Regeneron disclosed that its bispecific antibody Lynozyfic (linvoseltamab) achieved a very good partial response or better in more than 70% of patients in the Phase 1/2 LINKER‑MM4 study of newly diagnosed multiple myeloma. The data were presented at the American Society of Hematology Annual Meeting and were delivered in an oral presentation by lead investigator Dr. Robert Orlowski of MD Anderson Cancer Center.
The LINKER‑MM4 trial enrolled 45 patients, 28 of whom were transplant‑eligible and 17 transplant‑ineligible. Across three dose levels—50 mg, 100 mg, and 200 mg—Lynozyfic was administered as a single agent. The study design allowed for early assessment of efficacy and safety in a population that traditionally receives complex quadruplet or triplet regimens.
The most striking finding was that 70% or more of patients reached very good partial response or better, and 95% of those responders were also minimal residual disease negative at a sensitivity of 10‑5. These deep responses suggest that Lynozyfic monotherapy can achieve outcomes comparable to multi‑drug combinations while potentially reducing treatment burden and toxicity.
From a business perspective, the data position Lynozyfic as a potential frontline therapy that could simplify treatment algorithms for newly diagnosed patients. By delivering high response rates and deep disease eradication with a single agent, Regeneron may be able to capture a share of the growing multiple‑myeloma market, which is currently dominated by complex combination regimens. The results also reinforce the value of Regeneron’s VelocImmune platform, which accelerates the development of bispecific antibodies and may give the company a competitive edge in the expanding BCMA‑targeted therapy space.
Dr. Orlowski noted that “Lynozyfic monotherapy is already achieving MRD negativity rates comparable to quadruplet regimens, but earlier in the treatment course, and these compelling results are expected to deepen with longer follow‑up.” Senior Vice President L. Andres Sirulnik added that the company’s momentum in hematology continues with additional frontline candidates, underscoring Regeneron's commitment to earlier interventions. Safety data from the trial were encouraging, with no Grade 4 or 5 infections reported and a decline in infections after the first three months.
Regeneron is expected to pursue regulatory submissions for the newly diagnosed indication in the coming months, building on the accelerated approval it received for relapsed/refractory disease. The company’s leadership views the LINKER‑MM4 results as a key milestone that could broaden Lynozyfic’s label and strengthen its position against competitors such as Tecvayli and Elrexfio.
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