Regeneron Pharmaceuticals (REGN) Study Update summary

Overview and Strategy

• Linvoseltamab (Lynozyfic), a BCMAxCD3 bispecific antibody, aims to transform multiple myeloma treatment by simplifying regimens and targeting both active disease and precursor conditions, including high-risk smoldering myeloma and MGUS.

• The development strategy spans late-line, early-line, and precursor settings, focusing on deep, durable responses and manageable safety.

• Eight registrational studies are underway or planned, including pivotal phase III trials in various patient populations.

• The approach emphasizes monotherapy and simplified combinations to reduce treatment burden and improve outcomes.

• Ambition includes potentially eliminating myeloma by treating precursor conditions and reshaping the treatment paradigm.

Clinical Data and Study Results

• In late-line relapsed/refractory myeloma, linvoseltamab achieved a 71% overall response rate and up to 52% complete response at 20–21.3 months, with rapid, durable responses and median time to response under 1 month.

• Early-line studies show high efficacy: second-line combination with carfilzomib yielded 90% overall response and 76% complete response; first-line monotherapy achieved ≥70% VGPR or better and 43% complete response at nine months.

• Profound MRD negativity rates observed, with up to 100% MRD negativity in some cohorts and 95% among evaluable newly diagnosed patients.

• Safety profile is favorable, with low rates and severity of cytokine release syndrome, manageable adverse events, and no new safety signals.

• Early data in high-risk smoldering myeloma and amyloidosis indicate rapid, deep responses and high MRD negativity rates.

Ongoing and Future Studies

• Confirmatory phase III LINKER-MM3 study in third-line myeloma is fully enrolled, with results expected in 2027.

• Phase III LINKER-MM5 (second-line) and LINKER-MM6, MM7, MM8 (first-line) studies are planned or enrolling, targeting both transplant-eligible and ineligible patients.

• Pivotal studies in precursor conditions (LINKER-SMM2 for high-risk smoldering myeloma) and amyloidosis (LINKER-AL2) are underway, with key data expected from 2026 onward.

• Subcutaneous formulation development is ongoing, with future data presentations planned.

• MRD negativity is being used as a primary endpoint in pivotal studies, supported by regulatory acceptance.