SAN DIEGO, May 17, 2017 /PRNewswire/ -- Results from a
Phase 2 randomized, multi-center clinical trial in pancreas cancer
patients conducted by Halozyme Therapeutics (NASDAQ: HALO) of its
targeted investigational therapy, PEGPH20, will be presented in an
oral presentation on June 4 at the
American Society of Clinical Oncology (ASCO) annual conference.
Principal Investigator Sunil R.
Hingorani, M.D., Ph.D., a pancreas cancer expert at Fred
Hutchinson Cancer Research Center and professor at University of Washington School of Medicine will
present the HALO-202 results, which include the study meeting its
primary and key secondary endpoints.
"The HALO-202 data confirm for the first time in a randomized
Phase 2 trial using the current standard of care that
a biopsy-based biomarker for hyaluronan content can
potentially identify patients who will have a meaningfully greater
response when PEGPH20 is added to their treatment," said Dr.
Hingorani. "The analysis suggests statistically significant
and clinically important progress in this very difficult to treat
cancer. The median PFS is a notable increase over the current
standard of care and supports ongoing exploration in the current
Phase 3 study."
The study demonstrated that PEGPH20 plus standard chemotherapy
of ABRAXANE® (nab-paclitaxel) and gemcitabine improved
median progression-free survival (mPFS) by 77 percent over
chemotherapy alone in stage IV pancreas cancer patients with high
levels of hyaluronan (HA-High). Halozyme is currently enrolling
HA-High patients in a global Phase 3 clinical trial.
In a subanalysis of patients who received uninterrupted therapy
with PEGPH20 plus chemotherapy (Stage 2 patients), a 91 percent
improvement in mPFS and a 4-month benefit in overall survival were
observed.
Dr. Helen Torley, president and
chief executive officer of Halozyme said, "The results in the
HA-High patient cohort are particularly encouraging given that we
are using this biomarker and recruiting this specific patient
population in our ongoing global Phase 3 study, HALO-301. We
believe that HALO-301 is the first targeted or biomarker driven
Phase 3 study to date in this highly lethal cancer type."
Pancreas cancer is the third-leading cause of cancer related
death in the United States, and
more than 65,000 people in the U.S. and top five European countries
are diagnosed annually with advanced cases of the disease.
About HALO-301 and HALO-202
HALO-301 is a phase 3
global, randomized, double-blind placebo controlled clinical trial
evaluating investigational new drug PEGPH20 as a first-line therapy
for potential treatment of patients with metastatic pancreas
cancer. The trial will be conducted at approximately 200 sites with
two primary endpoints, progression free survival and overall
survival in patients receiving investigational new drug PEGPH20 in
combination with gemcitabine and ABRAXANE (nab-paclitaxel) compared
to gemcitabine and nab-paclitaxel alone. Secondary endpoints also
include objective response rate and overall survival. More
information may be found at clinicaltrials.gov (search HALO 301 or
trial identifier NCT02715804) or www.HALO301.com.
HALO-202 (Halo 109-202) is a phase 2 multi-center, randomized
clinical trial evaluating investigational new drug PEGPH20 as a
first-line therapy for potential treatment of patients with
metastatic pancreas cancer. The primary outcome of the trial is to
measure improvement in progression-free survival in patients
receiving investigational new drug PEGPH20 in combination with
gemcitabine and nab-paclitaxel compared to gemcitabine and
nab-paclitaxel alone. A second primary endpoint assesses the
thromboembolic event rate in the PEGPH20 treatment arm. Secondary
endpoints also include objective response rate and overall
survival.
About PEGPH20
PEGPH20 is an investigational PEGylated
form of Halozyme's proprietary recombinant human hyaluronidase
under clinical development for the potential systemic treatment of
tumors that accumulate hyaluronan. PEGPH20 is an enzyme that
temporarily degrades HA, a dense component of the tumor
microenvironment that can accumulate in higher concentrations
around certain cancer cells, potentially constricting blood vessels
and impeding the access of other therapies.
FDA granted orphan drug designation to PEGPH20 for
treatment of pancreas cancer and fast track designation for PEGPH20
in combination with gemcitabine and nab-paclitaxel for the
treatment of metastatic pancreas cancer. Additionally,
the European Commission, acting on the recommendation from the
Committee for Orphan Medicinal Products of the European
Medicines Agency, designated investigational drug PEGPH20 an orphan
medicinal product for the treatment of pancreas cancer.
About Halozyme
Halozyme Therapeutics is a
biotechnology company focused on developing and commercializing
novel oncology therapies that target the tumor microenvironment.
Halozyme's lead proprietary program, investigational drug PEGPH20,
applies a unique approach to targeting solid tumors, allowing
increased access of co-administered cancer drug therapies to the
tumor in animal models. PEGPH20 is currently in development for
metastatic pancreas cancer, non-small cell lung cancer, gastric
cancer, metastatic breast cancer and has potential across
additional cancers in combination with different types of cancer
therapies. In addition to its proprietary product portfolio,
Halozyme has established value-driving partnerships with leading
pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen,
AbbVie and Lilly for its ENHANZE® drug delivery
technology. Halozyme is headquartered in San Diego. For more information visit
www.halozyme.com.
Safe Harbor Statement
In addition to historical
information, the statements set forth above include forward-looking
statements (including, without limitation, statements concerning
the possible activity, benefits and attributes of PEGPH20, the
possible method of action of PEGPH20, its potential application to
improve cancer therapies and statements concerning future actions
relating to the development of PEGPH20) that involve risk and
uncertainties that could cause actual results to differ materially
from those in the forward-looking statements. The forward-looking
statements are typically, but not always, identified through use of
the words "believe," "enable," "may," "will," "could," "intends,"
"estimate," "anticipate," "plan," "predict," "probable,"
"potential," "possible," "should," "continue," and other words of
similar meaning. Actual results could differ materially from the
expectations contained in forward-looking statements as a result of
several factors, including unexpected expenditures and costs,
unexpected results or delays in development and regulatory review,
regulatory approval requirements, unexpected adverse events and
competitive conditions. These and other factors that may result in
differences are discussed in greater detail in the Company's most
recent Annual and Quarterly Reports filed with the Securities and
Exchange Commission.
Contacts:
Jim
Mazzola
858-704-8122
ir@halozyme.com
Chris Burton
858-704-8352
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.