Cellectar Biosciences Presents Compelling Efficacy Data from Phase 2b CLOVER WaM Subset Analysis of Iopofosine I 131 in Patients Relapsed/Refractory to BTK Inhibitor Therapy at the International Workshop for Waldenström Macroglobulinemia
Globe Newswire•15/10/2026•07:00 ET
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Key Highlights
- ➤Immediate post-BTKi subgroup achieved 87.5% overall response rate
- ➤Median duration of response reached 16.0 months
- ➤Clinical benefit rate was 100% in 24-patient subgroup
- ➤Phase 3 trial sites and initiation underway; first dosing expected 1Q27
- ➤U.S. accelerated approval application anticipated in 1H27
Expert Statements
Jarrod Longcor, Chief Operating Officer of Cellectar Biosciences
“These compelling data further strengthen the growing body of evidence supporting the potential of iopofosine I 131 to address a critical unmet need and offers something WM patients rarely get after BTK inhibitors: deep, durable responses from a short, fixed course of treatment. Because its targeted radiation works independently of the BTK pathway and other pathways currently targeted or attempting to be targeted, we believe it has the potential to remain effective as patients become refractory to today’s targeted therapies, and those still to come”
Jarrod Longcor, Chief Operating Officer of Cellectar Biosciences
“Patients in the immediate post-BTKi setting often face limited treatment options and increasingly refractory disease, making the robust response rates, durable clinical benefit, and favorable tolerability profile observed in this analysis especially encouraging. With Breakthrough Therapy Designation, a mature and expanding CLOVER WaM dataset, and plans underway to dose patients in our confirmatory clinical trial in early 2027, we believe iopofosine I 131 is well positioned to become a meaningful new treatment option for these patients, and we remain focused on advancing the program toward potential regulatory approval.”
Subgroup analysis of patients who received Bruton Tyrosine Kinase inhibitor (BTKi) treatment immediately prior to iopofosine I 131 achieved 87.5% ORR, 79.2% MRR and 100% CBR with median DOR of 16 months
Initiation and site selections for Phase 3 confirmatory randomized clinical trial in post-first line, post-BTKi population evaluating Progression-Free Survival as primary endpoint underway; dosing of first patients expected in 1Q27 and application for U.S. accelerated market approval anticipated in 1H27
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