Belantamab mafodotin

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DREAMM-8 trial showed BPd (belantamab mafodotin-blmf, pomalidomide, dexamethasone) was generally well-tolerated and maintained HR-QOL over time in relapsed/refractory multiple myeloma patients compared to PVd (bortezomib, pomalidomide, dexamethasone). BPd led to more significant improvements in physical functioning and fatigue, supporting its potential as a new standard of care.

The GEM-BELA-VRD trial showed 94% ORR with belantamab mafodotin-blmf, bortezomib, lenalidomide, and dexamethasone in newly diagnosed multiple myeloma patients, with CR rates improving from 36% to 82% over treatment phases. MRD-negative rates increased from 60.9% to 91.2%. High-risk patients achieved 100% MRD-negative status post-consolidation. PFS rates were 90% at 12 months and 85% at 24 months, with OS rates of 92% and 85% respectively. Ocular toxicity was the main adverse effect, with manageable outcomes.

The phase 2 GEM-BELA-VRD trial showed encouraging efficacy and manageable toxicity with belantamab mafodotin-blmf plus bortezomib, lenalidomide, and dexamethasone in transplant-eligible NDMM patients. The ORR was 94%, with CR rates improving from 36% to 82% over treatment phases. MRD-negative rates increased to 91.2% after maintenance. PFS rates were 90% at 12 months and 85% at 24 months, with OS rates at 92% and 85% respectively. Ocular AEs were common but manageable, with no impaired vision reported.

Japan's health ministry accepts GSK's Blenrep NDA for blood cancer treatment, following EU and UK approvals. Blenrep granted orphan drug status in Japan, supported by DREAMM-7 and DREAMM-8 trials. GSK aims to expedite global regulatory pathways for Blenrep.

Japan's MHLW accepts GSK's NDA for Blenrep plus BorDex or PomDex for relapsed/refractory multiple myeloma, based on DREAMM-7 and DREAMM-8 trials. Blenrep shows potential to redefine treatment landscape.

China's NMPA grants GSK's Blenrep breakthrough therapy designation for relapsed or refractory multiple myeloma treatment, based on Phase III DREAMM-7 trial results showing significant PFS improvements.

NMPA grants Breakthrough Therapy Designation to Blenrep (belantamab mafodotin) combined with bortezomib plus dexamethasone for relapsed or refractory multiple myeloma, based on phase III DREAMM-7 trial results showing significant PFS improvements. A positive OS trend was observed but not statistically significant at interim analysis.

GSK's Blenrep (belantamab mafodotin) combined with bortezomib plus dexamethasone (BorDex) received Breakthrough Therapy Designation in China for relapsed or refractory multiple myeloma. The designation is based on the DREAMM-7 trial's interim results showing significant improvements in progression-free survival (PFS) compared to daratumumab plus BorDex. A positive overall survival (OS) trend was observed but not statistically significant at the interim analysis. The trial also showed deeper and more durable responses across secondary endpoints. Multiple myeloma is a growing concern in China with approximately 30,000 new cases annually.

European stock markets closed higher; Stoxx Europe 600 gained 0.72%, Swiss Market Index rose 0.46%, France's CAC increased 0.41%, FTSE up 0.39%, and Germany's DAX closed 0.92% higher. Eurostat reported a 0.3% decline in euro area industrial production and a 2.6% job vacancy rate in Q2. France's consumer price index rose 0.5% in August. HSBC discusses selling its South African unit, Grifols seeks consultancy for minority investors, GSK's Blenrep gets breakthrough therapy designation in China, and Ascendis Pharma reports clinical activity in ovarian cancer trial.