The approval was based on the results from the Phase 3 RATIONALE 302 study in which Tevimbra indicated statistically significant and clinically meaningful survival benefit
FDA clears BeiGene's Tevimbra for oesophageal cancer. (Credit: Natural Herbs Clinic from Pixabay)
BeiGene has received the US Food and Drug Administration (FDA) approval for Tevimbra (tislelizumab-jsgr) to treat certain type of advanced oesophageal cancer in patients who were previously administered with chemotherapy.
Tislelizumab is a humanised monoclonal antibody with high affinity and binding specificity against programmed cell death protein 1 (PD-1). It is specifically intended to target PD-1.
The FDA has approved Tevimbra as monotherapy in adults with unresectable or metastatic oesophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
The approval was based on the results from the global, randomised, open-label, Phase 3 RATIONALE 302 study.
It assessed the efficacy and safety of the monoclonal antibody against investigator’s choice of chemotherapy as a second-line treatment in 512 patients.
The late-stage trial met its primary endpoint in the intention-to-treat (ITT) population.
The results indicated statistically significant and clinically meaningful survival benefit for Tevimbra in comparison to chemotherapy.
In the ITT group, the chemotherapy arm’s median overall survival (OS) was 6.3 months whereas the Tevimbra arm’s median OS was 8.6 months. Compared to chemotherapy, the anti-PD-1 monoclonal antibody had a safer profile.
BeiGene solid tumours chief medical officer Mark Lanasa said: “Today’s FDA approval of Tevimbra for patients with ESCC who have previously received chemotherapy, along with its ongoing review of our BLA for first-line ESCC patients, represents a significant step in our commitment to bringing this therapy to more patients around the world.
“As BeiGene’s first drug candidate produced through our immuno-oncology program and second approved medicine in the US, Tevimbra is poised to be a critical pillar of our solid tumour development programme, which spans more than 17 registration-enabling clinical trials in more than 30 countries across regions globally.”
The European Commission approved the medication in 2023 for advanced or metastatic ESCC following prior chemotherapy.
In addition, tislelizumab’s biologics license applications (BLAs) are being reviewed by the FDA as a first-line treatment in patients with certain gastric or gastroesophageal junction (G/GEJ) adenocarcinoma or ESCC.
The pharmaceutical company regained worldwide rights to develop, manufacture, and commercialise tislelizumab from Novartis in September last year.
BeiGene has started over 17 potentially registration-enabling trials with Tevimbra. Of which 11 Phase 3 randomised trials and four Phase 2 trials have already produced encouraging results.