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No starring role for GSK’s Tim-3

GSK’s anti-Tim-3 antibody cobolimab, which has looked like a long shot for a while, is officially a flop. The company slipped out the failure of its pivotal Costar Lung study, in post-PD-(L)1 NSCLC, in its second-quarter earnings release on Wednesday. GSK said only that the trial hadn’t met its primary overall survival endpoint; Costar Lung compared cobolimab, Jemperli and docetaxel, or Jemperli plus docetaxel, versus docetaxel alone – so the result is also bad news for Jemperli. Cobolimab’s chances, meanwhile, had looked slim after various Tim-3 exits, most recently from AstraZeneca and Bristol Myers Squibb. While Kyowa Kirin recently entered the space with its ADC KK2845, others also seem to be cooling on this target. BeOne Medicines has yet to report data from two studies featuring its contender surzebiclimab that completed this year. Chia Tai recently terminated a Chinese phase 1/2 oesophageal cancer trial of TQB2618 for “business reasons”, while studies in solid tumours and head and neck cancer have “unknown status” on clinicaltrials.gov. And Biocity is apparently yet to begin recruiting patients into a trial of BC3402, despite that study first being posted in 2023 – although an investigator-sponsored study was more recently listed.

 

The clinical-stage Tim-3 pipeline

ProjectDescriptionCompanyStatus
CobolimabTim-3 MAbGSKFailed ph3 Costar Lung study in post-PD-(L)1 NSCLC in Jul 2025
SurzebiclimabTim-3 MAbBeOne MedicinesPh1/2 Tevimbra combo in solid tumours, completed Feb 2025; ph2 Tevimbra combo in H&N, completed Jun 2025
TQB2618Tim-3 MAbChia Tai TianqingChina ph1/2 in oesophageal cancer terminated Jul 2025 owing to “business reasons”
LB1410Tim-3 x PD-1 bispecific MAbL & L biopharmaChina ph1/2 TriggerCD8 in solid tumours + LB4330 (anti-Claudin18.2/CD8 fusion protein); ORR 50% at ASCO 2025
BC3402Tim-3 MAbBioCity BiopharmaChina ph1/2 in liver cancer not yet recruiting
NB002Tim-3 MAbNeologics BioscienceChina ph1 in solid tumours completes Apr 2026
KK2845Tim-3 ADCKyowa KirinJapanese ph1 in r/r AML began Oct 2024
Sym023Tim-3 MAbServierPh1 completed in 2024

Source: OncologyPipeline & clinicaltrials.gov.

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