BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) declared today that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for TEVIMBRA® (tislelizumab) combined with fluoropyrimidine- and platinum-containing chemotherapy. This application targets the treatment of patients grappling with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. The FDA is anticipated to make a decision on the BLA by December 2024.

BeiGene, emphasized the pressing necessity for fresh treatment alternatives in gastric cancer, often diagnosed at advanced stages. He highlighted TEVIMBRA's potential to bolster survival rates in patients afflicted with gastric and gastroesophageal junction cancer, expressing optimism about its potential as a new treatment avenue.

The BLA submission draws upon findings from the global RATIONALE-305 trial, demonstrating substantial efficacy. Results indicated an overall survival of 15.0 months with TEVIMBRA plus chemotherapy compared to 12.9 months with placebo plus chemotherapy, signifying a 20% decrease in the risk of death. Moreover, TEVIMBRA plus chemotherapy showcased a higher objective response rate and longer duration of response compared to the placebo combination. Safety evaluations revealed a manageable profile consistent with known anti-PD-1 antibody safety profiles.

In RATIONALE-305, Grade ≥3 treatment-related adverse events (TRAEs) were reported in 53.8% of patients receiving TEVIMBRA plus chemotherapy and 49.8% of patients receiving placebo plus chemotherapy. Common TRAEs included nausea, decreased appetite, platelet count decrease, neutrophil count decrease, vomiting, and anemia.

TEVIMBRA recently secured approval from the European Commission for treating patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) post-chemotherapy. The FDA is also reviewing a BLA for TEVIMBRA as a first-line treatment for unresectable, recurrent, locally advanced, or metastatic ESCC, with a decision expected in July 2024. Additionally, a BLA for treating patients with advanced or metastatic ESCC post-chemotherapy is under FDA review.

BeiGene has initiated over 17 potentially registration-enabling trials involving TEVIMBRA, with 11 Phase 3 randomized trials and 4 Phase 2 trials already yielding positive outcomes. These trials collectively demonstrate TEVIMBRA's capacity to significantly improve survival outcomes and enhance quality of life for numerous cancer patients across various tumor types, irrespective of PD-(L)1 status, whether used alone or in combination with other regimens. Globally, more than 900,000 patients have received prescriptions for TEVIMBRA to date.

RATIONALE-305 (NCT03777657) enrolled 997 patients with advanced unresectable or metastatic G/GEJ adenocarcinoma in a randomized, double-blind, placebo-controlled, global Phase 3 trial. The primary endpoint was overall survival, with a prespecified hierarchy testing for the PD-L1 high population followed by the intent-to-treat (ITT) population. Results from the ITT population were presented at the European Society for Medical Oncology (ESMO) Congress 2023.

Gastric cancer ranks as the fifth most common cancer worldwide and the fifth highest cause of cancer mortality. In 2022, nearly 1 million new cases of gastric cancer were diagnosed globally, with 660,000 reported deaths. In the U.S., approximately 27,000 new cases and 11,000 deaths were reported in 2024, with a five-year survival rate of 36%. Gastroesophageal junction adenocarcinoma typically occurs at the juncture of the esophagus and stomach, just below the diaphragm.

TEVIMBRA® (tislelizumab) is a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody designed to have high affinity and binding specificity against PD-1. Its design minimizes binding to Fc-gamma (Fcγ) receptors on macrophages, enhancing the body’s immune response against tumors.

 

Source: beigene.com

Report Abuse