Benefit of I-O/chemo combo over chemotherapy alone in advanced GC/GEJC/EAC

The addition of nivolumab to chemotherapy demonstrated improved survival benefit along with an acceptable safety profile, while maintaining tolerability and quality of life in patients with gastric cancer/gastric-oesophageal junction cancer and oesophageal adenocarcinoma (GC/GEJC/EAC), additional data from CheckMate 649 showed.

Standard chemotherapy for advanced GC/GEJC/EAC results in poor overall survival (median <1 year) [1]. Recently, the CheckMate 649 trial (NCT02872116) demonstrated a survival benefit of nivolumab/chemotherapy versus chemotherapy alone in patients with advanced GC/GEJC/EAC [2]. Prof. Markus Moehler (Mainz University Clinic, Germany) presented additional data [3].

CheckMate 649 enrolled 789 patients in the nivolumab/chemotherapy arm and 792 patients in the chemotherapy alone arm. At 12.1 months minimum follow-up, nivolumab/chemotherapy treatment continued to have a statistically significant overall survival benefit versus chemotherapy alone (HR 0.80; 99.3% CI 0.68–0.94; P=0.0002). Progression-free survival benefit was also seen (HR 0.77; 95% CI 0.68–0.87). An overall survival benefit was observed in multiple prespecified subgroups. The objective response rate was 58% in the nivolumab/chemotherapy arm versus 46% in the chemotherapy alone arm.

Treatment-related adverse events grade 3-4 with potential immunologic aetiology were observed in 16% of patients treated with nivolumab/chemotherapy. Treatment with nivolumab/chemotherapy was associated with maintaining health-related quality of life and a decreased risk of symptom deterioration versus chemotherapy alone. This data supports nivolumab/chemotherapy as a new first-line standard therapy in advanced non-HER2-positive GC/GEJC/EAC.

1. Fuchs CS, et al. Lancet Oncol. 2019;20:420-435.
2. Moehler MH, et al. Abstract LBA6, ESMO 2020, 19-21 Sept.
3. Moehler MH, et al. First-line (1L) nivolumab (NIVO) plus chemotherapy (chemo) versus chemo in advanced gastric cancer/gastroesophageal junction cancer/esophageal adenocarcinoma (GC/GEJC/EAC): Expanded efficacy and safety data from CheckMate 649. Abstract 4002, ASCO 2021 Virtual Meeting, 4–8 June.

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Posted on 12 August 202121 May 2024