Articles about new radioimmunotherapy drugs, treatment methods etc.
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*Repeated Radioimmunotherapy With 131I-Labetuzumab In Colorectal Cancer With Liver Metastases Found Safe And Well-Tolerated In Initial Phase II Study
03 Jun 2006
Immunomedics, Inc. (Nasdaq: IMMU), a biopharmaceutical company focused on developing monoclonal antibodies, today reported that repeated use of its radiolabeled antibody against the carcinoembryonic antigen (CEA), 131I-labetuzumab, has been found to be safe and well-tolerated by patients with Colorectal Cancer that has metastasized to the liver. Results from this study were accepted for publication at the 42nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta, Georgia.
Twelve patients have been enrolled in this Phase II study led by Dr. Torsten Liersch at the Department of General Surgery of the University of Gottingen, Germany. Within 2 months of surgery to remove liver metastases of colorectal cancer, patients received a first dose of 50 mCi/m2 of 131I-labetuzumab. Three months after the first radioimmunotherapy (RAIT), a second infusion of the radiolabeled, humanized, CEA-antibody was given in the same amount. Transient grade-4 myelosuppression occurred in 4 out of 12 patients after the first dose, but no cumulative toxicity was seen thus far in 7 patients who have received the second infusion. Complete bone marrow recovery was reported in all cases. At a median follow-up of 4 months, no cancer recurrence has been detected in the 12 patients enrolled to date. In all, a total of 15 patients will be enrolled in this study.
"We are pleased that a new study has been initiated to evaluate the effect of repeated dosing of 131I-labetuzumab in colorectal cancer patients and we look forward to learning more about the clinical effects," commented Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics. "Since about two-thirds of patients with colorectal cancer metastases to the liver relapse after resection of these liver tumors, an adjuvant therapeutic, such as perhaps our 131I-labetuzumab, may prove useful in this setting of disseminated disease," she remarked.
This is a second trial conducted by the German researchers using 131I-labetuzumab for colorectal cancer patients with liver metastases. In the previous study, only one 131I-labetuzumab dose was given to colorectal cancer patients after surgery to remove liver metastases. Five-year survival was achieved by 51.3% of the 19 patients who received RAIT. Median overall survival from the first surgery was 68.0 months and median disease-free survival was 18.0 months. Results of this study had been published in the September 20, 2005, issue of the Journal of Clinical Oncology.
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