.

 

Embryo-Fetal Toxicity

ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of ENHERTU. Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of ENHERTU. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months after the last dose of ENHERTU.

 

Additional Dose Modifications

Thrombocytopenia

For Grade 3 thrombocytopenia (platelets <50 to 25 x 10⁹/L) interrupt ENHERTU until resolved to Grade 1 or less, then maintain dose. For Grade 4 thrombocytopenia (platelets <25 x 10⁹/L) interrupt ENHERTU until resolved to Grade 1 or less, then reduce dose by one level.

 

Adverse Reactions

Metastatic Breast Cancer and HER2-Mutant Solid Tumors (5.4 mg/kg)

The pooled safety population reflects exposure to ENHERTU 5.4 mg/kg intravenously every 3 weeks in 984 patients in Study DS8201-A-J101 (NCT02564900), DESTINY-Breast01, DESTINY-Breast03, DESTINY-Breast04, and NCT04644237. Among these patients 65% were exposed for >6 months and 39% were exposed for >1 year. In this pooled safety population, the most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (76%), decreased white blood cell count (71%), decreased hemoglobin (66%), decreased neutrophil count (65%), decreased lymphocyte count (55%), fatigue (54%), decreased platelet count (47%), increased aspartate aminotransferase (48%), vomiting (44%), increased alanine aminotransferase (42%), alopecia (39%), increased blood alkaline phosphatase (39%), constipation (34%), musculoskeletal pain (32%), decreased appetite (32%), hypokalemia (28%), diarrhea (28%), and respiratory infection (24%).

Contacts

U.S.:
Don Murphy

Daiichi Sankyo, Inc.

domurphy@dsi.com
+1 917 817 2649 (mobile)

Japan:

Masashi Kawase

Daiichi Sankyo Co., Ltd.

kawase.masashi.a2@daiichisankyo.co.jp
+81 3 6225 1126 (office)

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The Carnegie family of institutions salutes five individuals who are forces for positive change:

Manu Chandaria, Lyda Hill, Dolly Parton, Lynn Schusterman, and Stacy Schusterman

With a special presentation of the Carnegie Catalyst Award to:

World Central Kitchen

 

NEW YORK — (BUSINESS WIRE) — #CMoP–The international family of Carnegie institutions named five distinguished philanthropists as recipients of the 2022 Carnegie Medal of Philanthropy today in recognition of their extraordinary contributions toward addressing the challenges facing our world. The goal of the medal is to inspire a culture of giving by honoring innovative philanthropists and by elevating the importance and relevance of philanthropic contributions to our society.

The Carnegie institutions also announced a special Carnegie Catalyst Award, created to celebrate the transformative power of human kindness. It honors a nonprofit organization that has been exceptionally effective in catalyzing people’s desire to help one another during times of crisis.

 

At a time when global giving stands at some $485 billion annually, the 2022 honorees have been leading the field of philanthropy by example. The medal seeks to honor their vision and generosity and to encourage others to join them in making the world a better place for all. This year’s honorees have had a significant and lasting impact on many of today’s most pressing issues through their support of medical research in cancer and pediatric care; the advancement of women in STEM fields; the reduction of racial, gender, and economic inequities; the furtherance of early childhood literacy and K–12 education; and the improvement of the quality of life in African countries.

 

Among the most prestigious honors in the field, the Carnegie Medal of Philanthropy has been awarded for more than two decades, since its establishment in 2001, by the family of Carnegie institutions — more than 20 organizations in the United States and Europe founded by the philanthropist Andrew Carnegie. To date, more than 65 philanthropists have been honored with the medal.

 

The 2022 Carnegie Medal of Philanthropy Honorees:

Manu Chandaria (Kenya) The Chandaria Foundation
For advancing opportunity and addressing critical needs in Africa through investments in health-care infrastructure, secondary and higher education, poverty relief, and environmentalism.

 

Lyda Hill (U.S.) Lyda Hill Philanthropies
For investments in the life sciences, including cancer and mental health research and treatment; conservation; supporting women in STEM fields and inspiring girls to be interested in STEM careers; and empowering community-based nonprofits to maximize impact.

 

Dolly Parton (U.S.) The Dollywood Foundation
For alleviating poverty, strengthening early childhood education through the distribution of free books worldwide, increasing college access, and advancing medical research, including on pediatric infectious diseases and the development of a COVID-19 vaccine.

 

Lynn Schusterman and Stacy Schusterman (U.S.) Charles and Lynn Schusterman Family Philanthropies
For advancing racial, gender, and economic equity through investments in areas such as K–12 education, democracy and voting rights, gender and reproductive equity, and criminal justice; and supporting Jewish communities and a secure, inclusive Israel.

 

The 2022 Carnegie Catalyst Award Honoree:

World Central Kitchen (U.S.)

Founded by chef José Andrés in 2010, the organization is recognized for mobilizing volunteers to provide meals in communities affected by humanitarian and natural disasters. World Central Kitchen has served more than 150 million meals in countries around the world, and the organization continues to build one of the largest food relief organizations in Ukraine during the current conflict.

 

The new Carnegie Catalyst Award was created in honor of the cofounder of the Carnegie Medal of Philanthropy, Vartan Gregorian, who died in April 2021. He served for 24 years as the beloved president of Carnegie Corporation of New York, leading the Carnegie Medal of Philanthropy in honoring 10 classes of medalists. Gregorian himself was a catalyst who believed in the transformational power of human kindness — and who led by example.

 

“The 2022 Carnegie Medal of Philanthropy honorees have a wide range of important priorities, yet they share a common goal through their determination to have impact and create positive change,” said Governor Thomas H. Kean, chairman of Carnegie Corporation of New York’s board of trustees and former governor of New Jersey. “This year, the Carnegie Catalyst Award will expand on their example by celebrating the ability of an organization to inspire and mobilize others. The recipient, World Central Kitchen, is an outstanding model of how humankind can respond in times of dire need by activating the inherent goodness in others — an ideal that was embodied through the life and work of Vartan Gregorian.”

 

“Today we acknowledge the significant contributions of five philanthropists who are energizing the field of philanthropy through their forward-looking goals for the world, including in Africa through the work of Manu Chandaria,” said Sarah Davidson, chief executive of Carnegie UK and a member of the medal selection committee. “This is also an opportunity to celebrate the giving by women who continue to strengthen the sector through their fresh perspectives and long-term commitments. Lyda Hill, Dolly Parton, Lynn Schusterman, and Stacy Schusterman are leading the way in motivating the next generation of women philanthropists.”

 

“Andrew Carnegie sought to do what he called ‘real and permanent good in this world’ through his giving, and today, we acknowledge the 2022 Carnegie Medal of Philanthropy honorees for upholding this ideal through their philanthropy,” said William Thomson CBE, honorary chair of the medal selection committee and Carnegie’s great-grandson. “For most of Carnegie’s life, he was completely devoted to his ‘duty of administering surplus wealth for the good of the people’ while inspiring others to do the same. This virtuous cycle is the true meaning of the Carnegie Medal of Philanthropy.”

 

Every two years, medalists are nominated by the family of Carnegie institutions — and a selection committee representing seven of those institutions makes the final selection. The recipients of the 2022 Carnegie Medal of Philanthropy will be honored on Thursday, October 13, 2022, during a private ceremony in New York City. The event will be hosted by Carnegie Corporation of New York, and Judy Woodruff, anchor and managing editor of the PBS NewsHour, will serve as master of ceremonies.

 

The Medal Selection Committee:

• William Thomson CBE, Honorary Chair, Former Chair and Honorary President, Carnegie UK, and great-grandson of Andrew Carnegie
• Mariano-Florentino Cuéllar, President, Carnegie Endowment for International Peace
• Sarah Davidson, Chief Executive, Carnegie UK
• Eric D. Isaacs, President, Carnegie Institution for Science
• Farnam Jahanian, President, Carnegie Mellon University
• Thomas H. Kean, Chairman of the Board of Trustees, Carnegie Corporation of New York
• Andy Walker, Secretary and Treasurer, Carnegie Trust for the Universities of Scotland

 

Past recipients of the Carnegie Medal of Philanthropy:

• 2019: Anne G. Earhart, Mellody Hobson and George Lucas, Marie-Josée and Henry R. Kravis, Morton L. Mandel, Robert F. Smith, Leonard Tow, and Sir Ian Wood KT GBE
• 2017: Mei Hing Chak, Marguerite and H. F. “Gerry” Lenfest, Azim Premji, Julian Robertson, Jeff Skoll, Kristine McDivitt Tompkins, Shelby White, and Sir James D. Wolfensohn KBE AO
• 2015: Paul G. Allen, Charles F. Feeney, Hanne and Jeremy Grantham, The Haas Family, Jon M. Huntsman, Sr., Joan and Irwin Jacobs, Richard L. Menschel and Robert B. Menschel, and David M. Rubenstein
• 2013: Her Highness Sheikha Moza bint Nasser, Sir Tom Hunter, Marilyn H. and James H. Simons, The Wolfson Family, and Dmitry Borisovich Zimin
• 2011: The Crown Family, The Danforth Family, Fiona and Stanley Druckenmiller, Fred Kavli, The Lauder Family, Li Ka-shing, Pamela and Pierre Omidyar, The Pew Family, and The Pritzker Family
• 2009: Michael R. Bloomberg, The Koç Family, Betty and Gordon Moore, and Joan and Sanford Weill
• 2007: Eli Broad, The Heinz Family, The Mellon Family, and The Tata Family
• 2005: His Highness the Aga Khan, The Cadbury Family, Sir Tom Farmer, Agnes Gund, The Hewlett Family, and The Packard Family
• 2003: Kazuo Inamori and The Sainsbury Family
• 2001: Leonore and Walter H. Annenberg, Brooke Astor, Irene Diamond, The Gates Family, The Rockefeller Family, George Soros, and Ted Turner

 

To learn more about the Carnegie Medal of Philanthropy (including current and past honorees), the family of Carnegie institutions, and Andrew Carnegie, please visit MedalofPhilanthropy.org and follow new developments on social media @carnegiemedal (Twitter), @MedalofPhilanthropy (Facebook), and #CMoP.

 

About Carnegie Medal of Philanthropy

The Carnegie Medal of Philanthropy, bestowed by the Carnegie family of institutions since 2001, seeks to inspire a culture of giving by recognizing outstanding philanthropists who reflect the values of Andrew Carnegie and his philosophy of giving — that the surplus wealth of the few should be administered “for the good of the people.”

Contacts

Celeste Ford

Director of External Relations

Carnegie Corporation of New York

cfc@carnegie.org

• NUBEQA now has indications in both metastatic hormone-sensitive prostate cancer (mHSPC) and non-metastatic castration-resistant prostate cancer (nmCRPC)¹
• Today’s approval under the FDA’s Real-Time Oncology Review (RTOR) pilot program was based on the pivotal Phase III ARASENS trial, which showed a significant overall survival (OS) benefit with NUBEQA plus androgen deprivation therapy (ADT) and docetaxel compared to ADT and docetaxel¹
• NUBEQA is the only androgen receptor inhibitor (ARi) approved in combination with docetaxel for mHSPC, demonstrating a 32% reduction in the risk of death compared to docetaxel alone and with a proven tolerability profile¹

 

WHIPPANY, N.J. — (BUSINESS WIRE) — Bayer announced today the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the oral androgen receptor inhibitor (ARi) NUBEQA^® (darolutamide) with docetaxel for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).¹

The approval is based on results of the Phase III ARASENS trial that demonstrated a statistically significant increase in overall survival (OS), the trial’s primary endpoint, with a reduction in the risk of death by 32% for those treated with NUBEQA plus androgen deprivation therapy (ADT) and docetaxel compared to ADT and docetaxel (HR=0.68, 95% CI 0.57-0.80; P<0.0001). Treatment with NUBEQA plus ADT and docetaxel also resulted in a statistically significant delay in time to pain progression (HR=0.79, 95% CI 0.66-0.95; P=0.006).¹

 

The ARASENS results were presented earlier this year at the 2022 ASCO GU Cancers Symposium and simultaneously published in The New England Journal of Medicine.² NUBEQA is also indicated for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). NUBEQA is being investigated in further studies across various stages of prostate cancer.

 

Incidence of adverse reactions was similar between both study arms. Adverse reactions reported for NUBEQA with docetaxel above 10% with a ≥2% increase over placebo with docetaxel were constipation (23% versus 20%), decreased appetite (19% versus 13%), rash (19% versus 15%), hemorrhage (18% versus 13%), increased weight (18% versus 16%), and hypertension (14% versus 9%). Serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel and in 42% of patients receiving placebo with docetaxel. Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel and in 4% of patients receiving placebo with docetaxel.¹

 

“NUBEQA plus ADT and docetaxel has shown significant benefit in overall survival and a favorable safety profile for patients with metastatic hormone-sensitive prostate cancer,” said Matthew Smith, M.D., Ph.D., Director of the Genitourinary Malignancies Program, Massachusetts General Hospital Cancer Center. “This new indication for NUBEQA is particularly meaningful, as it highlights its proven tolerability and provides a new option for patients.”

 

Prostate cancer remains the second leading cancer-related cause of death among men in the U.S., with up to one-third of patients developing metastatic disease.^3,4 The incidence of mHSPC has increased by 72% in the U.S. over the past 10 years.⁵ Approximately one in three patients who are diagnosed with mHSPC survive the disease five years or longer, with most eventually experiencing progression to castration-resistant prostate cancer (CRPC).^4,5

 

“With compelling data from the Phase III ARASENS and ARAMIS trials, NUBEQA has demonstrated significant efficacy in mHSPC and nmCRPC,” said Christine Roth, Member of the Executive Committee of Bayer’s Pharmaceutical Division and Head of the Oncology SBU at Bayer. “The expansion of NUBEQA’s indication to reach a broader population in the U.S. reaffirms Bayer’s commitment to provide proven and tolerable treatment options to eligible patients across different stages of prostate cancer.”

 

“Prostate cancer is the most common cancer among men in the U.S., with chances of survival decreasing dramatically for those diagnosed with mHSPC compared to localized prostate cancer,” said Charles J. Ryan, M.D., President and Chief Executive Officer, Prostate Cancer Foundation (PCF). “This approval adds a different treatment approach for mHSPC patients and their physicians to choose from.”

 

The application received Priority Review designation granted by the FDA and was submitted under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to provide a more efficient review process of applications to ensure that safe and effective cancer treatments are available to patients as early as possible. Ongoing reviews are also being conducted under the FDA Oncology Center of Excellence’s (OCE) Project Orbis initiative, which provides a framework for concurrent submission and review of cancer treatments among participating international health authorities.

 

About the ARASENS Trial⁶

The ARASENS trial (NCT02799602) is the only randomized, Phase III, multi-center, double-blind, placebo-controlled trial prospectively designed to compare the use of a second-generation androgen receptor inhibitor (ARi) (NUBEQA) plus androgen deprivation therapy (ADT) and the chemotherapy docetaxel to ADT and docetaxel (a guideline recommended treatment) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). A total of 1,306 newly diagnosed patients were randomized in a 1:1 ratio to receive 600 mg of NUBEQA twice a day or matching placebo, plus ADT and 75 mg/m² of docetaxel, for 6 cycles. Treatment with NUBEQA plus ADT or ADT continued until symptomatic progressive disease, change of antineoplastic therapy, unacceptable toxicity, death, or withdrawal.

 

The primary endpoint of this trial was overall survival (OS). Time to pain progression was a secondary endpoint.

 

Permanent discontinuation of NUBEQA due to adverse reactions occurred in 14% of patients treated in the NUBEQA with docetaxel arm. The most common adverse reactions which resulted in permanent discontinuation of NUBEQA were rash (1.1%), musculoskeletal pain (0.9%), and increased aspartate aminotransferase (AST) (0.9%). Dosage interruptions of NUBEQA due to adverse reactions occurred in 23% of patients treated in the NUBEQA with docetaxel arm. The most common adverse reactions (>2%) requiring dosage interruption of NUBEQA were increased alanine aminotransferase (ALT) (3.2%), increased AST (3.1%) and febrile neutropenia (2.1%). Dosage reductions of NUBEQA due to adverse reactions occurred in 9% of patients treated in the NUBEQA with docetaxel arm. The most common adverse reactions (>2%) requiring dosage reduction of NUBEQA were increased ALT (2.8%) and increased AST (2.5%). The most common adverse reactions (≥10% with a ≥2% increase over placebo with docetaxel) were constipation, decreased appetite, rash, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (≥30%) were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia.

 

About NUBEQA^® (darolutamide)¹

NUBEQA is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.¹

 

On July 30, 2019, the FDA approved NUBEQA^® (darolutamide) based on the ARAMIS trial, a randomized, double-blind, placebo-controlled, multi-center Phase III study, which evaluated the safety and efficacy of oral NUBEQA in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were receiving a concomitant gonadotropin-releasing hormone (GnRH) analog or had a bilateral orchiectomy. In the clinical study, 1,509 patients were randomized in a 2:1 ratio to receive 600 mg of NUBEQA orally twice daily in combination with androgen deprivation therapy (ADT), or ADT alone. The primary efficacy endpoint was metastasis-free survival (MFS). NUBEQA is also being investigated in further studies across various stages of prostate cancer, including in the ARANOTE Phase III trial evaluating NUBEQA plus ADT versus ADT alone for metastatic hormone-sensitive prostate cancer (mHSPC), as well as in the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) led international Phase III co-operative group DASL-HiCaP (ANZUP1801) trial evaluating NUBEQA as an adjuvant treatment for localized prostate cancer with very high risk of recurrence. Information about these trials can be found at www.clinicaltrials.gov.

 

Developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company, NUBEQA is indicated for the treatment of adults with nmCRPC and mHSPC.¹ The approvals of NUBEQA for nmCRPC in the U.S., European Union (EU), and other global markets have been based on the pivotal Phase III ARAMIS trial data evaluating the efficacy and safety of NUBEQA plus ADT compared to ADT alone.¹ Filings in other regions are underway or planned.

 

INDICATIONS

NUBEQA^® (darolutamide) is an androgen receptor inhibitor indicated for the treatment of adult patients with:

• Non-metastatic castration-resistant prostate cancer (nmCRPC)
• Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel

 

IMPORTANT SAFETY INFORMATION

Warnings & Precautions

Ischemic Heart Disease – In a study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA versus 2.5% receiving placebo, including Grade 3-4 events in 1.7% vs. 0.4%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA vs. 0.2% receiving placebo. In a study of patients with mHSPC (ARASENS), ischemic heart disease occurred in 2.9% of patients receiving NUBEQA with docetaxel vs. 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% vs. 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel vs. 0.1% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease.

 

Seizure – In ARAMIS, Grade 1-2 seizure occurred in 0.2% of patients receiving NUBEQA vs. 0.2% receiving placebo. Seizure occurred 261 and 456 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.6% of patients receiving NUBEQA with docetaxel, including one Grade 3 event, vs. 0.2% receiving placebo with docetaxel. Seizure occurred 38 to 340 days after initiation of NUBEQA. It is unknown whether anti-epileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment.

 

Embryo-Fetal Toxicity – Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

 

Adverse Reactions

In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA vs. 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA vs. 3.2% of patients receiving placebo. Fatal adverse reactions in patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common adverse reactions (>2% with a ≥2% increase over placebo), including laboratory test abnormalities, were increased AST, decreased neutrophil count, fatigue, increased bilirubin, pain in extremity, and rash. Clinically relevant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease and heart failure.

 

In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel vs. 42% of patients receiving placebo with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), decreased neutrophil count (2.8%), musculoskeletal pain (2.6%), and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel vs. 4% of patients receiving placebo with docetaxel. Fatal adverse reactions in patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common adverse reactions (≥10% with a ≥2% increase over placebo with docetaxel) were constipation, decreased appetite, rash, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (≥30%) were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia. Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures, ischemic heart disease, seizures, and drug-induced liver injury.

 

Drug Interactions

Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use.

 

Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed.

 

Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate.

 

NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates.

 

Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.

 

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

About Metastatic Hormone-Sensitive Prostate Cancer

Prostate cancer is the second most commonly diagnosed malignancy in men worldwide. In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, and about 375,000 died from the disease worldwide.⁷

 

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy.^8,9 Upon relapse, when the disease will metastasize or spread, the disease is hormone-sensitive and androgen deprivation therapy (ADT) is the cornerstone of treatment. Current treatment options for men with metastatic hormone-sensitive prostate cancer (mHSPC) include hormone therapy, such as ADT, androgen receptor pathway inhibitors plus ADT or a combination of docetaxel chemotherapy and ADT. Despite these treatments, a large proportion of men with mHSPC will eventually experience progression to metastatic castration-resistant prostate cancer (mCRPC), a condition with high morbidity and limited survival.^3,5

 

About Oncology at Bayer

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The oncology franchise at Bayer includes six marketed products and several other assets in various stages of clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cancer is treated.

 

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability, and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to www.bayer.com.

^© 2022 Bayer

 

BAYER, the Bayer Cross and NUBEQA are registered trademarks of Bayer.

 

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

 

References

1. NUBEQA^® (darolutamide) tablets [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, August 2022.
2. Smith M., Hussain M., Saad F. et al. Darolutamide and Survival in Metastatic, Hormone-Sensitive Prostate Cancer. N Engl J Med. 2022.
3. Siegel DA, O’Neil ME, Richards TB, Dowling NF, Weir HK. Prostate Cancer Incidence and Survival, by Stage and Race/Ethnicity — United States, 2001–2017. MMWR Morb Mortal Wkly Rep 2020;69:1473–1480. http://dx.doi.org/10.15585/mmwr.mm6941a1.
4. Ng, K., Smith, S., Shamash, J. Metastatic Hormone-Sensitive Prostate Cancer (mHSPC): Advances and Treatment Strategies in the First-Line Setting. Oncol Ther 8, 209–230 (2020). https://doi.org/10.1007/s40487-020-00119-z.
5. Hahn AW, Higano CS, Taplin ME, Ryan CJ, Agarwal N. Metastatic Castration-Sensitive Prostate Cancer: Optimizing Patient Selection and Treatment. Am Soc Clin Oncol Educ Book. 2018 May 23;38:363-371. https://doi.org/10.1200/edbk_200967.
6. ClinicalTrials.gov NCT02799602. ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (ARASENS). https://clinicaltrials.gov/ct2/show/NCT02799602.
7. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA: A Cancer Journal for Clinicians. https://acsjournals.onlinelibrary.wiley.com/doi/epdf/10.3322/caac.21660. Accessed August 2022.
8. Cancer.Net 2020: Prostate Cancer Statistics. https://www.cancer.net/cancer-types/prostate-cancer/statistics. Accessed August 2022.
9. American Cancer Society: Hormone Therapy for Prostate Cancer. https://www.cancer.org/cancer/prostate-cancer/treating/hormone-therapy.html. Accessed August 2022.

 

PP-NUB-US-1690-1 08/22

Contacts

Media Contact:
Sue Ann Pentecost, Tel +1 910.221.6446

Email: sueann.pentecost@bayer.com

The milestone exhibits OwnBackup’s continued commitment to being the leader in data protection for public sector organizations

 

ENGLEWOOD CLIFFS, N.J. — (BUSINESS WIRE) — OwnBackup, the leading SaaS data protection platform, today announced that they have achieved the Federal Risk and Authorization Management Program’s (FedRAMP) “In Process” designation under the sponsorship of the US Department of Agriculture, and are working toward full authorization by the end of the calendar year.

 

FedRAMP is a government-wide program that provides a standardized approach to security assessment, authorization and monitoring for cloud products and services. Its certification process includes an in-depth examination of a solution’s data security and data governance capabilities, as well as the security practices of its cloud services.

 

Public sector organizations provide essential services that require available and accurate data at all times. However, the value of this data also makes these organizations more susceptible to cyberattacks and other nefarious threats. Globally, government organizations are now some of the most popular targets for bad actors, second only to those in the education and research sectors. Once full certification is achieved, OwnBackup’s FedRAMP solutions will enable U.S. government agencies to avoid disruption to critical services, ensure a continuity of operations, and maintain trust with their customers.

 

“Our FedRAMP In Process designation is significant and demonstrates OwnBackup’s commitment to cloud security and data protection,” said Sam Gutmann, CEO at OwnBackup. “With this designation, we can better help public sector organizations accelerate their digital transformation goals, especially when it comes to large development projects where data is at higher risk of corruption or loss.”

 

OwnBackup’s data protection platform, which is used by over 4,700 customers across three different SaaS platforms, was designed from the beginning with security in mind. Their solutions are architected with a variety of security controls across multiple tiers to address a range of security risks. Most recently, OwnBackup achieved ISO 27001 certification, which requires adherence to a documented management system that demonstrates a commitment to protect information assets’ confidentiality, availability, and integrity from threats and vulnerabilities.

 

To learn more, visit ownbackup.com.

 

About OwnBackup

OwnBackup is a leading SaaS data protection platform for some of the largest SaaS ecosystems in the world, including Salesforce, Microsoft Dynamics 365, and ServiceNow. Through capabilities like data security, backup and recovery, archiving, and sandbox seeding, OwnBackup empowers thousands of organizations worldwide to manage and protect the mission-critical data that drives their business.

 

Co-founded by seasoned data recovery, data protection, and information security experts, OwnBackup is a trusted independent software vendor (ISV) partner on the Salesforce AppExchange, AWS Marketplace, and Microsoft Marketplace. Headquartered in Englewood Cliffs, New Jersey, with research and development (R&D), support, and other functions in Israel, EMEA and APAC, OwnBackup is the partner of choice for some of the world’s largest users of SaaS applications.

 

Contacts

Media:
Colin Snell
press@ownbackup.com