A BeiGene cancer immunotherapy has received a long anticipated approval, but the regulatory win comes as the company loses its partnership on the drug with Novartis, which had inked the global development and commercialization alliance as part of its own immunotherapy ambitions.
The European Commission approval announced Tuesday for the BeiGene drug, tislelizumab, covers the treatment of adults whose esophageal squamous cell carcinoma has advanced after treatment with chemotherapy. The drug is already approved in China, where BeiGene is based. The immunotherapy will be marketed in Europe under the brand name Tevimbra.
Tevimbra is a checkpoint inhibitor, a type of drug that blocks proteins that stop the immune system from recognizing a cancer cell. The BeiGene drug is an antibody designed to block PD-1, a checkpoint protein found on T cells. While the checkpoint inhibitor market is dominated by Merck’s Keytruda and Bristol Myers Squibb’s Opdivo, the BeiGene drug would give Novartis an opportunity to compete.
In 2021, Novartis paid $650 million up front to license Tevimbra’s rights in North America, Europe, and Japan. At the time, the Swiss pharmaceutical giant said the deal accelerated its immunotherapy strategy, providing it a drug that could be the basis of multiple potential combinations with Novartis products. Now, those combinations are less certain.
According to a BeiGene regulatory filing, the two companies mutually ended their Tevimbra partnership effective Sept. 17. The termination returns to BeiGene all rights to the drug. No royalties are due to Novartis. However, the Swiss company will continue ongoing tests of Tevimbra, and if it still wants to test its own drugs in combination with the BeiGene drug, it may do so with BeiGene’s approval, the filing states. BeiGene has agreed to provide Novartis with supplies of Tevimbra to support the ongoing clinical trials. Novartis has agreed to provide transition services for the program to enable BeiGene to proceed with the drug’s commercialization without disruption.
The Tevimbra alliance is the second BeiGene/Novartis drug development pact to end this year. In July, the two companies mutually agreed to terminate an agreement centered on the development and commercialization of ociperlimab, an antibody that blocks a different immune cell checkpoint protein called TIGIT. That termination followed disappointing clinical trial results from other companies developing TIGIT-blocking drugs.
Tevimbra has had other setbacks. An FDA decision expected last year was delayed because the regulator was unable complete inspections of the facilities where the immunotherapy is made. According to BeiGene, the FDA cited Covid-19 travel restrictions as the reason for the delay. But progress has been made since then. BeiGene said Tuesday that the FDA has accepted the submission of Tevimbra for use in combination with chemo as a first-line treatment for esophageal cancer. The FDA set a second half 2024 target date for a regulatory decision.
With the European approval in hand and an FDA decision coming, BeiGene said Tevimbra is the backbone of its pipeline of immunotherapies for solid tumors. Mark Lanasa, chief medical officer, solid tumors at BeiGene, said the drug complements the company’s drug candidates in other modalities, such as antibody drug conjugates and bispecific antibodies.
“We are eager to continue to explore Tevimbra’s full potential to address unmet clinical needs around the world, including in combination with our deep and diverse solid tumor pipeline, which has over 20 immuno-oncology and targeted molecules that could be paired with Tevimbra to help more patients,” Lanasa said in a prepared statement.
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