Novartis Drops Anti-TIGIT Checkpoint Inhibitor Partnership with BeiGene

Pictured: Novartis headquarters/Courtesy Adobe Stock, Yingko

Pictured: Novartis headquarters/Courtesy Adobe Stock, Yingko

Swiss pharma Novartis has ended its agreement with Chinese biotech BeiGene for option rights to ociperlimab, an anti-TIGIT checkpoint inhibitor, less than two years after the collaboration began, according to BeiGene’s SEC filing on Tuesday.

Novartis paid $300 million upfront for the deal in December 2021 and BeiGene would have been eligible to receive an additional $700 million had Novartis exercised its option by the end of 2023.

Novartis’ decision to end the agreement was made after evaluating “the totality of the current information, including Phase II data, benefit/risk, competitive space, timing, development programs, and future investments," a company spokesperson told Fierce Biotech. As a result, Novartis will not proceed with a Phase III study of ociperlimab in non-small cell lung cancer (NSCLC) or a Phase II study of the drug in triple negative breast cancer, according to the spokesperson.

BeiGene in its SEC filing said that “due to the changing treatment paradigm” the company will discontinue the Phase III AdvanTIG 301 trial of ociperlimab in combination with its anti-PD-1 antibody tislelizumab versus AstraZeneca's Imfinzi (durvalumab) following concurrent chemoradiotherapy in patients with stage III unresectable NSCLC.

However, BeiGene said it will continue enrollment for the Phase III AdvanTIG 302 trial of ociperlimab in combination with tislelizumab for the first-line treatment of patients with locally advanced, unresectable or metastatic NSCLC.

“The company will carefully evaluate all available data to inform future development opportunities with ociperlimab,” according to BeiGene’s SEC filing.

Anti-TIGIT checkpoint inhibitors like ociperlimab are a relatively new technology and represent a novel immunotherapy approach to cancer treatment. TIGIT is an immune checkpoint that inhibits the body’s ability to fight cancer by inhibiting lymphocyte T cells. Some tumors have shown the ability to express TIGIT’s ligands, weakening the immune response to cancer. Anti-TIGIT checkpoint inhibitors in turn disrupt the TIGIT pathway, preventing the localized immunosuppression caused by the tumor.

However, the technology suffered a significant setback in May 2022 after Genentech, a Roche-owned company, posted disappointing Phase III results casting doubt over other companies developing their own anti-TIGIT drugs. The Phase III SKYSCRAPER-01 trial was evaluating anti-TIGIT checkpoint inhibitor tiragolumab in combination with another drug for the treatment of NSCLC. The drug failed to meet its co-primary endpoint of progression-free survival (PFS). 

The news came on the heels of other disappointing results. In March 2022, Genentech announced that another Phase III trial of tiragolumab and Roche's Tecentriq (atezolizumab) combination with chemotherapy, this time for treatment of extensive-stage small cell lung cancer (ES-SCLC), had also failed to meet a co-primary endpoint of PFS.

However, at last month’s American Society for Clinical Oncology (ASCO) conference, anti-TIGIT drugs got a boost when Gilead Sciences and Arcus announced promising Phase II results of domvalanimab—an anti-TIGIT monoclonal antibody—in combination with other drugs that showed consistent improvement in PFS for patients with first-line metastatic NSCLC.

In addition, results presented last month by Roche at  ASCO suggested tiragolumab in combination with other drugs may be an effective treatment for liver cancer. The Phase Ib/II trial found improvements in both PFS as well as overall response rate in patients with unresectable hepatocellular carcinoma.

Connor Lynch is a freelance writer based in Ottawa, Canada. Reach him at lynchjourno@gmail.com.

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