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Immunomedics, Inc.
,
a biopharmaceutical company primarily focused on the development of monoclonal
antibody-based products for the targeted treatment of cancer, autoimmune and
other serious diseases, today announced that 5 patients reported a partial
response as their best response, based on RECIST 1.1 criteria, in the
Company's ongoing Phase I/II clinical trial of its investigational
antibody-drug conjugate (ADC), IMMU-132, in patients with solid cancers.
IMMU-132 is an anti-TROP-2 antibody with SN-38, the active metabolite of
irinotecan, linked to the antibody.
Results from this multicenter study, as well as initial data from the
expansion phase of the trial, were presented by Dr. Alexander Starodub of
Indiana University Health Goshen Center for Cancer Care, Goshen, IN, at the
2014 Annual Meeting of the American Association for Cancer Research (AACR) in
San Diego, CA.
Two of the 3 patients with small-cell lung cancer (SCLC), 2 of the seven
patients with triple- negative breast cancer, and 1 of the 11 patients with
colorectal cancer were partial responders by at least one computer tomography
(CT) assessment. In addition to these 5 partial responses, among the 35
patients who had at least one response assessment by CT, 22 patients had
stable disease as their best response, giving an overall disease control rate
of 77%. Besides colorectal, triple-negative breast, and SCLC, the 35
CT-assessable patients include 14 other types of solid cancer. These patients
had failed a median of 4 prior treatments, some including topoisomerase-I and
-II inhibiting drugs, and in some cases are showing durable responses up to
almost one year.
Grade 3 or 4 adverse events (AE) ≥ 8 % were neutropenia (31%), fatigue (10%),
and diarrhea (8%), while mild AE ( > 20%) were reported for nausea, fatigue,
alopecia, diarrhea and vomiting.
IMMU-132 was administered once weekly for two weeks followed by one week of
rest in a 3-week cycle. Despite repeated dosing, no antibodies against the
ADC, either to the antibody or to the SN-38, have been detected. The conjugate
clears completely within 7 days, which is consistent with our preclinical
studies showing 50% of the SN-38 is released in the serum every day.
Dr. Starodub commented, "Our experience in the IMMU-132 trial has shown
promising efficacy results with a manageable and acceptable safety profile in
multiple patient populations, including those with limited therapy options,
such as triple-negative breast cancer and small-cell lung cancer."
"IMMU-132 continues to produce encouraging results as more patients with
advanced solid cancers are enrolled into our expansion trial," said Cynthia L.
Sullivan, President and Chief Executive Officer. "We believe this
SN-38-containing ADC that targets the TROP-2 antigen has the potential to be a
novel platform technology for the therapy of diverse metastatic solid
cancers," she added.
Results from 13 pancreatic cancer patients with CT-assessments also showed a
high disease control rate, but are not included in this report because they
will be presented at the upcoming AACR Special Conference on Pancreatic Cancer
in May, 2014.
The pancreatic cancer patient part of the study was supported in part by Award
Number R43CA171388 from the National Cancer Institute. The content is solely
the responsibility of the Company and does not necessarily represent the
official views of the National Cancer Institute or the National Institutes of
Health.
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