Cellectar Biosciences to Present Compelling Efficacy Data from Phase 2 CLOVER WaM Subset Analysis of Iopofosine I 131 in Patients Refractory/Resistant to BTK Inhibitor Therapy at International Workshop for Waldenström Macroglobulinemia
Globe Newswire•29/09/2026•07:30 ET
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Key Highlights
- ➤Major response rate 79.2% in BTK inhibitor-refractory/resistant patients
- ➤Overall response rate 87.5% in BTK inhibitor-refractory/resistant patients
- ➤Duration of response exceeded 16 months in subset analysis
- ➤Phase 3 confirmatory trial dosing targeted for early 2027
- ➤Accelerated approval NDA filing planned for first half of 2027
Expert Statements
Jarrod Longcor, Chief Operating Officer of Cellectar Biosciences
“We are pleased to present these data from the CLOVER-WaM study at IWWM and share additional evidence supporting the potential of iopofosine I 131 to address a significant unmet need for patients with WM. This analysis evaluated patients who received iopofosine I 131 immediately following BTK inhibitor therapy after at least two prior lines of treatment, representing a particularly challenging, heavily pretreated population”
Jarrod Longcor, Chief Operating Officer of Cellectar Biosciences
“We remain on-target to dose patients in the confirmatory Phase 3 clinical trial in early 2027 and to file our New Drug Application for accelerated approval in the first half of 2027. Given iopofosine I 131 has Breakthrough Therapy Designation, we expect a six-month review with a potential approval by the end of 2027.”
Demonstrated Major Response Rate of 79.2%, Overall Response Rate of 87.5%, and Duration of Response Exceeding 16 Months in Subset Analysis of Patients Treated with Iopofosine I 131 Immediately Post-BTKi Therapy
Data Further Support Company’s Plans to Advance Iopofosine I 131 in Phase 3 Confirmatory Trial and Submit for U.S. Accelerated Market Approval in 1H27
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