GSK's Conditionally Approved Blood Cancer Drug Fails On Progression-Free Survival Goal Over Standard Care

GSK's Conditionally Approved Blood Cancer Drug Fails On Progression-Free Survival Goal Over Standard Care
  • GSK plc's GSK DREAMM-3 Phase 3 head-to-head superiority trial of Blenrep (belantamab mafodotin) for relapsed or refractory multiple myeloma (RRMM) did not meet its primary endpoint of progression-free survival (PFS).
  • The trial evaluated Blenrep monotherapy versus pomalidomide in combination with low-dose dexamethasone (PomDex).
  • In the DREAMM-3 trial, the primary endpoint of PFS demonstrated a hazard ratio (HR) of 1.03. 
  • The median progression-free survival was longer for Blenrep vs. PomDex (11.2 months vs. 7 months). 
  • The overall response rate (ORR) was 41% for belantamab mafodotin and 36% for PomDex. 
  • Blenrep demonstrated a deeper response rate when compared with PomDex (25% vs. 8%). 
  • Also See: Citing Efficacy, GSK Stops Two Pivotal UTI Antibiotic Trials Early.
  • The median follow-up was 11.5 months for Blenrep and 10.8 months for PomDex; the median duration of response (DOR) was not reached for Blenrep vs. 8.5 months for PomDex.
  • DOR rates at 12 months were 76.8% and 48.4% for Blenrep and PomDex, respectively. 
  • At the time of the primary analysis, the overall survival (OS) data had only achieved 37.5% overall maturity. 
  • The median OS was 21.2 and 21.1 months for Blenrep and PomDex, respectively, with an HR of 1.14.
  • Blenrep received FDA accelerated approval as a monotherapy for RRMM patients who have received at least four prior therapies. 
  • Additional trials within the DREAMM clinical trial program will continue. Data from the DREAMM-7 and DREAMM-8 Phase 3 trials are anticipated in 1H of 2023.
  • Price Action: GSK shares are down 1.36% at $32.54 during the premarket session on the last check Monday.

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