According to follow-up date from a phase 3 trial, nivolumab plus chemotherapy demonstrated a long-term survival benefit with an acceptable safety profile for patients with previously untreated advanced gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma.

Data from this trial were presented on Thursday, January 19, 2023, at the American Society of Clinical Oncologists Gastrointestinal Cancers Symposium in San Francisco, CA, by Yelena Janjigian, MD, Memorial Sloan Kettering Cancer Center, New York, NY.

In CheckMate 649, nivolumab plus chemotherapy demonstrated superior overall survival and a clinically meaningful benefit to progression-free survival compared with chemotherapy alone in this patient population. The current analysis reports on 3-year follow-up data from this trial.

Eligible patients had previously untreated, unresectable advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma, regardless of PD-L1 status but excluded. Patients with known HER2-positive status were excluded. Patients were randomized to receive either nivolumab plus chemotherapy, nivolumab plus ipilimumab, or chemotherapy alone. The dual primary end points for the nivolumab arm vs the chemotherapy arm were overall survival and progression-free survival in patients with PD-L1 combined positive score (CPS) ≥5.

The minimum follow-up duration was 36 months. Among 581 patients concurrently randomized to nivolumab plus chemotherapy or chemotherapy alone, nivolumab plus chemotherapy continued to demonstrate a benefit to both overall survival and progression-free survival for those patients with PD-L1 CPS ≥5, and all randomized patients. This benefit to overall survival was seen across most prespecified subgroups. The objective response rate for patients with PD-L1 CPS ≥5 who had measurable lesions at baseline was 60% in the nivolumab plus chemotherapy arm and 45% in the chemotherapy alone arm. For all randomized patients, the objective response rate was 58% in the nivolumab plus chemotherapy arm and 46% in the chemotherapy alone arm. Responses were more durable for both patients with PD-L1 CPS ≥5 and all randomized patients in the nivolumab plus chemotherapy arm, compared to the chemotherapy alone arm.

There were no new safety signals identified. In the nivolumab plus chemotherapy arm, 60% of patients experienced a grade 3/4 treatment-related adverse event, with 42% leading to discontinuation, in the nivolumab plus chemotherapy arm. In the chemotherapy alone arm, 45% of patients experienced a grade 3/4 treatment-related adverse event, with 26% leading to discontinuation.

Dr Janjigian et al concluded the durability demonstrated with nivolumab plus chemotherapy  in these data “further support[s] its use as a standard [first-line] treatment in previously untreated patients with advanced [gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma].”

Source:

Janjigian YY, Shitara K, Moehler MH, et al. Nivolumab (NIVO) plus chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 3-year follow-up from CheckMate 649. Presented at 2023 ASCO Gastrointestinal Cancers Symposium; January 19-21, 2023; San Francisco, CA. Abstract 291