“Tislelizumab is the first medicine to come from BeiGene’s immuno-oncology research program and our team partnered with patients, caregivers, and clinical researchers across the world to generate the evidence supporting this CHMP recommendation,” said Lai Wang, Ph.D., Global Head of R&D at BeiGene. “We continue to make progress in our mission to bring the highest quality therapies to more people around the world and look forward to working with Novartis and health authorities on regulatory filings for tislelizumab.”

The Marketing Authorization Application (MAA) for ESCC is based on results from BeiGene’s RATIONALE 302, a global, randomized, open-label, Phase 3 study (NCT03430843) to investigate the efficacy and safety of tislelizumab when compared with investigator’s choice chemotherapy as a second-line treatment for patients with unresectable, locally advanced or metastatic ESCC. The study enrolled 513 patients from 132 research sites in 11 countries in Asia, Europe, and North America. The study met its primary endpoint with a statistically significant and clinically meaningful survival benefit for tislelizumab compared with chemotherapy (HR 0.70 [95%CI 0.57 - 0.85]; one-sided P=.0001; median overall survival 8.6 vs 6.3 months). The safety profile for tislelizumab was consistent with previous trials.ⁱ The MAA included safety data for 1,972 patients who received tislelizumab monotherapy in seven clinical trials.

Tislelizumab is not currently authorized for use in Europe.