FAILED TRIAL: Ph 3 DREAMM-3 trial of Blenrep (belantamab mafodotin) in patients with RRMM did not meet primary endpoint of progression-free survival (PFS)
- In the DREAMM-3 trial, the primary endpoint of PFS demonstrated a hazard ratio (HR) of 1.03 (95% CI: 0.72 1.47).
- The observed median progression-free survival was longer for belantamab mafodotin vs PomDex (11.2 months vs 7 months).
- Secondary endpoints include overall response rate (ORR), duration of response (DOR) and overall survival (OS).
- The ORR was 41% for belantamab mafodotin and 36% for PomDex. Belantamab mafodotin demonstrated a deeper response rate when compared with PomDex (25% VGPR or better with belantamab mafodotin compared to 8% with PomDex).
- The median follow-up was 11.5 months for belantamab mafodotin and 10.8 months for PomDex; the median DOR was not reached for belantamab mafodotin (95% CI: 17.9, –) vs 8.5 months (95% CI: 7.6, –) for PomDex; DOR rates at 12 months were 76.8% and 48.4% for belantamab mafodotin and PomDex respectively.
- The safety and tolerability profile of belantamab mafodotin was consistent with the known safety profile, and no new safety signals were identified. Overall rates of grade 3 keratopathy are consistent with prior reported data.
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