Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-negative, PD-L1 (TAP) >= 1% status confers therapeutic sensitivity to Capecitabine, Oxaliplatin, Tislelizumab in patients with Adenocarcinoma of the Gastroesophageal Junction.
The U.S. Food and Drug Administration (FDA) granted approval to tislelizumab in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of adult patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors are HER2-negative and express PD-L1 (>=1). This indication is based on RATIONALE-305, a randomized, multicenter, double-blind, placebo-controlled trial where the chemotherapy regimens consisting of either: oxaliplatin and capecitabine, or cisplatin and 5-FU. Patients were enrolled regardless of their tumor's PD-L1 expression level, but PD-L1 status was evaluated using both TAP and CPS criteria.
This statement is based on a regulatory approval from the Food and Drug Administration:
TEVIMBRA is a programmed death receptor-1 (PD-1)-blocking antibody indicated in combination with platinum and fluoropyrimidine-based chemotherapy in adults for the first line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocracinoma whose tumors express PD-L1 (>=1).