BeiGene Reclaims Tislelizumab as Novartis Surrenders Cancer Asset

Novartis Makes a Strategic Pivot: Returns Cancer Drug Tislelizumab to BeiGene as Europe Approves Tevimbra

In a noteworthy twist of pharmaceutical fate, Novartis has handed back the reins of the investigational monoclonal antibody tislelizumab to BeiGene. This move marks a pivotal moment as it returns global rights to develop, manufacture, and commercialize the anti-PD-1 candidate to the cancer-focused biotech.

Adding to the excitement, BeiGene has just received European Commission approval for tislelizumab, now branded as Tevimbra, to treat patients with unresectable, locally advanced, or metastatic esophageal squamous cell carcinoma (ESCC) who had previously faced the disappointment of platinum-based chemotherapy. And that’s not all; the FDA has accepted BeiGene’s Biologics License Application (BLA) for tislelizumab as a first-line treatment option for this indication after more than a year of regulatory delay.

The Novartis-BeiGene journey began in January 2021 when they joined forces in a collaboration and license agreement for tislelizumab’s development in ESCC, as well as other formidable foes like non-small cell lung cancer and hepatocellular carcinoma.

However, their path hit a regulatory roadblock in July 2022 when the FDA deferred action on tislelizumab’s BLA in ESCC, pending an inspection of BeiGene’s facilities in China. Fast forward to July 2023, during BeiGene’s R&D day, and the good news arrived—FDA site inspections were successfully completed.

In this twist of fate, the two companies have amicably parted ways, terminating their 2021 contract. But don’t fret; they’ve sealed a new deal. Novartis will provide essential transition services to BeiGene, ensuring a smooth continuation of tislelizumab’s development and commercialization plans, including manufacturing, regulatory, clinical, and safety support. In return, BeiGene will continue to supply Novartis with tislelizumab for its clinical trials.

With tislelizumab back in BeiGene’s arsenal, the company is revving up its regulatory and development efforts for this versatile candidate, expanding its scope across various cancer types, according to CEO John Oyler.

Interestingly, Novartis isn’t entirely saying goodbye to tislelizumab. They plan to collaborate with BeiGene on development, regulatory matters, and manufacturing priorities. Novartis will also handle Tevimbra manufacturing for many global markets and explore potential combinations with their oncology assets.

Tislelizumab, a humanized monoclonal antibody, takes the spotlight for its ability to thwart the PD-1 protein’s interference with Fc-gamma receptors on macrophages. This action unleashes the immune system’s anti-cancer prowess, making it a formidable weapon against tumor cells. Already approved in 11 indications in China under the name Tevimbra, this drug is poised for further global impact.

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