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DREAMM-3 phase III trial for Blenrep
DREAMM-3 phase III trial for Blenrep.
About this update from Gsk Plc
[{"type":"text","content":"\n \n \n Issued: 7 November 2022, London UK\n \n \n \n \n \n \n \n \n GSK provides update on DREAMM-3 phase III trial for Blenrep in relapsed/refractory multiple myeloma\n \n \n \n \n \n \n \n \n \n \n \n \n \n GSK plc (LSE/NYSE: GSK) today announced that DREAMM-3, the phase III open-label, randomised head-to-head superiority trial of Blenrep (belantamab mafodotin) monotherapy versus pomalidomide in combination with low dose dexamethasone (PomDex) in patients with relapsed or refractory multiple myeloma (RRMM), did not meet its primary endpoint of progression-free survival (PFS).\n \n \n \n \n \n In the DREAMM-3 trial, the primary endpoint of PFS demonstrated a\n hazard ratio (HR) of 1.03 (95% CI: 0.72 1.47). The\n 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\n belantamab mafodotin and\n 36% for PomDex. B\n elantamab mafodotin\n demonstrated a deeper response rate when compared with PomDex (25% VGPR or better with\n belantamab mafodotin\n compared to 8% with PomDex).\n The median follow-up was 11.5 months for\n belantamab mafodotin and 10.8 months for PomDex\n ; the median DOR was not reached for\n belantamab mafodotin\n (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\n 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.\n \n \n \n \n \n At the time of the primary analysis, the OS data had only achieved 37.5%\n overall maturity.\n The median OS was 21.2 and 21.1 months for\n belantamab mafodotin\n and PomDex, respectively, with an HR of 1.14 (95% CI: 0.77, 1.68).\n \n \n \n \n \n \n Blenrep\n \n was granted accelerated approval by the US Food and Drug Administration (FDA) as a monotherapy for treating adult patients with RRMM who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent. The accelerated approval was based on the ...