GSK’s Cobolimab Fails Phase III NSCLC Trial Amid Growing Market Competition

GSK has announced that cobolimab, its investigational anti-TIM-3 monoclonal antibody, failed to meet the primary endpoint of overall survival in the Phase III COSTAR Lung study for advanced non-small cell lung cancer (NSCLC). Neither the triple combination of cobolimab, Jemperli (dostarlimab), and docetaxel nor the dual combination of dostarlimab and docetaxel showed efficacy. However, the treatments were generally well-tolerated with no unexpected safety issues.

This setback is a disappointment following promising Phase II results, especially given GSK’s $5.1B acquisition of Tesaro in 2018 to obtain cobolimab. The drug remains under evaluation in Phase II trials for liver cancer, melanoma, and cervical cancer.

Other companies have also seen anti-TIM-3 candidates fail, including Novartis, Roche, and BMS. Meanwhile, the NSCLC market is forecast to grow to $56.5B by 2032, with major contributions from PD-1/PD-L1 inhibitors like Keytruda and Opdivo, alongside EGFR and KRAS-targeted therapies.

31-07-2025