OMER - Omeros reports final efficacy and safety narsoplimab data

Omeros (OMER) has announced final data from its pivotal trial for narsoplimab (OMS721) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), a frequently lethal complication of HSCT. Interim data from the study was reported in December last year.The study met the primary efficacy endpoint showing that 61% of (n=28) patients receiving at least one dose of narsoplimab (full analysis set FAS), achieved complete response rate as did 74% who received narsoplimab for at least four weeks (per-protocol, PP).Secondary endpoint: 100-day survival was 68% in patient receiving at least one dose of narsoplimab, 83% in patients who received at least 4 weeks of narsoplimab treatment, and 94% in complete responders.Median overall survival was 274 days in the FAS, 361 days in the PP population and, for complete responders, was not estimable as more than half of the responders were alive at last follow-up.Adverse events were typical of the post-HSCT

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Omeros reports final efficacy and safety narsoplimab data