In a significant development for the treatment of multiple myeloma, GlaxoSmithKline’s (GSK) Blenrep (belantamab mafodotin) has shown promising results in a Phase 3 combination trial, potentially paving the way for its re-entry into the U.S. market. The drug, a BCMA-targeting antibody-drug conjugate (ADC), was previously withdrawn but now demonstrates a potential for a comeback.
The DREAMM-7 study compared Blenrep in combination with a regimen known as BorDex—comprising Takeda’s Velcade (bortezomib) and dexamethasone—to a similar combination with Genmab and Johnson & Johnson’s Darzalex (daratumumab), an anti-CD38 monoclonal antibody. The results indicated a significant improvement in progression-free survival (PFS), the trial’s primary endpoint, for patients receiving the Blenrep combination. Additionally, a trend toward improved overall survival (OS) was observed, although the trial is ongoing to collect more definitive OS data.
Dr. Hesham Abdullah, GSK’s SVP and Global Head of Oncology R&D, expressed optimism about the findings, highlighting the potential of Blenrep plus BorDex to meet the substantial unmet needs in the relapsed/refractory multiple myeloma patient population. The trial was unblinded early based on recommendations from an independent data monitoring committee, and no new safety concerns were reported.
These results are particularly noteworthy given Blenrep’s history. Approved in 2020 as a fifth-line treatment for multiple myeloma, the drug was part of GSK’s renewed focus on oncology following the divestiture of its consumer health joint venture with Pfizer, which became Haleon. However, the need for a confirmatory trial, as stipulated by the FDA’s accelerated approval program, led to Blenrep’s withdrawal from the market in November 2022 when the DREAMM-3 trial did not meet its objectives.
Despite this setback, GSK continued to explore Blenrep’s efficacy in combination with other therapies. The positive outcome of the DREAMM-7 trial could vindicate the company’s persistence, especially considering the commercial success of Darzalex, which reported nearly $8 billion in global sales in 2022, primarily for multiple myeloma treatment.
Looking ahead, GSK is conducting another head-to-head Phase 3 trial, DREAMM-8, which evaluates Blenrep in combination with Bristol Myers Squibb’s Pomalyst (pomalidomide) and dexamethasone, with results expected in the latter half of 2024. This continued investment in the DREAMM trial program underscores GSK’s commitment to establishing Blenrep as a viable treatment option in earlier lines of therapy for multiple myeloma.
The forthcoming presentation of the DREAMM-7 study results at an upcoming scientific meeting and their dissemination to health authorities will be a critical step for GSK. If the data continue to support Blenrep’s efficacy and safety profile, the drug could once again play a pivotal role in the multiple myeloma treatment landscape, offering new hope to patients battling this challenging cancer.
