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news.The US Food and Drug Administration (FDA) has granted approval for BeiGene’s TEVIMBRA (tislelizumab-jsgr) for the treatment of adults with specific types of gastric cancer.
TEVIMBRA is intended for the treatment of certain gastric cancers. Credit: derneuemann on Pixabay.
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The new indication specifically targets unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) expressing programmed death-ligand 1 (PD-L1).
The approval for the combination therapy as a first-line treatment for the indication is based on the findings of the randomised, placebo-controlled, double-blind Phase III RATIONALE-305 trial that aims to assess the therapy’s safety and efficacy. The trial met its primary endpoint, showing a significant improvement in overall survival (OS) rates.
Subjects receiving the combination therapy had a median OS of 15 months, compared to 12.9 months for those on placebo plus chemotherapy, representing a 20% decrease in the mortality risk.
BeiGene Solid Tumors chief medical officer Mark Lanasa said: “Today’s FDA approval of TEVIMBRA for the treatment of gastric or gastroesophageal junction cancers in PD-L1 positive adult patients marks a significant step forward in our mission to deliver transformative therapies to patients with cancer.
“This is the second US approval for TEVIMBRA this year, underscoring its potential to address critical needs in oncology.”
Safety data for the therapy was pooled from 1,972 subjects participating in seven studies that enrolled subjects with oesophageal squamous cell carcinoma and various advanced or recurrent tumours.
TEVIMBRA is a humanised immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody.
Designed with ‘high’ affinity and binding ‘specificity’ for PD-1, TEVIMBRA claims a distinct design that minimises interaction with Fc-gamma receptors on macrophages, enhancing the immune system’s ability to identify and diminish tumours.
In addition to its new approval, the therapy is already approved in the US as a single agent for adults with unresectable or metastatic oesophageal squamous cell carcinoma (ESCC) who have previously undergone systemic chemotherapy without a PD-(L)1 inhibitor.
Moreover, an additional biologics license application (BLA) is currently under FDA review for TEVIMBRA as a first-line treatment for locally advanced unresectable or metastatic ESCC.
BeiGene has also recently announced its plans to rebrand as BeOne Medicines.
