BeOne announces EC approval of Tevimbra in combination with chemotherapy

BeOne Medicines (ONC) announced that the European Commission has approved TEVIMBRA, in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with metastatic or recurrent nasopharyngeal carcinoma, not amenable to curative surgery or radiotherapy. Nasopharyngeal carcinoma is a rare cancer in which malignant cells form in the nasopharynx, the upper part of the throat located behind the nose.The approval in NPC is based on results of RATIONALE-309, a double-blind, placebo-controlled, multicenter, Phase 3 study, which randomized 263 treatment-naive patients who received either TEVIMBRA in combination with gemcitabine plus cisplatin or placebo in combination with gemcitabine plus cisplatin. The primary endpoint was met at the first prespecified interim analysis in which TEVIMBRA significantly prolonged progression-free survival in the intent-to-treat population, showing a 48% reduction in the risk of disease progression or death. The median PFS in the TEVIMBRA plus chemotherapy arm was 9.2 months compared to 7.4 months in the placebo plus chemotherapy arm. An updated analysis with an additional 12 months of follow-up showed efficacy results consistent with the interim analysis. Clinically meaningful and sustained improvement in overall survival was observed, with a median OS of 45.3 months for TEVIMBRA plus chemotherapy compared to 31.8 months for placebo plus chemotherapy.