Elranatamab 用于复发/难治性多发性骨髓瘤：MagnetisMM-1 1 期试验

Multiple myeloma (MM) is a plasma cell malignancy expressing B cell maturation antigen (BCMA). Elranatamab, a bispecific antibody, engages BCMA on MM and CD3 on T cells. The MagnetisMM-1 trial evaluated its safety, pharmacokinetics and efficacy. Primary endpoints, including the incidence of dose-limiting toxicities as well as objective response rate (ORR) and duration of response (DOR), were met. Secondary efficacy endpoints included progression-free survival (PFS) and overall survival (OS). Eighty-eight patients with relapsed or refractory MM received elranatamab monotherapy, and 55 patients received elranatamab at efficacious doses. Patients had received a median of five prior regimens; 90. 9% were triple-class refractory, 29. 1% had high cytogenetic risk and 23.

6% received prior BCMA-directed therapy. No dose-limiting toxicities were observed during dose escalation. Adverse events included cytopenias and cytokine release syndrome. Exposure was dose proportional. With a median follow-up of 12. 0 months, the ORR was 63. 6% and 38. 2% of patients achieving complete response or better. For responders, the median DOR was 17. 1 months.

All 13 patients evaluable for minimal residual disease achieved negativity. Even after prior BCMA-directed therapy, 53. 8% achieved response. For all 55 patients, median PFS was 11. 8 months, and median OS was 21. 2 months. Elranatamab achieved durable responses, manageable safety and promising survival for patients with MM. ClinicalTrials. gov Identifier: NCT03269136 .