Immunomedics, Inc., (NASDAQ:IMMU) (“Immunomedics”
or “the Company”) today reported that sacituzumab govitecan
(IMMU-132), the Company’s lead antibody-drug conjugate (ADC), has
activity and manageable toxicity in patients with advanced and
heavily-pretreated metastatic small-cell lung cancer (SCLC).
“Despite recent progress in immunotherapy and
the identification of other novel targets for SCLC, this still is a
lethal disease, especially in the population that is chemoresistant
to first-line therapy,” remarked Jhanelle E. Gray, MD, Medical
Oncologist and the Director of Clinical Research in the Department
of Thoracic Oncology at H. Lee Moffitt Cancer Center and Research
Institute in Tampa, Florida, who presented the updated results at
the 2017 AACR Annual Meeting.
The relapse of SCLC to frontline chemotherapy
continues to be divided into two categories, resistant relapse,
occurring within three months of the first platinum-based therapy,
and sensitive relapse, which occurs after at least 3 months post
treatment. Although there is still some ambiguity regarding the
best management of recurrent SCLC, topotecan, a topoisomerase-I
inhibitor similar to the SN-38 used in the ADC studied here, is the
only product approved for second-line chemosensitive relapse. In
the twenty years since the approval of topotecan in the second-line
setting, no new agent has been licensed for metastatic SCLC therapy
in second-line or later therapy.
It is in this setting that the results reported
at the AACR conference with sacituzumab govitecan in
advanced-disease patients (stage IV) are promising. A total of 53
patients with metastatic SCLC were enrolled into the open-label
Phase 2 study after receiving a median of 2 prior lines of therapy
(range, 1 to 7). All patients had previously received cisplatin or
carboplatin plus etoposide, and were considered chemosensitive
(N=27, 51%) or chemoresistant (N=26, 49%) to their
platinum-containing frontline therapy, based on a duration of
response of more than 3 months or less than 3 months, respectively.
Treatments with sacituzumab govitecan were administered at a dose
of either 8 or 10 mg/kg on days 1 and 8 of 21-day cycles. The
primary endpoints were safety and objective response rate (ORR),
with duration of response, progression-free survival (PFS), and
overall survival (OS) as secondary endpoints.
Sixty percent of patients showed tumor shrinkage
from baseline measurements using computed tomography (CT). On an
intention-to-treat (ITT) basis (N= 50), the ORR was 14% (17% for
the 10 mg/kg group) and the median response duration was 5.7 months
(95% confidence interval [CI], 3.6 to 19.9 months). Clinical
benefit rate (CBR) at 4 months was 34%, with median PFS and median
OS at 3.7 months (95% CI, 2.1 to 4.3 months) and 7.5 months (95%
CI, 6.2 to 8.8 months), respectively. There was no statistical
difference in ORR, PFS or OS between those patients who were
chemosensitive or chemoresistant to first-line chemotherapy, but
the CBR was 50% and 26%, respectively. There was a statistically
significant higher OS in those patients who received prior
topotecan versus no topotecan therapy.
“The current results of sacituzumab govitecan in
heavily-pretreated patients with advanced, relapsed, stage IV,
SCLC, despite the limitations of a one-arm trial, suggest that this
investigational ADC may gain a role in the therapy of both
chemosensitive and chemoresistant SCLC patients, both before or
after topotecan treatment, and thus needs to be studied further in
such settings,” commented Cynthia L. Sullivan, President and Chief
Executive Officer of Immunomedics.
Grade 3 or higher adverse events included
neutropenia (34%), fatigue (13%), diarrhea (9%), and anemia (6%).
Trop-2 tumor staining was not required for patient selection, due
to 92% (23/25) positivity. No antibodies to the drug conjugate or
its components were detected on serial blood collections, despite
more than 60 doses being given.
In addition to Dr. Gray, other clinical
investigators who participated in this multicenter study included
Drs. Rebecca S. Heist and Leena Gandhi, Massachusetts General
Hospital Cancer Center, Harvard Medical School, Boston, MA; Drs.
Alexander N. Starodub and Ebenezer Kio, Indiana University Health
Center for Cancer Care, Goshen, IN (Dr. Starodub’s current address
is Parkview Cancer Institute, Fort Wayne, IN); Drs. D. Ross
Camidge, W. Thomas Purcell and Wells A. Messersmith, University of
Colorado Cancer Center, Aurora, CO; Drs. Gregory Masters, Michael
J. Guarino, Jamal Misleh and Charles J. Schneider, Helen F Graham
Cancer Center, Newark, DE; Drs. Bryan J. Schneider, Allyson J.
Ocean and Ronald J. Scheff, Weill Cornell Medicine, New York, NY;
Dr. Tirrell Johnson, UF Health Cancer Center, Orlando, FL; and Dr.
Kevin Kalinsky, Columbia University-Herbert Irving Comprehensive
Cancer Center, New York, NY.
About Small-Cell Lung Cancer
(SCLC)SCLC comprises approximately 15% of all lung
cancers, yet has one of the lowest 5-year survival rates at 6%.
This is because of its highly aggressive nature, with about
two-thirds of patients already having metastatic disease at
diagnosis. While palliative first-line therapy of metastatic SCLC
has a high initial response rate of 60 to 75%, the outcome is poor,
with a median progression-free survival of only 5.5 months and a
median overall survival of less than 10 months with platinum-based
chemotherapy. Responses to second-line therapy have been poorer,
such as less than 10%, and with a median survival of only 4 to 5
months following second- or third-line chemotherapy. Since 1998,
the only approved drug in this second-line setting is topotecan,
indicated for recurrent patients who were sensitive (duration of
response exceeding 3 months). Unfortunately, those patients with
platinum-resistant metastatic SCLC (i.e., response duration of less
than 3 months) fare even worse.
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
toxicities 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
310 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.
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, 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
Immunomedics (NASDAQ:IMMU)
Historical Stock Chart
From Aug 2024 to Sep 2024
Immunomedics (NASDAQ:IMMU)
Historical Stock Chart
From Sep 2023 to Sep 2024