Yelena Y. Janjigian, MD, discusses the FDA approval of nivolumab plus chemotherapy in frontline gastric cancer.
Yelena Y. Janjigian, MD, a medical oncologist at Memorial Sloan Kettering Cancer Center, discusses the FDA approval of nivolumab (Opdivo) plus chemotherapy in frontline gastric cancer.
On April 16, 2021, the FDA approved nivolumab plus select chemotherapy regimens for the frontline treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma. Notably, nivolumab became the first immunotherapy agent approved in the United States for patients with frontline gastric cancer.
The regulatory decision was based on findings from the phase 3 CheckMate-649 trial (NCT02872116), in which the frontline combination of nivolumab and standard chemotherapies significantly improved survival among patients with treatment-naïve advanced gastric, GEJ, and esophageal adenocarcinoma vs chemotherapy alone.
The approval indicates that patients with gastric, GEJ, or esophageal adenocarcinoma are eligible to receive nivolumab irrespective of PD-L1 status, concludes Janjigian.