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Actinium (ATNM) Announces Successful Pre-Planned Ad Hoc Interim Analysis of Phase 3 SIERRA trial

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Additional Relevant Details A single ad hoc analysis was exercised by Actinium in April 2020 consistent with the study's design that allowed for up to two ad hoc analyses between 70 to 110 patients.  This ad hoc analysis was exercised for a number of patients representing less than two thirds of anticipated final enrollment which required a higher success threshold compared to 100% of trial enrollment. With Actinium exercising only a single analysis, there was a minimal alpha spend resulting in a p-value threshold of 0.046 for the primary endpoint evaluation at full enrollment of 150 patients.  The SIERRA trial is currently over 75% enrolled.  Data from the first 75% of patients showing that 100% of patients receiving a therapeutic dose of Iomab-B proceeded to transplant and achieved engraftment compared to 16% of patients on the control arm was recently highlighted in an oral presentation at the American Society of Hematology Annual Meeting. A second oral presentation evaluated  safety data showing lower rates of serious adverse events categories including sepsis, febrile neutropenia, mucositis and 100-day non-relapse transplant related mortality (TRM) in patients receiving Iomab-B and BMT compared to those on the control arm.
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Catalyst Date
Occurred on:
Dec 29, 2020
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