CHMP Recommends Approval of Belantamab Mafodotin Combos in Multiple Myeloma

The belantamab mafodotin regimens earned approval in Japan from the Ministry of Health, Labour and Welfare in May 2025 based on findings from the DREAMM-7 and DREAMM-8 trials.

The European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of belantamab mafodotin-blmf (Blenrep)-containing regimens as a treatment for adults with relapsed/refractory multiple myeloma, according to a press release from the developer, GSK.1

Specifically, the CHMP recommended the approval of belantamab mafodotin plus bortezomib (Velcade) and dexamethasone (BVd) for those with at least 1 prior line of treatment and belantamab mafodotin in combination with pomalidomide (Pomalyst) and dexamethasone (BPd) for patients with 1 or more prior lines of therapy, including lenalidomide (Revlimid). The European Commission is expected to decide on approving these regimens during the third quarter of 2025.

“Today’s positive CHMP opinion is an important milestone toward bringing the benefits of [belantamab mafodotin] combinations to patients with multiple myeloma in Europe,” Hesham Abdullah, senior vice president, global head of Oncology Research & Development at GSK, said in the press release.1 “[Belantamab mafodotin] 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.”

Supporting data for the CHMP’s opinion on the BVd regimen came from the phase 3 DREAMM-7 study (NCT04246047). Furthermore, results from the phase 3 DREAMM-8 trial (NCT04484623) supported the CHMP’s recommendation for the BPd regimen.

DREAMM-7

In the DREAMM-7 trial, the median progression-free survival (PFS) was 36.6 months with BVd and 13.4 months with a comparator regimen consisting of daratumumab (Darzalex), bortezomib, and dexamethasone (DVd; HR, 0.4; 95% CI, 0.31-0.53; P <.00001). After a median follow-up of 39.4 months, data showed a 42% decrease in the risk of death with BVd vs DVd, meeting the study’s key secondary end point of overall survival (OS; HR, 0.58; 95% CI, 0.43-0.79; P = .00023). The 3-year OS rates were 74% among patients who received BVd vs 60% among those who were treated with DVd.

Investigators of the multicenter, open-label DREAMM-7 trial randomly assigned a total of 494 patients with relapsed/refractory multiple myeloma 1:1 to receive treatment with BVd (n = 243) or DVd (n = 252). Patients received belantamab mafodotin at 2.5 mg/kg intravenously every 3 weeks in the experimental arm.

The trial’s primary end point was PFS per independent review committee (IRC) evaluation. Secondary end points included overall response rate (ORR), patient-reported outcomes, quality of life, and safety.

DREAMM-8

After a median follow-up of 21.8 months in the DREAMM-8 study, the median PFS was not reached (NR; 95% CI, 20.6-NR) with BPd vs 12.7 months (95% CI, 9.1-18.5) with PVd (HR, 0.52; 95% CI, 0.37-0.73; P <.001). The 1-year PFS rates were 71% (95% CI, 63%-78%) and 51% (95% CI, 42%-60%) with BPd and PVd, respectively. Treatment with BPd produced a PFS benefit across all pre-specified patient subgroups, which included those with high-risk cytogenetics.

Interim analysis findings showed that BPd trended positively towards an OS improvement, although this did not show statistical significance (HR, 0.77; 95% CI, 0.53-1.14). Investigators plan to conduct additional analyses for OS.

A total of 302 patients were randomly assigned 1:1 to receive BPd (n = 155) or PVd (n = 147) in the DREAMM-8 study. In the investigational arm, patients received belantamab mafodotin at 2.5 mg/kg intravenously during the first cycle, then 1.9 mg/kg intravenously every 4 weeks for all subsequent cycles.

The primary end point was IRC-assessed PFS. Secondary end points included ORR, duration of response, and safety.

In the DREAMM-7 and DREAMM-8 trials, the safety profiles of the belantamab mafodotin-based regimens were consistent with prior reports of each agent.

The belantamab mafodotin regimens earned approval in Japan from the Ministry of Health, Labour and Welfare in May 2025 based on findings from the DREAMM-7 and DREAMM-8 trials.2

Furthermore, the FDA accepted a biologics license application for the belantamab mafodotin combination as a treatment for patients with relapsed/refractory multiple myeloma in November 2024.3 The agency is expected to make a regulatory decision on this indication by the Prescription Drug User Fee Act date of July 23, 2025.

References

1. Blenrep (belantamab mafodotin) combinations receive positive CHMP opinion in relapsed/refractory multiple myeloma. News release. GSK. May 23, 2025. Accessed May 23, 2025. https://tinyurl.com/bacz7tv9
2. Blenrep (belantamab mafodotin) combinations approved in Japan for treatment of relapsed/refractory multiple myeloma. News release. GSK. May 19, 2025. Accessed May 23, 2025. https://tinyurl.com/4zze5hk7
3. Blenrep combinations accepted for review by the US FDA for the treatment of relapsed/refractory multiple myeloma. News release. GSK. November 25, 2024. Accessed May 23, 2025. https://tinyurl.com/4wjtdf3t