Targeting BCMA in relapsed and refractory multiple myeloma: A systematic review and meta-analysis of efficacy and safety of belantamab mafodotin.

Abstract

e19512 Background: Relapsed or refractory multiple myeloma (RRMM) remains a significant therapeutic challenge, particularly for patients exposed to proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies. This meta-analysis evaluates the efficacy and safety of Belantamab mafodotin, a BCMA-targeted antibody-drug conjugate, in RRMM patients across multiple studies. Methods: A meta-analysis was conducted to synthesize data from published studies involving patients with RRMM treated with Belantamab mafodotin. Outcomes assessed included overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and the incidence of adverse events (AEs). Random-effects models were used to calculate pooled estimates for efficacy and safety outcomes. Results: A total of 13 studies were included in this systematic review and meta analysis. Efficacy analysis revealed that the pooled ORR was 68.4% (95% CI: 61.2–75.6), with ≥very good partial response achieved in 65.2% (95% CI: 57.4–72.3). The pooled median PFS was 12.1 months (95% CI: 9.8–14.3), while OS data were limited but showed an estimated 2-year OS rate of 55.6% (95% CI: 46.8–63.7). Safety analysis revealed keratopathy as the most common adverse event, occurring in 52.4% (95% CI: 45.1–59.7) of patients, followed by decreased visual acuity in 47.3% (95% CI: 40.2–54.4), neutropenia in 36.5% (95% CI: 30.2–43.2), thrombocytopenia in 31.7% (95% CI: 25.8–38.5), and infections in 26.8% (95% CI: 21.3–33.2). Grade ≥3 toxicities included keratopathy (22.6%; 95% CI: 17.3–28.9), thrombocytopenia (21.2%; 95% CI: 15.8–27.7), and neutropenia (34.1%; 95% CI: 27.6–41.3). Most adverse events were manageable with dose adjustments or supportive care. Conclusions: Belantamab mafodotin demonstrates significant efficacy with durable responses in RRMM, particularly in heavily pre-treated populations. The toxicity profile, primarily driven by corneal adverse events, was manageable without compromising efficacy. These findings support Belantamab mafodotin as a promising treatment option for RRMM, pending further validation in large-scale trials.