Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that HER2-positive and PD-L1 (CPS) >= 1 status confers therapeutic sensitivity to Cisplatin, Fluorouracil, Pembrolizumab, Trastuzumab in patients with Adenocarcinoma of the Gastroesophageal Junction.

The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with trastuzumab, fluoropyrimidine-, and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS >=1), as determined by an FDA-approved test. This indication is based on KEYNOTE-811 (NCT03615326), a multicenter, randomized, double-blind, placebo-controlled trial where patients received investigator's choice of chemotherapy between either cisplatin and 5-fu, or oxaliplatin and capecitabine.

This statement is based on a regulatory approval from the Food and Drug Administration:

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS >=1) as determined by an FDA-approved test.

Citation

Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/125514Orig1s186lbl.pdf. Revised February 2026. Accessed March 2, 2026. Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125514s143lbl.pdf. Revised November 2023. Accessed October 6, 2026.

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Contributions

Date Contributor Description
2025-03-19 Food and Drug Administration Indication received traditional approval.
2024-10-30 Van Allen lab Initial access of FDA approvals
2023-11-16 Food and Drug Administration Indication received accelerated approval.