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Promising Results for Iopofosine I 131 in Waldenstrom’s Macroglobulinemia Study

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Shares of Cellectar Biosciences rose by 21% to reach a 52-week high of $3.29 following the announcement of positive topline data in their study evaluating iopofosine I 131 as a potential targeted radiotherapy option for patients with relapsed/refractory Waldenstrom’s macroglobulinemia.

Promising Results in Targeted Radiotherapy Study

Cellectar Biosciences has reported significant findings in their study evaluating iopofosine I 131 as a targeted radiotherapy treatment for relapsed/refractory Waldenstrom’s macroglobulinemia. The study, which met its primary endpoint, demonstrated a major response rate of 61% among the participants. Furthermore, the overall response rate among evaluable patients reached as high as 75.6%, with all patients experiencing disease control. The responses were durable, with an impressive median duration of response that has not yet been reached. Additionally, 76% of patients remained progression free after a median follow-up period of eight months. Notably, iopofosine monotherapy achieved an 8% stringent complete remission (sCR) in this particularly challenging patient population.

Registration Study with Encouraging Patient Enrollment

This single-arm registration study aimed to enroll a total of 50 patients. The positive results observed in the current patient cohort provide promising outcomes that will be included in Cellectar’s NDA submission. The company also plans to request an accelerated approval for iopofosine I 131, leveraging their WM fast track designation.

Favorable Safety Profile and Tolerability

In addition to its efficacy, iopofosine I 131 was well tolerated by the patients in the study. The toxicity profile aligned with Cellectar’s previously reported safety data, and there were no treatment-related adverse events that led to discontinuation. Patients experienced a recovery from cytopenias, with no reported aplastic sequela. Furthermore, no clinically significant bleeding events occurred, and the rate of febrile neutropenia was only 2%. Importantly, there were no treatment-related deaths.

“We are confident that the impressive response rates and durable responses will continue to improve as the data matures,” stated James Caruso, President and CEO of Cellectar. “We intend to incorporate these encouraging outcomes into our NDA submission, while also seeking accelerated approval based on our WM fast track designation.”

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