1. Lynozyfic shows over 70% efficacy in NDMM patients from LINKER-MM4 trial. 2. 95% of VGPR+ patients achieved minimal residual disease negative status. 3. Regeneron presents results at ASH; increased interest in multiple myeloma treatments. 4. Virtual investor event scheduled for December 10 to discuss myeloma program. 5. Lynozyfic demonstrates potential as foundational treatment in myeloma therapy.
FAQ
Why Bullish?
The data from LINKER-MM4 suggest significant efficacy for Lynozyfic, enhancing investor sentiment.
How important is it?
Significant clinical data could lead to regulatory advances and increased market demand for Lynozyfic.
Why Long Term?
As efficacy data deepens and support from upcoming events increases, market confidence may rise.
Regeneron Pharmaceuticals Announces Promising Results for Lynozyfic™ in Newly Diagnosed Multiple Myeloma
TARRYTOWN, N.Y., Dec. 7, 2025 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) has unveiled encouraging data from the Phase 1/2 LINKER-MM4 trial, evaluating Lynozyfic™ (linvoseltamab) as a monotherapy for adults diagnosed with newly diagnosed multiple myeloma (NDMM). These findings, presented at the American Society of Hematology (ASH) Annual Meeting, highlight the potential of Lynozyfic as a foundational treatment option for patients, both transplant-eligible and ineligible.
Trial Overview and Efficacy Data
The LINKER-MM4 trial is a pioneering clinical investigation assessing the effectiveness of a BCMAxCD3 bispecific antibody. The trial included 45 patients in total, with 28 being transplant-eligible and 17 transplant-ineligible.
- All three dosing groups (50 mg, 100 mg, and 200 mg) exhibited a **very good partial response (VGPR+)** rate of **≥70%**.
- A remarkable **95%** of evaluable patients who achieved VGPR+ reached **minimal residual disease (MRD)** negativity status.
- The median time to onset of response across all dose levels was **1.2 months**.
These results indicate that the efficacy of Lynozyfic is expected to increase further with continued follow-up, suggesting strong potential for improving treatment outcomes for NDMM patients.
Expert Insights on Lynozyfic’s Potential
Robert Orlowski, M.D., Ph.D., Deputy Chair and Director of Translational Myeloma Research at The University of Texas MD Anderson Cancer Center and lead investigator of the trial, stated, “The treatment of newly diagnosed multiple myeloma often relies on complicated combinations of therapies, which can be burdensome for these patients. Our findings from LINKER-MM4 emphasize that a single-agent approach with Lynozyfic can potentially simplify treatment while achieving comparable efficacy to complex regimens.”
Orlowski further noted that Lynozyfic is already achieving MRD negativity rates comparable to those seen in multi-drug regimens but at an earlier stage of treatment.
Safety Profile of Lynozyfic
In terms of safety, the most common treatment-emergent adverse events (TEAEs) observed included:
- Cytokine release syndrome (CRS) at **44%** (all Grade 1)
- Neutropenia at **38%** (any Grade) and **33%** (Grade 3/4)
- Infections occurring in **84%** of patients, primarily within the initial three months of treatment.
Importantly, there were no reports of Grade 4 or higher infections, and no dose-limiting toxicities were observed during the trial.
Future Directions and Investor Event
Regeneron plans to expand its investigative efforts through a broad clinical development program for Lynozyfic, including ongoing studies like:
- The Phase 2 portion of the LINKER-MM4 trial at the recommended **200 mg** dose
- The LINKER-MM6 trial, examining a combination of daratumumab, lenalidomide, and dexamethasone followed by Lynozyfic monotherapy.
A virtual investor event titled the ‘Regeneron Roundtable’ will be hosted on **Wednesday, December 10** at **8:30 a.m. ET**, where further discussions on their multiple myeloma program and future prospects for Lynozyfic will take place.
For more information about the event, please visit the Investors and Media section on Regeneron’s website.
Understanding Multiple Myeloma
Multiple myeloma (MM) is the second most common type of blood cancer, with over **187,000** new cases diagnosed annually worldwide. In the U.S. alone, **36,000** new diagnoses and **12,000** deaths are projected for 2025. This condition is characterized by the proliferation of malignant plasma cells within the bone marrow, leading to a significant impact on healthy blood cell production and overall health.
About Lynozyfic
Lynozyfic, developed using Regeneron's VelocImmune® technology, is a fully human BCMAxCD3 bispecific antibody that targets B-cell maturation antigen on myeloma cells, facilitating T-cell activation to promote cancer cell destruction. Currently approved for certain adults with relapsed or refractory multiple myeloma in the U.S. and EU, Lynozyfic demonstrates promising potential as a therapeutic agent in earlier treatment stages of multiple myeloma.