A Nature research paper reports long term follow up results from the CheckMate 649 Phase III trial of chemo and immunotherapy in gastric cancer
In conclusion, the long-term clinically meaningful overall survival and PFS benefit, improved and durable responses, maintained health-related quality of life, and acceptable safety profile indicate a favourable benefit–risk profile of nivolumab plus chemotherapy. These results further support the use of this regimen as a standard first-line treatment in previously untreated patients with advanced gastric, GEJ or oesophageal adenocarcinoma.
Tumours were assessed using computed tomography or magnetic resonance imaging per RECIST, version 1.1, at baseline, every 6 weeks from the start of cycle 1 for 48 weeks and every 12 weeks thereafter, until disease progression per BICR assessment. Adverse events were assessed throughout the treatment period and during follow-up according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0.
For nivolumab plus ipilimumab versus chemotherapy, the analysis of overall survival was pre-planned at a minimum follow-up of approximately 36 months, which corresponded with the pre-planned final analysis of overall survival for nivolumab plus chemotherapy versus chemotherapy at a 24-month minimum follow-up.
The statistical power estimation for the comparison of primary endpoints for the nivolumab-plus-chemotherapy versus the chemotherapy groups has been described previously
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