FDA Accepts Priority Review for Linvoseltamab to Treat Adult Patients With R/R MM


Currently, the safety and efficacy of linvoseltamab in adult patients with relapsed or refractory multiple myeloma is being compared to elotuzumab, pomalidomide, and dexamethasone in a phase 3 clinical trial.

The FDA has accepted for priority review the biologics license application (BLA) for linvoseltamab (REGN5458; Regeneron Pharmaceuticals) to treat adult patients with relapsed or refractory (R/R) multiple myeloma (MM) that has progressed after at least 3 prior therapies. The FDA noted that the target action date for decision is August 22, 2024.1

Burgundy ribbon for multiple myeloma awareness -- Image credit: Jo Panuwat D | stock.adobe.com

Image credit: Jo Panuwat D | stock.adobe.com

Linvoseltamab is an investigational bispecific antibody that is designed to bridge B-cell maturation antigen on MM cells with CD3-expressing T cells to accelerate T-cell activation and the killing of cancer cells. The BLA comes after data from an ongoing open-label, multicenter, dose-escalation, dose-expansion phase 1 and phase 2 trial, LINKER-MM1 (NCT03761108), which investigates linvoseltamab in 282 enrolled patients with R/R MM. Linvoseltamab was administered with an initial step-up dosing regimen, followed by a full dose.

The phase 1 portion of the trial had assessed safety, tolerability, and dose-limiting toxicities across 9 different levels of linvoseltamab and administration regimens, whereas the phase 2 dose expansion portion assessed safety and anti-tumor activity of linvoseltamab. To be eligible for the phase 2 portion of the trial, patients had to have received at least 3 prior lines of therapy or have triple-class refractory MM. Further, in the phase 2 portion of the study, patients who achieved a very good partial response or a complete response that were treated with a response-adapted regimen consisting of 200 mg of linvoseltamab shifted from therapy every 2-week to every 4-week dosing after a minimum of 24 weeks of therapy. The primary end point was objective response rate, and key secondary end points were duration of response, progression-free survival, rate of minimal residual disease negative status, and overall survival (OS).

Previously, linvoseltamab was accepted for a marketing authorization application (MAA) following the results from the phase 1 and phase 2 trials. The MMA was indicated for adult patients with R/R MM who progressed after receiving at least 3 prior therapies.

Currently, there is a phase 3 portion of the study, LINKER-MM3 (NCT05730036). This phase of the trial examines patients who have MM that has returned or needs to receive further treatment after 1 to 4 prior treatments with standard cancer treatment options available. The safety and efficacy of linvoseltamab is compared with a combination of 3 cancer drugs—elotuzumab, pomalidomide, and dexamethasone (EPd)—in patients who have received prior treatment (eg, lenalidomide, a proteosome inhibitor, and a CD38 antibody). Further, half of the participants will receive linvoseltamab, whereas the other half will receive EPd.

According to the investigators, the study is specifically determining how long patients will benefit from linvoseltamab compared to EPd, how many patients will see improvement in their MM, adverse events, OS, and improvement in pain after treatment with linvoseltamab compared to EPd.3


  1. Regeneron. Linvoseltamab BLA For Treatment of Relapsed/Refractory Multiple Myeloma Accepted For FDA Priority Review. News release. February 21, 2024. Accessed February 22, 2024.
  2. Regeneron. Linvoseltamab Receives EMA Filing Acceptance For Treatment of Relapsed/Refractory Multiple Myeloma. News release. February 2, 2024. Accessed February 22, 2024. https://investor.regeneron.com/news-releases/news-release-details/linvoseltamab-receives-ema-filing-acceptance-treatment
  3. A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/​Refractory Multiple Myeloma (LINKER-MM3). ClinicalTrials.gov identifier: NCT05730036. Updated February 20, 2024. Accessed February 22, 2024. https://clinicaltrials.gov/study/NCT05730036
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