“Real-life” data of the efficacy and safety of belantamab mafodotin in relapsed multiple myeloma—the Mayo Clinic experience

Abstract

Belantamab mafodotin is a highly selective targeted therapy for multiple myeloma. It targets the B cell maturation antigen (BCMA) on plasma cells and showed promising results in several randomized clinical trials. We report the outcomes of 36 patients treated at Mayo Clinic. Our cohort received a median of eight prior lines of therapy. Six patients received belantamab in combination with other medications (pomalidomide, cyclophosphamide, thalidomide), 13 patients (36%) were 70 years or older, two patients had a creatinine of >2.5 mg/dL, and one patient was on dialysis. All three patients with renal failure received full dose belantamab. Chimeric antigen receptor (CAR-T) therapy was used prior to belantamab in seven patients and none of them responded to belantamab therapy. The overall response rate (ORR) was 33% (CR 6%, VGPR 8%, PR 19%), like the ORR reported in the DREAMM-2 trial. Keratopathy developed in 16 patients (43%), grade 1 in six patients, grade 2 in seven patients, and grade 3 in three patients. Eight percent discontinued therapy due to keratopathy. The median PFS and OS was 2 months and 6.5 months, respectively.

Efficacy and safety of belantamab-mafodotin in triple-refractory multiple myeloma patients: A multicentric real-life experience

“…Our rate of patients with renal impairment was 71% (20/28), and this dysfunction was mild (60 ≤GFR <90 ml/min), moderate (30 ≤GFR <60 ml/min), and severe (GFR <30 ml/min) in 8/28 (29%), 8/28 (29%), and 4/28 (13%) subjects, respectively, slightly higher than that reported in the Mayo Clinic and DREAMM-2 trials, especially for severe renal failure. Notably, our patients with mild, moderate, or severe renal failure showed an ORR of 50%, 25%, or 50%, respectively, similar to that reported in DREAMM-2 and Mayo clinic trials ( 11 , 23 ), even considering the special population of the DREAMM-2 trial with mild (N = 48) and moderate (N = 24) renal dysfunction. Indeed, also in this case, our ORR was similar to those already reported (50% vs. 33% and 25% vs. 33% for mild and moderate renal impairment, respectively) ( 25 ).…”

“…In a recent retrospective real-life experience, clinical outcomes from 36 heavily pretreated MM patients (median prior lines, 8) who have received belantamab-mafodotin monotherapy or in association with other anti-myeloma agents have been reported showing an ORR of 33% (mostly PR, 19%), a median DOR of 5 months, and a median PFS and OS of 2 and 6.5 months, respectively, at a median follow-up period of 6 months ( 23 ). Our slightly higher responses could be linked to the lower number of prior lines of treatments in our cohort (N = 6; range, 3–14) compared with the DREAMM-2 (N = 7), with the Mayo Clinic (N = 8) studies, and with our smaller sample size (N = 28) versus DREAMM-2 (N = 97) and Mayo Clinic (N = 36) experiences ( 11 , 21 ).…”

“…Interestingly, 19% of Mayo Clinic patients had been previously exposed to chimeric antigen T-lymphocytes (CAR-T), another innovative anti-BCMA therapy ( 23 ). In DREAMM-2 and in our trial, no patients underwent CAR-T therapy before BM administrations ( 11 ).…”

“…Our trial has several limitations. First, our study was a retrospective experience conducted on a small patient cohort, with a sample size lower than that from the DREAMM-2 trial but similar to that of the Mayo Clinic real-life experience (N = 36) ( 23 ). Second, cytogenetic alterations at diagnosis were missing, although the negative prognostic significance of these genetic alterations at onset might be less important in pluri-refractory MM.…”

Real-World Outcomes of Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma (RRMM): Preliminary Results of a Spanish Expanded Access Program (EAP)

“…Belantamab mafodotin (BM) is the first-in-class ADC in MM that utilizes a humanized anti-BCMA mAb linked to the microtubule-disrupting agent monomethyl auristatin F (MMAF) [ 12 ]. It has been recently approved by the FDA and EMA as monotherapy for triple-class refractory MM patients that have previously received four or more therapies [ 2 , 4 , 13 ], including at least one PI, one IMiD, and one anti-CD38 mAb.…”