Belantamab Mafodotin Plus BVd Produces PROs Comparable to DVd in Relapsed/Refractory Multiple Myeloma

Treatment with belantamab mafodotin-blmf (Blenrep) plus bortezomib (Velcade) and dexamethasone (BVd) elicited patient-reported outcomes (PROs) comparable with those for daratumumab (Darzalex) plus bortezomib and dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma, according to data from the phase 3 DREAMM-7 trial (NCT04246047) which were shared at the 2024 ASCO Annual Meeting.¹

Across 494 patients in the intent-to-treat population who received treatment with BVd (n = 243) or DVd (n = 251), more than 90% had adherence to PRO assessments during visits. Additionally, global health status or quality of life (QOL) per EORTC QLQ-C30 assessment remained stable for patients and was similar between both treatment arms. Similar trends occurred for role functioning, physical functioning, fatigue, and pain.

Most patients in both arms reported no or a low number of symptomatic adverse effects (AEs) or low severity, interference, and frequency of such toxicities per maximum PRO-Common Terminology Criteria for AE (CTCAE) scores. At week 13, 23% of patients in the BVd arm reported feeling bothered “quite a bit” or “very much” by AEs per FACT-GP5 assessment compared with 14% of those in the DVd arm reporting the same sentiments at week 16 and 19.

Data initially showed a higher rate of vision-related function deterioration across the BVd arm based on the Ocular Surface Disease Index (OSDI) assessment, although these toxicities and the overall impact of treatment diminished over time. Between months 0 to 6, the mean time between BVd doses increased from 4.35 weeks, 4.72 weeks during months 6 to 12, and up to 7.32 weeks at months 12 and onward. Investigators reported that vision-related function toxicity could be mitigated with dose modifications based on a relationship between dosing frequency reductions and improvements in OSDI-measured vision-related function.

“In patients who experienced a clinically meaningful deterioration in vision-related function, overall [QOL] was comparable to that in all patients receiving DVd,” Vania Hungria, MD, PhD, of Clinica São Germano in São Paulo, Brazil, and coauthors wrote. “Overall, these results further support the use of BVd as a potential new standard of care in patients with [relapsed/refractory multiple myeloma].”

In the DREAMM-7 trial, patients with relapsed/refractory multiple myeloma who received at least 1 prior line of therapy were assigned to receive belantamab mafodotin at 2.5 mg/kg intravenously every 3 weeks or daratumumab at 16 mg/kg every week in cycles 1 to 3 and every 3 weeks in cycle 4 to 8. During the first 8 cycles, all patients also received bortezomib at 1.3 mg/m2subcutaneously on days 1, 4, 8, and 11 of cycles 1 to 8 plus dexamethasone at 20 mg intravenously or orally on the day of and after bortezomib. In cycles 9 and onward, patients received maintenance with belantamab mafodotin monotherapy at 2.5 mg/kg intravenously every 3 weeks or daratumumab at 16 mg/kg intravenously every 4 weeks.

The trial’s primary end point was progression-free survival. Secondary end points included overall survival, duration of response, minimal residual disease status, objective response rate, clinical benefit rate, AEs, QOL, and QOL.

For this PRO analysis, investigators used the EORTC QLQ-C30 to assess global health status or QOL, role functioning, physical functioning, and fatigue across 30 items. Other assessments included the EORTC QLQ-IL52 for disease-related pain across 7 items, PRO-CTCAE for symptomatic toxicity across 124 items, OSDI for vision-related functioning across 12 items, and FACT-GP5 for the overall impact of bothersome AEs via 1 item.

Investigators collected assessments every 3 weeks, and OSDI assessments were conducted every 6 weeks in the BVd arm and every 12 weeks in the DVd arm starting after week 16. Summarizing PRO scores involved the use of descriptive statistics, and investigators estimated least square means via a restricted maximum likelihood-based mixed model adjusting for treatment groups, visits, baseline values, treatment-by-visit interactions, and value-by-visit interactions at baseline.

Reference

Hungria V, Robak P, Hus M, et al. Patient-reported outcomes (PROs) from the DREAMM-7 randomized phase 3 study comparing belantamab mafodotin, bortezomib, and dexamethasone (BVd) vs daratumumab, bortezomib, and dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma (RRMM). J Clin Oncol. 2024;42(suppl 16):7543. doi:10.1200/JCO.2024.42.16_suppl.7543