BARCELONA, Spain, June 28, 2017 /PRNewswire/ -- Results from
Halozyme Therapeutics (NASDAQ: HALO) Phase 2 randomized,
multi-center clinical trial in pancreas cancer patients were shared
today in two oral presentations at the European Society for Medical
Oncology's 19th World Congress on Gastrointestinal
Cancer.
The HALO-202 study represents the first clinical trial of a
molecularly targeted drug in pancreatic ductal adenocarcinoma and
the results support hyaluronan (HA) as a potential biomarker to
predict those patients who could benefit from Halozyme's
investigational new drug PEGPH20 (pegvorhyaluronidase alfa) when
added to standard chemotherapy.
As previously reported, the study met its primary efficacy and
safety endpoints and the key secondary endpoint of progression-free
survival (PFS) in HA-High patients. PEGPH20 plus standard
chemotherapy of ABRAXANE® (nab-paclitaxel) and
gemcitabine improved median PFS by 77 percent over chemotherapy
alone in HA-High patients.
Dr. Andrew Hendifar, the medical
oncology lead for the Gastrointestinal Disease Research Group at
Cedars-Sinai and co-director of Pancreas Oncology delivered the
presentation, "PEGPH20 Improves PFS in Patients With Metastatic
Pancreatic Ductal Adenocarcinoma: A Randomized Phase 2 Study in
Combination With nab-Paclitaxel/Gemcitabine."
Dr. Andrea Bullock, attending
physician in Gastrointestinal Oncology at Beth Israel Deaconess
Medical Center and an Instructor in Medicine at Harvard University delivered the presentation,
"Tumor Hyaluronan May Predict Benefit From PEGPH20 When Added to
nab-Paclitaxel/Gemcitabine in Patients With Previously Untreated
Metastatic Pancreatic Ductal Adenocarcinoma (mPDA)."
New safety data reported today show bleeding events were
balanced between the two arms after the introduction of low
molecular weight heparin in stage 2 of the study.
"The results of HALO-202 are encouraging and continue to support
our ongoing HALO-301 phase 3 study in HA-High pancreas cancer
patients," said Dr. Helen Torley,
president and chief executive officer. "HALO-301 is now open for
screening and enrollment at more than 200 centers in over 20
countries."
In addition to the oral presentations, Halozyme and its
investigators are presenting three posters pertaining to the study
of PEGPH20, including:
- Musculoskeletal Adverse Events with PEGPH20 Treatment and
Management in Patients with Previously Untreated Metastatic PDA
(HALO-202), presented by Dr. Bullock;
- Global, Phase 3, Randomized, Double-Blind, Placebo-Controlled
Study of PEGPH20 + nab-Paclitaxel & Gemcitabine in Pts
with Previously Untreated, HA-High, Stage IV PDA (HALO-301),
presented by Dr. E. Von Cutsem, a principal investigator in the
study; and
- A Systematic Review Examining the Relationship Between PFS and
OS Survival In Adults With Untreated Metastatic Pancreatic Cancer,
presented by Halozyme.
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 (pegvorhyaluronidase
alfa)
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.