The CheckMate -649 trial demonstrated statistically significant and clinically meaningful improvement in both the parameters for the Opdivo + chemotherapy arm compared to chemotherapy alone.
The late-stage trial assessed the overall survival (OS) and progression-free survival (PFS) of patients having unresectable advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma.
The benefits in OS and PFS were noted across patients whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5, thereby meeting the trial’s two primary endpoints.
Furthermore, the OS benefit was also seen in the all-randomised trial population, said Bristol Myers Squibb.
Median OS for Opdivo+chemotherapy was 14.4 months in comparison to 11.1 months recorded for chemotherapy in PD-L1 positive patients with CPS ≥ 5.
On the other hand, the median PFS was 7.7 months for Opdivo+chemotherapy in comparison to 6.0 months for the chemotherapy alone patient arm.
According to Bristol Myers Squibb, Opdivo is the first PD-1 inhibitor to deliver superior OS and PFS in combination with chemotherapy when compared to chemotherapy alone in such patients.
CheckMate -649 also evaluated Opdivo plus Yervoy (ipilimumab) combination in the gastric and esophageal cancer patients.
Bristol Myers Squibb gastrointestinal cancers development lead Ian Waxman said: “CheckMate -649 recently became the first global study in over a decade to demonstrate a significant overall survival benefit over chemotherapy in the first-line setting of non-HER2 positive gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma, highlighting the potential of Opdivo plus chemotherapy to become a new standard of care for these patients, regardless of their tumor location.”
“These available results of the CheckMate -649 study will be discussed with global health authorities as we strive to bring this important new treatment option to patients in need.”
The PD-1 immune checkpoint inhibitor has approvals across various countries as either a monotherapy or in combination with other drugs for the treatment of multiple types of cancer.