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GSK hatches pivotal Hansoh conjugate plans

Less than two years after picking up a low-cost B7-H3-targeting ADC from China’s Hansoh, GSK is planning a global pivotal trial of the project. The company disclosed in its first-quarter earnings release on Wednesday that the study of GSK5764227 would be in extensive-stage small-cell lung cancer; a spokesperson told ApexOnco that this would start in the fourth quarter, with results expected in 2027, but declined to give more details. The group will no doubt hope to replicate the 61% ORR seen in the phase 1 Chinese Artemis-001, among 31 relapsed extensive-stage SCLC patients receiving 8mg/kg. Still, there could be stiff competition from Merck/Daiichi’s ifinatamab deruxtecan, BioNTech/DualityBio’s BNT324 and MediLink’s YL201, which have produced similar results. Hansoh already has two Chinese phase 3s ongoing in SCLC, and recently began another late-stage trial in osteosarcoma – a niche in which no other B7-H3 players are active, according to OncologyPipeline. Meanwhile, GSK has a phase 1 study of GSK5764227 under way in solid tumours, and a phase 1/2 set to start soon in gastrointestinal cancers. Other potential avenues, based on the raft of Hansoh-led phase 2s, could include head and neck, oesophageal and prostate cancers.

 

Phase 3 studies of GSK5764227 (HS-20093)

TrialSponsorSettingNote
Artemis-008Hansoh2nd-line limited/extensive-stage SCLC, post-platinum chemo, vs topotecanCompletes Sep 2026
Artemis-009Hansoh1st-line limited-stage SCLC, not progressed after radiotherapy, vs active surveillanceCompletes Nov 2027
Atermis-011Hansoh3rd-line osteosarcoma, vs gemcitabine + docetaxelStarted Apr 2025
UnnamedGSKExtensive-stage SCLCTo start Q4 2025, data expected 2027

Source: OncologyPipeline, clinicaltrials.gov & company Q1 2025 earnings release.