BeiGene Announces European Medicines Agency Acceptance of Marketing Authorization Applications for Tislelizumab for the Treatment of Patients with ESCC and NSCLC

On Apr 6, 2022

BeiGene, Ltd. a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide, today announced that marketing authorization applications (MAA) for tislelizumab, submitted by Novartis, the license holder in Europe, have been validated for regulatory review by the European Medicines Agency (EMA) for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy and for patients with non-small cell lung cancers (NSCLC) including:

As monotherapy for the treatment of locally advanced or metastatic NSCLC after prior chemotherapy in adults,
In combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of locally advanced or metastatic squamous NSCLC in adults, and
In combination with pemetrexed and platinum-containing chemotherapy for the first-line treatment of locally advanced or metastatic non-squamous NSCLC in adults whose tumors have no EGFR or ALK positive mutations.

“In our global Phase 3 trials in second line ESCC and NSCLC, tislelizumab monotherapy demonstrated significant improvements in overall survival and was generally well-tolerated in these patient groups. In the two Phase 3 studies in first line NSCLC, tislelizumab in combination with chemotherapy demonstrated significant improvements in progression free survival compared to chemotherapy alone in both non-squamous and squamous histology, and the addition of tislelizumab to chemotherapy was generally well-tolerated with no new safety signal observed. These first submissions for tislelizumab to the EMA highlight the momentum in our collaboration with Novartis, and we look forward to continued progress as they submit tislelizumab for approvals in their licensed territories,” commented Mark Lanasa, M.D., Ph.D., Senior Vice President, Chief Medical Officer, Solid Tumors, at BeiGene. “We are motivated each day to advance tislelizumab’s progress on behalf of the many patients in Europe and around the world with these cancers, for whom we hope to provide an important new treatment option.”

The MAA for tislelizumab in NSCLC is supported by clinical results from three BeiGene-sponsored trials (NCT03358875, NCT03594747, NCT03663205) of 1,499 patients, including the global randomized, open-label, Phase 3 RATIONALE 303 trial comparing tislelizumab to docetaxel in the second- or third-line setting in patients with locally advanced or metastatic NSCLC who have progressed on prior platinum-based chemotherapy. In this trial, 805 patients in 10 countries across the Americas, Europe, Asia, and Oceania were enrolled in the trial, randomized 2:1 to either the tislelizumab arm or the docetaxel arm. As announced in November 2020, the trial met the primary endpoint of overall survival (OS) at the planned interim analysis, as recommended by the independent Data Monitoring Committee (IDMC). Tislelizumab was generally well-tolerated, consistent with known safety risks from previously reported results across different tumor types, with no new safety signals identified. The results of the interim analysis of the trial were presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2021.

The MAA submission for ESCC is based on results from BeiGene’s RATIONALE 302, a randomized, open-label, multicenter global Phase 3 trial (NCT03430843) designed to evaluate the efficacy and safety of tislelizumab when compared to investigator’s choice chemotherapy as a second-line treatment for patients with advanced or metastatic ESCC. Results of this trial were presented at the 2021 American Society of Clinical Oncology Annual Meeting (ASCO 2021). The submission also included safety data on 1,972 patients who received tislelizumab as a monotherapy from seven clinical trials. A biologics license application (BLA) in this indication is currently under review by the U.S. FDA. In addition to the EU and the U.S., this indication is also under regulatory review in China.