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Cellectar Biosciences Announces Positive DMC Review of Pivotal Trial of Iopofosine in Waldenstrom’s Macroglobulinemia
Unanimous Agreement on Successful Achievement of Futility/Efficacy Assessment FLORHAM PARK, N.J., April 26, 2022 (GLOBE NEWSWIRE) -- Cellectar Biosciences,
About this update from Cellectar Biosciences, Inc.
[{"type":"text","content":"Unanimous Agreement on Successful Achievement of Futility/Efficacy Assessment\nFLORHAM PARK, N.J., April 26, 2022 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, today announced an independent Data Monitoring Committee (DMC) has completed its planned futility/efficacy assessment of the company’s pivotal Phase 2b study of iopofosine in Waldenstrom’s macroglobulinemia (WM) and unanimously recommended continuation of the trial as planned. “We remain highly encouraged with the consistent performance of iopofosine I-131 in this difficult-to-treat refractory patient population,” said James Caruso, president and chief executive officer of Cellectar. “We have alignment with the FDA on a 20% major response rate hurdle as the primary endpoint of our pivotal study. In a poster presented at ASCO 2021, we showed an 83.3% major response rate with one complete response in six WM patients, which served as the basis for our pursuing this indication.” The pivotal trial is a global, non-comparator, single-arm, open-label expansion cohort of the currently ongoing Phase 2 CLOVER-1 study of CLR 131. The study will enroll 50 WM patients. Patients in the trial will receive up to four doses of iopofosine over two cycles (cycle one on days 1, 15, and cycle two on days 57 and 71). The primary endpoint of the trial is major response rate as defined as a partial response (a minimum of a 50% reduction in the biological marker IgM) or better in patients that receive a minimum total body dose of 60 mCi with secondary endpoints of treatment free survival, duration of response and progression free survival. The DMC is an independent committee of clinical research experts who review data in ongoing clinical trials. The DMC assessment was based on a pre-specified futility analysis within the first 10 patients as defined in the study protocol. About Waldenstrom’s macroglobulinemiaWaldenstrom’s macroglobulinemia (WM) is a rare and incurable disease defined by specific genotypic subtypes that defines patient responses and long-term outcomes. The U.S. annual incidence is 3,000 (anticipated annual growth rate of approximately 30% through 2025) with a current U.S. prevalence of approximately 45,000 pat...