ChemoCentryx Announces Presentation of Data from Ongoing Phase Ib Clinical Trial of CCR2 Inhibitor CCX872 in Patients with Ad...
January 20 2017 - 3:30PM
ChemoCentryx, Inc., (Nasdaq:CCXI) today announced the presentation
of results from its immuno-oncology program at the American Society
of Clinical Oncology (ASCO) 2017 Gastrointestinal Cancers Symposium
being held January 19-21, 2017 in San Francisco, California.
The presentation highlights results from a continuing
open-label, single-arm Phase Ib clinical trial of CCX872 when added
to standard of care FOLFIRINOX (5-fluorouracil, leucovorin,
irinotecan and oxaliplatin) in patients with advanced
non-resectable pancreatic cancer. CCX872 is a selective inhibitor
of the chemokine receptor known as CCR2.
The primary efficacy measurement of the trial is
progression-free survival (PFS) following 24 weeks of treatment.
The pre-specified evaluable primary analysis population consisted
of patients who had at least one post-baseline disease computerized
tomography (CT) assessment. All patients enrolled in the trial had
advanced non-resectable pancreatic cancer (78% of patients having
metastatic disease), and an Eastern Cooperative Oncology Group
(ECOG) Performance Status score of less than or equal to 2. Under
the study protocol, patients may continue to receive CCX872 for an
indefinite treatment period as long as there is no evidence of
disease progression. Accordingly, 48 week overall survival data is
also reported.
The results are presented in a poster entitled, “Orally
Administered CCR2 Selective Inhibitor CCX872-B Clinical Trial in
Pancreatic Cancer” (Abstract #276, January 20, 12:30 to 2:00 p.m.
PT, Poster Session B: Cancers of the Pancreas, Small Bowel and
Hepatobiliary Tract)
Data reported for CCR2 inhibitor CCX872 in combination with
FOLFIRINOX are as follows:
- PFS rate was 57% at week 24 in the primary analysis population;
median PFS was 179 days
- Overall survival rate was 52% at week 48 in the primary
analysis population; median survival time was 11.5 months
- The longest ongoing CCX872 treatment period for a patient in
the study to date is 73 weeks (and continuing)
CCX872 has been well tolerated in the clinical trial. There is
no apparent additional safety burden of combining CCX872 with
FOLFIRINOX, as evidenced by an incidence and rate of adverse events
in the trial to date which is consistent with data reported
historically for FOLFIRINOX on its own.
In preclinical and clinical studies, inhibition of CCR2 in
pancreatic cancer has shown to decrease tumor progression by
blocking recruitment and accumulation of monocytes or macrophages
that are thought to have an immune suppressive character in the
tumor microenvironment. The Company is also examining current
immunotherapy practices using model systems with so-called
checkpoint inhibitors (such as anti-PD-1 or PD-L1) combined with
chemokine receptor inhibitors including CX872. While it is known
that checkpoint inhibitors on their own lack efficacy in
immune-insensitive cancers (including pancreatic cancer), the
Company has demonstrated that the inhibition of CCR2 potentiates
anti-PD-1/PD-L1 immunotherapy in preclinical models of pancreatic
cancer. The Company plans to further investigate CCX872 in
combination with a checkpoint inhibitor.
“It is encouraging that a large percentage of patients with the
notoriously challenging disease of pancreatic cancer are still
alive in this ongoing study,” said Pirow Bekker, M.D., Ph.D., and
Chief Medical Officer of ChemoCentryx. “Given that all patients in
our study had non-operable disease, the large majority of whom were
also metastatic, we believe that any improvement in overall
survival is an important advancement for this patient population.
We will continue to follow these patients, and we look forward to
the 18-month survival analysis later this year. Additionally, we
are keen to further evaluate CCX872 in combination with a
checkpoint inhibitor.”
CCX872 Phase Ib Trial DesignThe open-label,
multi-center, Phase Ib clinical trial was designed to evaluate the
safety and efficacy of orally administered CCX872 plus FOLFIRINOX
in 50 patients with advanced non-resectable pancreatic cancer.
Patients received 150 mg CCX872 twice daily for 12 weeks. After 12
weeks, patients who achieved stable disease or better (as measured
by Response Evaluation Criteria In Solid Tumors, or RECIST 1.1)
were eligible to continue on study for at least an additional 12
weeks unless disease progression occurred. Per protocol, the
Eastern Cooperative Oncology Group (ECOG) performance status of
patients in the trial was 0, 1 or 2. The primary efficacy
measurement of the trial was progression-free survival (PFS)
following at least 24 weeks of treatment.
About Pancreatic Cancer It is estimated that
over 337,000 cases of pancreatic cancer are diagnosed worldwide
every year. In the United States in 2016, the incidence of
pancreatic cancer was approximately 53,000 people; prevalence is
only negligibly higher owing to the poor survival rates on current
therapy. Within five years of diagnosis, 93 percent of patients die
from their disease. Current standards of care include
chemotherapeutic regimens that have significant toxicities and, in
a minority of cases, surgical resection.
About ChemoCentryx ChemoCentryx is a
clinical-stage biopharmaceutical company primarily focused on
developing new medicines for patients with rare renal diseases.
ChemoCentryx targets the chemokine and chemoattractant systems to
discover, develop and commercialize orally-administered therapies
to treat orphan and rare diseases. Avacopan (CCX168), an inhibitor
of the complement 5a receptor (C5aR), is in Phase III development
for the treatment of anti-neutrophil cytoplasmic
auto-antibody-associated vasculitis (AAV). Avacopan was safe, well
tolerated and successful in allowing reduction and elimination of
high-dose steroids, part of standard of care for AAV patients,
while providing effective control of the disease in clinical
studies to date. Avacopan is also being developed in patients with
atypical hemolytic uremic syndrome (aHUS) and C3 glomerulopathy
(C3G). CCX140, an inhibitor of the chemokine receptor known as
CCR2, successfully completed a Phase II clinical trial where it was
shown to be safe and well tolerated while demonstrating
statistically significant improvement in proteinuria in patients
with diabetic nephropathy and is currently being developed in a
rare kidney disease known as focal segmental glomerulosclerosis
(FSGS). Both avacopan and CCX140 are part of a Vifor
Pharma-ChemoCentryx Kidney Health Alliance which provides Vifor
Pharma with exclusive rights to commercialize avacopan and CCX140
in certain markets outside of the U.S. ChemoCentryx has an
immuno-oncology program, which includes a distinct CCR2 inhibitor,
CCX872, currently in development for the treatment of advanced
non-resectable pancreatic cancer.
Forward-Looking
StatementsChemoCentryx cautions that statements
included in this press release that are not a description of
historical facts are forward-looking statements. Words such as
"may," "could," "will," "would," "should," "expect," "plan,"
"anticipate," "believe," "estimate," "intend," "predict," "seek,"
"contemplate," "potential," "continue" or "project" or the negative
of these terms or other comparable terminology are intended to
identify forward-looking statements. These statements include the
Company's statements regarding whether CCX872 will be shown to be
effective in ongoing or future clinical trials in the treatment of
advanced non-resectable pancreatic cancer and whether CCX872 will
be further developed in combination with a checkpoint inhibitor.
The inclusion of forward-looking statements should not be regarded
as a representation by ChemoCentryx that any of its plans
will be achieved. Actual results may differ from those set forth in
this release due to the risks and uncertainties inherent in
the ChemoCentryx business and other risks described in
the Company's filings with the Securities and Exchange
Commission ("SEC"). Investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof, and ChemoCentryx undertakes no
obligation to revise or update this news release to reflect events
or circumstances after the date hereof. Further information
regarding these and other risks is included under the heading "Risk
Factors" in ChemoCentryx's periodic reports filed with
the SEC, including ChemoCentryx's Annual Report on Form 10-K
filed with the SEC March 14, 2016 and its other
reports which are available from the SEC's website
(www.sec.gov) and on ChemoCentryx's website
(www.chemocentryx.com) under the heading "Investors." All
forward-looking statements are qualified in their entirety by this
cautionary statement. This caution is made under the safe harbor
provisions of Section 21E of the Private Securities Litigation
Reform Act of 1995.
CCXI-G
Contacts:
Susan M. Kanaya
Executive Vice President, Finance and Chief Financial and Administrative Officer
investor@chemocentryx.com
Media:
Denise Powell
denise@redhousecomms.com
510.703.9491
Investors:
Steve Klass
Burns McClellan
212.213.0006
sklass@burnsmc.com
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