The FDA approval is based on CheckMate-649, a Phase 3 trial evaluating Opdivo in combination with chemotherapy
Opdivo plus chemotherapy approved for gastric cancers. (Credit: Raman Oza from Pixabay.)
The US Food and Drug Administration (FDA) has approved Bristol Myers Squibb’s Opdivo (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, to treat certain cancer types.
Opdivo plus chemotherapy is indicated for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and oesophageal adenocarcinoma, regardless of PD-L1 expression status.
The US FDA has reviewed the regulatory application under its Real-Time Oncology Review (RTOR) pilot programme, and also under its Project Orbis initiative.
The RTOR programme ensures early access to safe and effective treatments, while the Project Orbis initiative enables concurrent review by the health authorities in Canada, Australia, Switzerland and Brazil.
Bristol Myers Squibb general manager and US oncology, immunology, cardiovascular head Adam Lenkowsky said: “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.
“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.
“Today’s approval may offer these patients hope for the chance at a longer life.”
The FDA approval is supported by the data from CheckMate-649, a randomised, multicentre, open-label Phase 3 trial evaluating Opdivo in combination with chemotherapy.
The study used mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) in combination with Opdivo, compared to mFOLFOX6 or CapeOX alone.
In the Phase 3 trial, Opdivo plus chemotherapy showed superior overall survival (OS) compared to chemotherapy alone, in all patient populations.
The exploratory analysis of all patients demonstrated that 55% of patients on Opdivo plus chemotherapy were alive after one year, compared to 48% on chemotherapy alone.
Also, the combination significantly reduced the risk of disease progression or death compared to chemotherapy alone, said the company.
CheckMate-649 trial principal investigator Yelena Janjigian said: “In CheckMate -649, Opdivo plus chemotherapy combination significantly improved survival for patients with metastatic gastric cancer, gastroesophageal junction cancer, and oesophageal adenocarcinoma, reducing the risk of death by 20%.
“Additionally, 55% of patients were still alive at one year. 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.”