First-Line Treatment of Advanced or Metastatic HER2-Negative Gastric Cancer with PD-L1 CPS ≥5

Clinical scenario

This protocol applies to patients with advanced or metastatic gastric cancer who are HER2-negative and have not yet received systemic treatment, where tumour biomarker testing shows a PD-L1 combined positive score (CPS) of 5 or more.

    A PD-L1 CPS of 5 or above is a defining eligibility criterion for the first-line immunotherapy-containing regimen described in this protocol. Biomarker testing for both HER2 status and PD-L1 CPS is required before treatment selection.
  

Treatment approach

For this population, the recommended first-line strategy incorporates nivolumab added to a chemotherapy backbone. The complete regimen — including the specific chemotherapy options and the full treatment algorithm — is set out in the structured protocol.

Instant Access to Structured Evidence-Based Regimens

References

DOI: 10.1016/j.annonc.2022.07.004

The phase III CheckMate 649 study evaluated the addition of nivolumab to ChT (either capecitabine–oxaliplatin or 5-FU–leucovorin–oxaliplatin) in patients with treatment-naive gastric, OGJ or oesophageal cancer.

Nivolumab–ChT resulted in significant improvements in OS and PFS versus ChT alone in patients with a PD-L1 CPS ≥5.

Nivolumab–ChT is recommended for advanced, untreated gastric, OGJ and oesophageal cancer with a PD-L1 CPS ≥5 [I, A; ESMO-MCBS v1.1 score: 4].

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