Novartis gives up on tislelizumab, BeiGene’s PD-1 inhibitor approved in Europe

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Novartis has terminated its significant cancer immunotherapy collaboration with BeiGene, ending a partnership that had granted Novartis co-development and co-commercialization rights for the PD-1 inhibitor tislelizumab. This decision follows Novartis’ discontinuation of another immuno-oncology partnership with BeiGene related to the anti-TIGIT candidate ociperlimab, which occurred approximately two months ago.

The termination of the tislelizumab agreement means that BeiGene has regained full rights to the PD-1 inhibitor. Under the previous collaboration, Novartis had rights to tislelizumab in North America, Japan, the EU, and several other countries, established through a $650 million upfront licensing deal in early 2021.

Novartis explained that changes in the landscape of PD-1 inhibitors influenced its decision to end the partnership with BeiGene. The company cited the need for greater flexibility to develop its unique pipeline assets, particularly in markets where approved PD-1 therapies are already available to support the development of novel combination programs.

The conclusion of this collaboration puts BeiGene in a challenging position as it enters the competitive PD-1/L1 landscape, where eight other drugs have received approval for various tumor types in the US.

Regarding BeiGene’s future plans, Josh Neiman, BeiGene’s Chief Commercial Officer for North America and Europe, did not specify whether the company would seek a new partner, stating that predicting the future with certainty is challenging.

This marks the second time that BeiGene has regained tislelizumab from a foreign pharmaceutical company. In 2019, Celgene returned the drug during its $74 billion merger with Bristol Myers Squibb, citing a conflict of interest with BMS’ Opdivo.

In addition to this development, BeiGene announced that the European Commission has granted its first approval for tislelizumab, which will be sold under the brand Tevimbra. This approval is for previously treated esophageal squamous cell carcinoma. However, there has been a significant delay in the FDA’s review of Tevimbra for the same indication. BeiGene has filed a new biologics license application for first-line use, and the FDA has accepted the submission, with a target decision date in the second half of the next year.

As for pricing in Europe, BeiGene now has full control over Tevimbra’s pricing, although negotiations for reimbursement with individual European markets are still required.

This shift will necessitate the expansion of BeiGene’s commercial team, particularly as the company moves beyond hematology into the broader field of solid tumors. BeiGene plans to build its team gradually to align with the scale of its initial indications.

Regarding ongoing clinical trials involving tislelizumab, there will be no changes due to the termination of the partnership. These trials include a phase 3 study combining tislelizumab with ociperlimab and chemotherapy in first-line metastatic non-small cell lung cancer (NSCLC) and a midstage study involving a LAG-3 agent in colorectal cancer.

Both companies have agreed that ongoing studies may continue under their current sponsors, and Novartis has indicated its intent to continue using tislelizumab for some clinical trials.

The termination of the partnership underscores the complexities of the evolving PD-1 inhibitor landscape and the strategic considerations of both companies in navigating the immuno-oncology space.

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