Originally published by our sister publication Clinical Oncology News

By Clinical Oncology News Staff

The FDA has approved tislelizumab-jsgr (Tevimbra, BeiGene), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) cancers in adults whose tumors express PD-L1 (programmed death ligand-1) (≥1).

The additional indication for first-line G/GEJ cancers is based on results from RATIONALE-305 (ClinicalTrials.gov. Identifier: NCT03777657), a randomized, double-blind, placebo-controlled, global phase 3 trial to evaluate the efficacy and safety of tislelizumab-jsgr in combination with chemotherapy as a first-line treatment for adult patients with advanced unresectable or metastatic G/GEJ cancers. The study met its primary end point and demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit with a median OS of 15.0 months for patients treated with tislelizumab-jsgr in combination with the investigator’s choice of chemotherapy compared with 12.9 months for those treated with placebo plus chemotherapy (n=997; hazard ratio, 0.80; 95% CI, 0.70-0.92; P=0.0011), resulting in a 20% reduction in the risk for death.

The pooled safety data in the application included 1,972 patients who received tislelizumab-jsgr monotherapy in two randomized, open-label, active-controlled studies (RATIONALE-302, BGB-A317-303) and five open-label, single-arm studies (BGB-A317-208, BGB-A317-204, BGB-A317-203, BGB-A317-102, BGB A317_Study_001), which enrolled 307 patients with esophageal squamous cell carcinoma and 1,665 with advanced or recurrent tumors. The most common grade 3 or 4 adverse reactions for tislelizumab-jsgr given in combination with chemotherapy were neutropenia, thrombocytopenia, anemia, fatigue, hypokalemia, hyponatremia, pneumonia, decreased appetite, rash, lymphopenia, alanine aminotransferase increased, aspartate aminotransferase increased, diarrhea, pneumonitis and hepatitis.

Tislelizumab-jsgr is also approved in the United States as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-L1 inhibitor. 

BeiGene recently announced its intent to change its name to BeOne Medicines Ltd.

The full prescribing information is posted here.

Based on a press release from BeiGene.