Phase III trial of tislelizumab + pemetrexed for first-line NSCLC met the primary endpoint of progression-free survival at interim analysis,- BeiGene

BeiGene, Ltd. a commercial-stage biotechnology company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, announced that the Phase III 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).

<p<The safety profile of tislelizumab in combination with pemetrexed and platinum chemotherapy was consistent with the known risks of each study treatment, and no new safety signals were identified.

This trial (NCT03663205, known as BGB-A317-304) is a Phase III, open-label, multi-center, randomized trial investigating tislelizumab (200mg every three weeks) combined with pemetrexed and investigator’s choice of platinum (either carboplatin or cisplatin) versus pemetrexed and platinum alone in patients with previously untreated stage IIIB or stage IV non-squamous NSCLC and with no EGFR mutations or ALK translocations. The primary endpoint is PFS as assessed by IRC. Key secondary endpoints included overall survival and safety. The study began enrollment in July 2018, and 334 patients were randomized 2:1 to receive tislelizumab in combination with chemotherapy or chemotherapy alone.