BeiGene‘s Phase 3 Trial of Tislelizumab for First-Line Non-Squamous Non-Small Cell Lung Cancer Meets Primary Endpoint at Interim Analysis

BeiGene‘s Phase 3 Trial of Tislelizumab for First-Line Non-Squamous Non-Small Cell Lung Cancer Meets Primary Endpoint at Interim Analysis

BeiGene announced that the Phase 3 trial evaluating its anti-PD-1 antibody tislelizumab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with non-squamous non-small cell lung cancer (NSCLC) met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) compared to pemetrexed and platinum chemotherapy alone at the planned interim analysis, as assessed by independent review committee (IRC).

The open-label, multi-center, randomized trial began enrollment in July 2018, and 334 patients with previously untreated stage IIIB or stage IV non-squamous NSCLC and with no EGFR mutations or ALK translocations. The patients were randomized 2:1 to receive tislelizumab (200mg every three weeks) combined with pemetrexed and investigator’s choice of platinum (either carboplatin or cisplatin) versus pemetrexed and platinum alone. The primary endpoint is PFS as assessed by IRC. Key secondary endpoints included overall survival and safety. 

BeiGene plans to file a supplemental new drug application (sNDA) with the Center for Drug Evaluation (CDE) at the National Medical Product...

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