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Cellectar Initiates Pivotal Trial of CLR 131 in Waldenstrom’s Macroglobulinemia
FLORHAM PARK, N.J., Jan. 12, 2021 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on
About this update from Cellectar Biosciences, Inc.
[{"type":"text","content":"FLORHAM PARK, N.J., Jan. 12, 2021 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, today announced the initiation of a pivotal trial for CLR 131 in Waldenstrom’s macroglobulinemia (WM). The pivotal trial is designed as a global, non-comparator, single arm, expansion cohort of the currently ongoing Phase 2 CLOVER-1 study of CLR 131. This design is in alignment with the feedback received from the U.S. Food and Drug Administration (FDA) during the guidance meeting held in September 2020. The study will enroll 50 WM patients who have failed first-line therapy and have failed to respond to, or have progressed while on treatment with a BTK inhibitor (i.e. ibrutinib). Patients in the trial will receive up to 4 doses of CLR 131 over 2 cycles (cycle one days 1, 15, and cycle two days 57, 71). The primary endpoint of the trial is 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. An independent data monitoring committee (iDMC) will perform an interim safety and futility evaluation on the first 10 patients enrolled. The assessment will occur patient by patient and will conclude after the tenth patient is evaluated; there is no planned study stoppage. The trial has been initiated at select US cancer centers and will roll out to additional US and international sites in early 2021. “CLR 131 has the potential to be an important therapeutic option for patients with Waldenstrom’s macroglobulinemia, an indication with limited treatment alternatives. The 100% overall response rate achieved to date at comparable doses bodes well for CLR 131 to deliver meaningful outcomes for patients,” said Jim Caruso, president and CEO of Cellectar. “The company now possesses an accelerated route to commercialization with Fast Track and Orphan Drug designations further facilitating a clear regulatory pathway and a balance sheet to support development through NDA approval.”About Waldenstrom’s macroglobulinemiaWaldenstrom’s macroglobulinemia (WM) is a rare and incurable disease d...