WASHINGTON (dpa-AFX) - Regeneron Pharmaceuticals Inc (REGN) said its Phase 1/2 LINKER-AL2 trial showed encouraging results for Lynozyfic in patients with relapsed or refractory systemic amyloid light chain (AL) amyloidosis
Systemic AL amyloidosis is a rare blood disorder with no approved therapies after initial treatment fails.
The trial enrolled 20 patients, including 7 who received Lynozyfic 80 mg and 13 who received Lynozyfic 240 mg, with 60% previously treated with a daratumumab-containing regimen. With a median follow-up of 9.5 months, no dose-limiting toxicities were observed.
In the preliminary analysis, all 20 patients treated with Lynozyfic achieved a hematologic response. Among patients receiving the 80 mg dose, all seven achieved a very good partial response or better, including five complete responses, while all 13 patients in the 240 mg group achieved a complete response.
The company said responses were rapid and durable, with no hematologic progression reported among the 17 patients still enrolled in the trial. Involved free light chains normalized by day 15, while the median time to complete response was 47 days, indicating the treatment quickly eliminated the plasma cells producing the harmful proteins.
Lynozyfic also showed encouraging organ response activity, with renal improvement seen in 73% of evaluable patients and cardiac improvement in 50% of evaluable patients. No patients experienced major organ deterioration during the study.
The Phase 2 registrational portion of the trial is underway as part of a broader development program for Lynozyfic, which is already approved for certain adults with relapsed or refractory multiple myeloma.
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