Approval is based on the CheckMate-77T trial, in which the Opdivo-based regimen demonstrated significantly longer event-free survival compared to the chemotherapy and placebo arm; a high pathologic complete response rate was also observed1
Opdivo is the only approved PD-1 inhibitor for resectable NSCLC in both a neoadjuvant-only regimen and as part of a perioperative treatment regimen1
This milestone adds to Bristol Myers Squibb’s thoracic portfolio and highlights the company’s commitment to advancing treatments for patients with early-stage disease
PRINCETON, NJ, USA I October 03, 2024 I Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo®(nivolumab) for the treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy,followed by single-agent Opdivo as adjuvant treatment after surgery – otherwise referred to as perioperative therapy, which is used before and after surgery.1 The approval is based on results from the CheckMate-77T trial, the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for the treatment of resectable NSCLC.1 Opdivo is now the only PD-1 inhibitor to demonstrate statistically significant and clinically meaningful benefits in this disease versus chemotherapy in both a neoadjuvant-only regimen and as part of a perioperative regimen.1
“Given the rates of disease recurrence in patients with resectable NSCLC, there is a clear need for options that can be administered before and after surgery that may target micrometastasis, help reduce the risk of cancer returning and improve the chance of successful surgical treatment,” said Tina Cascone, MD, PhD, associate professor of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center.2,3,4 “This approval is a step forward for patients with resectable disease, as the perioperative nivolumab plus neoadjuvant chemotherapy regimen can offer an improved event free survival (EFS) compared with neoadjuvant chemotherapy alone and has the potential for achieving a pathologic response (pCR) in one in four patients.”2
The CheckMate-77T trial evaluated the perioperative regimen of neoadjuvant Opdivo with platinum-doublet chemotherapy followed by surgery and adjuvant Opdivo monotherapy (n=229), compared to neoadjuvant platinum-doublet chemotherapy and placebo followed by surgery and adjuvant placebo (n=232) in adult patients with resectable NSCLC.2 In the trial, the Opdivo arm improved EFS, a primary endpoint, compared to the chemotherapy and placebo treatment arm.2 A high pCR rate was also observed as one of the pre-specified secondary endpoints.2
The risk of disease recurrence, progression or death was reduced by 42% (EFS Hazard Ratio [HR] 0.58; 95% Confidence Interval [CI]: 0.43 to 0.78; P=0.00025) in patients treated in the Opdivo arm, compared to the chemotherapy and placebo arm, with a median follow-up of 25.4 months.2 In addition, 18-month EFS was demonstrated in 70% of patients in the Opdivo arm, compared to 50% of patients in the chemotherapy and placebo arm.2 Furthermore, 25% of patients in the Opdivo arm achieved pCR, while 4.7% of patients in the comparator arm achieved pCR in the intent-to-treat population (estimated treatment difference of 20.5%; 95% CI,14.3 to 26.6).2
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 and renal dysfunction; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity.1 Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue and dexamethasone is not recommended outside of controlled clinical trials.1 Please see Important Safety Information below.
“This milestone expands the role of Opdivo-based treatments and builds upon the foundation set by the FDA approval of neoadjuvant-only Opdivo plus chemotherapy in resectable NSCLC based on the CheckMate-816 trial,” said Wendy Short Bartie, senior vice president of U.S. Oncology and Hematology at Bristol Myers Squibb.1 “With this new Opdivo-based regimen, we are reinforcing our commitment to helping improve patient outcomes and expanding our thoracic portfolio in early-stage disease.”
The recommended dose for Opdivo in this indication is 360 mg with platinum-doublet chemotherapy on the same day every three weeks for up to four cycles or until disease progression or unacceptable toxicity, then continued as a single-agent Opdivo 480 mg every four weeks after surgery for up to 13 cycles (approximately one year) or until disease recurrence or unacceptable toxicity.1 The FDA previously approved Opdivo for adult patients with resectable (tumors ≥4 cm or node positive) NSCLC in the neoadjuvant setting, in combination with platinum-doublet chemotherapy.1 Opdivo and Opdivo-based combinations have been approved by the FDA in the neoadjuvant, adjuvant or perioperative settings across four cancers to date, including lung cancer, melanoma, bladder cancer and esophageal/gastroesophageal junction cancer.1
About CheckMate-77T
CheckMate-77T is a Phase 3 randomized, double-blind, multi-center trial evaluating neoadjuvant Opdivo in combination with platinum-doublet chemotherapy followed by surgery and single-agent adjuvant Opdivo, compared to neoadjuvant platinum-doublet chemotherapy and placebo followed by surgery and adjuvant placebo in patients with resectable NSCLC.5
In the CheckMate-77T study, a total of 461 patients were randomized to receive either neoadjuvant Opdivo 360 mg with platinum-doublet chemotherapy every three weeks, or placebo and platinum-doublet chemotherapy every three weeks, until disease progression or unacceptable toxicity, for up to four cycles, followed by single-agent Opdivo 480 mg after surgery every four weeks or placebo every four weeks, until disease progression or unacceptable toxicity, for up to thirteen cycles (approximately one year).1 The primary endpoint of the trial is event-free survival determined by Blinded Independent Central Review (BICR). Secondary endpoints of the trial include pathologic complete response and major pathologic response, both determined by Blinded Independent Pathological Review (BIPR), as well as overall survival and safety.2
Select Safety Profile from CheckMate-77T
The most common adverse reactions (reported in ≥20%) in patients receiving Opdivo in combination with chemotherapy (n= 228) were anemia (39.5%), constipation (32.0%), nausea (28.9%), fatigue (28.1%), alopecia (25.9%), and cough (21.9%).6
Serious adverse reactions occurred in 21% of patients who received Opdivo in combination with platinum-doublet chemotherapy as neoadjuvant treatment (n=228).1 The most frequent (≥2%) serious adverse reaction was pneumonia.1 Fatal adverse reactions occurred in 2.2% of patients, due to cerebrovascular accident, COVID-19 infection, hemoptysis, pneumonia, and pneumonitis (0.4% each).1
In Checkmate 77T, 5.3% (n=12) of the OPDIVO-treated patients who received neoadjuvant treatment, did not receive surgery due to adverse reactions. The adverse reactions that led to cancellation of surgery in OPDIVO-treated patients were cerebrovascular accident, pneumonia, and colitis/diarrhea (2 patients each) and acute coronary syndrome, myocarditis, hemoptysis, pneumonitis, COVID-19, and myositis (1 patient each).
Serious adverse reactions occurred in 22% of the patients who received single-agent Opdivo as adjuvant treatment (n=142).1 The most frequent serious adverse reaction was pneumonitis/ILD (2.8%).1 One fatal adverse event due to COVID-19 occurred.1 The perioperative regimen had a safety profile consistent with previously reported Opdivo studies in NSCLC and no new safety signals were identified.2
About Lung Cancer
Lung cancer is the leading cause of cancer deaths in the United States.7 The two main types of lung cancer are non-small cell and small cell.7 Non-small cell lung cancer (NSCLC) represents up to 85% of diagnoses.7 For some non-metastatic early-stage NSCLC patients, surgery may be able to be used as a singular option for treatment.8 However, 30% to 55% of patients can develop recurrence, contributing to a need for treatment options administered before surgery (neoadjuvant) and after surgery (adjuvant) to improve long-term outcomes.2 Survival rates vary depending on the stage and type of the cancer when diagnosed.7
INDICATIONS
OPDIVO® (nivolumab) 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.
OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).
OPDIVO®(nivolumab) in combination with platinum-doublet chemotherapy, is indicated for neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO® as adjuvant treatment after surgery.
OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).
Please see U.S. 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 2024. Princeton, NJ: Bristol-Myers Squibb Company.
- Cascone T, Awad M, Spicer J, et al. Perioperative Nivolumab in Resectable Lung Cancer. N Engl J Med. 2024;390:1756-1769.
- Lampridis S, Scarci M. Perioperative systemic therapies for non-small-cell lung cancer: Recent advances and future perspectives. Front Surg. 2022; 9: 1126486.
- Marinelli D, Gallina FT, Pannunzio S, et al. Surgical and Survival Outcomes with Perioperative or Neoadjuvant Immune-checkpoint Inhibitors Combined with Platinum-based Chemotherapy in Resectable NSCLC: A Systematic Review and Meta-analysis of Randomised Clinical Trials. Crit Rev Oncol Hematol. 2023;Dec:192:104190.
- ClinicalTrials.gov: NCT04025879. A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer. Available at https://www.clinicaltrials.gov/study/NCT04025879. Accessed September 19, 2024.
- Data on file. BMS-REF-NIVO-0293. Princeton, NJ: Bristol-Myers Squibb Company; 2024.
- American Cancer Society. What is Lung Cancer? Available at https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed September 25, 2024.
- American Cancer Society. Surgery for Small Cell Lung Cancer. Available at https://www.cancer.org/cancer/types/lung-cancer/treating-small-cell/surgery.html. Accessed September 25, 2024.
SOURCE: Bristol Myers Squibb
Post Views: 4,357
Approval is based on the CheckMate-77T trial, in which the Opdivo-based regimen demonstrated significantly longer event-free survival compared to the chemotherapy and placebo arm; a high pathologic complete response rate was also observed1
Opdivo is the only approved PD-1 inhibitor for resectable NSCLC in both a neoadjuvant-only regimen and as part of a perioperative treatment regimen1
This milestone adds to Bristol Myers Squibb’s thoracic portfolio and highlights the company’s commitment to advancing treatments for patients with early-stage disease
PRINCETON, NJ, USA I October 03, 2024 I Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo®(nivolumab) for the treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy,followed by single-agent Opdivo as adjuvant treatment after surgery – otherwise referred to as perioperative therapy, which is used before and after surgery.1 The approval is based on results from the CheckMate-77T trial, the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for the treatment of resectable NSCLC.1 Opdivo is now the only PD-1 inhibitor to demonstrate statistically significant and clinically meaningful benefits in this disease versus chemotherapy in both a neoadjuvant-only regimen and as part of a perioperative regimen.1
“Given the rates of disease recurrence in patients with resectable NSCLC, there is a clear need for options that can be administered before and after surgery that may target micrometastasis, help reduce the risk of cancer returning and improve the chance of successful surgical treatment,” said Tina Cascone, MD, PhD, associate professor of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center.2,3,4 “This approval is a step forward for patients with resectable disease, as the perioperative nivolumab plus neoadjuvant chemotherapy regimen can offer an improved event free survival (EFS) compared with neoadjuvant chemotherapy alone and has the potential for achieving a pathologic response (pCR) in one in four patients.”2
The CheckMate-77T trial evaluated the perioperative regimen of neoadjuvant Opdivo with platinum-doublet chemotherapy followed by surgery and adjuvant Opdivo monotherapy (n=229), compared to neoadjuvant platinum-doublet chemotherapy and placebo followed by surgery and adjuvant placebo (n=232) in adult patients with resectable NSCLC.2 In the trial, the Opdivo arm improved EFS, a primary endpoint, compared to the chemotherapy and placebo treatment arm.2 A high pCR rate was also observed as one of the pre-specified secondary endpoints.2
The risk of disease recurrence, progression or death was reduced by 42% (EFS Hazard Ratio [HR] 0.58; 95% Confidence Interval [CI]: 0.43 to 0.78; P=0.00025) in patients treated in the Opdivo arm, compared to the chemotherapy and placebo arm, with a median follow-up of 25.4 months.2 In addition, 18-month EFS was demonstrated in 70% of patients in the Opdivo arm, compared to 50% of patients in the chemotherapy and placebo arm.2 Furthermore, 25% of patients in the Opdivo arm achieved pCR, while 4.7% of patients in the comparator arm achieved pCR in the intent-to-treat population (estimated treatment difference of 20.5%; 95% CI,14.3 to 26.6).2
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 and renal dysfunction; infusion-related reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity.1 Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue and dexamethasone is not recommended outside of controlled clinical trials.1 Please see Important Safety Information below.
“This milestone expands the role of Opdivo-based treatments and builds upon the foundation set by the FDA approval of neoadjuvant-only Opdivo plus chemotherapy in resectable NSCLC based on the CheckMate-816 trial,” said Wendy Short Bartie, senior vice president of U.S. Oncology and Hematology at Bristol Myers Squibb.1 “With this new Opdivo-based regimen, we are reinforcing our commitment to helping improve patient outcomes and expanding our thoracic portfolio in early-stage disease.”
The recommended dose for Opdivo in this indication is 360 mg with platinum-doublet chemotherapy on the same day every three weeks for up to four cycles or until disease progression or unacceptable toxicity, then continued as a single-agent Opdivo 480 mg every four weeks after surgery for up to 13 cycles (approximately one year) or until disease recurrence or unacceptable toxicity.1 The FDA previously approved Opdivo for adult patients with resectable (tumors ≥4 cm or node positive) NSCLC in the neoadjuvant setting, in combination with platinum-doublet chemotherapy.1 Opdivo and Opdivo-based combinations have been approved by the FDA in the neoadjuvant, adjuvant or perioperative settings across four cancers to date, including lung cancer, melanoma, bladder cancer and esophageal/gastroesophageal junction cancer.1
About CheckMate-77T
CheckMate-77T is a Phase 3 randomized, double-blind, multi-center trial evaluating neoadjuvant Opdivo in combination with platinum-doublet chemotherapy followed by surgery and single-agent adjuvant Opdivo, compared to neoadjuvant platinum-doublet chemotherapy and placebo followed by surgery and adjuvant placebo in patients with resectable NSCLC.5
In the CheckMate-77T study, a total of 461 patients were randomized to receive either neoadjuvant Opdivo 360 mg with platinum-doublet chemotherapy every three weeks, or placebo and platinum-doublet chemotherapy every three weeks, until disease progression or unacceptable toxicity, for up to four cycles, followed by single-agent Opdivo 480 mg after surgery every four weeks or placebo every four weeks, until disease progression or unacceptable toxicity, for up to thirteen cycles (approximately one year).1 The primary endpoint of the trial is event-free survival determined by Blinded Independent Central Review (BICR). Secondary endpoints of the trial include pathologic complete response and major pathologic response, both determined by Blinded Independent Pathological Review (BIPR), as well as overall survival and safety.2
Select Safety Profile from CheckMate-77T
The most common adverse reactions (reported in ≥20%) in patients receiving Opdivo in combination with chemotherapy (n= 228) were anemia (39.5%), constipation (32.0%), nausea (28.9%), fatigue (28.1%), alopecia (25.9%), and cough (21.9%).6
Serious adverse reactions occurred in 21% of patients who received Opdivo in combination with platinum-doublet chemotherapy as neoadjuvant treatment (n=228).1 The most frequent (≥2%) serious adverse reaction was pneumonia.1 Fatal adverse reactions occurred in 2.2% of patients, due to cerebrovascular accident, COVID-19 infection, hemoptysis, pneumonia, and pneumonitis (0.4% each).1
In Checkmate 77T, 5.3% (n=12) of the OPDIVO-treated patients who received neoadjuvant treatment, did not receive surgery due to adverse reactions. The adverse reactions that led to cancellation of surgery in OPDIVO-treated patients were cerebrovascular accident, pneumonia, and colitis/diarrhea (2 patients each) and acute coronary syndrome, myocarditis, hemoptysis, pneumonitis, COVID-19, and myositis (1 patient each).
Serious adverse reactions occurred in 22% of the patients who received single-agent Opdivo as adjuvant treatment (n=142).1 The most frequent serious adverse reaction was pneumonitis/ILD (2.8%).1 One fatal adverse event due to COVID-19 occurred.1 The perioperative regimen had a safety profile consistent with previously reported Opdivo studies in NSCLC and no new safety signals were identified.2
About Lung Cancer
Lung cancer is the leading cause of cancer deaths in the United States.7 The two main types of lung cancer are non-small cell and small cell.7 Non-small cell lung cancer (NSCLC) represents up to 85% of diagnoses.7 For some non-metastatic early-stage NSCLC patients, surgery may be able to be used as a singular option for treatment.8 However, 30% to 55% of patients can develop recurrence, contributing to a need for treatment options administered before surgery (neoadjuvant) and after surgery (adjuvant) to improve long-term outcomes.2 Survival rates vary depending on the stage and type of the cancer when diagnosed.7
INDICATIONS
OPDIVO® (nivolumab) 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.
OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).
OPDIVO®(nivolumab) in combination with platinum-doublet chemotherapy, is indicated for neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, followed by single-agent OPDIVO® as adjuvant treatment after surgery.
OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).
Please see U.S. 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 2024. Princeton, NJ: Bristol-Myers Squibb Company.
- Cascone T, Awad M, Spicer J, et al. Perioperative Nivolumab in Resectable Lung Cancer. N Engl J Med. 2024;390:1756-1769.
- Lampridis S, Scarci M. Perioperative systemic therapies for non-small-cell lung cancer: Recent advances and future perspectives. Front Surg. 2022; 9: 1126486.
- Marinelli D, Gallina FT, Pannunzio S, et al. Surgical and Survival Outcomes with Perioperative or Neoadjuvant Immune-checkpoint Inhibitors Combined with Platinum-based Chemotherapy in Resectable NSCLC: A Systematic Review and Meta-analysis of Randomised Clinical Trials. Crit Rev Oncol Hematol. 2023;Dec:192:104190.
- ClinicalTrials.gov: NCT04025879. A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer. Available at https://www.clinicaltrials.gov/study/NCT04025879. Accessed September 19, 2024.
- Data on file. BMS-REF-NIVO-0293. Princeton, NJ: Bristol-Myers Squibb Company; 2024.
- American Cancer Society. What is Lung Cancer? Available at https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed September 25, 2024.
- American Cancer Society. Surgery for Small Cell Lung Cancer. Available at https://www.cancer.org/cancer/types/lung-cancer/treating-small-cell/surgery.html. Accessed September 25, 2024.
SOURCE: Bristol Myers Squibb
Post Views: 4,357
