Clinical TrialMay 5, 2026, 07:12 AM
Cellectar's Iopofosine I 131 Phase 2b WM Data Shows 83.6% ORR
AI Summary
Cellectar Biosciences announced updated 12-month follow-up data from its Phase 2b CLOVER WaM trial for iopofosine I 131 in relapsed or refractory Waldenström macroglobulinemia. The data showed an 83.6% Overall Response Rate and 61.8% Major Response Rate, with a median Duration of Response of 17.8 months, meeting FDA expectations for accelerated approval. The company plans to initiate a confirmatory study in Q4 2026 and prepare for NDA filing, supported by a recent oversubscribed financing of up to $140 million.
Key Highlights
- Iopofosine I 131 Phase 2b CLOVER WaM trial achieved 83.6% Overall Response Rate (ORR).
- Major Response Rate (MRR) was 61.8%, meeting the primary endpoint.
- Median Duration of Response (DoR) reached 17.8 months, achieving a secondary endpoint.
- Median Progression-Free Survival (PFS) was 13.5 months.
- BTKi-exposed patients showed 64.1% MRR and 18.2 months median DoR.
- Data strengthens regulatory positioning for accelerated FDA approval.
- Confirmatory study is planned to initiate in Q4 2026.
- Recently announced oversubscribed financing of up to $140 million.