Cellectar Biosciences to Present Three Posters Highlighting Durable Clinical Activity of Iopofosine I 131 in Waldenström Macroglobulinemia at the American Society of Hematology Annual Meeting and Exposition
Updated analyses suggest greater durability of benefit after only two prior lines of therapy than after more extensive treatment.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Cellectar Biosciences (NASDAQ: CLRB) will present updated iopofosine I 131 clinical analyses and its Phase 3 study design at the ASH annual meeting. The three posters cover Waldenström macroglobulinemia, a blood cancer, and will be presented December 12 and 14, 2026, in New Orleans. Updated 12-month follow-up from the Phase 2b CLOVER WaM trial showed durable responses in heavily pretreated patients. Patients treated after only two prior lines of therapy had longer responses than more heavily pretreated patients.
The Phase 3 confirmatory study will compare iopofosine I 131 with rituximab-cyclophosphamide-dexamethasone in patients previously treated with a Bruton tyrosine kinase inhibitor. Site activation and start-up activities are underway. Cellectar anticipates first patient dosing in the first quarter of 2027 and targets an FDA submission seeking accelerated approval in the first half of 2027.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate point12-month Phase 2b follow-up showed durable responses in heavily pretreated Waldenström macroglobulinemia patients.
- Moderate point. Forward-looking: it has not happened yet and may not happen.FDA submission seeking accelerated approval is targeted by Cellectar for the first half of 2027.
- Minor pointOnly two prior lines of therapy were associated with longer responses than in more heavily pretreated patients.
- Minor point. Forward-looking: it has not happened yet and may not happen.Phase 3 site activation is underway; Cellectar anticipates first patient dosing in the first quarter of 2027.
Negative
- None.
Details
Market move: CLRB -6.11% in the Nov 4 session. Phase 2b clinical data
On Nov 4, the day this news came out, CLRB closed 6.11% below the previous close. Argus tracked a trough of -9.5% from its starting point during tracking. Our momentum scanner recorded 4 alerts for this stock that day.
Data tracked by StockTitan Argus for the Nov 4 session.
Key Figures
- Posters
- 3 posters
- ASH meeting presentations on iopofosine I 131
- Follow-up
- 12 months
- Updated Phase 2b CLOVER WaM data
- Prior treatment lines
- 2 prior lines of therapy
- Longer duration of response versus more heavily pretreated patients
- First patient dosing
- First quarter of 2027
- Phase 3 confirmatory study
- FDA filing target
- First half of 2027
- Submission seeking accelerated approval
Historical Context
-
BTKi-treated CLOVER WaM subgroup showed response rates and 16.0-month median response duration.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
waldenström macroglobulinemia medical
phase 2b medical
bruton tyrosine kinase inhibitor medical
accelerated approval regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Updated CLOVER WaM Phase 2b analyses show durable responses in heavily pretreated patients and suggest greater benefit when used earlier in treatment paradigm
Company to present Phase 3 trial-in-progress design as site activation advances, first patient dosing remains on track for 1Q 2027 and FDA filing for accelerated approval remains targeted for 1H27
FLORHAM PARK, N.J., Nov. 04, 2026 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of cancer therapies, today announced that three posters highlighting compelling data and clinical progress for its lead radiopharmaceutical candidate, iopofosine I 131 in Waldenström macroglobulinemia (WM), will be presented at the upcoming American Society of Hematology (ASH) Annual Meeting and Exposition taking place December 12 – 15 in New Orleans, Louisiana.
The presentations will summarize updated 12-month follow-up data from the Phase 2b CLOVER WaM clinical trial, including new analyses exhibiting a significantly longer duration of response in patients who received iopofosine I 131 after only two prior lines of therapy compared with more heavily pretreated patients. These findings strengthen the clinical rationale for iopofosine I 131 in relapsed or refractory WM and support its potential evaluation in earlier treatment settings, where substantial unmet need remains. The company will also present, for the first time, the detailed design of its Phase 3 confirmatory study in WM patients previously treated with a Bruton tyrosine kinase inhibitor (BTKi). Site activation and other start-up activities are underway for the company’s global Phase 3 confirmatory study, with first patient dosing anticipated in the first quarter of 2027.
“The new data being presented at ASH further strengthen the clinical profile of iopofosine I 131, underscoring its potential to deliver durable responses and address a significant unmet need in relapsed or refractory Waldenström macroglobulinemia,” said Jarrod Longcor, chief operating officer of Cellectar Biosciences. “These updated CLOVER WaM results demonstrate durable responses in heavily pretreated patients, while new analyses suggest the potential for even greater durability of benefit when iopofosine I 131 is used in earlier lines of therapy. These findings reinforce our confidence in its clinical potential as we advance our registrational strategy. In parallel, we are targeting the first half of 2027 for an FDA submission seeking accelerated approval. These planned milestones define a clear path forward as we work to bring iopofosine I 131 to patients with limited treatment options.”
Details of the upcoming presentations are as follows:
| Title: | “An Open-Label, Multicenter, Randomized, Phase 3 Trial of Iopofosine I 131 versus Rituximab-Cyclophosphamide-Dexamethasone (R-CD) in Waldenstrom Macroglobulinemia Patients Previously Treated with a Bruton Tyrosine Kinase Inhibitor: A Trial-in-Progress” |
| Session #: | 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I |
| Date/Time: | December 12, 2026, 5:30:00 PM - 7:30:00 PM |
| Location: | MCCNO - Hall F |
| Publication Number: | 1799 |
| Presenter: | Jarrod Longcor, Chief Operating Officer of Cellectar Biosciences |
| Title: | “Duration of Response to Iopofosine I 131 in Patients with Relapsed/Refractory Waldenström Macroglobulinemia by Prior Lines of Therapy: Results from the Pivotal Phase 2b CLOVER WaM Study” |
| Session #: | 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I |
| Date/Time: | December 12, 2026, 5:30:00 PM - 7:30:00 PM |
| Location: | MCCNO - Hall F |
| Publication Number: | 1790 |
| Presenter: | Jarrod Longcor, Chief Operating Officer of Cellectar Biosciences |
| Title: | “Iopofosine I 131 in Waldenström macroglobulinemia: 12-month follow up data from the CLOVER-WaM trial” |
| Session #: | 623. Mantle Cell, Follicular, Waldenstrom’s, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III I |
| Date/Time: | December 14, 2026, 6:00:00 PM - 8:00:00 PM |
| Location: | MCCNO - Hall F |
| Publication Number: | 5325 |
| Presenter: | Sikander Ailawadhi, MD, Professor of Medicine, Mayo Clinic |
About Cellectar Biosciences, Inc.
Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on the discovery and development of proprietary drugs for the treatment of cancer, independently and through research and development collaborations. The company’s core objective is to leverage its proprietary Phospholipid Drug Conjugate™ (PDC) delivery platform to develop the next-generation of cancer cell-targeting treatments, delivering improved efficacy and better safety as a result of fewer off-target effects.
The company’s product pipeline includes iopofosine I 131, which is a PDC designed to provide targeted delivery of iodine-131 (radioisotope). Iopofosine I 131 has been tested in Phase 2b trials as a treatment for relapsed or refractory Waldenström Macroglobulinemia (WM), in relapsed or refractory multiple myeloma (MM) and central nervous system (CNS) lymphoma. The CLOVER-2 Phase 1b study is evaluating iopofosine I 131 in pediatric patients with high-grade gliomas, for which Cellectar is eligible to receive a Pediatric Review Voucher from the FDA upon approval. The FDA has granted iopofosine I 131 Breakthrough, six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations for various cancer indications, and the EMA has granted iopofosine I 131 PRIority MEdicines (PRIME) designation.
Cellectar is also developing CLR 121125 (CLR 125), an iodine-125 Auger-emitting program targeted for solid tumors, such as triple negative breast (TNBC), lung, and colorectal cancer, and is currently being evaluated in a Phase 1b study for TNBC, which will determine the recommended dose for the subsequent Phase 2 trial. CLR 125 has been well tolerated in vivo and has demonstrated strong preclinical data showing reduction or inhibition of solid tumor growth.
In addition to these assets, the Cellectar team is developing CLR 121225 (CLR 225), an actinium-225 based program targeting solid tumors in indications with significant unmet need, such as pancreatic cancer, as well as proprietary preclinical PDC chemotherapeutic programs and multiple partnered PDC assets.
For more information, please visit https://www.cellectar.com/or join the conversation by liking and following us on the company’s social media channels: X, LinkedIn, and Facebook.
Forward Looking Statements
This news release contains forward-looking statements. You can identify these statements by our use of words such as "may," "expect," "believe," "anticipate," "intend," "could," "estimate," "continue," "plans," or their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the FDA and EMA regulatory pathways, ability to execute strategic alternatives, identify suitable collaborators, partners, licensees or purchasers for our product candidates and, if we are able to do so, to enter into binding agreements with regard to any of the foregoing, or to raise additional capital to support our operations, or our ability to fund our operations if we are unsuccessful with any of the foregoing. A complete description of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange Commission including our Form 10-K for the year ended December 31, 2025, and our Form 10-Q for the quarterly period ending June 30, 2026. These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking statements.
INVESTORS:
Anne Marie Fields
Precision AQ
212-362-1200
annemarie.fields@precisionaq.com
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Cellectar's updated CLOVER WaM analyses show for iopofosine I 131?
Updated 12-month follow-up showed durable responses in heavily pretreated patients with Waldenström macroglobulinemia. Patients receiving iopofosine I 131 after only two prior lines of therapy had longer responses than more heavily pretreated patients.
When does Cellectar expect Phase 3 dosing and an FDA submission for iopofosine I 131?
Cellectar anticipates first patient dosing in the first quarter of 2027 and targets an FDA submission seeking accelerated approval in the first half of 2027. Site activation and other start-up activities for the global Phase 3 confirmatory study are underway.