GSK’s Blenrep (belantamab mafodotin) combinations have been approved by the European Commission (EC) to treat adults with relapsed or refractory multiple myeloma.
The drug has been authorised alongside bortezomib plus dexamethasone (BVd) to treat patients who have received at least one prior therapy, and in combination with pomalidomide plus dexamethasone (BPd) to treat those who have received at least one prior therapy including lenalidomide.
More than 50,000 cases of multiple myeloma, a type of blood cancer that develops in plasma cells in the bone marrow, are diagnosed in Europe each year. While some patients may experience long remissions following treatment, most will eventually relapse.
GSK’s Blenrep is the only B-cell maturation antigen-targeted antibody-drug conjugate approved for multiple myeloma, offering patients a differentiated mechanism of action. Blenrep combinations can also be given across oncology treatment settings without hospitalisation or complex pre-administration regimens.
The EC’s decision was based on positive results from the late-stage DREAMM-7 and DREAMM-8 trials, which both demonstrated statistically significant and clinically meaningful progression-free survival (PFS) improvements for the Blenrep combinations compared to standard-of-care triplet combinations.
In DREAMM-7, the Blenrep combination almost tripled median PFS versus the daratumumab-based comparator, at 36.6 months versus 13.4 months, respectively. In DREAMM-8, median PFS was not reached in the Blenrep cohort at a median follow-up of 21.8 months, compared to 12.7 months for the bortezomib combination.
DREAMM-7 also met the key secondary endpoint of overall survival, and both trials showed clinically meaningful improvements across all other secondary efficacy endpoints, including deeper and more durable responses.
Hesham Abdullah, senior vice president, global head oncology, research and development at GSK, described the approval as a “redefining moment for patients with relapsed or refractory multiple myeloma in the EU”.
“Blenrep has the potential to extend remission and survival, with superior efficacy versus standards of care in our DREAMM clinical trial programme and the option to administer in both academic and community-based settings,” Abdullah added.
DREAMM-7 principal investigator, María-Victoria Mateos, said: “The robust efficacy supported by the DREAMM-7 and DREAMM-8 trials, together with manageable outpatient administration in academic and community settings, positions Blenrep combinations as a fundamentally differentiated treatment approach for multiple myeloma patients starting from first relapse.”