Linvoseltamab Pivotal Data Presented at AACR Reinforce High Response Rate that Deepens Over Time in Patients with Heavily Pre-Treated Multiple Myeloma

Regulatory applications for linvoseltamab currently under review by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)

TARRYTOWN, N.Y., April 07, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced the oral plenary session presentation of positive pivotal data from the Phase 1/2 LINKER-MM1 trial of linvoseltamab in patients with relapsed/refractory (R/R) multiple myeloma (MM) at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego. Linvoseltamab is an investigational bispecific antibody designed to bridge B-cell maturation antigen (BCMA) on multiple myeloma cells with CD3-expressing T cells to facilitate T-cell activation and cancer-cell killing.

“The presentation of these pivotal results in an oral plenary session at AACR recognizes the exciting potential of linvoseltamab to advance the treatment of multiple myeloma,” said Sundar Jagannath, M.D., Director of the Multiple Myeloma Center of Excellence at Tisch Cancer Center at Mount Sinai in New York City and a trial investigator. “In clinical trials, linvoseltamab treatment led to responses that occurred early, were durable and deepened over time – all critical efficacy measures for this heavily pre-treated patient population. Further, among patients who had at least 24 weeks of treatment, the majority achieved a very good partial response, enabling them to transition from every two-week to every four-week dosing. This is an important accomplishment that I’ve seen firsthand in my trial patients, and I eagerly anticipate the FDA decision expected this August.”

With an 11-month median duration of follow up, the linvoseltamab data among 117 patients presented at AACR reinforce the strength of previously shared findings and included a:

• 71% objective response rate (ORR), with 46% of patients achieving a complete response (CR) or better and 62% achieving a very good partial response (VGPR) or better, as determined by an independent review committee.
• 1-month median time to response (range: <1-6 months). In responders, the median time to a VGPR or better was 3 months (range: <1-13 months) and to a CR or better was 8 months (range: 2-14 months).
• Median duration of response (DoR), median progression-free survival (PFS) and median overall survival (OS) were not reached. At 12 months, the estimated probability of maintaining a response was 78%, being progression free was 69% and survival was 75%.
• Among patients who had a CR or better and were minimum residual disease (MRD) evaluable, 93% (25 of 27 patients) were MRD negative at 10^-5.

The trial included a response-adapted regimen that enabled linvoseltamab patients to shift to every four-week dosing if they achieved a VGPR or better and completed at least 24 weeks of therapy. In the dose expansion portion of the trial (n=105), of the patients who had at least 24 weeks of therapy at data cutoff, 90% (56 of 62) achieved a VGPR or better and were able to transition to every four-week dosing. Of the 29 patients who transitioned to the extended dosing regimen prior to achieving a CR, 48% (14 of 29) subsequently experienced a deepening of response to CR or better.