The shift is in who owns a drug. On Tuesday, 19 September 2023, BeiGene announced two things at once: the European Commission had approved its cancer antibody Tevimbra, and Novartis was handing back the global rights it had bought two years earlier.
Start with the approval. Tevimbra, generically tislelizumab, is cleared in Europe as a stand-alone treatment for adults with advanced oesophageal squamous cell carcinoma, a cancer of the lining of the gullet, whose tumours cannot be removed or have spread. It is meant for people who have already been through platinum-based chemotherapy. The Commission acted after a positive opinion from the EU’s medicines committee.
How it works
The drug blocks PD-1, a receptor on immune cells. Some tumours release proteins that lock onto that receptor and switch the immune cell off. With PD-1 covered, the cancer loses that trick, and the body’s defences are free to attack. It is a monoclonal antibody given as an infusion into a vein every three or six weeks, and the European Medicines Agency says only a physician with cancer experience should begin and oversee treatment.
The evidence
The approval rests on RATIONALE 302, a global phase 3 trial that enrolled 513 patients at 132 sites in 11 countries across Europe, Asia and North America. Patients on tislelizumab were compared with those given a chemotherapy chosen by their doctor. Median overall survival was 8.6 months on the antibody against 6.3 months on chemotherapy. BeiGene reported no new safety signals, and the marketing application also drew on safety data from 1,972 patients across seven trials.
Prof. Florian Lordick of the University Cancer Center Leipzig called the approval “a noteworthy moment for patients, their caregivers and their physicians” given the lack of options.
A crowded field, a new owner
Tevimbra is not the first of its kind. Reuters pointed out that Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo both won approvals as early as 2014; Keytruda now leads treatment in a big lung cancer market. BeiGene already sold its drug in China.
The second announcement explains the strategy. Novartis had paid $650 million in 2021 for the rights. It ended the deal after deciding the PD-1 field had “changed considerably” since then. BeiGene gets full global rights back with no royalties owed to Novartis, which keeps manufacturing. TD Cowen analyst Yaron Werber told Reuters the move matters less for Tevimbra’s own sales than as a stepping stone toward a franchise in solid tumours.
Mark Lanasa, BeiGene’s chief medical officer for solid tumours, said the company hoped the US regulator would finish its review of the drug by the end of the year. That review had been delayed since 2021 because Covid restrictions kept inspectors out of China. The FDA did approve Tevimbra for the same cancer in March 2024.
Sources
- BeiGene announces positive regulatory updates in Europe and the US (BusinessWire via BioSpace)
- UPDATE 3-BeiGene to go solo with cancer drug after Novartis deal ends (Reuters)
- Tevimbra: European Medicines Agency
- FDA Approves BeiGene's Tevimbra (PharmExec)
