The European Commission (EC) has approved BeOne Medicines’ Tevimbra (tislelizumab) as part of a first-line combination treatment for nasopharyngeal cancer.
The company formerly known as BeiGene announced that the drug has been authorised in combination with gemcitabine and cisplatin chemotherapy to treat adults with metastatic or recurrent nasopharyngeal carcinoma that is not amenable to curative surgery or radiotherapy.
The EC’s decision was supported by positive results from the late-stage RATIONALE-309 trial, in which Tevimbra demonstrated a 48% reduction in the risk of disease progression or death compared to placebo in the intent-to-treat population. Median progression-free survival in the Tevimbra plus chemotherapy cohort was 9.2 months versus 7.4 months in the placebo plus chemotherapy arm.
Clinically meaningful and sustained improvements in overall survival were also observed, with a median overall of 45.3 months for Tevimbra plus chemotherapy compared to 31.8 months for placebo plus chemotherapy.
Accounting for approximately 133,000 of new global cancer cases in 2020, nasopharyngeal cancer is a form of head and neck cancer that starts in the upper throat passage that connects the nose to the lungs.
The disease is often diagnosed at advanced stages and, while the overall five-year survival rate is around 63%, this decreases to 49% for those with advanced cases.
Administered as an intravenous infusion, Tevimbra is a humanised immunoglobulin G4 anti-PD-1 monoclonal antibody that is designed to help the body’s immune cells detect and fight tumours.
“The approval of Tevimbra combined with chemotherapy in Europe marks an important advancement for people with recurrent or metastatic nasopharyngeal carcinoma – a rare and challenging disease,” said Lisa Licitra, chief of the head and neck cancer medical oncology department at Fondazione IRCCS Istituto Nazionale dei Tumori, Italy.
Beyond nasopharyngeal cancer, Tevimbra is already approved in the EU to treat certain cases of non-small lung cancer, small cell lung cancer, oesophageal squamous cell carcinoma and gastric or gastroesophageal junction adenocarcinoma.
Mark Lanasa, chief medical officer, solid tumours at BeOne, 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.”