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Cellectar Biosciences Inc (NASDAQ:CLRB) announced data from its CLOVER WaM pivotal study, evaluating iopofosine I 131, a targeted radiotherapy candidate for the treatment of relapsed/refractory Waldenstrom's macroglobulinemia (WM) patients that have received at least two prior lines of therapy.
Waldenström macroglobulinemia is a rare blood cell cancer characterized by an excess of abnormal white blood cells in the bone marrow.
CLOVER WaM is the largest study to date in relapsed or refractory WM patients post-BTKi therapy and represents the most refractory population ever tested in clinical studies based upon a review of published literature.
The CLOVER WaM study met its primary endpoint with a major response rate (MRR) of 61%.
The overall response rate (ORR) in evaluable patients was 75.6%, and 100% experienced disease control.
Responses were durable, with a median duration of response not reached and 76% of patients remaining progression-free at a median follow-up of eight months.
These outcomes exceed real-world data, demonstrating a 4-12% MRR and duration of response of approximately six months or less despite continuous treatment in a patient population that is less pretreated and less refractory to multiple classes of drugs.
Iopofosine monotherapy achieved an 8% stringent complete remission (sCR) in this highly refractory WM population.
Iopofosine I 131 was well tolerated, and its toxicity profile was consistent with the company's previously reported safety data.
Price Action: CLRB shares are up 29.50% at $3.47 on the last check Monday.
Posted In: CLRB
