-- Partial Responses in Colorectal, Triple-Negative Breast, and Small-Cell-Lung Cancers --
-- Clinical Trial Expanding to Phase II Focusing on Select Tumor Types --
Results from the multicenter, dose-escalation Phase I trial were presented by Dr.
In addition to the 3 partial responses observed by computed tomography (CT) using RECIST criteria, 15 patients also reported stable disease as their best response for an overall disease control rate of 86% in 21 patients with at least 1 CT assessment reported at the Conference. In terms of CT-confirmed tumor shrinkage, about half of the patients showed this result.
"We, as well as our clinical investigators, are very encouraged by these early promising results with IMMU-132 in this refractory, advanced cancer patient population with difficult-to-treat tumors that failed multiple prior therapies," commented
At the time of reporting, a total of 25 patients with 12 different types of epithelial cancers have been enrolled into the Phase I trial. These patients had failed a median of 3 (range 1-6) prior standard therapies for their tumor types and were enrolled with disease progression. IMMU-132 was administered weekly for 2 consecutive weeks, followed by one week off, in 3-week cycles. Treatments may continue for up to 8 cycles until unacceptable toxicity or progression of disease. Currently, 10 patients are continuing treatments.
The major side-effects of IMMU-132 are neutropenia and controllable diarrhea, consistent with the toxicity experienced with irinotecan, the parent drug of SN-38, despite this agent releasing about 20-fold more SN-38 than when irinotecan is given.
This study was supported in part by Award Number R43CA171388 from the