Cellectar to Present Iopofosine Data at ASH
Cellectar Biosciences will present three posters on its investigational iopofosine I 131 at the ASH Annual Meeting in New Orleans.
Updated on Nov. 4, 2026 in Cancer
Cellectar Biosciences, a late-stage clinical biopharmaceutical company based in Florham Park, N.J., will present three poster presentations on iopofosine I 131 at the ASH Annual Meeting on December 12-15 in New Orleans. The posters will include updated 12-month follow-up data from the Phase 2b CLOVER WaM trial.
Why it matters
The presentations provide an update on iopofosine I 131 for patients with Waldenström's macroglobulinemia, a rare blood cancer, including data on patients who had received two prior lines of therapy. The company also plans to show the detailed design of a planned Phase 3 confirmatory study.
The updated data come from 12 months of follow-up in the Phase 2b CLOVER WaM trial, with patients after two prior lines of therapy showing a significantly longer duration of response than more heavily pretreated patients. Whether these findings will hold in the planned Phase 3 study has not yet been determined.
The players
Cellectar Biosciences
Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing cancer therapies, headquartered in Florham Park, New Jersey.
Jarrod Longcor
Jarrod Longcor is the chief operating officer of Cellectar Biosciences, overseeing the company's operational activities.
The details
Three posters will be presented in Session #623 at the ASH Annual Meeting, with Posters I and II on December 12 from 5:30-7:30 PM and Poster III on December 14 from 6:00-8:00 PM in MCCNO Hall F. Cellectar also plans to present the detailed design of a Phase 3 confirmatory study in patients previously treated with a BTK inhibitor, and site activation for that study is underway.
Timeline
December 12, 2026: Posters I and II presented at ASH from 5:30-7:30 PM.
December 14, 2026: Poster III presented at ASH from 6:00-8:00 PM.
First quarter 2027: First patient dosing in the Phase 3 confirmatory study is anticipated.
First half 2027: An FDA submission seeking accelerated approval is targeted.
Big Picture
Iopofosine I 131 has received Breakthrough, six Orphan Drug, four Rare Pediatric Drug and two Fast Track Designations from the FDA, and PRIME designation from the EMA. These designations reflect the regulatory recognition the therapy has earned as it advances toward a potential accelerated approval submission.
For patients with Waldenström's macroglobulinemia, the data may inform discussions with their oncologists about treatment options after prior therapy. Whether iopofosine I 131 becomes available will depend on the outcome of the planned Phase 3 study and regulatory review.
The takeaway
Patients and caregivers tracking Waldenström's macroglobulinemia treatments should watch for the Phase 3 results and any FDA decision on accelerated approval. Staying in touch with a hematologist can help clarify which emerging options may be relevant.
What happens next
Cellectar expects first patient dosing in its Phase 3 confirmatory study in the first quarter of 2027 and plans an FDA submission seeking accelerated approval in the first half of 2027.
Further reading
Explore more on Cancer research and treatment developments.
More information
Learn more on the Cellectar Biosciences website.
Source note: This article includes information reported by The Manila times.
