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Four-year follow-up data demonstrates the benefits of nivolumab plus chemotherapy over chemotherapy alone in newly diagnosed patients with advanced 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-esophageal junction cancer, or esophageal 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) randomized 2,031 participants with previously untreated advanced gastric cancer, gastro-esophageal junction cancer, or esophageal adenocarcinoma to nivolumab plus chemotherapy, to chemotherapy alone, or to nivolumab plus ipilimumab. Nivolumab plus chemotherapy outperformed chemotherapy alone in terms of efficacy.1 Kohei Shitara, MD, 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 or greater (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-esophageal junction cancer, esophageal adenocarcinoma.
Medical writing support was provided by Robert van den Heuvel.
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