BeOne Medicines has secured approval from the European Commission (EC) for Tevimbra (tislelizumab) to be used along with gemcitabine and cisplatin for adult patients suffering from metastatic or recurrent nasopharyngeal carcinoma (NPC) for which curative surgery or radiotherapy is not an option.
NPC is a rare type of cancer in which malignant cells are formed in the upper part of the throat behind the nose.
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Tevimbra is a specially engineered humanised immunoglobulin G4 (IgG4) monoclonal antibody that targets programmed cell death protein 1 (PD-1) with high affinity and specificity.
Its design minimises interaction with Fc-gamma (Fcγ) receptors on macrophages, enhancing the ability of the body’s immune cells to recognise and combat tumours.
BeOne solid tumours chief medical officer Mark Lanasa stated: “Following our recent EU [European Union] 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.”
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By GlobalDataThe approval by the EC was based on the findings from RATIONALE-309, a Phase III double-blind, placebo-controlled multicentre study. It involved 263 participants who had not received previous treatment and were administered either Tevimbra alongside gemcitabine plus cisplatin, or a placebo in combination with gemcitabine plus cisplatin.
At its first prespecified interim analysis, the primary endpoint was achieved. It was shown that Tevimbra significantly extended progression-free survival (PFS).
The risk of disease progression or death was reduced by 48% within the intent-to-treat population. Patients receiving Tevimbra experienced a median PFS of 9.2 months compared to 7.4 months for those on placebo.
