On April 3, BeiGene (SH688235) announced that it has discontinued clinical development plans for the TIGIT (immune checkpoint protein) antibody Ociperlimab (osperlimab, BGB-A1217) as a potential treatment for lung cancer.

Based on the results of a pre-planned invalidity analysis, the Independent Data Monitoring Committee (IDMC) recommended the termination of the Phase 3 clinical trial (AdvanTIG-302). An assessment of the overall efficacy and safety data suggests that the study may struggle to meet the primary endpoint of overall survival.

It was disclosed that osperlimab (BGB-A1217) is an investigational humanized IgG1 variant monoclonal antibody against TIGIT, after the company was exploring the efficacy of osperlimab in combination with tislelizumab for the treatment of NSCLC (non-small cell lung cancer). As of December 2024, more than 2,000 patients have been enrolled in the osperlimab development program.

By the end of the first half of 2024, BeiGene had invested a total of RMB 2.090 billion in osperlimab projects.

It is worth mentioning that on July 10, 2023, BeiGene and Novartis Pharmaceuticals Group (Novartis) signed a mutual termination and release agreement for ociperlimab, terminating the option, collaboration and license agreement signed by the two parties in December 2021. Since then, BeiGene has chosen to continue advancing the clinical study of ociperlimab.

TIGIT is considered to be the next potential target for tumor immunotherapy after PD-1/PD-L1 (programmed cell death receptor 1/programmed death ligand 1), and its mechanism is to reactivate T cell attack on tumors by blocking TIGIT from binding to ligands.

Globally, Roche is a leader in TIGIT targets, and since its discovery in 2002, the company has conducted dozens of clinical trials around the target. According to reports, due to the failure of several phase III clinical trials for lung cancer to achieve the expected results, Roche announced in its 2024 annual report that it would terminate some clinical trials related to TIGIT antibodies and retain only clinical studies for liver cancer indications.

In December 2024, Merck also announced on its official website that it would officially terminate the clinical development program of TIGIT monoclonal antibody vibostolimab. In August, the Phase III clinical trial of KeyVibe-008 had failed and was halted.

However, the prospect of TIGIT targets is still attracting many multinational pharmaceutical companies. At present, Gilead Sciences, AstraZeneca, and GlaxoSmithKline still have related drugs under development. In China, Akeso is also conducting clinical studies of related drugs, and announced in July 2023 that the Phase Ia/Ib clinical study of TIGIT monoclonal antibody AK127 in combination with PD-1/CTLA-4 (cytotoxic T lymphocyte-associated protein 4) bispecific antibody cadonilib (AK104) for the treatment of advanced malignant solid tumors has completed the first patient enrollment in China.

Cover image source: Visual China-VCG211378715275