CheckMate 649: Nivolumab plus chemotherapy continues to deliver efficacy benefit in gastric cancer

The 4-year follow-up data of CheckMate 649 continued to demonstrate an efficacy benefit of nivolumab plus chemotherapy over chemotherapy alone in newly diagnosed patients with advanced gastric cancer, gastro-oesophageal junction cancer, or oesophageal adenocarcinoma. With no newly identified safety issues, the regimen of nivolumab plus chemotherapy is further supported as the first-line standard-of-care in this population.

The open-label, global, phase 3 CheckMate 649 study (NCT02872116) randomised 2,031 participants with previously untreated advanced gastric cancer, gastro-oesophageal junction cancer, or oesophageal adenocarcinoma to nivolumab plus chemotherapy, to chemotherapy alone, or to nivolumab plus ipilimumab. Nivolumab plus chemotherapy outperformed chemotherapy alone in terms of efficacy [1]. Dr Kohei Shitara (National Cancer Center Hospital East, Japan) presented the updated results after 4 years of follow-up [2].

The median overall survival was 13.7 months in the nivolumab arm and 11.6 months in the chemotherapy arm, resulting in a significant difference between the 2 groups (HR 0.79; 95% CI 0.71–0.88. This finding was consistent in the subgroup of participants with PD-L1 CPS ≥1 (HR 0.77; 95% 0.68–0.88) and appeared to be more pronounced among patients with PD-L1 CPS ≥5 (HR 0.71; 95% CI 0.62–0.82). Also, progression-free survival (PFS) was prolonged among participants receiving nivolumab and chemotherapy compared with those receiving chemotherapy alone, with median PFS durations of 7.7 months and 6.9 months (HR 0.80; 95% CI 0.71–0.89).

The efficacy benefit of nivolumab plus chemotherapy over chemotherapy alone was sustained across various endpoints, further supporting the use of nivolumab plus chemotherapy as standard first-line treatment in patients with advanced gastric cancer, gastro-oesophageal junction cancer, oesophageal adenocarcinoma.

1. Janjigian YY, et al. Lancet. 2021;398(10294):27-40.
2. Shitara K, et al. Nivolumab (NIVO) + chemotherapy (chemo) vs chemo as first-line (1L) treatment for advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): 4 year (yr) follow-up of CheckMate 649. Abstract 306, ASCO Gastrointestinal Cancers Symposium, San Francisco, CA, USA, 18-20 January 2024.

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Posted on 13 February, 202427 March, 2024