BMS Announces Positive Results from CheckMate-649 China Cohort: Nivolumab Plus Chemotherapy Demonstrates Significant Survival Benefit in First-Line Treatment of Advanced Gastric and Gastroesophageal Junction Cancer

Source: Medical Perspectives

On April 10, Bristol-Myers Squibb Company (BMS) announced the primary results from the China subgroup of the pivotal Phase 3 CheckMate -649 study. The results demonstrated that, in the Chinese population, first-line treatment with Opdivo (nivolumab) in combination with chemotherapy for unresectable advanced or metastatic gastric cancer and gastroesophageal junction cancer yielded clinically meaningful benefits in overall survival (OS) and progression-free survival (PFS) compared with chemotherapy alone. OS and PFS benefits were observed regardless of PD-L1 expression status—both in patients with a combined positive score (CPS) ≥5 or CPS ≥1 and in the entire randomized population. These subgroup analysis findings are consistent with the results from the global overall population of patients with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma in the CheckMate -649 study.

Among clinical studies on immunotherapy for gastric cancer and gastroesophageal junction (GEJ) cancer involving patients in mainland China, CheckMate -649 is the first and currently only Phase 3 study of first-line treatment to have achieved positive results. It enrolled a total of 208 previously untreated, unresectable, HER2-negative patients with advanced or metastatic gastric or GEJ cancer from mainland China, who were randomized to receive either nivolumab plus chemotherapy or chemotherapy alone. Enrollment was open regardless of PD-L1 expression status.

As a PD-1 inhibitor developed with the direct involvement of Nobel laureates in Physiology or Medicine, Opdivo has been approved for more than ten oncology indications worldwide since its approval in July 2014 as the first PD-1 immunotherapy globally. These indications include lung cancer, head and neck cancer, gastric cancer, esophageal cancer, liver cancer, renal cell carcinoma, colorectal cancer, urothelial carcinoma, melanoma, Hodgkin lymphoma, and pleural tumors.

In China, Opdivo is also the first approved immuno-oncology drug, currently indicated for non-small cell lung cancer, head and neck squamous cell carcinoma, and gastric or gastroesophageal junction adenocarcinoma.

CheckMate-649 is a phase 3, randomized, multicenter, open-label clinical study designed to evaluate the efficacy of nivolumab plus chemotherapy or nivolumab plus ipilimumab versus chemotherapy alone in patients with previously untreated HER2-negative advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma. The primary endpoints were overall survival (OS) with nivolumab plus chemotherapy versus chemotherapy alone in patients with PD-L1 expression positive, defined as a Combined Positive Score (CPS) ≥5, and progression-free survival (PFS) as assessed by the Blinded Independent Central Review Committee (BICR).

The study results showed that, for the primary endpoint in patients with PD-L1 positivity and a CPS ≥ 5, the median OS was 15.5 months in the Opdivo plus chemotherapy group versus 9.6 months in the chemotherapy-alone control group. The median PFS was 8.5 months in the Opdivo plus chemotherapy group compared with 4.3 months in the chemotherapy-alone group. Furthermore, for secondary endpoints, the objective response rate (ORR) was 68% in the Opdivo plus chemotherapy group versus 48% in the chemotherapy-alone group.

Opdivo in combination with chemotherapy also demonstrated clinically meaningful overall survival (OS) benefits in both patients with PD-L1 positivity and a CPS ≥1, and in the overall randomized population. Among patients with PD-L1 positivity and CPS ≥1, the median OS was 14.3 months in the Opdivo plus chemotherapy group versus 9.9 months in the chemotherapy-alone group. In the overall randomized population, the median OS was 14.3 months in the Opdivo plus chemotherapy group versus 10.3 months in the chemotherapy-alone group.

In this study, the safety profile of Opdivo in combination with chemotherapy was consistent with the known safety profiles of Opdivo and chemotherapy, and no new safety signals were observed. Furthermore, the overall safety in the Chinese subgroup was consistent with that of the global population.

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