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Omeros Announces Update on Statistical Analysis of Narsoplimab Pivotal Trial Primary Endpoint
– Newly Completed Sensitivity Analyses Demonstrate Robustness of Previously Announced Survival Superiority Over External Control in Patients with TA-TMA –
About this update from Omeros Corporation
[{"type":"text","content":"\n – Newly Completed Sensitivity Analyses Demonstrate Robustness of Previously Announced Survival Superiority Over External Control in Patients with TA-TMA –\n\n\n\nSensitivity analyses support the results of the primary endpoint analysis, with representative sensitivity analyses demonstrating:\n\n\nNarsoplimab-treated patients had an over 2-fold reduction (hazard ratio = 0.42 [95% confidence interval: 0.21, 0.83]) to an over 4-fold reduction (hazard ratio = 0.24 [95% confidence interval: 0.13, 0.47] in risk of mortality\n\n\n\nP-values ranging from 0.0124 to \n\n\n\n\n\n\nThe primary endpoint analysis, previously reported on December 19, 2024, showed an over 3-fold reduction in risk of mortality (hazard ratio = 0.32 [95% confidence interval: 0.23, 0.44]; p \n\n\n\nOmeros plans to resubmit to FDA later this quarter the BLA for narsoplimab to become the first approved therapeutic for TA-TMA, a life-threatening complication of hematopoietic stem cell transplantation; MAA submission to European regulators targeted by mid-year\n\n\n\n SEATTLE--(BUSINESS WIRE)--\nOmeros Corporation (Nasdaq: OMER) today announced statistical sensitivity analysis results related to the primary endpoint analysis for narsoplimab, Omeros’ first-in-class monoclonal antibody inhibiting the lectin pathway of complement, in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA), a life-threatening complication in both adult and pediatric hematopoietic stem cell transplantation. The sensitivity analyses, conducted by an independent statistical group, demonstrate the robustness of the results of the previously reported primary endpoint analysis, with representative hazard ratios ranging from 0.24 (95 percent confidence interval: 0.13, 0.47) to 0.42 (95 percent confidence interval: 0.21, 0.83) and p-values ranging from less than 0.00001 to 0.0124.\n\n\nThe following are representative sensitivity analyses conducted by the independent statistical group:\n\n\n\n\n1.\n\n\n\n\n\nOverall survival with only treatment as a factor using Inverse Probability of Treatment Weighting (IPTW):\n\n\n\n\nHazard ratio = 0.40 (95 percent confidence interval: 0.29, 0.54)\n\n\n\n\nP-value \n\n\n\n\n\n \n\n\n\n2.\n\n\n\n\n\nTesting proportional hazards assumptions in a sequence of four models in which patient follow-up is truncated at 100 d...