Lancet: Nivolumab + chemotherapy is significantly better than chemotherapy alone for advanced gastroesophageal adenocarcinoma

The median overall survival (OS) of patients with advanced or metastatic human epidermal growth factor receptor 2 (HER2) negative gastric or gastroesophageal junction adenocarcinoma after first-line chemotherapy is less than 1 year
.

The CheckMate 649 study aims to evaluate the application of PD-1 inhibitor-based first-line therapy in the junction of the stomach and gastroesophagus and esophageal adenocarcinoma

This article reports the preliminary results of nivolumab combined with chemotherapy compared to chemotherapy alone for such patients

The CheckMate 649 study is a multi-center, randomized, open-label Phase 3 clinical trial that recruited untreated, unresectable, non-HER2-positive, non-HER2 positive patients who were over 18 years old from 175 hospitals and cancer centers in 29 countries Patients with gastric, gastroesophageal junction or esophageal adenocarcinoma, regardless of the expression of PD-1/L1
.

The tested patients were randomly divided into three groups 1:1:1 and received nivolumab combined with chemotherapy, nivolumab combined with ipilimumab or chemotherapy alone

OS: (A) Patients with PD-L1 CPS≥5 points (B) Patients with PD-L1 CPS≥1 points

OS: (A) Patients with PD-L1 CPS≥5 points (B) Patients with PD-L1 CPS≥1 points

From March 27, 2017 to April 24, 2019, among the 2687 patients who qualified for the assessment, the researchers randomly assigned 1581 patients to two groups ( nivolumab + chemotherapy group: 789 people, 50%) ; Single chemotherapy group: 792 people, 50% )
.

The median follow-up OS of the nivolumab + chemotherapy group and the single chemotherapy group were 13.

Nivolumab + chemotherapy group: 789 people, 50%; single chemotherapy group: 792 people, 50% of the patients with PD-L1 combined positive score (CPS) ≥ 5 (the shortest follow-up 12.

PFS: (A) patients with PD-L1 CPS≥5 points (B) patients with PD-L1 CPS≥1 points

PFS: (A) patients with PD-L1 CPS≥5 points (B) patients with PD-L1 CPS≥1 points

Among all the patients receiving treatment, 462 (59%) of 782 patients in the nivolumab combined chemotherapy group had grade 3-4 treatment-related adverse events, while among the 767 patients in the single chemotherapy group, there were 341 (44%)
.

The most common grade 3-4 treatment-related adverse events (≥25%) in the two groups were nausea, diarrhea, and peripheral neuropathy

In conclusion, among patients with advanced gastric, gastro-esophageal junction or esophageal adenocarcinoma who have not been treated before, nivolumab is the first to be used in combination with chemotherapy to show OS, PFS and acceptable safety superior to chemotherapy alone.
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Nivolumab combined with chemotherapy may become a new choice for such patients

Among previously untreated patients with advanced gastric, gastro-esophageal junction or esophageal adenocarcinoma, nivolumab is the first to be used in combination with chemotherapy to demonstrate OS, PFS and acceptable safety over chemotherapy alone PD-1 inhibitors In patients with advanced gastric, gastro-esophageal junction or esophageal adenocarcinoma who have not been treated before, nivolumab is the first to be used in combination with chemotherapy to show superior OS, PFS, and efficacy in combination with chemotherapy.

Original source:

Yelena Y Janjigian, et al.

First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial in this message