Clinical TrialMay 21, 2026, 05:03 PM
Regeneron Lynozyfic Achieves 100% CR in AL Amyloidosis Trial
AI Summary
Regeneron announced positive Phase 1/2 LINKER-AL2 trial results for Lynozyfic (linvoseltamab) in second-line-plus systemic AL amyloidosis. The trial showed a 100% hematologic complete response (CR) rate at the highest tested dose and 71% CR at the lower dose, significantly outperforming the 53% CR rate of standard-of-care in untreated patients. Additionally, a majority of patients with renal (73%) or cardiac (50%) involvement demonstrated improved organ function. The Phase 2 portion of the trial, with registrational intent, is currently underway, and these results will be presented at the ASCO 2026 Annual Meeting.
Key Highlights
- Lynozyfic achieved 100% hematologic complete response (CR) at 240 mg dose in AL amyloidosis.
- 71% of patients achieved CR and 100% VGPR or better at 80 mg dose.
- Normalization of free light chains occurred by day 15 across all doses.
- 73% of renal and 50% of cardiac patients showed improved organ function.
- Median time to hematologic CR was 47 days.
- No dose-limiting toxicities observed; common AEs included CRS (50%) and neutropenia (40%).
- Phase 2 portion of the LINKER-AL2 trial with registrational intent is ongoing.
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