Cellectar's Iopofosine I 131 Phase 2b Data Shows Durable Efficacy, Strengthens Accelerated Approval Prospects
Summary
Cellectar Biosciences reported positive 12-month follow-up data from its Phase 2b CLOVER WaM study for iopofosine I 131 in relapsed/refractory Waldenström Macroglobulinemia. The data demonstrated an 83.6% Overall Response Rate (ORR) and 61.8% Major Response Rate (MRR), with a median Duration of Response (DoR) of 17.8 months. This updated dataset, which includes a minimum of 12 months of follow-up for all enrolled patients as requested by the FDA, significantly strengthens the regulatory positioning for an accelerated approval submission. This builds upon the efficacy results from a subset of the trial announced on April 21st, providing more mature and comprehensive data. For a clinical-stage biotech, this is a highly material development, indicating a clearer and more robust path to market for a potential new treatment option in a heavily pretreated patient population. The company plans to initiate its confirmatory study in Q4 2026 and proceed with an NDA filing for accelerated approval, which will be key catalysts to monitor.
At the time of this announcement, CLRB was trading at $6.15 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $12M. The 52-week trading range was $2.43 to $20.59. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.