U.S. Food and Drug Administration Approves Opdivo® (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma....

 

U.S. Food and Drug Administration Approves Opdivo^® (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma, Regardless of PD-L1 Expression Status

Bristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) (injection for intravenous use), in combination with fluoropyrimidine- and platinum-containing chemotherapy, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, regardless of PD-L1 expression status.¹ The approval is based on the Phase 3 CheckMate -649 trial evaluating Opdivo in combination with mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin), compared to chemotherapy (mFOLFOX6 or CapeOX) alone.^1,2

In the trial of this patient population, Opdivo plus chemotherapy demonstrated superior overall survival (OS) compared to chemotherapy alone, both in all randomized patients (OS HR 0.80; 95% CI: 0.71 to 0.90; P=0.0002), as well as in patients with PD-L1 combined positive score (CPS) ≥ 5 (OS HR 0.71; 95% CI: 0.61 to 0.83; P<0.0001).¹ In an exploratory analysis of all patients, 55% of patients on Opdivo in combination with chemotherapy were alive at one year versus 48% of patients on chemotherapy alone.² The combination also significantly reduced the risk of disease progression or death compared to chemotherapy alone (PD-L1 CPS ≥ 5: progression-free survival (PFS) HR 0.68; 95% CI: 0.58 to 0.79; P<0.0001).¹

“In CheckMate -649, Opdivo plus chemotherapy combination significantly improved survival for patients with metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, reducing the risk of death by 20%.¹ Additionally, 55% of patients were still alive at one year,” said Yelena Y. Janjigian, M.D., CheckMate -649 principal investigator and chief of gastrointestinal oncology, Memorial Sloan Kettering Cancer Center.² “These findings are important, reinforcing the potential of this Opdivo-based combination as a standard of care for this population of patients in high need of treatment options that may extend their lives.”^1,3,4

Opdivo is associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, nephritis and renal dysfunction, dermatologic adverse reactions, 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 the Important Safety Information section below, as well as select safety information from CheckMate -649.

“We are focused on bringing transformative medicines to patients in need, and historically, there has been little progress for patients diagnosed with these metastatic gastroesophageal adenocarcinomas,” said Adam Lenkowsky, general manager and head, U.S., Oncology, Immunology, Cardiovascular, Bristol Myers Squibb.^5,6,7,8 “As demonstrated in the CheckMate -649 trial, Opdivo is the first and only immunotherapy combined with chemotherapy to deliver superior overall survival versus chemotherapy alone in first-line metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.^1,3,4 Today’s approval may offer these patients hope for the chance at a longer life.”¹

The application was reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.⁹ The review was also conducted under the FDA’s Project Orbis initiative, enabling concurr