SAN DIEGO, June 4, 2016 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company
developing novel oncology and drug-delivery therapies, today
announced results from a final analysis of 135 metastatic
pancreatic cancer patients who were treated in Stage One of HALO
109-202, a phase 2 clinical study of its investigational new drug
PEGPH20 in combination with ABRAXANE (nab-paclitaxel) and
gemcitabine (PAG arm) as compared to ABRAXANE and gemcitabine alone
(AG arm).
This final analysis of secondary and exploratory endpoints was
conducted using the Ventana companion diagnostic to retrospectively
identify high levels of hyaluronan (HA). The key results based on a
February 2016 data cut-off showed in
the HA-high patient population:
- Median progression-free survival (PFS) was 9.2 months in the
PAG arm versus 6.0 months in the AG arm, hazard ratio (HR) with a
95 percent confidence interval (CI): 0.46 (0.15, 1.40);
- Overall response rate (ORR) of 50 percent, including one
complete response in the PAG arm versus 33 percent and all partial
responses in the AG arm;
- Median duration of response (DoR) of 8.1 months in the PAG arm
versus 3.7 months in the AG arm;
- The exploratory analysis of median overall survival (OS) was
similar between the treatment arms -- 11.8 months vs. 10.9 months
in the PAG vs. AG arms respectively. Factors potentially having an
impact on these results include less aggressive disease among
patients in the AG arm and a greater than 40 percent
discontinuation rate of PEGPH20 treatment at the time of the
clinical hold, resulting in all patients receiving AG alone in both
arms;
- The rate of thromboembolic (TE) events reduced from 43 percent
to 9 percent in the PAG arm and from 25 percent to 6 percent in the
AG arm with the introduction of prophylaxis with low molecular
weight heparin (enoxaparin) from Stage One to Stage Two of the
study.
"We are encouraged by the positive trends in this final Stage
One dataset, even with PEGPH20 treatment being discontinued for
more than 40 percent of patients in the PAG arm due to the prior
clinical hold," said Dr. Athena
Countouriotis, senior vice president and chief medical
officer. "The safety profile continues to show the benefit of
prophylactic enoxaparin use and the dataset continues to support
our ongoing phase 3 study."
Prior interim analyses were based on patient follow up through
December 2014. Results announced
today include 14 months of additional follow up through
February 2016. Stage One of HALO 202
enrolled a total of 146 patients between May
2013 to July 2014. The study
was placed on clinical hold from April to July 2014 during which time PEGPH20 was
discontinued while patients in both arms continued to receive
treatment with ABRAXANE and gemcitabine alone. Stage Two enrolled a
total of 133 patients as of February
2016 and Halozyme remains blinded to the overall efficacy.
The company projects to report mature PFS and ORR results from
Stage Two late in the fourth quarter.
Dr. Andrea Bullock, attending
physician in Gastrointestinal Oncology at Beth Israel Deaconess
Medical Center and an Instructor in Medicine at Harvard University said: "As one of the highest
enrollers in the HALO 202 study, I am encouraged by the final data
from Stage One in the HA-high patients. While the sample size
remains small, the median PFS and ORR continue to favor the PEGPH20
combination treatment arm compared to the standard of care AG arm.
I look forward to the Stage Two results later this year and to
participating in the phase 3 global study very soon."
Halozyme's ongoing phase 3 study, HALO 301, uses the Ventana
companion diagnostic to prospectively identify HA-high patients and
mirrors the design of the phase 2 study including the current
inclusion/exclusion criteria; 2:1 randomization; and dosing
regimens. This double-blinded placebo-controlled study plans to
enroll a total of 420 patients at approximately 200 centers within
20 countries. The co-primary endpoints are PFS and OS, with a
target hazard ratio of 0.59 for PFS, which is well supported by the
final results from Stage One of HALO 202.
Halozyme is the only oncology biotech targeting HA, 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.
About HALO 301
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 pancreatic
cancer. The trial will be conducted at approximately 200 sites with
two co-primary endpoints of 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.
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, 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 pancreatic 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
and clinical trials (including the potential identification of
HA-High patients for inclusion in such clinical trials using the
companion diagnostic) 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, clinical trials and
the companion diagnostic not producing the results we expect,
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 Annual
Report on Form 10-Q filed with the Securities and Exchange
Commission on May 9, 2016.
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.