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Continued Advancements in Linvoseltamab Efficacy for Heavily Pre-Treated Multiple Myeloma

NextEdge Admin

17 Jun 2024

3 min 7 sec

Regeneron Pharmaceuticals, Inc. announced updated findings from its pivotal Phase 1/2 LINKER-MM1 trial of linvoseltamab for relapsed/refractory multiple myeloma (MM) at the European Hematology Association Congress 2024 and in the Journal of Clinical Oncology. Linvoseltamab, an investigational bispecific antibody, targets B-cell maturation antigen (BCMA) on MM cells, enhancing T-cell activation and cancer-cell killing.

The 14-month follow-up data reaffirmed the trial's initial efficacy and safety observations. Among patients receiving the 200 mg dose (N=117), results showed a 71% objective response rate (ORR), with 50% achieving a complete response (CR) or better, and 63% achieving a very good partial response (VGPR) or better. Importantly, median duration of response (DoR) was 29 months overall and not reached for those achieving CR or better, indicating durable responses.

Median progression-free survival (PFS) was not reached, with estimated 70% remaining progression-free at 12 months across all patients, and 96% among CR or better responders. Median overall survival (OS) reached 31 months for all patients, with 75% and 100% survival probability at 12 months among all patients and CR or better responders, respectively.

Safety profiles were consistent with earlier findings; cytokine release syndrome (CRS) and infections were notable adverse events, manageable with treatment. Comparing to real-world standard-of-care (SOC), linvoseltamab demonstrated superior outcomes: ORR of 70% vs. 32%, median PFS of 20 vs. 3 months, and superior median OS.

Regeneron has applied for Fast Track Designation and Priority Review from the FDA for linvoseltamab in R/R MM, with a decision expected in August 2024. The Phase 3 trial (LINKER-MM3) is ongoing, evaluating further the efficacy and safety of linvoseltamab.

This study underscores linvoseltamab's potential in heavily treated MM, supported by ongoing trials in earlier treatment lines and other hematologic conditions. Regeneron continues to advance its diverse portfolio, leveraging proprietary technologies like VelociSuite® to develop innovative therapies across various diseases, reaffirming its commitment to transforming patient care through biotechnology and scientific innovation.