The impact of reduced dosing frequency of elranatamab on patient‐reported outcomes in patients with relapsed or refractory multiple myeloma: Results from MagnetisMM‐3

Multiple myeloma (MM) is associated with a range of clinical symptoms, including bone pain, anemia, renal dysfunction, and hypercalcemia.1,2 Given the chronic nature of MM, its symptom burden, and the side effects of its treatments, monitoring health-related quality of life (HRQOL) via patient-reported outcomes (PROs) has emerged as a critical aspect of patient care.[3][4][5] Elranatamab, a humanized bispecific antibody that targets B-cell maturation antigen (BCMA) on myeloma cells and CD3 on T cells, has demonstrated efficacy and safety in patients with relapsed or refractory MM (RRMM) in the registrational Phase 2 MagnetisMM-3 clinical trial (NCT04649359).[6][7][8] Patients in the MagnetisMM-3 study reported improvements in PROs, regardless of prior exposure to BCMA-directed therapy, with notable reductions in pain and disease symptoms, and improvements in patients' outlook on their future health.9 Reduction in the dosing frequency of bispecific antibodies offers convenience and flexibility to patients.10 In the MagnetisMM-3 study, patients who received weekly (QW) elranatamab for ≥6 cycles and achieved a partial response (PR) or better persisting for ≥2 months were eligible to transition to an every 2-week (Q2W) dosing schedule.[7][8][9] While prior analyses have examined the impact of a Q2W dosing schedule on clinical outcomes, 7 here we report the effect of switching from QW to Q2W elranatamab dosing on PROs among both BCMA-naive and -exposed patients from the MagnetisMM-3 study, hypothesizing that HRQOL would, at a minimum, be maintained as the incidence of TEAEs decreased after a reduction in dosing frequency while most patients maintained their response to elranatamab.MagnetisMM-3 (NCT04649359) is an open-label, multicenter, nonrandomized, Phase 2 registrational study evaluating the efficacy and safety of elranatamab monotherapy in patients with RRMM. 7,8ligibility criteria have been previously described.[7][8][9] Two patient cohorts were enrolled, those without (BCMA naive) or with (BCMA exposed) prior exposure to a BCMA-directed antibody-drug conjugate and/or chimeric antigen receptor T-cell therapy.The study was conducted in accordance with the International Council for Harmonisation guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki.The study protocol was approved by local or independent institutional review boards or ethics committees at participating sites.All patients provided written informed consent.Patient-reported outcomes (PROs) were a prespecified exploratory endpoint of the MagnetisMM-3 study.9 All PRO measures were administered electronically on D1 and D15 of the first three cycles and D1 of each subsequent cycle through Cycle 12. Thereafter, PRO assessments were administered every three cycles.Additional information can be found in the Supporting Information.The data cutoff for this analysis was March 26, 2024, which represented a median follow-up of approximately 28 months for the overall study population.The analysis dataset included all patients who switched from QW to Q2W dosing intervals.The point at which patients switched from QW to Q2W administration was classified as their baseline ("Q2W baseline").Of the 61 BCMA-naive patients and 22 BCMA-exposed patients who were treated with elranatamab through at least Cycle 7 in the MagnetisMM-3 study, a total of 58 and 19 patients, respectively, transitioned from QW to Q2W dosing (93%).This analysis focused exclusively on these patients.Demographic and clinical characteristics were generally similar between the two cohorts (Table S1).BCMA-naive and -exposed patients had a median age of 67.5 and 67.0 years, respectively.Differences between the BCMA-naive and -exposed cohorts, respectively, included the median number of prior lines of therapy (5.0 and 7.0) as well as the incidence of an Eastern Cooperative Oncology Group performance status of 2 (5.2% and 10.5%), Revised International Staging System disease Stage III (6.9% and 15.8%), and high-risk cytogenetics (22.4% and 15.8%).

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