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Cancer Types Include Colorectal, Esophageal, Triple-Negative Breast, Small-Cell and Non-Small-Cell Lung –
-- Preclinical Study on IMMU-132 Also Presented --
CHICAGO, June 2, 2014 (GLOBE NEWSWIRE) --
Immunomedics, Inc., (Nasdaq: IMMU) today reported that 71% of patients (34 of 48) with diverse metastatic solid cancers had durable disease stabilization after receiving treatments with the Company's novel investigational antibody-drug conjugate (ADC), IMMU-132. These include 7 patients (15%) with colorectal, small-cell and non-small-cell lung, esophageal, and triple-negative breast cancers showing partial responses with tumor shrinkage of 30% or more as measured by computed tomography (CT).
"We believe this is the first ADC for solid cancers that is active in so many cancer types, consistent with the broad increased expression of the target antigen, TROP-2, in most epithelial cancers," commented Cynthia L. Sullivan, President and Chief Executive Officer.
IMMU-132 is made up of SN-38, the active metabolite of irinotecan, conjugated to the Company's humanized anti-TROP-2 antibody. In patients who relapsed or were refractive to prior topoisomerase I or II inhibitors, this ADC demonstrated subsequent activity, suggesting that it can overcome resistance to such inhibitors, including irinotecan.
Even after failing multiple prior therapies, a median time to progression of at least 12.6 weeks (range 6.0-51.4 weeks) was observed in 48 patients with at least 1 CT assessment. One patient with hormone-refractive prostate cancer has a long-term, durable stable disease response, which is approaching a year. This patient has received 30 doses of IMMU-132 and treatment is continuing. Despite repeated dosing, no antibodies against the ADC, neither to the antibody nor to SN-38, have been detected in this or any other patients.
A total of 69 patients with a median of 3 prior therapies have been enrolled into the multicenter trial, including 13 patients with pancreatic cancer. Results from the pancreatic cancer patients have recently been presented and were not included in this report. Please refer to the Company's press release at
http://www.immunomedics.com/pdfs/news/2014/pr05202014.pdf for more information on the results in pancreatic cancer. Also excluded were 8 patients who had clinical progression and withdrew before CT assessment.
The Phase I/II results were presented by Alexander Starodub, M.D., Ph.D., of Indiana University Health Goshen Center for Cancer Care, Goshen, IN, at the 2014 Annual Meeting of the American Society of Clinical Oncology in Chicago, IL. Earlier at the same Annual Meeting, the Company also presented preclinical studies on the characterization of IMMU-132.