Novartis expands oncology pipeline with in-licensing of tislelizumab from BeiGene.

Novartis has signed a strategic collaboration agreement to in-license tislelizumab from BeiGene, Ltd. in major markets outside of China, accelerating the potential for Novartis to enter the large and growing checkpoint inhibitor field. Tislelizumab is an anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcyR on macrophages. In pre-clinical studies, binding to Fc?R on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Under the terms of the agreement, Novartis will obtain the development and commercialization rights to tislelizumab in the United States, Canada, Mexico, the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan in exchange for an upfront payment of $ 650 million plus royalties and milestone payments. BeiGene will retain the rights to tislelizumab in China and other countries. The transaction has been approved by the Boards of Directors of both companies. More than 7,700 patients have been enrolled in 15 potentially registration-enabling clinical trials with tislelizumab in a dozen indications, including non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma, gastric cancer and nasopharyngeal carcinoma. The first ex-China regulatory filing is expected in 2021. In addition, Novartis and BeiGene have identified multiple tislelizumab plus Novartis therapy combination clinical trial opportunities in solid tumors. Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for certain patients with classical Hodgkin’s lymphoma and metastatic urothelial carcinoma. In addition, BeiGene has filed three supplemental new drug applications for tislelizumab in China for first-line treatment of patients with advanced squamous NSCLC in combination with chemotherapy, first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and previously treated unresectable HCC.