EMA Begins Review of BeiGene, Novartis’s PD-1 Antibody for Esophageal and Lung Cancer

EMA has accepted the marketing authorization applications (MAA) for BeiGene’s anti-PD-1 antibody tislelizumab, submitted through license holder Novartis. The immunotherapy will be reviewed for treating esophageal squamous cell carcinoma (ESCC) and non-small cell lung cancers (NSCLC). If approved, it will be the first time tislelizumab is marketed outside of China. 

The review will cover tislelizumab for indications 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.

Trials Supporting the MAA for Tislelizumab

The MAA for tislelizumab is supported by results from three BeiGene-sponsored trials, including the Phase 3 Rationale 303 trial which pit tislelizumab against docetaxel in the second- or third-line treatment of locally advanced or metastatic NSCLC after platinum-based chemotherapy has failed. 

The randomized trial, which was held across the Americas, Europe, Asia, and Oceania, met its primary endpoint of overall survival in November 2020. Tislelizumab was also shown to be well-tolerated and its safety risks did not deviate from previously reported results. 

For ESCC, BeiGene’s Rationale 302 assessed tislelizumab against a chemotherapy picked by the investigators. Results of the randomized, global Phase 3 trial were presented at ASCO 2021, and included safety data from nearly 2,000 patients who received tislelizumab as monotherapy from seven trials. Besides Europe, the drug is also being evaluated by the US FDA and China’s NMPA for ESCC. 

Tislelizumab and Novartis

Novartis in-licensed tislelizumab from BeiGene at the start of 2021 in an effort to expand its oncology portfolio. 

Under the deal, BeiGene gave Novartis the right to develop and sell the drug in the US, Canada, the EU, Japan and seven other countries, in exchange for a $650 million upfront payment plus royalties and milestones. The Beijing-based company retained the rights to the drug in China and other countries.

Author

Joy Lin

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