Cellectar's Iopofosine I 131: 80% MRR, >16-Month DOR in WM
Cellectar Biosciences announced compelling efficacy results from a subset of patients treated with iopofosine I 131 immediately post-BTKi therapy in its Phase 2 CLOVER WaM clinical trial for relapsed or refractory Waldenström macroglobulinemia. The data, highlighted at ASCO, showed an 80% major response rate and a median duration of response exceeding 16 months in this challenging patient population. Based on these positive findings, the company plans to pursue accelerated approval in the U.S. and initiate a confirmatory Phase 3 study in the fourth quarter of 2026.
Key Highlights
- Iopofosine I 131 achieved a 79.2% major response rate in Waldenström macroglobulinemia patients post-BTKi therapy.
- Median duration of response was 16 months, with a range of 7.3 to 25.4 months.
- 20% of patients exceeded 30 months duration of response.
- The overall response rate was 87.5%, and the clinical benefit rate was 100%.
- Cellectar plans to pursue accelerated approval in the U.S. for iopofosine I 131.
- A Phase 3 confirmatory clinical trial is planned to initiate in Q4 2026.
Price Impact
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