Cellectar Biosciences reported third-quarter results and outlined progress toward seeking accelerated FDA approval for iopofosine I 131 in Waldenström macroglobulinemia, a blood cancer. The company said it remains on track to begin dosing patients in a confirmatory Phase 3 trial in the first quarter of 2027 and to submit an application for accelerated approval in the first half of 2027.
The update also included new results from a subgroup of a Phase 2b study, a newly initiated dosimetry trial, and a case study describing a long-lasting response in another lymphoma. The release text provided here does not include the company’s financial figures.
Key details
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New results in patients treated after BTK inhibitors: At an international meeting on Waldenström macroglobulinemia, Cellectar presented data from 24 evaluable patients who received iopofosine I 131 immediately after treatment with a BTK inhibitor. Patients had received a median of three prior lines of therapy, with a range of two to seven.
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Reported response and durability measures: In this subgroup, the overall response rate was 87.5%, the major response rate was 79.2%, and the clinical benefit rate was 100%. Median duration of response was 16 months, while treatment-free survival was 19.1 months.
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Safety findings: The presentation reported treatment-emergent adverse events in fewer than 10% of patients; cytopenias were the only reported adverse events of Grade 3 or higher.
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Trial and regulatory timeline: Cellectar said it expects to dose the first patients in the confirmatory Phase 3 study in the first quarter of 2027 and plans to file for accelerated approval in the first half of 2027. The company also described a planned new drug application submission during that same half of the year.
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Additional trial underway: The company has started a Phase 1b dosimetry trial intended to further characterize iopofosine I 131 across treatment settings, including first- and second-line use. The company’s release did not provide further trial details in the text supplied.
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Separate lymphoma case study: Cellectar highlighted a published case study of a heavily pretreated patient with diffuse large B-cell lymphoma who achieved a complete response lasting more than eight years.
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Financial results: Although Cellectar announced results for the quarter ended September 30, 2026, the supplied release text contains no revenue, expense, net-loss or cash-balance figures, so it does not provide a basis to assess the company’s current cash position or runway.
What the update means
Cellectar is advancing iopofosine I 131 toward a potential regulatory application in Waldenström macroglobulinemia, with the Phase 3 trial and planned filing both targeted for 2027. The newly presented subgroup results concern 24 patients treated after BTK-inhibitor therapy; they add clinical data for that population but do not, on their own, establish the outcome of the confirmatory trial.