- Adds tislelizumab, a uniquely designed anti-PD-1 monoclonal antibody for monotherapy and proprietary combination cancer therapies with Novartis portfolio and pipeline therapies
- Novartis will co-develop tislelizumab with BeiGene and expand access to patients in North America, Europe and Japan
- Specifically designed to minimize binding to FcγR on macrophages, tislelizumab will be key asset in Novartis immuno-oncology combination strategy
Basel, February 26, 2021 — Novartis today announced that it has closed the in-licensing of tislelizumab from BeiGene, Ltd. in North America, Europe and Japan. Tislelizumab is a uniquely designed anti-PD-1 antibody, specifically engineered to minimize binding to FcyR on macrophages, that is approved in China for certain patients with non-small cell lung cancer, classical Hodgkin’s lymphoma and metastatic urothelial carcinoma.
“We are very excited about the recent positive results from BeiGene’s global trials of tislelizumab in non-small cell lung cancer and esophageal squamous cell carcinoma and the opportunity to discuss these data with health authorities,” said Susanne Schaffert, PhD, President, Novartis Oncology. “We look forward to collaborating with BeiGene to initiate additional global clinical trials of tislelizumab in combination with Novartis Oncology therapies to fully tap the potential of this uniquely designed anti PD-1, and ultimately enable access to tislelizumab to people living with cancer.”
Novartis has identified multiple opportunities to combine tislelizumab with other therapies in the Novartis portfolio and pipeline. Tislelizumab is currently being studied in non-small cell lung cancer, gastric cancer, hepatocellular carcinoma and nasopharyngeal carcinoma, with broad potential in several other solid tumors.
This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” “to initiate," “to initiate,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for tislelizumab, or regarding potential future revenues from tislelizumab; or regarding opportunities to combine tislelizumab with other therapies in the Novartis portfolio and pipeline. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that tislelizumab will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that tislelizumab will be commercially successful in the future. Neither can there be any guarantee that efforts to combine tislelizumab with other therapies in the Novartis portfolio and pipeline will be successful in the expected timeframe, or at all. In particular, our expectations regarding tislelizumab could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.
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