BeiGene has received the US Food and Drug Administration (FDA) approval for Tevimbra (tislelizumab-jsgr), in combination with platinum-based chemotherapy, for the treatment of metastatic oesophageal squamous cell carcinoma (ESCC).
Tevimbra is a humanised immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody.
It is designed to minimise binding to Fc-gamma (Fcγ) receptors on macrophages, enhancing the immune system’s ability to detect and combat tumours.
Tevimbra, which shows potential across various tumour types and disease settings, is approved in more than 42 countries and treated more than 1.3 million patients.
BeiGene solid tumours chief medical officer Mark Lanasa said: “Today’s approval, our third from the FDA in less than a year, reflects our dedication to advancing innovative therapies and addressing critical needs in cancer care.
“FDA approval of TEVIMBRA for the first-line treatment of advanced oesophageal squamous cell carcinoma marks a significant step forward in tackling the unmet needs in this challenging disease area.
“We are grateful to the patients, clinicians, and researchers whose commitment and courage have made this progress possible.”
The FDA approval is based on data from RATIONALE-306 randomised, placebo-controlled, double-blind Phase 3 study that evaluated the efficacy and safety of the Tevimbra regimen.
The study met its primary endpoint, showing a statistically significant improvement in overall survival (OS) for patients treated with Tevimbra combination compared to placebo plus chemotherapy.
In the PD-L1 positive subgroup, patients treated with Tevimbra plus chemotherapy showed a median OS of 16.8 months, compared to 9.6 months for placebo plus chemotherapy.
The results showed a 34% reduction in the risk of death, highlighting a remarkable improvement in OS for first-line ESCC patients.
Common adverse reactions include anaemia, fatigue, decreased appetite, nausea, constipation, weight loss, diarrhoea, peripheral sensory neuropathy, vomiting, and stomatitis.
Furthermore, BeiGene has announced plans to change its name to BeOne Medicines, reflecting its commitment to developing innovative treatments to eliminate cancer.
