Business
Cellectar Biosciences Reports Positive 12-Month Follow-Up Data from Phase 2b CLOVER WaM Study Demonstrating Durable Responses and Efficacy of Iopofosine I 131 in r/r Waldenström Macroglobulinemia
83.6% ORR and 61.8% MRR achieved in heavily pretreated population with median duration of response of 17.8 months FDA-requested dataset with ≥12-month
About this update from Cellectar Biosciences, Inc.
[{"type":"text","content":"83.6% ORR and 61.8% MRR achieved in heavily pretreated population with median duration of response of 17.8 months FDA-requested dataset with ≥12-month follow-up on all patients strengthens regulatory positioning for accelerated approval and supports initiation of confirmatory trial in 4Q26 Compelling efficacy observed in post-BTKi patients, including ~64% MRR and durable responses exceeding 18 months Recently Announced Oversubscribed Financing of up to $140 Million with Leading Healthcare Institutional Investors Supports Confirmatory Study and NDA Filing for Accelerated Approval of Iopofosine I 131 in Waldenström Macroglobulinemia with the FDA FLORHAM PARK, N.J., May 05, 2026 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of targeted oncology therapies, today announced updated and mature 12-month follow-up data from its Phase 2b CLOVER WaM clinical trial evaluating iopofosine I 131 in patients with relapsed or refractory (r/r) Waldenström macroglobulinemia (WM). The updated dataset includes a minimum of 12 months of follow-up for all enrolled patients, as requested by the U.S. Food and Drug Administration (FDA), and the durability data presented here, further strengthen the previously reported efficacy results. The Company also reports subset analyses from CLOVER WaM showing iopofosine I 131 demonstrated strong and consistent efficacy in both BTKi-exposed and BTKi-refractory patients. “The depth, durability, and consistency of responses observed across both the total population and BTKi-treated subsets underscore iopofosine’s potential as a meaningful new treatment option in WM and differentiate it from currently available therapies,” said Jarrod Longcor, chief operating officer of Cellectar Biosciences. “With the completion of at least 12-month follow-up on all patients, we believe this dataset meets key regulatory expectations for an accelerated approval submission and positions us well as we advance toward initiating our confirmatory study.” Patients enrolled in the CLOVER WaM clinical trial had a median of four prior lines of therapy (range 2-15), with refractory rates running from 77% in Bruton tyrosine kinase inhibitors (BTKi)-exposed patients to 60% in chemotherapy-exposed patients and 58% in patients exposed to both ...