Phase 2 Results Reported at 2017 Genitourinary
(GU) Cancers Symposium
Immunomedics, Inc.,
(NASDAQ:IMMU) (“Immunomedics” or “the Company”) today announced
that sacituzumab govitecan (IMMU-132) is active in patients with
metastatic urothelial cancer (UC) and has the potential to become a
second line or later treatment to platinum-based or immuno-oncology
therapy for these patients.
“With larger numbers than the initial report, I
remain impressed with the safety and efficacy results produced by
sacituzumab govitecan in a difficult-to-treat patient population
that had a median of two prior therapies and had extensive
metastatic disease,” commented Dr. Scott T. Tagawa, the Richard A.
Stratton Associate Professor in Hematology and Oncology, and an
Associate Professor of Clinical Medicine and of Clinical Urology at
Weill Cornell Medicine and an oncologist at NewYork-Presbyterian,
who presented the results at the GU conference.
“While patients with metastatic UC usually
respond well to initial therapy with a platinum-containing regimen,
few options are available after they become refractive. Second-line
immune checkpoint-inhibitor (IO) therapy was recently approved by
the FDA, such as atezolizumab and nivolumab, with expected approval
of pembrolizumab as well. Although responders to the new IO therapy
may do well for a prolonged period of time, about three-fourths do
not respond and overall median PFS is less than 2.5 months and
median OS less than 13 months have been reported,” added Dr.
Tagawa, who has served as a consultant to Immunomedics.
In the ongoing Phase 2 study with sacituzumab
govitecan in metastatic UC, the ORR among 36 assessable patients
was 31% (11/36), including one confirmed CR and ten confirmed PRs.
The median duration of response for these ten patients was 7.5
months (95% confidence interval [CI], 4.4 to 12.9 months), with one
patient having a PR for more than 18 months and continuing therapy.
Overall, 69% of patients showed tumor shrinkage from baseline with
sacituzumab govitecan therapy, and 14 patients are still under
therapy.
For the 41 intention-to-treat patients, median
PFS was 7.2 months (95% CI, 6.7 to 11.7 months) and median OS was
15.5 months (95% CI, 8.9 to 17.2 months). Of the twelve patients
with progression after prior IO therapy and chemotherapy, there
were one unconfirmed PR and six patients with stable disease
following sacituzumab govitecan treatment.
The Company announced on February 10, 2017 that
an exclusive global licensing agreement was entered into with
Seattle Genetics (NASDAQ:SGEN), providing Seattle Genetics
worldwide rights to develop, manufacture and commercialize
sacituzumab govitecan in multiple indications, including UC.
“We are pleased with these promising results,
especially the long-term control of advanced disease in patients
who failed multiple prior therapies, and look forward to working
closely with Seattle Genetics to bring this important
investigational product to cancer patients expeditiously,” stated
Cynthia L. Sullivan, President and Chief Executive Officer of
Immunomedics. Ms. Sullivan added, “We remain on target to commence
our Phase 3 randomized trial in patients with advanced
triple-negative breast cancer in March, and are working diligently
to complete the submission of our Biologics License Application to
FDA for Accelerated Approval of this indication.”
In addition to Dr. Tagawa, other clinical
investigators participating in this study include Drs. Allyson J.
Ocean, Bishoy Faltas, and Ana Molina, his colleagues at
NewYork-Presbyterian and Weill Cornell Medicine, New York, NY;
Dr. Elaine Lam, University of Colorado Cancer Center, Aurora,
CO; Drs. Philip Saylor and Aditya Bardia, Massachusetts General
Hospital Cancer Center, Harvard Medical School, Boston, MA; Dr.
Julio J. Hajdenberg, UF Health Cancer Center-Orlando Health,
Orlando, FL; Dr. Alicia K. Morgans, Vanderbilt-Ingram Cancer
Center, Nashville, TN; Drs. Kevin Kalinsky and Emerson Lim,
NewYork-Presbyterian/Columbia University Medical Center-Herbert
Irving Comprehensive Cancer Center, New York, NY; and Dr. Matthew
D. Galsky, Icahn School of Medicine Mount Sinai, Tisch Cancer
Institute, New York, NY.
A total of 44 patients with metastatic UC had
been enrolled into this open-label multicenter study. Sites of
metastases included liver (N=9; 25%), lymph nodes (N=14; 39%),
lungs (N=14; 39%, pelvis (N=9, 25%), and bone (N=4; 11%). Patients
received a median of six doses (range, 1-50) of sacituzumab
govitecan, which was administered at 8 or 10 mg/kg on days 1 and 8
of 3-week cycles. Despite repeated dosing, grade 3 or higher
adverse events were limited to neutropenia (30%), febrile
neutropenia (11%), fatigue (11%), and diarrhea (3%).
Treatment response was assessed by computed
tomography (CT) every 8 weeks. Patients with more than 30% tumor
shrinkage required confirmation within 4 to 6 weeks after the
initial response in accordance with by RECIST 1.1 for single-arm
studies.
About ImmunomedicsImmunomedics
(the “Company”) 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 eight
clinical-stage product candidates. Immunomedics’ portfolio of
investigational products includes antibody-drug conjugates (ADCs)
that are designed to deliver a specific payload of a
chemotherapeutic directly to the tumor while reducing overall toxic
effects that are usually found with conventional administration of
these chemotherapeutic agents. Immunomedics’ most advanced ADCs are
sacituzumab govitecan (IMMU-132) and labetuzumab govitecan
(IMMU-130), which are in Phase 2 trials for a number of solid
tumors and metastatic colorectal cancer, respectively. IMMU-132 has
received Breakthrough Therapy Designation from the FDA for the
treatment of patients with triple-negative breast cancer who have
failed at least two prior therapies for metastatic disease.
Immunomedics has a research collaboration with Bayer to study
epratuzumab as a thorium-227-labeled antibody. Immunomedics has
other ongoing collaborations in oncology with independent cancer
study groups. The IntreALL Inter-European study group is conducting
a large, randomized Phase 3 trial combining epratuzumab with
chemotherapy in children with relapsed acute lymphoblastic leukemia
at clinical sites in Australia, Europe, and Israel. 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 preclinical development. These
include combination therapies involving its antibody-drug
conjugates, bispecific antibodies targeting cancers and infectious
diseases as T-cell redirecting immunotherapies, as well as
bispecific antibodies for next-generation cancer and autoimmune
disease therapies, created using its patented DOCK-AND-LOCK®
protein conjugation technology. The Company believes that its
portfolio of intellectual property, which includes approximately
306 active patents in the United States and more than 400 foreign
patents, protects its product candidates and technologies. 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.
Important Additional
InformationImmunomedics, Inc. (the “Company”), its
directors and certain of its executive officers will be deemed to
be participants in the solicitation of proxies from Company
stockholders in connection with the matters to be considered at the
Company’s 2016 Annual Meeting. The Company has filed a definitive
proxy statement and form of WHITE proxy card with the U.S.
Securities and Exchange Commission (the “SEC”) in connection with
any such solicitation of proxies from Company stockholders.
COMPANY STOCKHOLDERS ARE STRONGLY ENCOURAGED TO READ THE
DEFINITIVE PROXY STATEMENT (INCLUDING ANY AMENDMENTS AND
SUPPLEMENTS), THE ACCOMPANYING WHITE PROXY CARD AND ANY OTHER
RELEVANT DOCUMENTS THAT THE COMPANY FILES WITH THE SEC WHEN THEY
BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT
INFORMATION. Information regarding the identity of
participants, and their direct or indirect interests, by security
holdings or otherwise, is set forth in the proxy statement and
other materials filed by the Company with the SEC.
Stockholders will be able to obtain the proxy statement, any
amendments or supplements to the proxy statement and other
documents filed by the Company with the SEC for no charge at the
SEC’s website at www.sec.gov. Copies will also be available at no
charge at the Company’s website at www.immunomedics.com, by writing
to Immunomedics, Inc. at 300 The American Road, Morris Plains, New
Jersey 07950, or by calling the Company’s proxy solicitor,
MacKenzie Partners, Inc. at (212) 929-5500, or by calling Dr. Chau
Cheng, Senior Director, Investor Relations & Corporate
Secretary, (973) 605-8200, extension 123.
Forward-Looking StatementsThis
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, anticipated patient enrollment, trial outcomes, timing or
associated costs), regulatory applications and related timelines,
out-licensing arrangements (including the timing and amount of
contingent payments under the licensing and development agreement
with Seattle Genetics), 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, the
Company’s dependence on business collaborations or availability of
required financing from capital markets, or other sources on
acceptable terms, if at all, in order to further develop our
products and finance our operations, new product development
(including clinical trials outcome and regulatory
requirements/actions), the risk that we or any of our collaborators
may be unable to secure regulatory approval of and market our drug
candidates, risks associated with the outcome of pending litigation
and competitive risks to marketed products, and the Company’s
ability to repay its outstanding indebtedness, if and when
required, 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.
For More Information:
Dr. Chau Cheng
Senior Director, Investor Relations & Corporate Secretary
(973) 605-8200, extension 123
ccheng@immunomedics.com
Media
Dan Katcher / Ed Trissel / Nick Lamplough
Joele Frank, Wilkinson Brimmer Katcher
(212) 355-4449
Investors
Dan Burch/Bob Marese
MacKenzie Partners, Inc.
dburch@mackenziepartners.com / bmarese@mackenziepartners.com
(212) 929-5500
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