Immunomedics Reports Final Efficacy Results of Phase Ib Trial With
Yttrium-90-Labeled Clivatuzumab Tetraxetan in Patients With Metastatic
Treatment Responses Improved Significantly With Repeated Cycles in Combination
CHICAGO, June 1, 2014 (GLOBE NEWSWIRE) -- Immunomedics, Inc., (Nasdaq:IMMU)
today reported an overall disease response rate of 41%, including 2 patients
(7%) with partial response and 10 patients (34%) with stable disease as best
response, in 29 patients with relapsed/refractory, metastatic pancreatic
cancer treated with the investigational pancreatic cancer therapeutic,
clivatuzumab tetraxetan labeled with yttrium-90 (^90Y), in combination with
low-dose gemcitabine as a radiosensitizer. This was compared to a control
group of 29 similar patients who received ^90Y-clivatuzumab tetraxetan without
low-dose gemcitabine. Treatment responses were assessed by computed tomography
(CT) based on RECIST criteria.
Results from the multicenter Phase Ib study were presented by Vincent J.
Picozzi Jr., M.D., Director of the Pancreas Center of Excellence at the
Virginia Mason Medical Center's Digestive Disease Institute, Seattle, WA, at
the 2014 Annual Meeting of the American Society of Clinical Oncology (ASCO).
Within the 2 subgroups of patients, adding low-dose gemcitabine extended the
median overall survival (OS) for the 29 patients in Arm A to 3.9 months, a
statistically significant (p=0.017) improvement compared with the 2.8 month
median OS for the 29 patients receiving only ^90Y-clivatuzumab tetraxetan in
Furthermore, for patients in Arm A, there were 48%, 34%, 21%, and 10% of
patients alive at 3, 6, 9, and 12 months, respectively, indicating that the
combination of radiolabeled antibody and gemcitabine improved survival
throughout the study.
Treatment Number of Patients Survival Results
Arm Enrolled 3 Months 6 Months 9 Months 12 Months
A 29 14 (48%) 10 (34%) 6 (21%) 3 (10%)
B 29 10 (34%) 3 (10%) 1 (3%) 0 (0%)
Patients who received multiple cycles of the combination therapy had the best
outcome, with a median OS of 7.9 months. This was statistically significant
(p=0.004) compared to the median OS of 3.4 months in patients receiving
multiple cycles of ^90Y-clivatuzumab tetraxetan only. Additionally, 2 patients
in Arm A had a partial response and 2 patients are still alive 13 and 15
months after the start of their combination treatment.
Since patients' response and outcome are expected to deteriorate with each
successive round of treatment, these results, obtained from patients who had
received at least 2 prior therapies, appear to compare favorably with those
from second-line investigational treatment regimens reported at the 2014 ASCO
Gastrointestinal Cancers Symposium.^1
The only clinically significant side effect was reduction in platelets, which
was transient and manageable.
"Based on these encouraging results, we have launched the Phase III
PANCRIT^®-1 registration trial, positioning ^90Y-clivatuzumab tetraxetan as a
therapy for patients in this late-stage setting," commented Cynthia L.
Sullivan, President and Chief Executive Officer of Immunomedics. "The primary
end-point will be overall survival and the protocol allows the independent
Data and Safety Monitoring Board one planned interim analysis of data on
overall survival to be conducted after a predetermined number of events have
occurred. We plan to complete patient accrual by the second half of 2015, with
top-line results expected in the first half of 2016," Ms. Sullivan reiterated.
1. Choi M, Saif MW, Kim R. Is there a role for second line therapy in advanced
pancreatic cancer? JOP 2014 Mar 10;15(2):106-109. doi: 10.6092/1590-8577/2325.
Immunomedics is a clinical-stage biopharmaceutical company developing
monoclonal antibody-based products for the targeted treatment of cancer,
autoimmune disorders and other serious diseases. Immunomedics' advanced
proprietary technologies allow the Company to create humanized antibodies that
can be used either alone in unlabeled or "naked" form, or conjugated with
radioactive isotopes, chemotherapeutics, cytokines or toxins. Using these
technologies, Immunomedics has built a pipeline of nine clinical-stage product
candidates. Immunomedics has an ongoing collaboration with UCB, S.A. (UCB),
who has worldwide rights in non-cancer indications to Immunomedics' Phase III
product candidate, epratuzumab. UCB expects Phase III data in systemic lupus
erythematosus (SLE) in the first quarter of 2015. Immunomedics is exploring
epratuzumab in oncology in collaboration with outside cancer study groups.
Immunomedics' most advanced wholly owned candidate is ^90Y-clivatuzumab
tetraxetan, which is in an ongoing Phase III registration trial in patients
with pancreatic cancer. Immunomedics' portfolio of wholly owned product
candidates also includes antibody-drug conjugates (ADCs) that are designed to
deliver a specific payload of a chemotherapeutic directly to the tumor while
reducing overall toxicity effects that typically occur when these
chemotherapeutic agents are dosed alone. Immunomedics' most advanced ADCs are
IMMU-132 and IMMU-130, which are in Phase I/II trials for a number of solid
tumors and metastatic colorectal cancer (mCRC), respectively. Immunomedics
also has a number of other product candidates that target solid tumors and
hematologic malignancies, as well as other diseases, in various stages of
clinical and pre-clinical development. These include bispecific antibodies
which have application as T-cell redirecting immunotherapies targeting cancers
and infectious diseases as well as next-generation therapies in cancer and
autoimmune disease. Immunomedics creates these bispecific antibodies using its
patented DOCK-AND-LOCK™ (DNL™) protein conjugation technology. The Company
believes that its portfolio of intellectual property, which includes
approximately 248 active patents in the United States and more than 400
foreign patents, protects its product candidates and technologies.
Immunomedics' strength in intellectual property has resulted in the top-4
ranking in the January 2014 Patent Board scorecard in the Biotechnology
industry. For additional information on the Company, please visit its website
at www.immunomedics.com. The information on its website does not, however,
form a part of this press release.
This release, in addition to historical information, may contain
forward-looking statements made pursuant to the Private Securities Litigation
Reform Act of 1995. Such statements, including statements regarding clinical
trials (including the funding therefor, outcomes, timing or associated costs),
out-licensing arrangements (including the timing and amount of contingent
payments), forecasts of future operating results, potential collaborations,
and capital raising activities, involve significant risks and uncertainties
and actual results could differ materially from those expressed or implied
herein. Factors that could cause such differences include, but are not limited
to, new product development (including clinical trials outcome and regulatory
requirements/actions), our dependence on UCB for the further development of
epratuzumab for non-cancer indications, risks associated with the outcome of
pending litigation, competitive risks to marketed products and availability of
required financing and other sources of funds on acceptable terms, if at all,
as well as the risks discussed in the Company's filings with the Securities
and Exchange Commission. The Company is not under any obligation, and the
Company expressly disclaims any obligation, to update or alter any
forward-looking statements, whether as a result of new information, future
events or otherwise.
CONTACT: For More Information:
Dr. Chau Cheng
Senior Director, Investor Relations & Grant Management
(973) 605-8200, extension 123
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