GSK’s anti-TIM monoclonal antibody (mAb) cobolimab has failed a Phase III trial in non-small cell lung cancer (NSCLC).
The COSTAR Lung study (NCT04655976) missed the primary endpoint of overall survival (OS) in patients with advanced NSCLC after treatment with prior immuno-oncology therapies.
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Neither the triple therapy arm of cobolimab, Jemperli (dostarlimab), and docetaxel, nor the double combination of dostarlimab and docetaxel, met the efficacy endpoint.
All regimens were well tolerated, and toxicities were consistent with the known safety profiles of docetaxel and immune checkpoint inhibitors.
GSK has not shared any information on whether the study met any secondary endpoints, such as objective response rate (ORR), progression-free survival (PFS) or duration of response (DoR).
This will likely come as somewhat of a shock to investors, as the therapy showed promise in a Phase II study when used in the same triple combination.
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By GlobalDataGSK acquired cobolimab as part of a $5.1bn takeover of Tesaro in 2018.
Despite the late-stage failure, this is not the end of the road for cobolimab, as the therapy remains in Phase II studies in liver cancer, cervical cancer and melanoma.
GSK isn’t alone in facing setbacks with anti-TIM-3 antibodies. In early 2024, Novartis’ sabatolimab failed a late-stage study in patients with myelodysplastic syndrome or leukaemia. Roche also stopped the development of a PD-1×TIM-3 bispecific in 2022, and BMS also culled a TIM-3 candidate, BMS-986299, that was in a Phase I trial in 2022.
NSCLC market to reach $56bn
Across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan), GlobalData predicts the NCSLC market to reach $56.5bn in 2032.
Most of that will be through PD-1/PD-L1 and CTLA-4 inhibitors, including MSD’s Keytruda (pembrolizumab) and BMS’ Opdivo (nivolumab), with a sales forecast of $21.9bn in 2032.
EGFR inhibitors, such as AstraZeneca’s Tagrisso (osimertinib) and Johnson & Johnson’s Rybrevant (amivantamab-vmjw), will generate sales of $8.6bn in the same year.
Antibody-drug conjugates (ADCs), as well as ALK and KRAS inhibitors, are likely to play a prominent role.
GlobalData is the parent company of Clinical Trials Arena.
