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FDA to Evaluate BeiGene’s Tevimbra Combination for Gastric/Gastroesophageal Junction Adenocarcinoma


Trial data support Tevimbra combined with chemotherapy as a potential first-line treatment option for patients with locally advanced, unresectable or metastatic gastric or gastroesophageal junction cancer.

Image credit: Riz | stock.adobe.com

Image credit: Riz | stock.adobe.com

The FDA has accepted BeiGene’s Biologics License Application (BLA) for Tevimbra (tislelizumab) plus fluoropyrimidine- and platinum-containing chemotherapy, for locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. The humanized immunoglobulin G4, anti-PD-1 monoclonal antibody was specifically developed to minimize binding to the Fc-gamma receptors on macrophages.

“There is an urgent need for new treatment options for gastric cancer, which is often diagnosed at the advanced or metastatic stage,” said BeiGene Chief Medical Officer, Solid Tumors, Mark Lanasa, MD, PhD, in a press release. “In clinical trials, Tevimbra has demonstrated its potential to improve survival for patients with gastric and gastroesophageal junction cancer. This FDA acceptance brings us one step closer to delivering on a new treatment option for patients who often face poor prognoses.”1

The BLA submission was based on findings from the randomized, double-blind, placebo-controlled, global Phase III RATIONALE-305 (NCT03777657) trial. The study’s primary endpoint was overall survival (OS), with a prespecified hierarchy evaluation for the PD-L1 high patients population followed by the intent-to-treat population. Investigators enrolled 997 patients with advanced unresectable or metastatic G/GEJ adenocarcinoma.

The trial compared the efficacy and safety of Tevimbra plus platinum and fluoropyrimidine chemotherapy vs. placebo combined with platinum fluoropyrimidine chemotherapy as a first-line treatment. The 997 patients came from 13 countries and regions and were randomly assigned 1:1 to either the Tevimbra combination cohort or the placebo cohort. An OS analysis was conducted after an evaluation in the PD-L1 high population, which was found to be statistically significant in favor of the Tevimbra combination. Secondary endpoints included duration of response (DOR), overall response rate (ORR), progression-free survival (PFS), and safety.

In April 2023, BeiGene announced findings from an interim analysis of the trial, which showed a statistically significant and clinically meaningful OS improvement in the high PD-L1 expression cohort, with a consistent safety profile across the entire study population.2

“These data support [Tevimbra] combined with chemotherapy as a potential first-line treatment option for patients with locally advanced, unresectable or metastatic gastric, or gastroesophageal junction cancer,” Lanasa said.2

Prior data from a planned interim analysis show superior OS for the Tevimbra combination vs. chemotherapy in the PD-L1 high patient population. Tevimbra plus investigator’s choice of chemotherapy achieved the trial’s primary endpoint of OS at 15.0 months compared with 12.9 months in the placebo cohort, which translates to a 20% decrease in the risk of death. The ORR for the combination was 47.3% compared with 40.5% with placebo and median DOR was 8.6 months in the treatment cohort compared with 7.2 months in the placebo cohort.

Median PFS with the combination was 6.9 months compared with 6.2 months in the placebo cohort. In terms of safety, the Tevimbra combination was found to be manageable with no new safety signals differing from the known safety profile of anti-PD-1 antibodies.

Grade ≥3 treatment-related adverse events (TRAEs) were observed in 53.8% of patients administered the combination compared with 49.8% of those in the placebo cohort. The most common any grade TRAEs with an incidence ≥30% were nausea, reduced appetite, reduced platelet count, reduced neutrophil count, vomiting, and anemia.

The FDA assigned the BLA with a Prescription Drug User Fee Act date for December 2024.


1. BeiGene’s Biologics License Application for TEVIMBRA® (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDA. BeiGene. February 27, 2024. Accessed February 27, 2024. https://ir.beigene.com/news/beigene-s-biologics-license-application-for-tevimbra-tislelizumab-for-first-line-gastric-or-gastroesophageal-junction-cancers-accepted/4cc83f12-9249-4984-9a2a-c607c8a6e879/

2. BeiGene announces positive phase 3 tislelizumab trial in advanced gastric or gastroesophageal junction adenocarcinoma. News release. BeiGene. April 20, 2023. Accessed February 27, 2024. https://ir.beigene.com/news/beigene-announces-positive-phase-3-tislelizumab-trial-in-advanced-gastric-or-gastroesophageal-junction-adenocarcinoma/dc7ae8df-dbbb-4de2-834f-0f74feaaa519/

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