Regeneron Reports Promising Phase 1/2 Data Of Lynozyfic In Newly Diagnosed Multiple Myeloma

rttnews
2025.12.08 01:09
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Regeneron Pharmaceuticals announced promising Phase 1/2 trial results for Lynozyfic in newly diagnosed multiple myeloma patients. The trial showed impressive efficacy, with 70% achieving very good partial response or better, and 95% of evaluable patients achieving minimal residual disease negative status. These findings were presented at the American Society of Hematology Annual Meeting, highlighting Lynozyfic's potential for durable outcomes in early treatment lines.

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Regeneron Pharmaceuticals Inc. (REGN) announced encouraging results from the Phase 1/2 LINKER-MM4 trial evaluating Lynozyfic (linvoseltamab) in adults with newly diagnosed multiple myeloma (NDMM), both transplant-eligible and transplant-ineligible. The findings were shared in an oral presentation at the American Society of Hematology (ASH) Annual Meeting.

The data build on Regeneron's broad clinical development program assessing Lynozyfic in early lines of treatment, including precursor conditions, as monotherapy and in combination with standard-of-care or novel agents.

Across all three dose groups (50 mg, 100 mg, and 200 mg), Lynozyfic demonstrated impressive monotherapy efficacy, with 70% of patients achieving very good partial response (VGPR) or better, despite limited follow-up. Evidence suggests these responses are expected to deepen over time.

Importantly, 95% of evaluable VGPR+ patients (19 of 20) achieved minimal residual disease (MRD) negative status across all dose groups, underscoring the potential of Lynozyfic to deliver durable and meaningful outcomes for patients with newly diagnosed multiple myeloma.

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