Immunomedics Expands Clinical Collaboration With Astrazeneca to Include Metastatic Non-Small Cell Lung Cancer
November 07 2018 - 4:00PM
Phase 2 Platform Study to Evaluate the
Combination of Imfinzi® (Durvalumab) and Sacituzumab Govitecan in
Patients with Non-Small Cell Lung Cancer Who Progressed on or after
Immune Checkpoint Inhibitor Therapy
Immunomedics, Inc.,
(NASDAQ:
IMMU) (“Immunomedics” or the “Company”), a leading
biopharmaceutical company in the area of antibody-drug conjugates
(ADC), today announced its current clinical collaboration with
AstraZeneca (NYSE: AZN) and
MedImmune for the development of Imfinzi®
(durvalumab) and sacituzumab govitecan combination therapy has been
broadened to include second-line metastatic non-small cell lung
cancer (NSCLC).
“Sacituzumab govitecan has shown very
encouraging single-agent activity in NSCLC patients who have failed
multiple lines of therapy. The combination study with durvalumab,
together with our internal efforts to further develop sacituzumab
govitecan monotherapy, will help us define the best registration
strategies in NSCLC within accelerated timelines,” said Dr. Robert
Iannone, Head of Research & Development and Chief Medical
Officer of Immunomedics.
Immune checkpoint inhibitors (CPI) have
drastically changed the treatment landscape in NSCLC and
significantly improved patient outcomes. However, there is still a
substantial proportion of patients who don’t benefit from CPIs. As
CPIs increasingly move into front-line therapy, either alone or in
combination with chemotherapy, treatment options for second-line
and beyond are limited to single agent chemotherapies, which have
only very modest activity. Thus, there is a high unmet need in
NSCLC for patients who don’t respond or have progressed after
treatment with CPIs.
Hesham Abdullah, Head of Immuno-Oncology, Global
Medicines Development, AstraZeneca said, “The efficacy, safety and
tolerability of durvalumab in NSCLC and the clinical activity of
sacituzumab govitecan monotherapy in late-line NSCLC, provide
promising rationale for the development of the durvalumab and
sacituzumab govitecan combination in the metastatic setting. We are
excited about the potential of this combination in second-line
NSCLC, which may fill an important unmet medical need for patients
who desperately need new treatment options.”
Sacituzumab govitecan as monotherapy has
produced an overall response rate (ORR) of 19% in 47 patients with
pretreated metastatic NSCLC with a duration of response of 6.0
months. In a subgroup of patients (14 of 47 patients) who had
previously been treated with CPIs as their last line of therapy,
ORR was 14% (2/14).1
This open-label, multi-center Phase 1/2 study
will enroll two cohorts of patients, one in CPI primary refractory,
and one in acquired resistance to CPI.
Reference
- Heist RS, Guarino MJ, Masters G, et al. Therapy of advanced
non-small-cell lung cancer with an SN-38-anti-Trop-2 drug
conjugate, sacituzumab govitecan. J Clin Oncol. 2017 Aug
20;35(24):2790-2797.
About lung cancerAccording to
the National Cancer Institute, more than 234,000 Americans are
estimated to be diagnosed with lung cancer in 2018 and
approximately 154,000 lung cancer patients will die from the
disease. NSCLC is the most common type of lung cancer, accounting
for about 84 percent of all lung cancer cases. It is estimated that
approximately 57 percent of lung cancer diagnoses in the United
States are made when the disease has metastasized. The five-year
relative survival rate for patients suffering from metastatic lung
cancers is estimated to be 4.7 percent.
About Sacituzumab
GovitecanSacituzumab govitecan, Immunomedics’ most
advanced product candidate, is a novel, first-in-class
antibody-drug conjugate (ADC). It is currently under priority
review by the U.S. Food and Drug Administration for accelerated
approval as a treatment of patients with metastatic triple-negative
breast cancer who have received two prior therapies for metastatic
disease. If approved, sacituzumab govitecan would be the first and
only ADC approved for the treatment of metastatic triple-negative
breast cancer.
About DurvalumabDurvalumab is a
human monoclonal antibody that binds to PD-L1 and blocks the
interaction of PD-L1 with PD-1 and CD80, countering the tumor’s
immune-evading tactics and releasing the inhibition of immune
responses.
As part of a broad development program,
durvalumab is being investigated as monotherapy and in combination
with IO, small molecules, and chemotherapies across a range of
tumors and stages of disease.
About ImmunomedicsImmunomedics
is a clinical-stage biopharmaceutical company developing monoclonal
antibody-based products for the targeted treatment of cancer.
Immunomedics’ corporate objective is to become a fully-integrated
biopharmaceutical company and a leader in the field of
antibody-drug conjugates. 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 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, 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
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,
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Investor
Contact:Dr. Chau Cheng(973)
531-9123ccheng@immunomedics.com |
Media
Contact:Kara Golub(973)
998-3344kgolub@immunomedics.com |
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