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Belantamab Mafodotin Combos Approach EU Approval for R/R Multiple Myeloma

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of belantamab mafodotin (Blenrep) in adult patients with relapsed or refractory multiple myeloma.

Image Credit: © ChaoticMind – stock.adobe.com

Image Credit: © ChaoticMind – stock.adobe.com

The recommendation covers the agent’s use in combination with bortezomib (Velcade) and dexamethasone (BVd) for those who previously received at least 1 therapy and in combination with pomalidomide (Pomalyst) and dexamethasone (BPd) in those who received at least 1 prior therapy, including lenalidomide (Revlimid). The positive opinions are supported by data from the phase 3 DREAMM-7 (NCT04484623) and DREAMM-8 (NCT04484623) studies.

“Today’s positive CHMP opinion is an important milestone toward bringing the benefits of Blenrep combinations to patients with multiple myeloma in Europe,” Hesham Abdullah, senior vice president and global oncology, Research and Development at GlaxoSmithKline, stated in a news release. “Blenrep is well positioned to address the unmet needs of these patients while also providing the benefit of in-office administration in both academic and community treatment settings without complex pre-administration regimens or hospitalization.”

Diving Into DREAMM-7

The open-label, randomized, phase 3 study enrolled patients with multiple myeloma who had previously received at least 1 line of therapy and experienced progressive disease on or following their most recent treatment.2 Patients were randomly assigned 1:1 to receive BVd (n = 243) vs daratumumab (Darzalex) plus bortezomib and dexamethasone (DVd; n = 251). The trial’s primary end point was progression-free survival (PFS), and key secondary end points included overall survival (OS), duration of response, and minimal residual disease–negative status.

At a median follow-up of 28.2 months (range, 0.1-40.0), the median PFS was 36.6 months (95% CI, 28.4-not reached) with BVd compared with 13.4 months (95% CI, 11.1-17.5) with DVd, translating to a 59% reduction in the risk of disease progression or death (HR, 0.41; 95% CI, 0.31-0.53; P < .001). The 18-month OS rates were 84% and 73% in the BVd and DVd groups, respectively. Moreover, an analysis of restricted mean response duration favored the BVd regimen over the DVd regimen (P < .001).

Regarding safety, all patients experienced at least 1 adverse effect (AE). Grade 3 or higher AEs were reported in 95% of those in the BVd arm (n = 242) vs 78% of those on the DVd arm (n = 246), and serious toxicities occurred in 50% and 37% of patients, respectively. AEs related to treatment led to discontinuation in 26% of those who received BVd vs 15% of those given DVd.

The most common grade 3 or higher AEs experienced in the BVd arm were thrombocytopenia (55%), anemia (55%), and (blurred vision (22%); in the DVd arm, it was thrombocytopenia (35%), anemia (10%), pneumonia (4%), COVID-19 (4%), diarrhea (4%), and peripheral neuropathy (4%).

Delving Into DREAMM-8

The open-label, randomized, phase 3 trial included patients with prior exposure to lenalidomide who had relapsed or refractory multiple myeloma after at least 1 prior line of therapy.3 Patients were randomly assigned 1:1 to receive BPd (n = 155) vs pomalidomide plus bortezomib and dexamethasone (PVd; n = 147). The primary end point was PFS, and investigators also evaluated disease response and safety.

At a median follow-up of 21.8 months (range, <0.1 to 39.2), the estimated 12-month PFS rates in the BPd and PVd arms were 71% (95% CI, 63%-78%) and 51% (95% CI, 42%-60%), respectively (HR, 0.52; 95% CI, 0.37-0.73; P < .001). The OS data were immature at the time of publication in New England Journal of Medicine. The percentages of patients who responded to treatment in the respective arms were 77% (95% CI, 70%-84%) and 72% (95% CI, 64%-79%), respectively; 40% (95% CI, 32%-48%) and 16% (95% CI, 11%-23%) of patients, respectively, experienced a complete response or better.

Grade 3 or higher AEs were reported in 94% of those in the BPd arm vs 76% of those in the PVd arm. Ocular toxicities were reported in 89% and 30% of patients, respectively; they were managed through dose modifications. These effects resulted in treatment discontinuation for 9% of those in the BPd arm vs 0% of those in the PVd arm.

References

  1. Blenrep (belantamab mafodotin) combinations receive positive CHMP opinion in relapsed/refractory multiple myeloma. News release. GlaxoSmithKline. May 23, 2025. Accessed May 23, 2025. https://www.gsk.com/en-gb/media/press-releases/blenrep-belantamab-mafodotin-combinations-receive-positive-chmp-opinion-in-relapsedrefractory-multiple-myeloma/
  2. Hungria V, Robak P, Hus M, et al. Belantamab mafodotin, bortezomib, and dexamethasone for multiple myeloma. N Engl J Med. 2024;391(5):393-407. doi:10.1056/NEJMoa2405090
  3. Dimopoulos MA, Beksac M, Pour L, et al. Belantamab mafodotin, pomalidomide, and dexamethasone in multiple myeloma. N Engl J Med. 2024;391(5):408-421. doi:10.1056/NEJMoa2403407

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