Cellectar BioSciences publishes corporate presentation on phospholipid drug conjugate radiotherapy pipeline, led by iopofosine I-131 in Waldenstrom macroglobulinemia

Cellectar said a Phase 3 confirmatory trial is planned, with first patient enrollment projected for the first quarter of 2027 and potential approval targeted for the fourth quarter of 2027 or first quarter of 2028.

Phase 2b CLOVER-WaM data showed a major response rate of 61.8%, an overall response rate of 83.6%, and a disease control rate of 98.2% in 55 evaluable patients.

The company said median duration of response was 533 days and median progression-free survival was 406 days, based on a December 2025 data cutoff.

Cellectar said the Phase 3 design targets 200 patients and the estimated total study cost is $42 million, including about $15 million to accelerated approval.

Cellectar BioSciences published a corporate presentation on its phospholipid drug conjugate radiotherapy pipeline, led by iopofosine I-131 in Waldenström macroglobulinemia.

The company said it plans to seek U.S. accelerated approval for iopofosine I-131 in the first half of 2027.