BeiGene receives positive CHMP opinions for tevimbra in gastric cancers

BeiGene (BGNE) announced that the Committee for Medicinal Products for Human Use – CHMP – of the European Medicines Agency issued positive opinions recommending an extended authorization for tevimbra – tislelizumab – in gastric or gastroesophageal junction, or G/GEJ, adenocarcinoma, and esophageal squamous cell carcinoma, or ESCC. In G/GEJ adenocarcinoma, the CHMP positive opinion is for tevimbra in combination with platinum- and fluoropyrimidine-based chemotherapy for the first-line treatment of adult patients with HER2-negative locally advanced unresectable or metastatic G/GEJ cancer whose tumors express PD-L1 with a tumor area positivity score greater than or equal to 5%. In ESCC, the CHMP positive opinion is for tevimbra in combination with platinum-based chemotherapy for the first-line treatment of adult patients with unresectable, locally advanced or metastatic ESCC whose tumors express PD-L1 with a TAP score greater than or equal to 5%. The study met its primary endpoint and demonstrated a statistically significant and clinically meaningful overall survival benefit with a median OS of 15.0 months for patients treated with tevimbra in combination with investigator’s choice of chemotherapy compared to 12.9 months for patients treated with placebo plus chemotherapy, resulting in a 20% reduction in the risk of death. In the PD-L1 greater than or equal to 5% population, the median OS was 16.4 months for tevimbra plus chemotherapy vs. 12.8 months for the placebo arm, which represents a 29% reduction in the risk of death. The study met its primary endpoint, with first-line tevimbra in combination with chemotherapy resulting in statistically significant and clinically meaningful OS benefit compared with placebo plus chemotherapy in the intent-to-treat population. Tevimbra is approved in the EU for eligible patients with advanced or metastatic ESCC after prior platinum-based chemotherapy and for three non-small cell lung cancer indications covering both the first- and second-line settings.