Gastric and Gastroesophageal Junction Cancer · Medical · Advanced / Metastatic · First-line HER2-negative advanced gastric/GEJ adenocarcinoma, PD-L1 CPS ≥1

KEYNOTE-062

Clinical question: In first-line her2-negative advanced gastric/gej adenocarcinoma, pd-l1 cps ≥1, does the investigational strategy improve clinically meaningful outcomes versus its control?

Registry: NCT02494583 · One underlying study; aliases and follow-up publications consolidated.

Phase III, randomized, open-label, three-arm trial; 763 patients. Evidence cut-off: 13 November 2026.

Design, population and eligibility

Design / sample size

Phase III, randomized, open-label, three-arm trial; 763 patients.

Eligibility

Previously untreated locally advanced unresectable or metastatic HER2-negative gastric/GEJ adenocarcinoma with PD-L1 CPS ≥1.

Intervention

Pembrolizumab alone; pembrolizumab + cisplatin/fluoropyrimidine; or chemotherapy alone.

Pembrolizumab 200 mg IV every 3 weeks; chemotherapy was cisplatin plus 5-FU or capecitabine per protocol.

Comparator

As described in the study design; see primary publication.

Primary endpoint: OS and PFS with hierarchical testing; primary comparisons included pembrolizumab monotherapy and pembrolizumab-chemotherapy versus chemotherapy.

Key efficacy outcomes

CPS ≥1: pembrolizumab OS 10.6 vs 11.1 months, HR 0.91 (99.2% CI 0.69–1.18), meeting non-inferiority but not superiority. Pembrolizumab + chemotherapy OS 12.5 vs 11.1 months, HR 0.85 (95% CI 0.70–1.03); superiority not demonstrated. CPS ≥10 monotherapy OS 17.4 vs 10.8 months, HR 0.69, but this comparison was not formally tested after hierarchy failure.

Reported outcome

10.6

Comparator: 11.1. The bars are a simple display of the first reported pair only; consult the endpoint and time horizon above.

Safety and treatment delivery

Grade 3–5 TRAEs: pembrolizumab 17%, pembrolizumab-chemotherapy 73%, chemotherapy 69%.

Clinical interpretation and limitations

A critical negative/discordant first-line study. Do not claim pembrolizumab-chemotherapy superiority or definitive CPS ≥10 monotherapy superiority from the exploratory/un-tested subgroup. Monotherapy non-inferiority is not superiority.

Interpret the reported hazard ratios in the context of the prespecified endpoint, statistical hierarchy, follow-up maturity, crossover/subsequent therapy and enrolled population. Median survival differences are not risk differences and must not be converted into NNT.

Absolute effect

No NNT/NNH is displayed unless an absolute event-risk difference at a clearly stated fixed timepoint can be calculated from reported trial data. Median survival differences and hazard ratios alone do not support an NNT. The visual above uses reported outcome data only.

Primary publication and follow-up

Primary publication

Registry / follow-up / authoritative source

Source-level verification status: primary publication identified and key quoted outcomes transcribed; where full-text toxicity or procedural details were not available, the page explicitly flags the limitation rather than inferring values.

Current-practice context · 13 November 2026

This page separates historical trial results from contemporary practice. Verify the applicable jurisdictional guideline, regulatory approval, biomarker assay, liver function, comorbidity and treatment availability before applying the evidence. NCCN Guidelines Insights are not a substitute for the full NCCN guideline.

Guideline/regulatory reconciliation and browser-rendered QA remain scheduled for the subsequent quality-control pass.