Dr Lee on the Rationale for Investigating Linvoseltamab in R/R Multiple Myeloma

Hans Lee, MD, associate professor, director, Multiple Myeloma Clinical Research, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the rationale for the phase 1/2 LINKER-MM1 trial (NCT03761108) of linvoseltamab (REGN5458) in patients with relapsed/refractory multiple myeloma.

At the 2023 ASH Annual Meeting, Lee and colleagues presented updated data from the LINKER-MM1 trial, which investigated the BCMA-directed bispecific T-cell antibody linvoseltamab in patients with relapsed/refractory multiple myeloma. BCMA is an important target in relapsed/refractory multiple myeloma, and several studies have demonstrated the efficacy of BCMA-directed immunotherapies in this disease, Lee says.

This updated presentation of the LINKER-MM1 trial is important because it shows mature data with longer follow-up, Lee emphasizes. This presentation was also the first time that independent review committee–adjudicated overall response rate (ORR) data, the trial’s primary end point, were reported, Lee explains. Key secondary end points of this trial included investigator-assessed ORR, duration of response, progression-free survival, minimal residual disease (MRD) status, and overall survival.

At a median follow-up of 8.1 months, linvoseltamab elicited an ORR of 69.2% among 12 patients from the phase 1 portion of the trial and 105 patients from the phase 2 portion of the trial with relapsed/refractory multiple myeloma who received the agent at 200 mg. A total of 59% of patients achieved a very good partial response (VGPR) or better and 39% of patients achieved a complete response (CR) or better. Furthermore, 10% of patients achieved a best response of PR. The median times to PR or better, VGPR or better, and CR or better were 1 month, 2.6 months, and 7.6 months, respectively. Among the 10 patients who had prior exposure to belantamab mafodotin (Blenrep), the ORR was 70%. Among the 37 patients who achieved a CR or stringent CR with available MRD data, 50% were MRD negative at 10^–5. Fifty percent of patients were still receiving core treatment with linvoseltamab at median follow-up.