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Cellectar Biosciences Reports Successful Case Study of iopofosine I 131 Treatment
Cellectar Biosciences announced results from a case study highlighting a durable complete response in a heavily pretreated patient with diffuse large B-cell lymphoma treated with iopofosine I 131. The case study describes a 53-year-old woman with high-grade, double-hit diffuse large B-cell lymphoma who had received four prior lines of therapy. A single administration of iopofosine I 131 produced a durable complete response lasting more than eight years, following multiple prior therapies and stem cell transplantation. As of May, the patient has experienced no disease progression and has required no additional anticancer therapy. The patient experienced expected hematologic toxicities, all of which resolved. The company plans to submit these findings for journal publication or presentation at a medical meeting. "While this case represents a single patient experience, we believe the durability and depth of response observed underscore the broader potential of iopofosine I 131 across B-cell malignancies," said Jarrod Longcor, COO.
Cellectar Reports iopofosine I 131 Clinical Trial Results
Cellectar Biosciences announced that efficacy results from a subset of patients treated with iopofosine I 131 immediately post-Bruton Tyrosine Kinase inhibitor, or BTKi, therapy in the company's Phase 2b CLOVER WaM clinical trial of iopofosine I 131 to treat relapsed or refractory Waldenstrom macroglobulinemia, or WM, were presented at the International Workshop for Waldenstrom Macroglobulinemia, or IWWM, taking place October 14 to October 16 in Palm Springs, California. The poster highlighted data from a subgroup of patients treated with a BTKi immediately prior to iopofosine I 131 from the CLOVER WaM trial in WM. This subgroup analysis is derived from the CLOVER WaM clinical trial 12-month follow-up data set previously reported. The patients included in this subset analysis were enrolled in the CLOVER WaM clinical trial and were treated with iopofosine I 131 immediately after receiving a regimen containing BTKi. Seventy-five percent were BTKi refractory and more than 54% had received multiple BTKi therapies. Patients had a median of three prior lines of therapy with 17% being TP53 mutated and 29% being MYD88 wild type, both of which confer greater resistance and rapid progression. Key findings included: overall response rate, or ORR: 87.5%; major response rate, or MRR: 79.2%; median duration of response, or DoR: 16.0 months; treatment free survival, or TFS: 19.1 months; clinical benefit rate, or CBR: 100% and safety: treatment emergent adverse events, or TEAE, occurred in less than 10% of patients, with the only Grade 3 or higher TEAE being cytopenias. Cellectar is advancing plans to dose the first patients in the confirmatory Phase 3 randomized clinical trial in a post-first line, post-BTKi population. The registration-directed trial is expected to evaluate progression-free survival as the primary endpoint, consistent with regulatory guidance. The company is also preparing to submit a new drug application for accelerated approval with the FDA in the first half of 2027, supported by the strength and maturity of the CLOVER WaM dataset.
Cellectar Biosciences to Present iopofosine I 131 Data at International Workshop for Waldenstrom Macroglobulinemia
Cellectar Biosciences announced that a subset analysis of data from the company's Phase 2 CLOVER WaM clinical trial that support the potential of iopofosine I 131 as a potential treatment option for Waldenstrom Macroglobulinemia patients who are refractory or resistant to BTK inhibitor therapy will be highlighted in a presentation at the upcoming International Workshop for Waldenstrom Macroglobulinemia taking place October 14 - 16, 2026 in Palm Springs, California. Key highlights: Demonstrated Major Response Rate of 79.2%, Overall Response Rate of 87.5%, and Duration of Response Exceeding 16 Months in Subset Analysis of Patients Treated with Iopofosine I 131 Immediately Post-BTKi Therapy; Data Further Support Company's Plans to Advance Iopofosine I 131 in Phase 3 Confirmatory Trial and Submit for U.S. Accelerated Market Approval in 1H27
Cellectar Advances Regulatory Strategy for iopofosine I 131
"Our second quarter marked another period of significant execution as we continued to advance multiple programs across our oncology pipeline while laying the foundation for several important near-term catalysts," said James Caruso, president and chief executive officer of Cellectar. "Most notably, we progressed our regulatory strategy for iopofosine I 131 in Waldenstrom macroglobulinemia, including initiation of site activation activities for our confirmatory Phase 3 trial, which is an important first step toward our accelerated approval application in the U.S., which we plan to submit in mid-2027. The compelling data we continue to generate from the Phase 2b CLOVER WaM study reinforce our belief that iopofosine has the potential to address a critical unmet need for WM patients, including those previously treated with BTK inhibitors and prior to off-label salvage therapies."
Cellectar Publishes Results of iopofosine I 131 Study
Cellectar Biosciences announced the publication of results from a Phase 1 dose-escalation study evaluating iopofosine I 131 in combination with low-dose dexamethasone in 31 patients with heavily pretreated relapsed/refractory multiple myeloma. The manuscript was published in the peer-reviewed journal, Cancers. The study evaluated both single-dose and fractionated-dose regimens of iopofosine I 131 in 31 heavily pretreated r/r MM patients, many of whom had exhausted available treatment options. Among 26 efficacy-evaluable patients: clinical activity appeared more pronounced in patients receiving higher total administered doses; 84.6% achieved stable disease or better following treatment; 30% overall response rate observed among evaluable patients receiving at least 60 mCi of iopofosine I 131; the overall response rate was 15.4%, with four patients achieving partial responses; investigators reported a favorable and manageable safety profile, with adverse events primarily consisting of predictable and reversible hematologic toxicities and no new safety signals were identified, and non-hematologic adverse events were generally low grade.
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