TOPLINE:
METHODOLOGY:
- Belantamab mafodotin, a first-in-class anti-BCMA monoclonal antibody conjugate, was approved in the US in 2020 for adult patients with relapsed or refractory multiple myeloma who had received at least 4 prior therapies. However, in February 2023, the FDA withdrew this approval, following disappointing findings from a large confirmatory trial, called DREAMM-3. Although the agent is still being investigated to treat relapsed or refractory multiple myeloma, the current FDA label says the agent is only available in the US through a restricted program.
- Patients with multiple myeloma who relapse often become refractory to frontline triplet or quadruplet regimens and need effective second-line options.
- In the current phase 3 DREAMM-7 study, the researchers evaluated triplet therapy with belantamab mafodotin vs daratumumab as a second-line or later treatment option in patients with relapsed or refractory multiple myeloma.
- In this multicenter, open-label, randomized, phase 3 trial, 494 patients with relapsed/refractory multiple myeloma who previously received at least one prior line of therapy received bortezomib plus dexamethasone with either belantamab mafodotin or daratumumab.
- The primary outcome was PFS; secondary endpoints were overall survival, duration of response, and overall response rate.
TAKEAWAY:
- At a median follow-up of 28.2 months, patients who received belantamab mafodotin demonstrated significantly longer median PFS than those who received daratumumab (36.6 vs 13.4 months; hazard ratio [HR], 0.41). The improvement was evident in all prespecified groups, including patients refractory to lenalidomide (HR, 0.37) and those with a high risk for cytogenetic abnormalities (HR, 0.36).
- The early overall survival trend favored belantamab mafodotin — with 84% of patients alive at 18 months vs 73% in the daratumumab group — but overall survival follow-up is ongoing.
- The overall response rate was 83% in the belantamab mafodotin group vs 71% in the daratumumab group. Complete response rates were also higher in the belantamab mafodotin: 34.6% vs 17.1%. Median duration of response was twice as long in the belantamab mafodotin group (36 vs 18 months).
- Grade 3 or higher non-ocular adverse events in belantamab mafodotin vs daratumumab group included thrombocytopenia (55% vs 35%), infections and infestations (31% vs 20%), neutropenia (12% vs 6%), pneumonia (12% vs 4%), and anemia (8% vs 10%). Grade 3 or higher ocular adverse events were reported in 34% of patients treated with belantamab mafodotin, but ocular toxicities reversed in most patients.
IN PRACTICE:
Based on favorable PFS and manageable safety profile, belantamab mafodotin in combination with bortezomib plus dexamethasone has potential to become a new standard of care in the second line or later among patients with relapsed or refractory multiple myeloma, the author concluded.