Linvoseltamab

LYNOZYFIC®

Overview

Linvoseltamab is a bispecific antibody being tested for use in multiple myeloma that targets BCMA on cancer cells and CD3 on T-cells . 

SparkCures ID 351
Developed By Regeneron Pharmaceuticals
Brand Name Lynozyfic®
Generic Name Linvoseltamab
Additional Names REGN5458
Treatment Classifications
Treatment Targets

Clinical Trials

All Clinical Trials

View all active clinical trials around the US.

Untreated / Newly Diagnosed Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have been newly diagnosed or have not yet received treatment.

Early Relapse Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have received one to two prior lines of therapy.

Late Relapse Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have received three or more prior lines of therapy.

Smoldering Myeloma

The following is a listing of clinical trials for patients with Smoldering Myeloma.

Monoclonal Gammopathy of Undetermined Significance (MGUS)

The following is a listing of clinical trials for patients with Monoclonal Gammopathy of Undetermined Significance (MGUS).

Published Results

Updated Linvoseltamab Data Showcase Continued Deepening of Responses in Patients with Heavily Pre-Treated Multiple Myeloma

June 16, 2024

The 14-month median follow-up LINKER-MM1 data for linvoseltamab among patients treated at the 200 mg dose (N=117) reinforce the durability and increasing depth of response shown in previous data cuts. Per the presentation and publication, results showed:

  • 71% objective response rate (ORR), with 50% of patients achieving a complete response (CR) or better and 63% achieving a very good partial response (VGPR) or better, as determined by an independent review committee.
  • Median duration of response (DoR) of 29 months for all responders, while median DoR was not reached for those who achieved a CR or better. In analyses that were not pre-specified, there was an 81% and 95% estimated probability of maintaining a response at 12 months after achieving a partial response or better among all patients and those who achieved a CR or better, respectively.
  • Median progression-free survival (PFS) was not reached. There was a 70% estimated probability of being progression free at 12 months among all patients; the estimated probability was 96% among those who achieved a CR or better, per an analysis that was not pre-specified.
  • Median overall survival (OS) of 31 months for all patients (95% CI: 22 months to NE). In analyses that were not pre-specified, the median OS was not reached for patients who achieved a CR or better, and there was a 75% and 100% estimated probability of survival at 12 months among all patients and those who achieved a CR or better, respectively.
  • High rates of CRs or better in prespecified subgroups, including 55% (17 of 31 patients) among those aged 75 years or older, 48% (22 of 46 patients) among those with high cytogenetic risk, 45% (9 of 20 patients) among Black or African American patients, and 28% (10 of 36 patients) among those with plasmacytomas (including extramedullary and paramedullary).

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