SAN DIEGO, May 31, 2015 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company
developing novel oncology and drug-delivery therapies, today
announced interim findings from the ongoing phase 2 clinical study
of its investigational new drug PEGPH20 for the potential treatment
of patients with metastatic pancreatic cancer.
The encouraging interim data was presented today at the American
Society of Clinical Oncology annual meeting in an oral presentation
by Principal Investigator Sunil
Hingorani, M.D., Ph.D., Associate Member of the Fred
Hutchinson Cancer Research Center and Associate Professor at
University of Washington School of
Medicine.
The trial included 135 treated patients in stage 1, of whom a
total of 44 patients -- 23 receiving PEGPH20 in combination
with ABRAXANE® and gemcitabine (PAG treatment
arm) and 21 receiving ABRAXANE and gemcitabine
alone (AG treatment arm) -- had available biopsies that were
determined in a retrospective analysis to have high levels of
hyaluronan (HA). PEGPH20 targets HA to help improve cancer
therapy access to tumor cells. Results reported
include:
- A more than doubling of median progression-free survival of 9.2
months versus 4.3 months in high HA patients treated with PAG vs.
AG (hazard ratio of 0.39; p-value of 0.05);
- A more than doubling of overall response rate of 52 percent
versus 24 percent (p-value of 0.038) and a duration of response of
8.1 months compared to 3.7 months in high HA patients treated with
PAG versus AG;
- In the 30 high HA patients (15 PAG treatment arm versus 15 AG
treatment arm) who were evaluated for response prior to the
April 2014 clinical hold and
subsequent PEGPH20 treatment discontinuation, the overall response
rate was 73 percent versus 27 percent (p-value of 0.01),
respectively, consistent with findings presented in January;
- A trend toward improvement in median overall survival of 12
months compared to 9 months in high HA patients treated with PAG
versus AG (hazard ratio of 0.62) despite discontinuation of PEGPH20
in more than half of the PAG-treated patients at the time of the
clinical hold in April 2014.
Data was also presented on the rate of thromboembolic (TE)
events in 55 patients treated in stage 2 of the trial, which is
currently randomizing patients at a 2:1 ratio of PAG versus AG.
Stage 2 began after a protocol amendment in July 2014, excluding patients at high risk of TE
events and adding prophylaxis with low molecular weight heparin
(enoxaparin) to all patients in both treatment arms. Reported
results included:
- A TE event rate of 13 percent in 38 patients treated with PAG
versus 18 percent in 17 patients receiving AG;
- In the 20 PAG patients receiving 1 mg/kg/day of enoxaparin, no
TE events have been reported to date.
"The interim results from the ongoing study are very
encouraging," said Dr. Hingorani. "We have a high unmet need in
pancreas cancer and the trend we observed toward longer survival
rates and the slowing of disease progression are noteworthy in a
cancer that has seen very few therapeutic developments in the past
several years."
"We remain very encouraged by the interim data presented today
from our ongoing phase 2 study, including the positive trend in
overall survival, and we continue to plan for the first-quarter
2016 initiation of our phase 3 study," said Dr. Athena Countouriotis, senior vice president and
chief medical officer.
HA is a glycosaminoglycan – or chain of natural sugars
throughout the body – that can accumulate around cancer cells
inhibiting other therapies. PEGPH20 is designed to degrade HA to
improve the access to tumor cells for chemotherapy, monoclonal
antibodies and other immuno-therapy agents.
Halozyme previously announced it plans to proceed in Q1 2016
with a phase 3 clinical study (Study 301) of PEGPH20 in patients
with metastatic pancreatic cancer, using a design allowing for
potential marketing application based on either progression-free
survival or overall survival. The use of progression-free
survival as the basis for marketing approval will be subject to the
overall benefit and risk profile associated with PEGPH20 combined
with ABRAXANE and gemcitabine therapy, including the:
- Magnitude of the progression-free survival treatment effect
observed;
- Toxicity profile; and
- Interim overall survival data.
About Study 202
Study 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 pancreatic 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 will assess the
thromboembolic event rate in the PEGPH20 treatment arm. Secondary
endpoints also include objective response rate and overall
survival. More information may be found at:
http://oncologytrials.halozyme.com/pancreatic/
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.
FDA granted orphan drug designation to PEGPH20 for treatment of
pancreatic cancer and fast track for PEGPH20 in combination with
gemcitabine and nab-paclitaxel for the treatment of metastatic
pancreatic 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 pancreatic
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, an investigational drug
PEGPH20, applies a unique approach to targeting solid tumors,
allowing increased access of co-administered cancer drug therapies
to the tumor. PEGPH20 is currently in development for
metastatic pancreatic cancer and non-small cell lung cancer and has
potential across additional cancers in combination with different
types of therapies. In addition to its proprietary product
portfolio, Halozyme has established value-driving partnerships with
leading pharmaceutical companies including Roche, Pfizer, Janssen
and Baxter for its drug delivery
platform, ENHANZE™, which enables biologics and small molecule
compounds that are currently administered intravenously to be
delivered subcutaneously. 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
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on May 11,
2015.
Contacts:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com
Jim Mazzola
Halozyme Therapeutics
858-704-8122
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.