Neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo reduced the risk of disease recurrence, progression or death by 42% in patients with resectable non-small cell lung cancer
CheckMate -77T is the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for the treatment of non-metastatic non-small cell lung cancer
Late-breaking data from the trial to be presented during a Presidential Symposium at the European Society for Medical Oncology Congress 2023
PRINCETON, NJ, USA I October 17, 2023 I Bristol Myers Squibb (NYSE: BMY) today announced the first disclosure of data from the Phase 3 CheckMate -77T trial evaluating the perioperative regimen of neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo in patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). In the study, the perioperative regimen showed a statistically significant and clinically meaningful improvement in the primary efficacy endpoint of event-free survival (EFS) as assessed by Blinded Independent Central Review (BICR) compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo.
With a median follow-up of 25.4 months, in patients treated with neoadjuvant Opdivo and chemotherapy followed by surgery and adjuvant Opdivo, the risk of disease recurrence, progression or death was reduced by 42% (EFS Hazard Ratio [HR] 0.58; 97.36% Confidence Interval [CI]: 0.42 to 0.81; p=0.00025). Additionally, neoadjuvant Opdivo and chemotherapy showed improvements in the secondary efficacy endpoints of pathologic complete response (pCR; 25.3% vs. 4.7%) and major pathologic response (MPR; 35.4% vs 12.1%). The study is ongoing to assess its other secondary endpoint of overall survival (OS). Definitive surgery rates were 78% with the Opdivo-based regimen vs. 77% with chemotherapy and placebo, with complete resection achieved in 89% vs. 90% of patients, respectively. The safety profile of the Opdivo-based regimen was consistent with previously reported studies in NSCLC. No new safety signals were identified.
The first disclosure of these data will be featured in a Presidential Symposium during the European Society of Medical Oncology (ESMO) Congress 2023 on October 21, 2023, from 10:30 a.m. to 12:15 p.m. EDT / 16:30 to 18:15 CEST (Abstract #LBA1).
“Over the past few years, we have witnessed incredible progress in the treatment of patients with non-metastatic non-small cell lung cancer. Now, we are evaluating therapeutic strategies that expand on these advances with the goal of providing clinical benefit to a greater number of patients with resectable disease,” said Tina Cascone, M.D., Ph.D., associate professor of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center. “I am extremely encouraged by the findings of CheckMate -77T evaluating neoadjuvant nivolumab and chemotherapy followed by surgery and adjuvant nivolumab, and by how continuing adjuvant nivolumab after surgery may further improve outcomes and provide a potentially more durable benefit for our patients. The results from the CheckMate -77T study are promising for physicians, patients and their families alike. I look forward to seeing how the data from this ongoing trial continues to unfold, especially the secondary endpoint of overall survival.”
“The results from the CheckMate -77T study add to the evidence supporting the use of Opdivo-based therapies in resectable non-small cell lung cancer and reinvigorate our commitment to treating cancer at earlier stages of the disease in the hopes of helping patients attain durable benefit,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers global program lead, Bristol Myers Squibb. “We are pleased to be presenting research from multiple trials in resectable NSCLC at ESMO, building on our deep scientific understanding of thoracic cancer treatment. We look forward to upcoming discussions with regulatory authorities and hope that we may offer yet another option to patients with non-metastatic NSCLC that could potentially reduce their risk of disease recurrence, progression or death, and lead to better long-term outcomes.”
To date, Opdivo and Opdivo-based combinations have shown improved efficacy in the neoadjuvant, adjuvant or perioperative treatment of four tumor types: lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.
Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -77T clinical trial.
About CheckMate -77T
CheckMate -77T is a Phase 3 randomized, double-blind, placebo-controlled, multi-center trial evaluating neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo versus neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo in 452 patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). The primary endpoint of the trial is event-free survival (EFS). Secondary endpoints include overall survival (OS), pathologic complete response (pCR) and major pathologic response (MPR).
About Lung Cancer
Lung cancer is the leading cause of cancer deaths globally. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84% of diagnoses. Non-metastatic cases account for the majority of NSCLC diagnoses (approximately 60%, with up to half of these being resectable), and the proportion is expected to grow over time with enhanced screening programs. While many non-metastatic NSCLC patients are cured by surgery, 30% to 55% develop recurrence and die of their disease despite resection, contributing to a need for treatment options administered before surgery (neoadjuvant) and/or after surgery (adjuvant) to improve long-term outcomes.
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 Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
INDICATIONS
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.
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.
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 YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
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), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
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).
OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
SOURCE: Bristol Myers Squibb
Post Views: 166
Neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo reduced the risk of disease recurrence, progression or death by 42% in patients with resectable non-small cell lung cancer
CheckMate -77T is the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for the treatment of non-metastatic non-small cell lung cancer
Late-breaking data from the trial to be presented during a Presidential Symposium at the European Society for Medical Oncology Congress 2023
PRINCETON, NJ, USA I October 17, 2023 I Bristol Myers Squibb (NYSE: BMY) today announced the first disclosure of data from the Phase 3 CheckMate -77T trial evaluating the perioperative regimen of neoadjuvant Opdivo (nivolumab) with chemotherapy followed by surgery and adjuvant Opdivo in patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). In the study, the perioperative regimen showed a statistically significant and clinically meaningful improvement in the primary efficacy endpoint of event-free survival (EFS) as assessed by Blinded Independent Central Review (BICR) compared to neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo.
With a median follow-up of 25.4 months, in patients treated with neoadjuvant Opdivo and chemotherapy followed by surgery and adjuvant Opdivo, the risk of disease recurrence, progression or death was reduced by 42% (EFS Hazard Ratio [HR] 0.58; 97.36% Confidence Interval [CI]: 0.42 to 0.81; p=0.00025). Additionally, neoadjuvant Opdivo and chemotherapy showed improvements in the secondary efficacy endpoints of pathologic complete response (pCR; 25.3% vs. 4.7%) and major pathologic response (MPR; 35.4% vs 12.1%). The study is ongoing to assess its other secondary endpoint of overall survival (OS). Definitive surgery rates were 78% with the Opdivo-based regimen vs. 77% with chemotherapy and placebo, with complete resection achieved in 89% vs. 90% of patients, respectively. The safety profile of the Opdivo-based regimen was consistent with previously reported studies in NSCLC. No new safety signals were identified.
The first disclosure of these data will be featured in a Presidential Symposium during the European Society of Medical Oncology (ESMO) Congress 2023 on October 21, 2023, from 10:30 a.m. to 12:15 p.m. EDT / 16:30 to 18:15 CEST (Abstract #LBA1).
“Over the past few years, we have witnessed incredible progress in the treatment of patients with non-metastatic non-small cell lung cancer. Now, we are evaluating therapeutic strategies that expand on these advances with the goal of providing clinical benefit to a greater number of patients with resectable disease,” said Tina Cascone, M.D., Ph.D., associate professor of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center. “I am extremely encouraged by the findings of CheckMate -77T evaluating neoadjuvant nivolumab and chemotherapy followed by surgery and adjuvant nivolumab, and by how continuing adjuvant nivolumab after surgery may further improve outcomes and provide a potentially more durable benefit for our patients. The results from the CheckMate -77T study are promising for physicians, patients and their families alike. I look forward to seeing how the data from this ongoing trial continues to unfold, especially the secondary endpoint of overall survival.”
“The results from the CheckMate -77T study add to the evidence supporting the use of Opdivo-based therapies in resectable non-small cell lung cancer and reinvigorate our commitment to treating cancer at earlier stages of the disease in the hopes of helping patients attain durable benefit,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers global program lead, Bristol Myers Squibb. “We are pleased to be presenting research from multiple trials in resectable NSCLC at ESMO, building on our deep scientific understanding of thoracic cancer treatment. We look forward to upcoming discussions with regulatory authorities and hope that we may offer yet another option to patients with non-metastatic NSCLC that could potentially reduce their risk of disease recurrence, progression or death, and lead to better long-term outcomes.”
To date, Opdivo and Opdivo-based combinations have shown improved efficacy in the neoadjuvant, adjuvant or perioperative treatment of four tumor types: lung cancer, bladder cancer, esophageal/gastroesophageal junction cancer and melanoma.
Bristol Myers Squibb thanks the patients and investigators involved in the CheckMate -77T clinical trial.
About CheckMate -77T
CheckMate -77T is a Phase 3 randomized, double-blind, placebo-controlled, multi-center trial evaluating neoadjuvant Opdivo with chemotherapy followed by surgery and adjuvant Opdivo versus neoadjuvant chemotherapy and placebo followed by surgery and adjuvant placebo in 452 patients with resectable stage IIA to IIIB non-small cell lung cancer (NSCLC). The primary endpoint of the trial is event-free survival (EFS). Secondary endpoints include overall survival (OS), pathologic complete response (pCR) and major pathologic response (MPR).
About Lung Cancer
Lung cancer is the leading cause of cancer deaths globally. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84% of diagnoses. Non-metastatic cases account for the majority of NSCLC diagnoses (approximately 60%, with up to half of these being resectable), and the proportion is expected to grow over time with enhanced screening programs. While many non-metastatic NSCLC patients are cured by surgery, 30% to 55% develop recurrence and die of their disease despite resection, contributing to a need for treatment options administered before surgery (neoadjuvant) and/or after surgery (adjuvant) to improve long-term outcomes.
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 Opdivo
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.
Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.
In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.
INDICATIONS
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years of age and older with unresectable or metastatic melanoma.
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.
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 YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
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), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
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).
OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum- containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
SOURCE: Bristol Myers Squibb
Post Views: 166
