Top-line Phase III results for tislelizumab in ESCC show improved survival

Sino-American biotech firm BeiGene (Nasdaq: BGNE) says that the global Phase III RATIONALE 302 trial of its anti-PD-1 antibody tislelizumab versus investigator’s choice chemotherapy in patients with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have received prior systemic treatment met its primary endpoint.

In the trial results, tislelizumab demonstrated a statistically-significant and clinically-meaningful improvement in overall survival (OS) in the intention-to-treat (ITT) population, when compared to chemotherapy. The safety profile of tislelizumab was consistent with its known risks, with no new safety signals identified.

Earlier this month, BeiGene signed a deal with Novartis (NOVN: VX), granting the Swiss giant the right to develop and commercialize the treatment in major markets outside of China, in a deal that earned the company $650 million upfront and eligibility for a further $1.3 billion in regulatory milestones and up to $250 million based on sales targets, plus royalties.