In the Phase 3 CheckMate -76K trial, Opdivo demonstrated a statistically significant improvement in recurrence-free survival compared to placebo1
CheckMate -76K marks the fifth Opdivo-based indication in earlier stages of cancer, in the U.S.1
Opdivo is the only PD-1 inhibitor that is indicated as an adjuvant treatment for eligible patients with stages IIB, IIC, III, as well as stage IV completely resected melanoma1
PRINCETON, NJ, USA I October 13, 2023 IBristol Myers Squibb (NYSE: BMY) today announced that Opdivo® (nivolumab) was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma, expanding upon the existing adjuvant indication for Opdivo and further reinforcing the company’s legacy of providing treatment options for melanoma patients.1 The approval is based on the Phase 3 CheckMate -76K trial, which compared Opdivo (n=526) to placebo (n=264).1,2
In the trial, Opdivo reduced the risk of recurrence, new primary melanoma, or death in patients with completely resected stage IIB or IIC melanoma by 58% compared to placebo (Hazard Ratio [HR] 0.42; 95% Confidence Interval [CI]: 0.30-0.59; P<0.0001).1 At one year, the recurrence-free survival (RFS) rate was 89% (95% CI: 86-92) for Opdivo versus 79% (95% CI: 74-84) for placebo.3 Additionally, in a pre-specified, exploratory subgroup analysis, the RFS unstratified HR was 0.34 (95% CI: 0.20-0.56) in patients with stage IIB melanoma, and 0.51 (95% CI: 0.32-0.81) in stage IIC melanoma patients.3 One-year RFS rates by stage for patients who received Opdivo were 93% (95% CI: 89–95) in stage IIB versus 84% (95% CI: 77–89) with placebo, and 84% (95% CI: 78–88) in stage IIC versus 72% (95% CI: 62–80) with placebo.3
“Following surgical removal of melanoma, patients may believe they are free of disease,” said John M. Kirkwood, M.D., Distinguished Professor of Medicine at the University of Pittsburgh School of Medicine and Co-Director of the Melanoma Center at UPMC Hillman Cancer Center. “However, within five years of diagnosis, one-third of patients with surgically resected stage IIB and nearly one-half of patients with surgically resected IIC melanoma see their cancer return, underscoring the need for additional treatment options that may help reduce the risk of cancer coming back.4 The significant recurrence-free survival improvement observed with nivolumab in CheckMate -76K is an important step forward for these patients.”1
Opdivo is associated with the following Warnings & Precautions: severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.1 Please see Important Safety Information below.
“Stage IIB and IIC melanoma patients may still face the threat of disease recurrence, despite the benefit of surgery, which can impact outcomes,” said Catherine Owen, senior vice president and general manager, U.S. Cardiovascular, Immunology and Oncology at Bristol Myers Squibb.4,5 “This approval builds on our existing adjuvant indication in completely resected stage III or IV disease and now provides eligible patients with completely resected stage IIB or IIC melanoma an additional treatment option which may help prevent recurrence. BMS remains committed to its goal of helping improve patient outcomes in melanoma and bringing immunotherapy to more patients, including in the earlier stages of disease.”1
The FDA previously approved Opdivo for the adjuvant treatment of adult and pediatric patients 12 years and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection, based upon data from the CheckMate -238 trial.1
Additional CheckMate -76K follow-up data will be presented at the Society for Melanoma Research Annual Meeting in November.
About CheckMate -76K
CheckMate -76K is a Phase 3, randomized, double-blind study evaluating adjuvant Opdivo (nivolumab) 480 mg IV Q4W (n=526) versus placebo IV Q4W (n=264) in patients with completely resected stage IIB or IIC melanoma.1,2
The primary endpoint of the trial is recurrence-free survival (RFS) as assessed by the investigator.1 Secondary endpoints of the trial include overall survival (OS), distant metastasis-free survival (DMFS), progression-free survival through next-line therapy (PFS2), and safety.3 Patients were treated for up to 1 year, or until disease recurrence or unacceptable toxicity.1 The trial excluded patients with ocular/uveal or mucosal melanoma, autoimmune disease, any condition requiring systemic treatment with either corticosteroids (≥10 mg daily prednisone or equivalent) or other immunosuppressive medications, as well as patients with prior therapy for melanoma except surgery.1
The FDA-approved dosing for Opdivo for adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB/C melanoma and weighing ≥40kg is Opdivo 240 mg every 2 weeks or 480 mg every 4 weeks administered as an IV infusion over 30 minutes until disease recurrence or unacceptable toxicity for up to 1 year.1 The FDA-approved dosing for Opdivo in pediatric patients age 12 years and older and weighing <40kg is Opdivo 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks administered as an IV infusion over 30 minutes until disease recurrence or unacceptable toxicity for up to 1 year.1
About Melanoma
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin.6 In the United States, approximately 97,610 new diagnoses of melanoma and about 7,990 related deaths are estimated for 2023.7 Stage II makes up approximately 16.5% of newly diagnosed stage I and II melanomas, and approximately half of these stage II diagnoses are IIB and IIC.4 Surgery (resection) remains a standard of care for stage IIB or IIC melanoma, but approximately one-third of patients with surgically resected stage IIB and nearly one-half of patients with surgically resected stage IIC melanoma experience recurrence within five years after diagnosis.4,8 As melanoma progresses to more advanced disease, it becomes more challenging to treat and survival rates decline.6
INDICATION
OPDIVO® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
Please see US Full Prescribing Information for OPDIVO.
Bristol Myers Squibb: Creating a Better Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle.
Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
About Bristol Myers Squibb’s Patient Access Support
Bristol Myers Squibb remains committed to providing assistance so that cancer patients who need our medicines can access them and expedite time to therapy.
BMS Access Support®, the Bristol Myers Squibb patient access and reimbursement program, is designed to help appropriate patients initiate and maintain access to BMS medicines during their treatment journey. BMS Access Support offers benefit investigation, prior authorization assistance, as well as co-pay assistance for eligible, commercially insured patients. More information about our access and reimbursement support can be obtained by calling BMS Access Support at 1-800-861-0048 or by visiting www.bmsaccesssupport.com.
About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies — as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
References
- Opdivo Prescribing Information. Opdivo U.S. Product Information. Last updated: October 2023. Princeton, NJ: Bristol-Myers Squibb Company.
- ClinicalTrials.gov: NCT04099251. Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma (CheckMate76K). https://classic.clinicaltrials.gov/ct2/show/NCT04099251. Last updated September 7, 2023.
- Long GV, Del Vecchio M, Weber J, et al. Adjuvant therapy with nivolumab versus placebo in patients with resected stage IIB/C melanoma (CheckMate 76K). Presented at: Society for Melanoma Research 2022 International Congress; October 17-20, 2022; Edinburgh, Scotland.
- Garbe C, Keim U, Amaral T, et al. Prognosis of Patients With Primary Melanoma Stage I and II According to American Joint Committee on Cancer Version 8 Validated in Two Independent Cohorts: Implications for Adjuvant Treatment. J Clin Oncol. 2022;40(32):3741-3749. doi:10.1200/JCO.22.00202
- Jang S, Poretta T, Bhagnani T, et al. Real-World Recurrence Rates and Economic Burden in Patients with Resected Early-Stage Melanoma. Dermatol Ther (Heidelb). 2020;10(5):985-999. doi:10.1007/s13555-020-00404-9
- What Is Melanoma Skin Cancer? American Cancer Society. https://www.cancer.org/cancer/melanoma-skin-cancer/about/what-is-melanoma.html. Published August 14, 2019. Accessed September 5, 2023.
- Key Statistics for Melanoma Skin Cancer. American Cancer Society. https://www.cancer.org/cancer/types/melanoma-skin-cancer/about/key-statistics.html. Revised January 12, 2023. Accessed September 5, 2023.
- Treatment of Melanoma Skin Cancer, by Stage. American Cancer Society. https://www.cancer.org/cancer/types/melanoma-skin-cancer/treating/by-stage.html. Revised March 22, 2022. Accessed September 5, 2023.
SOURCE: Bristol Myers Squibb
Post Views: 203
In the Phase 3 CheckMate -76K trial, Opdivo demonstrated a statistically significant improvement in recurrence-free survival compared to placebo1
CheckMate -76K marks the fifth Opdivo-based indication in earlier stages of cancer, in the U.S.1
Opdivo is the only PD-1 inhibitor that is indicated as an adjuvant treatment for eligible patients with stages IIB, IIC, III, as well as stage IV completely resected melanoma1
PRINCETON, NJ, USA I October 13, 2023 IBristol Myers Squibb (NYSE: BMY) today announced that Opdivo® (nivolumab) was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB or IIC melanoma, expanding upon the existing adjuvant indication for Opdivo and further reinforcing the company’s legacy of providing treatment options for melanoma patients.1 The approval is based on the Phase 3 CheckMate -76K trial, which compared Opdivo (n=526) to placebo (n=264).1,2
In the trial, Opdivo reduced the risk of recurrence, new primary melanoma, or death in patients with completely resected stage IIB or IIC melanoma by 58% compared to placebo (Hazard Ratio [HR] 0.42; 95% Confidence Interval [CI]: 0.30-0.59; P<0.0001).1 At one year, the recurrence-free survival (RFS) rate was 89% (95% CI: 86-92) for Opdivo versus 79% (95% CI: 74-84) for placebo.3 Additionally, in a pre-specified, exploratory subgroup analysis, the RFS unstratified HR was 0.34 (95% CI: 0.20-0.56) in patients with stage IIB melanoma, and 0.51 (95% CI: 0.32-0.81) in stage IIC melanoma patients.3 One-year RFS rates by stage for patients who received Opdivo were 93% (95% CI: 89–95) in stage IIB versus 84% (95% CI: 77–89) with placebo, and 84% (95% CI: 78–88) in stage IIC versus 72% (95% CI: 62–80) with placebo.3
“Following surgical removal of melanoma, patients may believe they are free of disease,” said John M. Kirkwood, M.D., Distinguished Professor of Medicine at the University of Pittsburgh School of Medicine and Co-Director of the Melanoma Center at UPMC Hillman Cancer Center. “However, within five years of diagnosis, one-third of patients with surgically resected stage IIB and nearly one-half of patients with surgically resected IIC melanoma see their cancer return, underscoring the need for additional treatment options that may help reduce the risk of cancer coming back.4 The significant recurrence-free survival improvement observed with nivolumab in CheckMate -76K is an important step forward for these patients.”1
Opdivo is associated with the following Warnings & Precautions: severe and fatal immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, dermatologic adverse reactions, nephritis with renal dysfunction, other immune-mediated adverse reactions; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.1 Please see Important Safety Information below.
“Stage IIB and IIC melanoma patients may still face the threat of disease recurrence, despite the benefit of surgery, which can impact outcomes,” said Catherine Owen, senior vice president and general manager, U.S. Cardiovascular, Immunology and Oncology at Bristol Myers Squibb.4,5 “This approval builds on our existing adjuvant indication in completely resected stage III or IV disease and now provides eligible patients with completely resected stage IIB or IIC melanoma an additional treatment option which may help prevent recurrence. BMS remains committed to its goal of helping improve patient outcomes in melanoma and bringing immunotherapy to more patients, including in the earlier stages of disease.”1
The FDA previously approved Opdivo for the adjuvant treatment of adult and pediatric patients 12 years and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection, based upon data from the CheckMate -238 trial.1
Additional CheckMate -76K follow-up data will be presented at the Society for Melanoma Research Annual Meeting in November.
About CheckMate -76K
CheckMate -76K is a Phase 3, randomized, double-blind study evaluating adjuvant Opdivo (nivolumab) 480 mg IV Q4W (n=526) versus placebo IV Q4W (n=264) in patients with completely resected stage IIB or IIC melanoma.1,2
The primary endpoint of the trial is recurrence-free survival (RFS) as assessed by the investigator.1 Secondary endpoints of the trial include overall survival (OS), distant metastasis-free survival (DMFS), progression-free survival through next-line therapy (PFS2), and safety.3 Patients were treated for up to 1 year, or until disease recurrence or unacceptable toxicity.1 The trial excluded patients with ocular/uveal or mucosal melanoma, autoimmune disease, any condition requiring systemic treatment with either corticosteroids (≥10 mg daily prednisone or equivalent) or other immunosuppressive medications, as well as patients with prior therapy for melanoma except surgery.1
The FDA-approved dosing for Opdivo for adjuvant treatment of adult and pediatric patients 12 years and older with completely resected stage IIB/C melanoma and weighing ≥40kg is Opdivo 240 mg every 2 weeks or 480 mg every 4 weeks administered as an IV infusion over 30 minutes until disease recurrence or unacceptable toxicity for up to 1 year.1 The FDA-approved dosing for Opdivo in pediatric patients age 12 years and older and weighing <40kg is Opdivo 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks administered as an IV infusion over 30 minutes until disease recurrence or unacceptable toxicity for up to 1 year.1
About Melanoma
Melanoma is a form of skin cancer characterized by the uncontrolled growth of pigment-producing cells (melanocytes) located in the skin.6 In the United States, approximately 97,610 new diagnoses of melanoma and about 7,990 related deaths are estimated for 2023.7 Stage II makes up approximately 16.5% of newly diagnosed stage I and II melanomas, and approximately half of these stage II diagnoses are IIB and IIC.4 Surgery (resection) remains a standard of care for stage IIB or IIC melanoma, but approximately one-third of patients with surgically resected stage IIB and nearly one-half of patients with surgically resected stage IIC melanoma experience recurrence within five years after diagnosis.4,8 As melanoma progresses to more advanced disease, it becomes more challenging to treat and survival rates decline.6
INDICATION
OPDIVO® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
Please see US Full Prescribing Information for OPDIVO.
Bristol Myers Squibb: Creating a Better Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle.
Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
About Bristol Myers Squibb’s Patient Access Support
Bristol Myers Squibb remains committed to providing assistance so that cancer patients who need our medicines can access them and expedite time to therapy.
BMS Access Support®, the Bristol Myers Squibb patient access and reimbursement program, is designed to help appropriate patients initiate and maintain access to BMS medicines during their treatment journey. BMS Access Support offers benefit investigation, prior authorization assistance, as well as co-pay assistance for eligible, commercially insured patients. More information about our access and reimbursement support can be obtained by calling BMS Access Support at 1-800-861-0048 or by visiting www.bmsaccesssupport.com.
About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies — as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
References
- Opdivo Prescribing Information. Opdivo U.S. Product Information. Last updated: October 2023. Princeton, NJ: Bristol-Myers Squibb Company.
- ClinicalTrials.gov: NCT04099251. Effectiveness Study of Nivolumab Compared to Placebo in Prevention of Recurrent Melanoma After Complete Resection of Stage IIB/C Melanoma (CheckMate76K). https://classic.clinicaltrials.gov/ct2/show/NCT04099251. Last updated September 7, 2023.
- Long GV, Del Vecchio M, Weber J, et al. Adjuvant therapy with nivolumab versus placebo in patients with resected stage IIB/C melanoma (CheckMate 76K). Presented at: Society for Melanoma Research 2022 International Congress; October 17-20, 2022; Edinburgh, Scotland.
- Garbe C, Keim U, Amaral T, et al. Prognosis of Patients With Primary Melanoma Stage I and II According to American Joint Committee on Cancer Version 8 Validated in Two Independent Cohorts: Implications for Adjuvant Treatment. J Clin Oncol. 2022;40(32):3741-3749. doi:10.1200/JCO.22.00202
- Jang S, Poretta T, Bhagnani T, et al. Real-World Recurrence Rates and Economic Burden in Patients with Resected Early-Stage Melanoma. Dermatol Ther (Heidelb). 2020;10(5):985-999. doi:10.1007/s13555-020-00404-9
- What Is Melanoma Skin Cancer? American Cancer Society. https://www.cancer.org/cancer/melanoma-skin-cancer/about/what-is-melanoma.html. Published August 14, 2019. Accessed September 5, 2023.
- Key Statistics for Melanoma Skin Cancer. American Cancer Society. https://www.cancer.org/cancer/types/melanoma-skin-cancer/about/key-statistics.html. Revised January 12, 2023. Accessed September 5, 2023.
- Treatment of Melanoma Skin Cancer, by Stage. American Cancer Society. https://www.cancer.org/cancer/types/melanoma-skin-cancer/treating/by-stage.html. Revised March 22, 2022. Accessed September 5, 2023.
SOURCE: Bristol Myers Squibb
Post Views: 203
