Immunomedics, Inc. (NASDAQ: IMMU)
(“Immunomedics” or the “Company”), a leading biopharmaceutical
company in the area of antibody-drug conjugates, today announced
that results from the confirmatory Phase 3 ASCENT study showed that
Trodelvy (sacituzumab govitecan-hziy) significantly extended
overall survival (OS) and improved overall response rate (ORR) and
clinical benefit rate (CBR), compared to treatment of choice (TPC)
standard single-agent chemotherapy in brain metastases-negative
patients with mTNBC who had previously received at least two prior
therapies for metastatic disease. These results will be presented
today as a late-breaking abstract (Abstract# LBA17) at the European
Society for Medical Oncology (ESMO) Virtual Congress 2020.
“The randomized Phase 3 study results confirm
that sacituzumab govitecan should be considered as a new standard
of care in patients with third-line mTNBC,” stated Aditya Bardia,
MD, MPH, Director of Precision Medicine at the Center for Breast
Cancer, Mass General Cancer Center and Assistant Professor of
Medicine at Harvard Medical School, who will give an oral
presentation of the study at the ESMO Congress. “We wish to express
our gratitude to the patients and their caregivers for their
valuable contribution, as well as the dedicated clinical trial
investigators and their devoted team members for making the ASCENT
trial possible. Ongoing studies are evaluating sacituzumab
govitecan in earlier lines of therapy, including the neoadjuvant
and adjuvant settings, in combination with other targeted agents,
and in patients with hormone receptor-positive, human epidermal
growth factor 2-negative metastatic breast cancer, which will help
accelerate our efforts to further improve outcomes for patients
with breast cancer.”
Despite having received a median of four prior
anticancer regimens, patients treated with Trodelvy in the ASCENT
study showed a statistically significant and clinically meaningful
improvement in OS with a median of 12.1 months (95% confidence
interval (CI), 10.7-14.0) versus 6.7 months (95% CI, 5.8-7.7) for
chemotherapy, with a hazard ratio of 0.48 (95% CI, 0.38-0.59;
p<0.0001). Trodelvy also demonstrated a statistically
significant improvement in ORR (35%) and CBR (45%) compared to
chemotherapy (5% and 9%, respectively). Ten complete responses were
observed (4%) in the Trodelvy arm compared with two (1%) in the
control group. As of data cutoff on March 11, 2020, 15 patients
continued to receive Trodelvy treatment while no patient remained
on study in the TPC control arm.
“We believe these remarkable results should
facilitate the establishment of Trodelvy as a new standard of care
in patients with third-line mTNBC,” said Dr. Loretta M. Itri, Chief
Medical Officer of Immunomedics. “We are working very
collaboratively with FDA under the RTOR program to submit a
supplemental Biologics License Application to have Trodelvy’s label
expanded to include these confirmatory new data. Additionally, we
plan to submit a Marketing Authorization Application to the
European Medicines Agency in the first half of 2021 in order to
make this important new treatment available to mTNBC patients in
Europe.”
Trodelvy was well tolerated by patients in the
ASCENT study, with a manageable safety profile consistent with the
U.S. Food and Drug Administration (FDA)-approved label; no new
safety signals were observed in the ASCENT study. Adverse events
leading to treatment discontinuation were low and similar (Trodelvy
4.7% vs TPC 5.4%) in both arms of the study.
“We are delighted to witness the clinically
meaningful survival benefit Trodelvy is bringing to mTNBC patients.
These outstanding results have inspired us to fully demonstrate the
potential of this valuable new treatment to improve the outlook of
cancer patients worldwide,” commented Dr. Behzad Aghazadeh,
Executive Chairman of Immunomedics.
Trodelvy was approved as a third-line treatment
for adult patients with mTNBC under the FDA’s Accelerated Approval
Program and carries a black box warning for severe neutropenia and
severe diarrhea. The most common adverse reactions occurring in 25
or more percent of patients included nausea, neutropenia, diarrhea,
fatigue, anemia, vomiting, alopecia, constipation, decreased
appetite, rash and abdominal pain. The most common Grade 3 or 4
adverse events occurring in more than 5 percent of patients were
neutropenia, white blood cell count decreased, anemia,
hypophosphatemia, diarrhea, fatigue, nausea and vomiting. Two
percent of patients discontinued treatment due to adverse events.
There were no deaths related to treatment and no severe cases of
neuropathy or interstitial lung disease.1
Conference Call
The Company will host a conference call and live
audio webcast with key opinion leaders today at 2:00 p.m. Eastern
Time to discuss the ASCENT results and provide a corporate update.
To access the conference call supported with slides, please dial
(877) 303-2523 or (253) 237-1755 using the Conference ID 1871157.
The conference call with supporting slides will be webcast via the
Investors page on the Company’s website at
https://immunomedics.com/investors/. Approximately two hours
following the live event, a webcast replay of the conference call
will be available on the Company’s website for approximately 30
days.
About
Triple-Negative
Breast
Cancer (TNBC)
TNBC is an aggressive type of breast cancer,
accounting for up to 20 percent of all breast cancers. The disease
is diagnosed more frequently in younger and premenopausal women and
is highly prevalent in African American and Hispanic women. TNBC
cells do not have estrogen or progesterone hormone receptors, or
very much of the human epidermal growth factor receptor 2 – hence
the term triple negative. This means that medicines that target
these receptors are not typically effective in TNBC. There is
currently no approved standard of care for people with
previously-treated mTNBC.
About ASCENT
The international, open-label confirmatory Phase
3 study enrolled more than 500 patients with metastatic
triple-negative breast cancer who had received at least two prior
therapies for metastatic disease. Patients were randomized to
receive either Trodelvy or a physician’s choice of chemotherapy.
The primary endpoint of the study was progression-free survival.
Secondary endpoints include overall survival, objective response
rate, duration of response, time to onset of response, and other
measures of safety and tolerability. More information about ASCENT
is available at http://clinicaltrials.gov/show/NCT02574455.
About TRODELVY
Trodelvy (sacituzumab govitecan-hziy) is the
lead product and the most advanced program in Immunomedics’ unique
antibody-drug conjugate (ADC) platform. Trodelvy is an ADC that is
directed against Trop-2, a cell-surface protein expressed in many
solid cancers. Trodelvy binds to Trop-2 and delivers the
anti-cancer drug, SN-38, to kill cancer cells. Immunomedics has an
extensive development program for Trodelvy, including multiple
ongoing studies in triple-negative breast cancer, metastatic
urothelial cancer, hormone receptor-positive/human epidermal growth
factor receptor 2-negative metastatic breast cancer, and metastatic
non-small cell lung cancer, either as a monotherapy or in
combination with other agents. Visit https://www.trodelvy.com/ for
more information.
About Immunomedics
Immunomedics is a leader in next-generation
antibody-drug conjugate (ADC) technology, committed to help
transform the lives of people with hard-to-treat cancers. Our
proprietary ADC platform centers on using a novel linker that does
not require an enzyme to release the payload to deliver an active
drug inside the tumor cell and the tumor microenvironment, thereby
producing a bystander effect. Trodelvy, our lead ADC, is the first
ADC the FDA has approved for the treatment of people with
metastatic triple-negative breast cancer and is also the first
FDA-approved anti-Trop-2 ADC. For additional information on the
Company, please visit its website at https://immunomedics.com/. The
information on its website does not, however, form a part of this
press release.
Cautionary note regarding forward-looking
statements
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 expectations for
achieving full FDA approval based on our confirmatory data for
TRODELVY and the Company’s development of TRODELVY for additional
indications, clinical trials (including the funding therefor,
anticipated patient enrollment, trial outcomes, timing or
associated costs), regulatory applications and related timelines,
including the filing and approval timelines for BLAs and BLA
supplements, out-licensing arrangements, forecasts of future
operating results, potential collaborations, capital raising
activities, and the timing for bringing any product candidate to
market, 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 reliance on third-party relationships
and outsourcing arrangements (for example in connection with
manufacturing, logistics and distribution, and sales and marketing)
over which it may not always have full control, including the
failure of third parties on which the Company is dependent to meet
the Company’s business and operational needs for investigational or
commercial products and, or to comply with the Company’s agreements
or laws and regulations that impact the Company’s business; the
Company’s ability to meet post-approval compliance obligations (on
topics including but not limited to product quality, product
distribution and supply chain requirements, and promotional and
marketing compliance); imposition of significant post-approval
regulatory requirements on our products, including a requirement
for a post-approval confirmatory clinical study, or failure to
maintain or obtain full regulatory approval for the Company’s
products, if received, due to a failure to satisfy post-approval
regulatory requirements, such as the submission of sufficient data
from a confirmatory clinical study; the uncertainties inherent in
research and development; safety and efficacy concerns related to
the Company’s products and product candidates; uncertainties in the
rate and degree of market acceptance of products and product
candidates, if approved; inability to create an effective direct
sales and marketing infrastructure or to partner with third parties
that offer such an infrastructure for distribution of the Company’s
products and product candidates, if approved; inaccuracies in the
Company’s estimates of the size of the potential markets for the
Company’s products and product candidates or limitations by
regulators on the proposed treatment population for the Company’s
products and product candidates; decisions by regulatory
authorities regarding labeling and other matters that could affect
the availability or commercial potential of the Company’s products
and product candidates; 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 relating to the COVID-19 pandemic
in the U.S. and around the world; risks associated with litigation
to which the Company is or may become a party, including the cost
and potential reputational damage resulting from such litigation;
loss of key personnel; 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.
Reference
1. TRODELVY Prescribing Information. Morris Plains, NJ:
Immunomedics Inc, 2020.
For More Information:
Dr. Chau Cheng(862)
260-3727ccheng@immunomedics.com
For Media Inquiries:
Darren Opland, Ph.D.(646)
627-8387Darren@lifescipublicrelations.com
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