Belantamab Mafodotin Plus Pomalidomide Maintains Quality of Life in Relapsed/Refractory Multiple Myeloma
核心洞察
The DREAMM-8 trial evaluated belantamab mafodotin, pomalidomide, and dexamethasone (BPd) versus bortezomib, pomalidomide, and dexamethasone (PVd) in relapsed/refractory multiple myeloma (搜索).
Patient-reported outcomes showed BPd maintained health-related quality of life (HR-QOL) compared to PVd, with comparable scores in global health status and key functioning domains.
A higher proportion of patients on BPd experienced meaningful improvements in physical functioning and fatigue compared to those on PVd.
Belantamab mafodotin-blmf (Blenrep) plus pomalidomide (Pomalyst) and dexamethasone (BPd) demonstrates maintained health-related quality of life (HR-QOL) compared to bortezomib (Velcade) plus pomalidomide and dexamethasone (PVd) in pretreated patients with relapsed/refractory multiple myeloma (搜索), according to patient-reported outcome (PRO) data from the phase 3 DREAMM-8 trial (NCT04484623).
Comparable Quality of Life Scores
Results presented at the 21st International Myeloma Society Annual Meeting showed no significant differences in global health status and QOL (GHS/QOL) scores between the BPd (n = 133) and PVd (n = 124) arms from week 5 to 137, as measured by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core Module 30 (QLQ-C30). Domain scores for role and physical functioning, fatigue, and disease symptoms/pain were also comparable across treatment arms.
Meaningful Improvements with BPd
Notably, a higher proportion of patients achieved meaningful improvements (≥10 points) in EORTC scores at any time point with BPd vs PVd. The most significant differences were observed for physical functioning (53.6% vs 31.3%) and fatigue (65.2% vs 46.3%), respectively. Differences were also seen in the GHS/QOL (49.0% vs 39.5%), role functioning (51.6% vs 39.5%), and disease symptom (56.8% vs 43.5%) domains.
Meletios A. Dimopoulos, MD, professor and chairman of the Department of Clinical Therapeutics at the National and Kapodistrian University of Athens School of Medicine in Greece, stated, “Overall, in combination with the significant progression-free survival [PFS] benefit [generated] with BPd vs PVd, [as] observed in DREAMM-8, these results further support the use of BPd as a potential new standard of care in patients with relapsed/refractory multiple myeloma (搜索).”
DREAMM-8 Trial Details
The DREAMM-8 trial enrolled patients with multiple myeloma (搜索) who had received at least one prior line of therapy including lenalidomide and had documented disease progression during or following their most recent treatment. Patients could not have had prior exposure to an anti-BCMA (搜索) agent or pomalidomide and were not enrolled if they were refractory or intolerant to bortezomib. Key stratification factors included prior treatment lines, prior exposure to bortezomib, and prior exposure to anti-CD38 therapy.
Patients were randomized 1:1 to the BPd arm or PVd arm. In the BPd arm, patients received 2.5 mg/kg of intravenous belantamab mafodotin during cycle 1, followed by 1.9 mg/kg every 4 weeks from cycle 2 onward; 4 mg of oral pomalidomide on days 1 to 21; and 40 mg of dexamethasone on days 1, 8, 15, and 22. The comparator arm comprised 1.3 mg/m2 of subcutaneous bortezomib, 4 mg of pomalidomide, and 20 mg of dexamethasone. Treatment continued until disease progression, death, unacceptable toxicity, withdrawal of consent, or study cessation.
The primary endpoint was PFS by independent review committee assessment. Secondary endpoints included overall survival, minimal residual disease negativity, duration of response, overall response rate, complete response rate, very good partial response or greater, time to best response, time to progression, PFS2, adverse effects (AEs), ocular findings, and PROs.
Additional Toxicity Data
Over 53% of patients with available data across both arms reported no to low severity, interference, or frequency of symptomatic AEs at all visits, with a maximum PRO-CTCAE score of less than 3 post-baseline. Ocular toxicities were generally manageable with dose modification and had a minimal impact on PRO QOL. The incidence of treatment discontinuation due to ocular toxicities was low.
Worsening of vision-related function was reported in a higher proportion of patients treated with BPd (73%) vs PVd (51%), per OSDI scores. However, most of these patients later reported improvements in vision-related functions; in the BPd arm (n = 110), 92% of patients experienced an improvement in vision-related function after a median of 57 days.