iopofosine I-131 (CLR 131) / Cellectar - LARVOL DELTA

Iopofosine I-131 treatment in late-line patients with relapsed/refractory multiple myeloma post anti-BCMA immunotherapy. (PubMed, Blood Cancer J) - No abstract available

Journal • Hematological Malignancies • Multiple Myeloma • Oncology

Iopofosine I 131 in Previously Treated Patients with Waldenstrom Macroglobulinemia (WM): Efficacy and Safety Results from the International, Multicenter, Open-Label Phase 2 Study (CLOVER-WaM) (ASH 2024) - P2 | "The treatment was well-tolerated with a manageable toxicity profile across broad biologic and clinical subgroups, irrespective of risk stratification. Based on the results of this trial, iopofosine I 131 shows promise as a novel treatment for WM patients."

Clinical • P2 data • Anemia • Febrile Neutropenia • Hematological Disorders • Infectious Disease • Lymphoma • Lymphoplasmacytic Lymphoma • Neutropenia • Septic Shock • Thrombocytopenia • Waldenstrom Macroglobulinemia • CXCR4 • MYD88

Evaluation of Iopofosine I 131 vs. R-CD in WM Patients (clinicaltrials.gov) - P3 | N=219 | Not yet recruiting | Sponsor: Cellectar Biosciences, Inc.

New P3 trial • Hematological Disorders • Hematological Malignancies • Lymphoma • Lymphoplasmacytic Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Waldenstrom Macroglobulinemia

Business Highlights (TradingView) - "Initiated site activation for the confirmatory Phase 3 randomized controlled trial of iopofosine I 131 in relapsed/refractory Waldenström macroglobulinemia, targeting ~100 patients per arm and first dosing expected in early 2027...Plans New Drug Application submission for iopofosine I 131 in mid-2027 under the FDA Accelerated Approval program..."

FDA filing • New P3 trial • Waldenstrom Macroglobulinemia

Iopofosine I-131 after BTK inhibitors in Waldenström macroglobulinemia: CLOVER-WaM subgroup efficacy and safety. (ASCO 2026) - P2 | "Of those, 22 (40%) had received a BTKi containing regimen immediately prior to iopofosine; and 11 who previously received at least 2 regimens utilizing BTKis and 12 who were refractory to rituximab. Iopofosine I 131 demonstrated significant efficacy; 100% CBR, 86.4% ORR and 68.2% MRR with a median PFS of 12 months (range: 1.6 – 28.0 months) in a pt population with no current standard of care therapy. The treatment was well-tolerated with a manageable toxicity profile with cytopenias as the only Grade 3 or greater TEAE. Based on the results of this pivotal trial, iopofosine I 131 could be a promising novel treatment for WM pts after BTKi therapy."

Clinical • Hematological Disorders • Leukopenia • Lymphoma • Lymphoplasmacytic Lymphoma • Neutropenia • Thrombocytopenia • Waldenstrom Macroglobulinemia • MYD88 • TP53

A Phase I Trial of Iopofosine I 131 and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma. (PubMed, Cancers (Basel)) - "For patients monitored through 85 days following the first infusion, 22 of 26 (84.6%) achieved stable disease after treatment, and 4 of 26 (15.4%) achieved a partial response. A favorable safety and tolerability profile and preliminary clinical activity support further development of iopofosine I 131 in RRMM."

Journal • P1 data • CNS Disorders • Hematological Malignancies • Insomnia • Leukopenia • Multiple Myeloma • Neutropenia • Sleep Disorder • Thrombocytopenia

Cellectar Biosciences Announces Publication of Phase 1 Study of Iopofosine I 131 in Peer-Reviewed Journal Cancers (Yahoo Finance) - "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 (n=10) 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; No new safety signals were identified, and non-hematologic adverse events were generally low grade."

P1 data • Multiple Myeloma

Longitudinal Swallowing and Salivary Changes With CLR 131 and Re-Irradiation in Recurrent Head and Neck Cancer. (PubMed, Head Neck) - "These findings suggest that CLR 131 + EBRT did not exacerbate objective swallowing impairment in the early post-treatment period, but patient-reported dysphagia was sensitive to post-treatment salivary alterations. Integrating salivary assessments with instrumental and patient-reported outcomes may enhance detection of functional toxicity and guide targeted dysphagia management in recurrent HNC."

Journal • Dental Disorders • Gastrointestinal Disorder • Head and Neck Cancer • Oncology • Solid Tumor • Xerostomia

First Quarter 2026 and Recent Corporate Highlights (Cellectar Biosciences Press Release) - "Selected to present data from the CLOVER WaM study of iopofosine I 131 in r/r WM patients at the upcoming American Society of Clinical Oncology Annual Meeting (ASCO) taking place May 29 - June 2, 2026....Advancing plans to initiate a Phase 3 confirmatory trial of iopofosine I 131 as a treatment for WM and file for accelerated approval with the U.S. FDA in alignment with the FDA requirements....Continuing to work with the European Medicines Agency (EMA) to file for a Conditional Marketing Approval (CMA) for iopofosine I 131 as a treatment option for post-BTKi refractory patients with WM."

European regulatory • FDA filing • New P3 trial • P2b data • Waldenstrom Macroglobulinemia

Cellectar Biosciences Announces Oversubscribed Financing Up to $140 Million (GlobeNewswire) - "Financing of up to $140 Million Supports Confirmatory Study and NDA Filing for Accelerated Approval of Iopofosine I 131 in Waldenström Macroglobulinemia with the FDA."

Financing • Waldenstrom Macroglobulinemia

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 (The Manila Times) - "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...Overall Response Rate (ORR): 83.6%; Major Response Rate (MRR): 61.8% (primary endpoint achieved); Median Duration of Response (DoR): 17.8 months (secondary endpoint achieved); Median Progression-Free Survival (PFS): 13.5 months; Very Good Partial Response/Complete Response Rate (VGPR/CR): 14.5%; Disease Control Rate (DCR): 98.2%....Summary of Efficacy Results in BTKi-Refractory Patients (n=33): MRR: 63.6%...The company also plans to present the full data sets at upcoming medical congresses or scientific meetings."

New trial • P2b data • Waldenstrom Macroglobulinemia

CLOVER-WaM: Study of Iopofosine I-131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) With Expansion in Waldenstrom (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Cellectar Biosciences, Inc. | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date • B Cell Lymphoma • Chronic Lymphocytic Leukemia • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • Waldenstrom Macroglobulinemia

Dose Escalation Study of CLR 131 in Pediatric Relapsed/Refractory Malignant Tumors Including Neuroblastoma and Sarcomas (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Cellectar Biosciences, Inc. | Trial primary completion date: Dec 2025 ➔ Aug 2026

Trial primary completion date • Brain Cancer • Ewing Sarcoma • Glioma • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Neuroblastoma • Oncology • Osteosarcoma • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor • CD34

On track to submit Conditional Marketing Authorization for iopofosine I 131 to European Medicines Agency in Q3 2026 for potential 2027 EU commercialization as a treatment for Waldenström Macroglobulinemia (GlobeNewswire) - "The CMA submission will be supported by data from the CLOVER WaM study, including 12-month follow-up on all patients, updated overall and major response rates, progression-free survival, duration of response, and compelling subset analyzes on post-BTKi patients."

EMA filing • Launch Europe • Waldenstrom Macroglobulinemia

Cellectar Biosciences...announced a broad expansion of its global intellectual property (IP) estate, including newly issued patents across Europe, Asia-Pacific, the Middle East, and the Americas. (The Manila Times) - "These additions strengthen the company’s protection around iopofosine I 131, its proprietary radiotherapeutic, as well as its broader portfolio, including CLR 125, the company’s Auger-emitting radiopharmaceutical in development as a treatment for triple negative breast cancer."

Patent • CNS Lymphoma • High Grade Glioma • Multiple Myeloma • Triple Negative Breast Cancer • Waldenstrom Macroglobulinemia

2026 Strategic Initiatives (Cellectar Biosciences Press Release) - "Submit CMA application to EMA for iopofosine I 131 in WM in 3Q 2026, with potential European market approval in early 2027; Advance NDA preparations for U.S. accelerated approval...Present final findings and subset analysis from the CLOVER WaM Phase 2 study of iopofosine I 131....Evaluate strategic collaborations for commercialization of iopofosine I 131."

Commercial • EMA approval • Filing • P2 data • Waldenstrom Macroglobulinemia

Phase 1 Parallel Study of CLR 125 in Triple Negative Breast Cancer (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Cellectar Biosciences, Inc.

New P1 trial • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Cellectar Biosciences Reports Third Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "Raised approximately $12.7 million. These funds will be used to advance the Company’s TNBC study and to complete the EMA Conditional Marketing Authorization application for iopofosine I 131 for WM."

Financing • Triple Negative Breast Cancer • Waldenstrom Macroglobulinemia

Interim data from CLOVER-2...were highlighted in an oral presentation at the recent American Association for Cancer Research (AACR) Special Conference on Pediatric Cancer that took place in late September 2025. (GlobeNewswire) - "...showed that all patients receiving a minimum of 55 mCi total administered dose (n=6) experienced an average of 5.4 months of PFS and 8.6 months of OS, ongoing. All patients experienced disease control, which according to the committee for the Response Assessment in Pediatric Neuro-Oncology (RAPNO) does correlate with survival benefit. Three patients who received additional dosing cycles (a minimum of four total infusions) had an average PFS of 8.1 months and an OS of 11.5 months (ranging from 4.9 to 14.9 months), ongoing, with two achieving an objective response (ORR)."

P1 data • High Grade Glioma

Cellectar Biosciences Receives Rare Pediatric Disease Designation from U.S. Food and Drug Administration for Iopofosine I 131 in Relapsed or Refractory Pediatric High-Grade Glioma (GlobeNewswire)

FDA event • High Grade Glioma

Cellectar Biosciences, Inc…announced that…the Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA) advised that filing for a Conditional Marketing Authorization (CMA) for iopofosine I 131 as a treatment for post-Bruton Tyrosine Kinase inhibitor (BTKi) refractory patients with Waldenstrom macroglobulinemia (WM) could be acceptable for a CMA. (GlobeNewswire) - "Cellectar’s briefing document to the SAWP included iopofosine I 131’s safety database, CLOVER WaM clinical study results, subset analyses, and manufacturing information...'we are rapidly proceeding toward a potential European approval and commercial availability in 2027'..."

EMA filing • Launch Europe • Waldenstrom Macroglobulinemia

The U.S. NDA will be submitted once the confirmatory trial is underway and will be supported by data from the Phase 2b CLOVER WaM clinical trial that demonstrated a statistically significant major response rate compared to a null hypothesis of 20% and meaningful duration of response. (GlobeNewswire) - "The data set now includes the FDA-requested 12-month follow-up results on all patients from the trial and new subset analysis of data from patients immediately following BTKi treatment failures regardless of line of therapy."

FDA filing • Waldenstrom Macroglobulinemia

The Optimal Management of Waldenström Macroglobulinemia (SOHO 2025) - "Standard treatment options include alkylating agents (eg, bend-amustine or cyclophosphamide) or proteasome inhibitors (eg, bortezomib, carfilzomib, or ixazomib) in combination with anti-CD20 monoclonal antibody rituximab, covalent Bruton tyrosine kinase (BKT) inhibitors (eg ibrutinib, acalabrutinib, or zanubrutinib), BCL2 antagonists (eg, venetoclax), and non-covalent BTK inhibitors (eg, pirtobrutinib) 13–23...The combination of bendamustine and rituximab showed superior progression-free survival (PFS) to rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone in a study by the STiL group 13...The all-oral, non-chemo, fixed-duration combination of pirtobrutinib and venetoclax has shown promise in early relapse 29.Inlate relapse, multiple agents are under active development, including second-generation BCL2 antagonists (eg, sonrotoclax), BTK degraders (eg, BGB-16673 30, NX-5948), conjugated radioisotopes (eg, iopofosine I-131 31), antibody-drug conjugates..."

IO biomarker • B Cell Lymphoma • Chronic Lymphocytic Leukemia • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Marginal Zone Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Waldenstrom Macroglobulinemia • B2M • BCL2 • CXCR4 • MYD88 • TP53

Oppenheimer 3rd Annual Targeted Radiopharmaceutical Therapies in Oncology Summit (GlobeNewswire) - "Provided data to EMA data from the Phase 2b CLOVER WaM clinical trial....Initiation of Phase 1b Dose Finding study of the company’s Auger-emitting radiopharmaceutical, CLR 125, for the treatment of relapsed triple-negative breast cancer (TNBC), planned for the fourth quarter 2025."

New P1 trial • Trial status • Triple Negative Breast Cancer • Waldenstrom Macroglobulinemia

Cellectar to Submit NDA for Iopofosine I-131 in WM by Early 2026, Focuses on Accelerated Approval (AInvest) - "The submission will be supported by data from the Phase 2b CLOVER WaM clinical trial. The company is also working with the European Medicines Agency (EMA) towards a potential submission for conditional approval in the EU. The EMA expects to make a decision late in the third quarter or early in the fourth quarter of 2025."

EMA approval • FDA filing • Waldenstrom Macroglobulinemia