Frontline tislelizumab plus chemotherapy significantly improved progression-free survival (primary endpoint) compared with chemotherapy alone in patients with non-squamous non-small cell lung cancer (NSCLC), according to phase III data published by the manufacturer of tislelizumab.
The open-label, multicenter, randomized BGB-A317-304 trial started enrollment in July 2018 and included 334 patients with previously untreated stage IIIB or stage IV non-squamous NSCLC without EGFR or ALK translocations. Patients were randomized 2:1 to receive tislelizumab 200 mg every three weeks combined with pemetrexed 500 mg/m2 and investigator’s choice of platinum chemotherapy (carboplatin or cisplatin) or pemetrexed and platinum chemotherapy alone.
Improved survival with addition of tislelizumab
At interim analysis, the trial met its primary endpoint, per independent review committee assessment.
The combination of tislelizumab and chemotherapy exhibited a safety profile consistent with the known profiles of each agent, and there were no new safety signals.
Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. Currently, tislelizumab is only approved in China for the treatment of previously treated classical Hodgkin lymphoma and locally advanced or metastatic urothelial carcinoma.