Retrospective, single-center, real-world experience of belantamab mafodotin in relapsed/refractory multiple myeloma.

Abstract

8060 Background: Belantamab mafodotin (belamaf) is a BCMA antibody drug conjugate approved for the treatment of relapsed refractory multiple myeloma (RRMM) patients (pts) based on the pivotal phase 2 DREAMM-2 study (Lonial et al, Lancet Oncology, 2019), which demonstrated an overall response rate (ORR) of 32%, median progression free survival (PFS) of 2.8 months, and overall survival (OS) of 13.7 months in triple class (proteasome inhibitor, IMiD, and anti-CD38) refractory (TCR) MM. In this single-center retrospective study, we report the efficacy and safety of belamaf in RRMM pts administered in a real-world, standard of care (SOC) setting. Methods: All MM pts who initiated therapy with SOC belamaf, either as monotherapy or in combination, between 11/1/2020 and 11/30/2021 at MD Anderson were included in this study. Response and progression were evaluated using International Myeloma Working Group standard criteria. Keratopathy and best corrected visual acuity (BCVA) adverse events (AEs) were graded per the Keratopathy and Visual Acuity (KVA) scale. The Kaplan-Meier method was used to estimate time to event endpoints. Results: A total of 39 consecutive pts with a median of 7 prior lines of therapy were included in the analysis, of whom 37 pts (95%) received single agent belamaf. Median age was 66 years (range 39-89), 14 of 37 (38%) pts with available FISH had high risk disease (del 17p, t(4;14, and/or t(14;16)), 14 pts (36%) had extramedullary disease, 37 (95%) pts were TCR, 32 (82%) pts were TCR and alkylator-refractory, and 8 pts (21%) were BCMA-refractory. Notably, the majority (69%) of pts in this analysis would have been ineligible for the DREAMM-2 trial based on key eligibility criteria. Median number of belamaf doses administered was 2 (range 1-9). Among 37 pts with measurable, response evaluable baseline disease, the best ORR (≥ PR) was 27% with ≥ VGPR of 3%. The clinical benefit rate (≥ MR) was 35%. Among 8 BCMA-refractory pts, there was 1 PR and 1 MR. Median PFS was 1.8 months and median OS was 9.2 months with a median follow-up of 10.1 months. Median duration of response has not been reached among 10 responding pts. Among 33 pts with a post-treatment ocular exam, 25 pts (76%) developed any grade keratopathy (Grade 1/2/3/4, 9%/55%/12%/0%, respectively) and BCVA changes (Grade 1/2/3/4, 42%/27%/6%/0%, respectively). Median time to first keratopathy or BCVA AE was 1.3 months. The most common reasons for treatment discontinuation were disease progression (75%) and AEs (9%). Conclusions: Our current study in heavily pretreated RRMM pts, of whom the majority would have been ineligible for the DREAMM-2 study, demonstrates an ORR, PFS, and ocular AE profile with SOC belamaf therapy comparable to outcomes reported in the pivotal registration study. Future studies are needed to further define the optimal use and sequencing of belamaf in MM pts, particularly in context of other BCMA-targeting modalities.

Single‐agent belantamab mafodotin in patients with relapsed/refractory multiple myeloma: Final analysis of the DREAMM‐2 trial

“…In this real‐world study, patients who were refractory to anti‐CD38 mAbs had a median OS of 8.6 months, with OS ranging from 11.2 months for patients not simultaneously refractory to an immunomodulatory agent and a PI, to 5.6 months for penta‐refractory patients 6 . Additional real‐world studies have demonstrated similar findings, consistent with the clinical trial setting 15–19 …”

“…6 Additional real-world studies have demonstrated similar findings, consistent with the clinical trial setting. [15][16][17][18][19] Despite having similar ORR and PFS, the shorter DoR reported here for the 3.4 mg/kg cohort may be due to tolerability issues requiring more frequent dose modifications. AEs such as thrombocytopenia and ocular events were frequently managed with dose delays that allowed for event resolution before recommencing treatment.…”

Real‐world experience with belantamab mafodotin therapy for relapsed/refractory multiple myeloma: A multicentre retrospective study

“…Median PFS was 1.8, 2.0 and 4.7 months respectively; median OS was 9.2, 6.5 and 7.4 months, respectively. Patients were treated with belantamab mafodotin as monotherapy (95% of the patients in Becnel et al 15 and 83% in Vaxman et al 16 ), or in combination with corticosteroids. 17 In this study, we aimed to analyse real-world outcomes of belantamab mafodotin therapy among a multisite Israeli cohort treated with belantamab mafodotin via the GSK compassionate access programme, and to assess whether clinical trial results are compatible with outcomes in the real-world setting.…”

“…This is of particular importance with a novel therapy such as belantamab, which presents a new challenge of managing ocular toxicity in collaboration with ophthalmologists. So far, three real‐world experience series were published, describing 39, 15 36 16 and 28 17 very heavily pretreated patients. Response rates were 27%, 33% and 46%, respectively.…”

“…Median PFS was 1.8, 2.0 and 4.7 months respectively; median OS was 9.2, 6.5 and 7.4 months, respectively. Patients were treated with belantamab mafodotin as monotherapy (95% of the patients in Becnel et al 15 and 83% in Vaxman et al 16 ), or in combination with corticosteroids. 17 …”