Triplet regimen extends OS in relapsed or refractory multiple myeloma
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A triplet regimen extended OS compared with the current standard of care for patients with relapsed or refractory multiple myeloma, according to a topline data announcement.
Patients with multiple myeloma often become refractory to first-line triplet or quadruplet therapy regimens, creating a need for effective second- or later-line treatments.
The randomized phase 3 DREAMM-7 trial compared the efficacy of a three-drug experimental regimen — the antibody-drug conjugate belantamab mafodotin (Blenrep, GSK) plus bortezomib and dexamethasone (BVd) — with the current standard of care, which consists of daratumumab (Darzalex, Janssen), bortezomib and dexamethasone (DVd).
The analysis included 494 adults with multiple myeloma who received at least one prior line of therapy. Participants had not received prior B-cell maturation antigen (BCMA)-targeted therapies, and they were not refractory to or intolerant of daratumumab or bortezomib.
Researchers randomly assigned 243 patients to BVd and 251 patients to DVd.
PFS served as the primary endpoint. OS, duration of response and minimal residual disease served as key secondary endpoints.
As Healio previously reported, results showed significantly improved PFS (median, 36.6 months vs. 13.4 months; HR = 0.41; 95% CI, 0.31-0.53) and longer median duration of response (35.6 months vs. 17.8 months) in the BVd group.
GSK announced today that the trial met its key secondary endpoint, with a preplanned interim analysis showing a statistically significant improvement in OS in the BVd group.
“The overall survival results from the DREAMM-7 trial underscore the potential for this Blenrep combination to extend the lives of patients with relapsed/refractory multiple myeloma,” Hesham Abdullah, MD, MSc, senior vice president and global head of oncology research and development for GSK, said in a company press release. “This is a statistically significant and clinically meaningful advancement for patients and potentially transformative for treatment.”
Complete OS data from the interim analysis, including safety data, will be presented at this year’s ASH Annual Meeting, scheduled for Dec. 7-10 in San Diego.
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