NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use on Friday recommended approval for Bristol Myers Squibb's nivolumab (Opdivo) plus fluoropyrimidine- and platinum-containing chemotherapy as a first-line treatment for patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal cancer whose tumors express PD-L1.
The approval is specifically for patients whose tumors express PD-L1 with a combined positive score, or CPS, of at least five. CHMP's recommendation is different than the US Food and Drug Administration approval in April, which allows BMS to market the nivolumab-chemo regimen as a first-line treatment for advanced gastric cancer regardless of patients' PD-L1 status.
The CHMP decision was based on data from the Phase III CheckMate-649 trial, which compared patients receiving nivolumab combined with leucovorin, 5-fluorouracil and oxaliplatin (FOLFOX) or with capecitabine and oxaliplatin (CapeOX) against patients receiving just chemotherapy. Those treated with the nivolumab-containing regimen had better overall survival than patients on only chemotherapy, 13.1 months versus 11 months, respectively. Patients with a PD-L1 CPS of five or greater had an even greater overall survival advantage, with a median overall survival of 14.4 months.
The European Commission will now review the CHMP recommendation for full approval.
"Gastric and gastroesophageal junction cancers, along with esophageal adenocarcinomas, are among the deadliest in the world, and there has been no major advancement for HER2-negative patients in many years,” Ian Waxman, development lead for gastrointestinal cancers at BMS, said in a statement. "With the results of the CheckMate-649 trial, Opdivo plus chemotherapy is the first regimen to deliver superior overall survival versus chemotherapy alone in this patient population."