Regeneron positions Lynozyfic (linvoseltamab) as a potential foundational frontline therapy or monotherapy for newly diagnosed multiple myeloma (NDMM), with multiple LINKER studies exploring monotherapy and combinations across transplant-eligible and ineligible patients.

In LINKER-MM6 (EMN39), induction with DRd is followed by Lynozyfic monotherapy versus continued DRd for transplant-ineligible NDMM, with several other LINKER trials (MM1–MM5, MMSS, and more) described across phases and indications.

Phase 1/2 data from LINKER-MM4 show encouraging Lynozyfic monotherapy results in adults with NDMM, including both transplant-eligible and ineligible patients.

Adverse events include mostly Grade 1 CRS and neutropenia as common TEAEs, with infections in a large portion of patients but rarely at Grade 4 or higher.

Among MRD-evaluable VGPR+ patients, 95% achieved MRD negativity at 10^-5 sensitivity, indicating a deep early response.

Specifically, MRD negativity at 10^-5 sensitivity was observed in 19 of 20 evaluable VGPR+ patients across all dose groups, supporting strong early depth of response.

Safety information highlights risks of CRS, IRR, neurologic events, infections, and liver problems, with explicit dosing precautions and monitoring requirements.

A REMS program is in place for Lynozyfic due to CRS and neurologic risks, including step-up dosing with inpatient monitoring after initial doses and ongoing infection, liver, and hematologic monitoring.

Post-induction, ten patients proceeded to autologous stem cell transplant with adequate CD34+ yield, demonstrating the feasibility of sequencing transplant in NDMM treated with Lynozyfic.

Ten patients underwent autologous stem cell transplant with acceptable CD34+ yield following Lynozyfic-containing induction.

Regeneron plans an investor event, the Regeneron Roundtable, on December 10, 2025, to discuss the myeloma program with investors.

This virtual investor event underscores Regeneron’s emphasis on communicating NDMM data and program updates to the market.

In dose-escalation and expansion (Phase 1A/1B), 45 patients (28 transplant-eligible, 17 transplant-ineligible) showed a median time to response of about 1.2 months, with CRS and neutropenia as the most common TEAEs and no Grade ≥4 infections or dose-limiting toxicities.

Across dose groups (50 mg, 100 mg, 200 mg), LD/monotherapy results show VGPR+ rates of at least 70% in NDMM, with expectations that responses will deepen over time.

Lynozyfic is a BCMAxCD3 bispecific antibody built on VelocImmune technology, designed to redirect T cells to myeloma cells, with ongoing development in earlier lines and precursor conditions.

Context includes the broader Lynozyfic program, VelocImmune technology, and REMS safety measures across LINKER trials and related studies.

Lynozyfic is investigational, and safety and efficacy have not yet been evaluated by regulatory authorities for frontline NDMM.