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Cellectar Biosciences Reports High Rate of Complete Remission in Investigator Initiated Phase I Study of Iopofosine in Combination with External Beam Radiotherapy in Recurrent Head and Neck Cancer
Complete Remission rate of 64% and Overall Response Rate of 73% demonstrated in highly refractory patients Durability of clinical activity achieved 67%
About this update from Cellectar Biosciences, Inc.
[{"type":"text","content":"Complete Remission rate of 64% and Overall Response Rate of 73% demonstrated in highly refractory patients Durability of clinical activity achieved 67% Overall Survival and 42% Progression Free Survival at One Year FLORHAM PARK, N.J., March 04, 2024 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development, and commercialization of drugs for the treatment of cancer, today announced that iopofosine I 131 in combination with external beam radiation therapy (EBRT) was safe and tolerated in a SPORE Grant supported investigator-initiated Phase 1 clinical trial. The twelve patients treated for locoregionally recurrent head and neck squamous cell carcinoma previously received chemoradiation alone (42%), surgery (58%) or surgery combined with radiation or chemoradiation (92%). The data were presented in a poster at the 2024 Multidisciplinary Head and Neck Cancers Symposium held February 29-March 2, 2024, in Phoenix, AZ. (Click HERE for poster.) Complete remission was achieved in 64% of patients, with an ORR of 73% (n=11). Prior to treatment with iopofosine I 131, six patients had multiple recurrence and one had metastatic disease both of which are indicative of poor outcomes. Additionally, the study demonstrated durability of tumor control with an overall survival of 67% and progression free survival of 42% at 12 months. “The study results underscore an important quality of iopofosine to safely combine with external beam radiotherapy and enhance therapeutic effect without significantly increasing toxicity of treatment,” commented Andrei Shustov, SVP Medical. “The durability of responses demonstrated by impressive progression free and overall survival in this patient population suggests that the combination of iopofosine and EBRT may target the primary tumor as well as micrometastatic disease beyond the conventional radiation field. This might result in synergistic therapeutic benefit applicable to a variety of solid tumors.” The patients received two therapeutic doses of iopofosine I 131 at a fixed fractionated dose of 15.6 mCi/m2 (days 1 and 8) with SPECT/CT imaging performed to quantitate the biodistribution of iopofosine I 131. Patients subsequently received EBRT to complete the designated radiation dose outlined in the reirradiation plan, whi...