BeOne Medicines has received the European Commission (EC) approval for Tevimbra (tislelizumab) in combination with gemcitabine and cisplatin to treat a type of nasopharyngeal carcinoma (NPC).
Nasopharyngeal carcinoma is a rare cancer where malignant cells form in the nasopharynx, the upper part of the throat behind the nose.
Tevimbra is a humanised immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody, designed to enhance the immune system’s ability to detect and fight tumours.
The drug was previously approved in the EU for gastric or gastroesophageal junction adenocarcinoma, oesophageal squamous cell carcinoma, extensive-stage small cell lung cancer, and three non-small cell lung cancer indications.
The current approval expands its indications, to include adult patients with metastatic or recurrent NPC who are not eligible for surgery or radiotherapy.
BeOne solid tumours’ chief medical officer Mark Lanasa said: “Following our recent EU approval of Tevimbra for extensive-stage small cell lung cancer, this new authorisation in nasopharyngeal carcinoma reflects strong momentum in broadening access to our immunotherapy across solid tumours.
“With a comprehensive EU label spanning lung and gastrointestinal cancers, and more than 100 regulatory approvals globally, we are delivering on our ambition to bring innovative therapies to more patients around the world.”
The EC’s approval is based on the RATIONALE-309 study, a double-blind, placebo-controlled, multicentre Phase 3 trial.
The study involved 263 treatment-naïve patients, with results showing that Tevimbra significantly prolonged progression-free survival (PFS) by 48% compared to placebo.
The median PFS for patients receiving Tevimbra plus chemotherapy was 9.2 months, compared to 7.4 months for those on placebo plus chemotherapy.
An updated analysis with an additional 12 months of follow-up confirmed the efficacy results.
The median overall survival (OS) was 45.3 months for Tevimbra plus chemotherapy, compared to 31.8 months for placebo.
Safety data pooled from over 3,900 patients indicated that Tevimbra, whether as monotherapy or in combination with chemotherapy, was generally well tolerated.
The most common adverse reactions were neutropenia, anaemia, and thrombocytopenia.
Tevimbra is a key asset in BeOne’s solid tumour portfolio, demonstrating potential across various tumour types and disease settings.
The global clinical development programme for Tevimbra includes nearly 14,000 patients across 35 countries and regions in 70 trials, with 21 being registration-enabling studies.
Tevimbra is approved in 46 countries and treated over 1.5 million patients worldwide.
