BeiGene Discontinues TIGIT Candidate Ociperlimab Amid Broader Setbacks in the Field

BeiGene has announced the discontinuation of its anti-TIGIT therapy ociperlimab, following disappointing results from a pre-planned futility analysis of its Phase III AdvanTIG-302 study in non-small cell lung cancer (NSCLC). This decision marks another setback in the increasingly challenging TIGIT inhibitor landscape, which has seen several high-profile failures in recent months.

Ociperlimab's Development Journey Comes to an End

An independent data monitoring committee found that ociperlimab was "unlikely to meet the primary endpoint of overall survival" in untreated NSCLC patients. While specific data from the AdvanTIG-302 study were not disclosed, BeiGene has promised to release more information at a later date.

Ociperlimab, a humanized IgG1 monoclonal antibody, targets the TIGIT receptor found on T cells and natural killer cells. By inhibiting this pathway, the drug aimed to prevent cancer cells from suppressing the immune response. BeiGene had high hopes for the molecule, with ongoing studies in various advanced solid tumors including cervical cancer, hepatocellular carcinoma, and esophageal squamous cell carcinoma.

The development of ociperlimab took a significant hit in July 2023 when Novartis, which had previously paid $300 million for licensing rights in North America, Europe, and Japan, backed out of the deal. This decision was based on a comprehensive review of available data, including Phase II results and competitive landscape analysis.

TIGIT Inhibitors Face Industry-Wide Challenges

BeiGene's decision to halt ociperlimab development is part of a broader trend of setbacks in the TIGIT inhibitor space:

• In May 2024, Merck discontinued a Phase III study of its anti-TIGIT antibody vibostolimab in combination with Keytruda for resected, high-risk melanoma due to high toxicity-related dropout rates.

• Merck subsequently terminated another late-stage trial of vibostolimab plus Keytruda in NSCLC following recommendations from an independent data review panel.

• Roche ended a Phase II/III study of tiragolumab in NSCLC in July 2024 after disappointing survival data.

• Bristol Myers Squibb abandoned its TIGIT partnership with Agenus in August 2024 as part of a strategic realignment.

These consecutive failures raise questions about the viability of TIGIT as a therapeutic target and highlight the challenges faced by pharmaceutical companies in developing effective treatments for complex diseases like cancer.