GSK PLC on Monday said that its blood cancer drug, Blenrep, has failed to meet its primary endpoint of progression-free survival in recent phase three trials.
GSK is a London-based multinational pharmaceutical and biotechnology company. Blenrep, or belantamab mafodotin, is an antibody drug conjugate designed to treat adult patients with relapsed or refractory multiple myeloma.
Blenrep is an anti-BCMA therapy. BCMA, or B-cell maturation antigen, is a cell-surface protein expressed on the membrane of normal and malignant plasma cells, but not other normal tissues. Overexpression leads to the survival of multiple myeloma cells.
In the recent DREAMM-3 trial, designed to evaluate the efficacy of Blenrep compared to Pomdex in patients with relapsed or refractory multiple myeloma patients, GSK found that the median progression-free survival rate was longer for the former than the latter.
However, the primary endpoint of progression-free survival demonstrated a hazard ratio of 1.03, just over a ratio of 1.00, which indicates no difference in mortality. Progression-free survival is considered an important measure of treatment benefit, and can be evaluated earlier than overall survival.
The overall response rate was 41% for belantamab mafodotin, and 36% for PomDex. GSK said that the safety and tolerability profile of belantamab mafodotin was consistent with the known safety profile, and no new safety signals were identified.
Data from the DREAMM-3 trial is in the process of being shared with health authorities, with whom discussions are ongoing.
GSK said additional trials within the DREAMM clinical trial programme will continue. They are designed to demonstrate the benefit of Blenrep in combination treatment with novel therapies and standard-of-care treatments in earlier lines of therapy.
The company expects data from the DREAMM-7 and DREAMM-8 phase III trials in the first half of 2023. These are combination treatment trials, designed to test the efficacy of Blenrep in combination with bortezomib and dexamethasone, and pomalidomide and dexamethasone, respectively.
GSK shares were trading 2.5% lower at 1,410.00 pence each in London on Monday morning.
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