3-year follow-up data confirms benefits of nivolumab plus chemotherapy

The 3-year follow-up results of the CheckMate 649 study demonstrated long-term survival benefits for patients with newly diagnosed, advanced gastric cancer (GC), gastro-oesophageal junction cancer (GOJC), or oesophageal adenocarcinoma (OAC) if they followed a regimen of nivolumab plus chemotherapy.

In CheckMate 649 (NCT02872116), a global phase 3 study, 1,622 patients with previously untreated advanced GC, GOJC, or OAC were randomised 1:1 to chemotherapy or chemotherapy plus nivolumab [1]. “Following the 1-year results of this trial [2], nivolumab plus chemotherapy was approved as first-line therapy for patients with advanced GC/GOJC/OAC in more than 50 countries worldwide,” added Dr Yelena Janjigian (Memorial Sloan Kettering Cancer, NY, USA). At ASCO GI 2023, she presented the 3-year follow-up results of CheckMate 649.

The median overall survival (OS) was 13.7 months in the experimental group compared with 11.6 months in the control group (HR 0.79; 95% CI 0.71–0.88). In addition, the 36-month OS rates were 17% and 10%, respectively. In patients with PD-L1 combined positive score ≥5, the median OS was 14.4 months in the nivolumab arm and 11.1 months in the chemotherapy arm (HR 0.70; 95% CI 0.61–0.81), with corresponding 3-year OS rates of 21% and 10%. The 3-year progression-free survival data showed similar results, favouring the nivolumab arm in all patients and in patients with PD-L1 combined positive score ≥5, specifically. Furthermore, patients with microsatellite instability-high (MSI-H) tumours appeared to have an increased benefit of the combination of chemotherapy and nivolumab compared with chemotherapy alone (median OS 38.7 vs 12.3 months; HR 0.34; 95% CI 0.16–0.74). According to Dr Janjigian, no new safety issues emerged with longer follow-up.

“These data further support the use of nivolumab plus chemotherapy in patients with advanced GC/GOJC/OAC,” decided Dr Janjigian. Patients with higher PD-L1 expression levels or those with MSI-H tumours appeared to experience the largest benefits from the addition of nivolumab to chemotherapy.

1. Janjigian YY, 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. Abstract 291, ASCO GI 2023, 19–21 January, San Francisco, CA, USA.
2. Janjigian YY, et al. Lancet. 2021;398:27–40.

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Posted on 17 March, 202316 March, 2023