The DREAMM-7 Phase III trial has spotlighted the potential of Blenrep (belantamab mafodotin) in combination with bortezomib and dexamethasone (BVd) to improve survival outcomes for relapsed or refractory multiple myeloma.
Blenrep was previously withdrawn from the US market in 2022 after the DREAMM-3 trial failed to confirm its initial accelerated approval. The current submissions, supported by DREAMM-7 and DREAMM-8, aim to re-establish its role with stronger evidence of efficacy and survival benefits.
Blenrep is an antibody-drug conjugate (ADC) created by linking a B-cell maturation antigen (BCMA)-targeting monoclonal antibody to a potent cytotoxic agent, auristatin F, using a stable, non-cleavable linker technology.
By delivering a cytotoxic agent directly to cancer cells, BCMA minimizes damage to healthy tissues, offering a highly focused approach to therapy.
The trial demonstrated a 42 percent reduction in the risk of death for patients treated with the Blenrep combination (Blenrep, bortezomib and dexamethasone) compared to those on daratumumab in combination with bortezomib and dexamethasone (DVd), a standard of care for relapsed or refractory multiple myeloma.
With a three-year overall survival (OS) rate of 74 percent for BVd versus 60 percent for DVd, these results mark a major advancement for patients with this challenging blood cancer.
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Recent regulatory milestones further bolster Blenrep’s momentum. The US Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) for Blenrep in combinations with BVd and pomalidomide plus dexamethasone (BPd), with a decision expected by July 2025.
In China, Blenrep has been granted Priority Review and Breakthrough Therapy designation, expediting its development as a promising option. The therapy is also under review in other major markets globally.
The DREAMM (Driving Excellence in Approaches to Multiple Myeloma) program explores Blenrep’s use in combination therapies across different patient settings.
DREAMM-7, an international, open-label trial, enrolled 494 participants with at least one prior multiple myeloma therapy. Patients were randomized to BVd or DVd regimens.
Results showed a three-year OS rate of 74 percent for BVd versus 60 percent for DVd. Although median OS was not reached, projections estimate 84 months for BVd versus 51 months for DVd.
Secondary outcomes, including minimal residual disease (MRD) negativity and duration of response (DOR), further demonstrated Blenrep’s efficacy, with deeper and more durable responses observed in the BVd arm.
DREAMM-8 provided additional insights by evaluating BPd in more heavily pretreated patients. While OS trends were positive, they were not statistically significant at the interim analysis, though the trial reinforced Blenrep combination’s versatility across patient populations.
Safety data for Blenrep combinations aligned with known profiles of the individual agents, with manageable side effects rarely leading to treatment discontinuation.
A day before GSK’s announcement, Johnson & Johnson also released two promising clinical trial results. Darzalex Faspro (daratumumab and hyaluronidase-fihj), an anti-CD38 antibody, improved MRD negativity rates and progression-free survival (PFS) in Phase III studies like CEPHEUS and AURIGA. Similarly, Tecvayli teclistamab-cqyv, a bispecific T-cell engager targeting BCMA, achieved 100 percent MRD negativity in evaluable patients in induction (MajesTEC-5 study) and maintenance (MajesTEC-4 study) settings. Blenrep, however, is unique in its mechanism of action.
With global regulatory reviews advancing, Blenrep combinations are poised to become a new standard for relapsed or refractory multiple myeloma.
Ongoing studies like DREAMM-10 aim to expand these breakthroughs to newly diagnosed patients, signaling a broader future for this innovative therapy.
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