Novartis retreats from TIGIT, handing $300M candidate back to BeiGene

Novartis may have insisted earlier this year that it hadn’t given up on anti-TIGIT checkpoint inhibitors, but, now, the Swiss Big Pharma seems to have had a change of heart. Having paid $300 million to enter the TIGIT space by acquiring ociperlimab in 2021, Novartis is now handing the candidate back to BeiGene.

In a Securities and Exchange Commission filing this morning, the Chinese drugmaker said the two companies agreed yesterday to mutually terminate the option agreement for ociperlimab with immediate effect. As a result, BeiGene’s Swiss unit will regain full global rights to the drug.

A Novartis spokesperson told Fierce Biotech that the decision had made after assessing "the totality of the current information, including phase 2 data, benefit/risk, competitive space, timing, development programs, and future investments."

The end of the agreement means the Big Pharma will no longer proceed with a phase 3 study of ociperlimab in non-small cell lung cancer (NSCLC) or its phase 2 study of the drug in triple negative breast cancer, the spokesperson added.

Novartis’ move shouldn’t come as a total surprise. Quizzed on an earnings call in February about why a pivotal phase 3 trial of ociperlimab in solid tumors hadn’t launched in the second half of 2022 as originally planned, CEO Vas Narasimhan, M.D., insisted to analysts that the TIGIT hadn’t been scrapped.

“We continue to pursue the TIGIT through the deal we have with BeiGene, and we have that as an option deal,” Narasimhan said on the call in what felt at the time like slightly half-hearted support for the candidate. “We also are assessing what other lines of therapy to take that TIGIT into given the competitive landscape."


With Novartis out of the picture, BeiGene plans to continue to enroll participants in a phase 3 trial of ociperlimab in combination with its own anti-PD-1 antibody tislelizumab in patients with locally advanced, unresectable, or metastatic NSCLC.

However, due to the “changing treatment paradigm,” BeiGene will discontinue another phase 3 trial comparing the TIGIT in combination with tislelizumab to AstraZeneca’s Imfinzi and chemotherapy in patients with stage 3 unresectable NSCLC.

“The company will carefully evaluate all available data to inform future development opportunities with ociperlimab,” BeiGene said.

Once hailed as the future of immuno-oncology, the hopes for TIGITs were thrown into doubt by the high-profile phase 3 failures of Roche’s tiragolumab last year. Those results came in after Novartis had paid $300 million upfront to BeiGene for the option rights to ociperlimab. Under the agreement, if Novartis had taken up its option to acquire the rights to the drug in the U.S., Europe, Japan and other territories by late 2023 then it would have to hand over an additional $700 million. With that deadline fast approaching, Novartis has instead opted to cut its losses and hand the candidate back.

There are two types of anti-TIGIT candidates. Some, like ociperlimab, have an FC receptor function. FC receptors are found on the cell surface and contribute to the protective functions of the immune system by binding to antibodies that are attached to infected cells or invading pathogens.

Other TIGITs, including Gilead Sciences and Arcus Biosciences’ domvanalimab, have mutated out the receptor function. Domvanalimab has been one of the few TIGITs to continue to demonstrate success in the clinic, although Roche’s troubled tiragolumab may finally be showing promise in combination with Tecentriq and Avastin.