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Adding the immunotherapy nivolumab to first-line chemotherapy helped patients with advanced stomach and oesophageal adenocarcinoma live longer, especially when the tumour showed PD-L1, making chemo-immunotherapy the new standard.
Open-label phase 3 trial of 1,581 patients with untreated, HER2-negative advanced gastric, gastro-oesophageal junction or oesophageal adenocarcinoma randomised to nivolumab plus chemotherapy (XELOX or FOLFOX) or chemotherapy alone (a third arm tested nivolumab plus ipilimumab). Primary endpoints were OS and PFS in patients with PD-L1 combined positive score (CPS) of 5 or more.
In CPS 5 or more, median OS was 14.4 vs 11.1 months (HR 0.71) and PFS 7.7 vs 6.0 months (HR 0.68); in all randomised patients OS was 13.8 vs 11.6 months (HR 0.80). It was the first immunotherapy to improve first-line survival in gastric cancer and it made PD-L1 CPS testing standard, though regulators disagreed about the CPS threshold for use.
Patients with newly diagnosed advanced stomach or oesophageal adenocarcinoma whose tumour is HER2-negative and PD-L1 positive (CPS 5 or more, or at least 1 in some regions) should receive chemotherapy with nivolumab (or pembrolizumab, from KEYNOTE-859), which adds about three months of median survival and doubles the chance of being alive at three years. The benefit in PD-L1-negative tumours is doubtful, and these patients may be better served by chemotherapy alone or by trials.
Shares Jaffer A. Ajani, Yelena Y. Janjigian, PD-L1-high gastric cancer, Combined positive score (CPS).
Shares Lines of therapy, Progression-free survival (PFS), Overall survival (OS), No one can predict who responds to immunotherapy.
Shares Lines of therapy, Combined positive score (CPS), Progression-free survival (PFS), Overall survival (OS).
Shares Kohei Shitara, Lines of therapy, Progression-free survival (PFS), Overall survival (OS).
Shares Jaffer A. Ajani, Ipilimumab, Oesophageal cancer, Nivolumab.
Shares Lines of therapy, Progression-free survival (PFS), Overall survival (OS), No one can predict who responds to immunotherapy.
Shares Lines of therapy, Progression-free survival (PFS), Overall survival (OS), No one can predict who responds to immunotherapy.
Shares Lines of therapy, Progression-free survival (PFS), Regulatory divergence between regions, Overall survival (OS).