Lynozyfic™ (linvoseltamab) Monotherapy in Newly Diagnosed Multiple Myeloma (NDMM) Shows Impressive Responses, Supporting Rationale as a Potential Foundation in Frontline Treatment

Core Insights - Regeneron Pharmaceuticals has reported promising results from the Phase 1/2 LINKER-MM4 trial evaluating Lynozyfic™ (linvoseltamab) for newly diagnosed multiple myeloma (NDMM) patients, demonstrating a VGPR+ rate of ≥70% across all dose groups [2][4][3] - The trial is significant as it is the first to assess a BCMAxCD3 bispecific monotherapy in NDMM, aiming to simplify treatment regimens and improve tolerability [3][4] - Lynozyfic has shown a high rate of minimal residual disease (MRD) negativity, with 95% of evaluable VGPR+ patients achieving MRD negative status [4][5] Company Overview - Regeneron is a leading biotechnology company focused on developing innovative medicines for serious diseases, including blood cancers [36][30] - The company utilizes its proprietary VelocImmune technology to create fully human antibodies, which are integral to its drug development efforts [35][33] Clinical Development - The LINKER-MM4 trial is part of a broader clinical development program for Lynozyfic, which includes various ongoing trials exploring its use as both monotherapy and in combination with other treatments [6][13] - The trial involved a dose escalation and expansion approach, with 45 patients treated across different dose levels [4][3] Treatment Efficacy - Lynozyfic monotherapy has achieved MRD negativity rates comparable to traditional quadruplet regimens but earlier in the treatment course, indicating its potential as a foundational treatment for multiple myeloma [3][4] - The median time to onset of response across all dose levels was 1.2 months, with responses expected to deepen over time [4][3] Safety Profile - The most common treatment-emergent adverse events included cytokine release syndrome (CRS) and neutropenia, with no Grade 4 infections or dose-limiting toxicities reported [5][4] - Infections were noted in 84% of patients, primarily occurring within the first three months of treatment, but the rate decreased over time [5][4] Future Outlook - Regeneron plans to host a virtual investor event to discuss its multiple myeloma development program, highlighting the ongoing advancements in its clinical pipeline [8][2] - The company is committed to exploring Lynozyfic's potential across various lines of therapy for multiple myeloma and related conditions [13][6]