Introduction:

Belantamab mafodotin (belamaf) is an antibody-drug conjugate targeting B-cell maturation antigen. In DREAMM-7 (NCT04246047), belamaf with bortezomib and dexamethasone (BVd) significantly prolonged progression-free survival and overall survival vs daratumumab, bortezomib, and dexamethasone (DVd) in patients with RRMM who received ≥1 prior line of therapy. Ocular events, including blurred vision, were more common with BVd; however, as previously described, patient-reported overall symptom bother on the FACT-GP5 showed only a small numerical increase in patients receiving belamaf. We sought to better contextualize the effect of meaningful visual changes and treatment benefit associated with BVd on patient health-related quality of life (HRQOL).

Methods

DREAMM-7 is an ongoing open-label, randomized phase 3 study evaluating BVd (n=243) vs DVd (n=251) in patients with RRMM and disease progression after ≥1 line of therapy. European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EORTC-QLQ-MY20 were secondary endpoints and are tools that use various scales to assess HRQOL in patients with cancer. This post-hoc analysis (data cutoff, October 2, 2023) focused on clinically meaningful changes in best corrected visual acuity (BCVA) across EORTC QLQ-C30 domains of global health status/QOL, role functioning (eg, work/daily activities, hobbies), and physical functioning (eg, self-care, walking). Patients were subdivided into 2 groups: (1) those with normal BCVA at baseline (20/25 or better in ≥1 eye) who experienced a bilateral worsening of BCVA to 20/50 or worse at any point on study and (2) those who either had normal BCVA at baseline and did not experience a bilateral worsening to 20/50 or worse or did not have normal BCVA at baseline. Ocular assessments occurred every 3 weeks and within 5 days prior to dosing, and EORTC-QLQ-C30 was collected every 3 weeks from cycle 1, day 1 on a fixed schedule throughout treatment, and less frequently thereafter. Time to sustained deterioration in physical functioning and disease-specific symptoms (eg, pain), defined as a meaningful decrease (≥10 points) in PRO scores for ≥2 consecutive assessments or death, was also evaluated in a post-hoc analysis (intent-to-treat population) with a focus on the EORTC QLQ-C30 physical functioning domain and QLQ-C30 MY20 disease symptoms. No formal hypothesis testing was performed.

Results

In the approximately one-third of patients with normal baseline BCVA who experienced a bilateral BCVA decline to 20/50 or worse, patient-reported global health status/QOL, role functioning, and physical functioning were maintained throughout treatment with BVd and were comparable to those in patients who received DVd. In the remaining approximately two-thirds of patients, a slight trend toward improvement (not meeting the meaningful change threshold) in overall global health status/QOL was seen with BVd vs DVd; physical and role functioning were similar between groups and were comparable to the DVd arm.

Clinically meaningful delays in time to sustained deterioration of physical functioning and time to worsening of disease-specific symptoms that would impact a patient's day-to-day activities were observed in patients receiving BVd vs DVd. Median time to sustained meaningful deterioration in physical functioning (BVd, 18.6 mo; DVd, 6.7 mo; hazard ratio [HR], 0.74; 95% CI, 0.58-0.94) and disease-specific symptoms (BVd, 28.4 mo; DVd, 10.8 mo; HR, 0.67; 95% CI, 0.51-0.86) was 2.5 to 3 times longer with BVd vs DVd.

Conclusions

Despite being common with belamaf, ocular events did not have a meaningful impact on HRQOL. Notably, in patients with bilateral worsening of BCVA to 20/50 or worse, HRQOL was maintained, likely due to the transient nature of ocular events and their management with dose reductions and delays, which have been shown to improve tolerability while maintaining efficacy. The significant efficacy benefits of belamaf prolonged time to deterioration in disease-specific symptoms and physical functioning, including self-care and walking. These data provide a broader picture of overall HRQOL and further support BVd as a potential new therapy for RRMM.

Drug-linker technology licensed from Seagen Inc; monoclonal antibody produced using POTELLIGENT Technology licensed from BioWa.

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2025
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