Therapeutic Response

HER2-negative and PD-L1 (TAP) >= 1% status confers therapeutic sensitivity to Cisplatin in combination with Fluorouracil and Tislelizumab in patients with Adenocarcinoma of the Gastroesophageal Junction.

Statements

Source and description

Tevimbra (tislelizumab-jsgr) [package insert]. FDA. 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.