Patient-reported outcomes from dreamm-7 and dreamm-8 using the EQ-5D-3L, patient global impression of severity, and patient global impression of change

Abstract Background: In DREAMM-7 (NCT04246047), belantamab mafodotin (belamaf) in combination with bortezomib and dexamethasone (BVd) demonstrated significant improvements in progression-free survival (PFS; median follow-up, 28.2 months; hazard ratio [HR], 0.41; 95% CI, 0.31-0.53; P<0.001) and overall survival (median follow-up, 39.4 months; HR, 0.58; 95% CI, 0.43-0.79; P=0.0002) compared with daratumumab-Vd (DVd) in patients with relapsed/refractory multiple myeloma (RRMM) who had received ≥1 prior line of therapy. In DREAMM-8 (NCT04484623), belamaf, pomalidomide, and dexamethasone (BPd) showed a significant PFS benefit (median follow-up, 21.8 months; HR, 0.52; 95% CI, 0.37-0.73; P<0.001) vs pomalidomide-Vd (PVd) in patients with RRMM who had received ≥1 prior line of therapy including lenalidomide. In both studies, patient-reported outcomes (PROs) on European Organisation for Research and Treatment of Cancer QLQ-C30 global health status/quality of life (QOL) were maintained throughout treatment and remained similar between treatment arms over time. To further characterize QOL, this analysis reports additional PRO findings using the EQ-5D-3L visual analogue scale (VAS), Patient Global Impression of Severity (PGIS), and Patient Global Impression of Change (PGIC), all of which are single-item, global scales that allow patients to provide their own direct assessment of their health and further inform overall benefit:risk profile. Methods: PROs were assessed using 3 instruments: EQ-5D-3L VAS, PGIS, and PGIC. The EQ-5D-3L VAS is a standardized tool, completed by patients or administered by interview, on which patients rate their overall health on a scale from 0 (“worst imaginable health”) to 100 (“best imaginable health”) with the score that best represents their status on the day of the assessment. The PGIS evaluated overall symptom severity at baseline and subsequent time points, with patients rating their symptom status over the past week as “none,” “mild,” “moderate,” “severe,” or “very severe.” The PGIC assessed change in overall symptom status since the start of treatment, using a 5-point scale ranging from “much better” to “much worse.” All PRO measures were assessed at baseline (day 1, cycle 1), throughout treatment (every 6 weeks in DREAMM-7; every 8 weeks for EQ-5D-3L and every 4 weeks for PGIS and PGIC in DREAMM-8), at the end-of-treatment visit, and during follow-up. Descriptive statistics were used to summarize PROs. HRs for time-to-event endpoints were estimated using the Cox model with Wald CIs. The Kaplan-Meier method was used to estimate median times with 95% Brookmeyer-Crowley CIs. Results: Per the EQ-5D-3L VAS, overall QOL did not differ between treatment arms in either DREAMM-7 or DREAMM-8. Median time to first deterioration in VAS score was 9.5 months with BVd and 13.7 months with DVd in DREAMM-7 (HR, 1.08; 95% CI, 0.84-1.41); in DREAMM-8, there was a delay in median time to first deterioration in VAS scores in the BPd (17.7 months) vs the PVd (9.3 months) arm (HR, 0.84; 95% CI, 0.60-1.17). When patients' impression of their overall status was assessed using the PGIS, a higher proportion of patients in the BVd arm and BPd arm reported ≥1-point improvements in symptom severity scores at nearly every assessment during treatment compared with patients in the DVd and PVd arms, respectively. Additionally, median time to first improvement in symptom severity was shorter in the BVd (5.6 months) and BPd (3.7 months) arms vs the comparator arms DVd (9.2 months; inverse HR, 0.89; 95% CI, 0.69-1.14) and PVd (6.1 months; inverse HR, 0.80; 95% CI, 0.59-1.10). PGIC scores were similar between treatment arms across time points in DREAMM-7 and DREAMM-8. Conclusions: No difference in overall QOL was observed between belamaf-based regimens and their respective triplet comparators in DREAMM-7 and DREAMM-8, as measured by the EQ-5D-3L VAS. However, patient-reported assessments of symptoms using the PGIS showed that throughout treatment, symptom burden was consistently rated as less severe in the BVd and BPd arms vs the DVd and PVd arms. PGIC scores were similar between the belamaf-based regimens and their respective comparators. Together with the previously demonstrated efficacy benefits and manageable safety profiles of BVd and BPd, these PRO findings further support the overall benefit of belamaf-based regimens in MM at first relapse.

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