CHICAGO, June 4, 2017 /PRNewswire/ -- Encouraging results
from a Phase 2 randomized, multi-center clinical trial in pancreas
cancer patients conducted by Halozyme Therapeutics (NASDAQ: HALO)
were presented today 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
expanded on findings from patient data as of December 2016 in the HALO-202 study of
investigational new drug, PEGPH20 (pegvorhyaluronidase alpha) in
combination with ABRAXANE® (nab-paclitaxel) and
gemcitabine.
The study met its primary endpoints and the key secondary
endpoint of progression-free survival (PFS) in patients with high
levels of a biomarker, hyaluronan (HA-High). PEGPH20 plus standard
chemotherapy of ABRAXANE and gemcitabine improved median PFS by 77
percent over chemotherapy alone in HA-High patients.
An exploratory endpoint of objective response rate by RECIST
v1.1 in the HA-High population, reported for the first time today,
was 45 percent in the PEGPH20 plus chemotherapy arm, including one
Complete Response, compared to 31 percent in patients receiving
chemotherapy alone. Key patient baseline characteristics also
reported for the first time today were generally well balanced
across both arms of the study.
Halozyme is currently conducting a global Phase 3 clinical
trial, HALO-301, in a similar population of HA-High stage IV
pancreas cancer patients.
"The HALO-202 study met key safety and efficacy objectives and
confirmed in a randomized Phase 2 trial that a biomarker may
be able to identify patients who will have a meaningfully greater
response when PEGPH20 is added to standard-of-care chemotherapy,"
said Dr. Hingorani. "The new data reported today suggest
potentially important progress in this very difficult to treat
cancer."
Dr. Helen Torley, president and
chief executive officer of Halozyme, said, "We are driven in our
study of PEGPH20 by the goal of providing new options to patients
affected by some of the hardest to treat cancers. The HALO-202
results in HA-High pancreas cancer patients provide encouraging
insights into a potentially new treatment option and support our
ongoing study of PEGPH20 in the global Phase 3 HALO-301 study."
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 (pegvorhyaluronadase alpha)
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
platform. 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.