BeiGene Secures Approval for TEVIMBRA in First-Line Treatment of Advanced Oesophageal and Gastric Cancers
Thursday, November 28, 2024
BeiGene has received approval from the European Commission for TEVIMBRA® (tislelizumab) in combination with chemotherapy as a first-line treatment for advanced or metastatic oesophageal squamous cell carcinoma (ESCC) and gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
Gastric cancer remains one of the leading causes of cancer mortality worldwide, with nearly one million new cases annually. Similarly, oesophageal cancer, particularly ESCC, poses significant challenges due to high mortality rates and limited survival prospects.
TEVIMBRA, a humanised anti-PD-1 monoclonal antibody, plays a key role in BeiGene's cancer treatment portfolio. Its clinical programme spans 66 global trials, with approvals in 42 countries and over 1.3 million patients treated worldwide.
This approval is based on evidence from two pivotal trials—RATIONALE-306 and RATIONALE-305—highlighting TEVIMBRA’s effectiveness. The trials demonstrated significant improvements in overall survival (OS) for eligible patients with high PD-L1 expression.
In ESCC, TEVIMBRA with platinum-based chemotherapy is now approved for adults with locally advanced or metastatic cancer expressing PD-L1 with a tumour area positivity (TAP) score of 5% or more. Similarly, in HER2-negative G/GEJ adenocarcinoma, TEVIMBRA combined with platinum and fluoropyrimidine chemotherapy is authorised for first-line treatment of eligible adults with advanced or metastatic disease.
In the RATIONALE-306 study for ESCC, TEVIMBRA combined with chemotherapy resulted in a median OS of 17.2 months compared to 10.6 months for the placebo group, reflecting a 34% reduction in the risk of death. In patients with a TAP score of 5% or higher, the median OS improved to 19.1 months, representing a 38% risk reduction.
For G/GEJ adenocarcinoma, the RATIONALE-305 trial demonstrated a median OS of 15 months for patients receiving TEVIMBRA with chemotherapy versus 12.9 months in the placebo group. Among patients with PD-L1 expression of 5% or more, the median OS was 16.4 months, marking a 29% reduction in the risk of death.
TEVIMBRA’s safety data was assessed in over 2,800 patients, with common grade 3 or 4 side effects including neutropenia, anaemia, fatigue, and liver enzyme elevations. These findings align with the known safety profile of immunotherapy-based treatments.
TEVIMBRA is already approved in the European Union for several other indications, including certain non-small cell lung cancers and advanced ESCC following prior chemotherapy. BeiGene’s portfolio reflects its ongoing commitment to expanding treatment access and improving outcomes for cancer patients globally.
With this latest authorisation, BeiGene strengthens its position as a provider of innovative oncology solutions while addressing the unmet medical needs of patients across Europe.
Source: beigene.com
