Second-line treatment with belantamab mafodotin plus bortezomib/dexamethasone in patients with relapsed/refractory multiple myeloma is supported by findings from the phase 3 DREAMM-7 study.
Topline findings from the phase 3 DREAMM-7 study (NCT04246047)—assessing belantamab mafodotin-blmf (Blenrep) plus bortezomib (Velcade)/dexamethasone vs daratumumab (Darzalex) plus bortezomib/dexamethasone as a second-line treatment for relapsed/refractory multiple myeloma—appear positive, according to a press release from GSK.1
Patients who were treated with belantamab mafodotin plus bortezomib/dexamethasone significantly extended the time to disease progression or death over daratumumab plus bortezomib/dexamethasone. This improvement met the study’s primary end point of progression-free survival. At the time of the analysis, investigators also reported a trend towards clinically meaningful overall survival (OS) with the experimental regimen (P <.0005). The trial will continue to be followed for OS.
Additionally, the combination’s safety matched with the agents’ known profiles. The DREAMM-7 study’s findings are set to be presented as part of a scientific meeting, as well as shared with health authorities.
“Patients with multiple myeloma need treatment options after first relapse that are efficacious, readily accessible and have novel mechanisms of action,” Hesham Abdullah, senior vice president, global head of oncology, Research & Development at GSK, said in the press release. “We are particularly encouraged by the potential for belantamab mafodotin when combined with [bortezomib/dexamethasone] to address high unmet need in relapsed/refractory multiple myeloma, given the head-to-head comparison with the daratumumab-based standard of care regimen.”
The multicenter, open-label DREAMM-7 study included a population of patients who were treated with 1 previous line of therapy and had documented disease progression on or following their most recent treatment. Investigators enrolled a total of 494 patients who were then randomly assigned 1:1 to receive either bortezomib/dexamethasone in combination with belantamab mafodotin or daratumumab.
Belantamab mafodotin was administered intravenously at a dose of 2.5 mg/kg every 3 weeks. The study’s secondary end points included OS, duration of response, overall response rate, time to response, time to progression, and minimal residual disease negativity determined via next-generation sequencing.
To be included in the study, patients were required to have an ECOG performance status of 0 to 2, as well as have all previous toxicities reduced to grade 1 at the time of study enrollment with the exception of alopecia. Adequate organ function was also required.
Patients who were intolerant to daratumumab, as well as refractory to the agent or other anti-CD38 agents were ineligible for enrollment. Additionally, those who were intolerant or refractory to bortezomib were unable to enroll on the study. Other exclusion criteria included grade 2 or higher peripheral neuropathy or neuropathic pain, previous treatment with an anti–B-cell maturation antigen agent, previous allogenic stem cell transplant, corneal epithelial disease, and the presence of serious and/or unstable pre-existing medical issues, psychiatric conditions, or other concerns; this included renal, liver, and cardiovascular conditions, as well as select prior malignancies.
In November 2022, a marketing authorization for belantamab mafodotin was withdrawn from an indication of patients with relapsed/refractory multiple myeloma who were treated with at least 4 previous lines of therapy.2 The decision followed a recommendation to withdraw from the FDA based on results from the confirmatory phase 2 DREAMM-3 study (NCT04162210); the regulatory organization concluded that the agent was not eligible for accelerated approval.