ChemoCentryx Reports Initial Results from Ongoing Phase Ib Clinical Trial of CCX872 in Patients with Advanced Pancreatic Canc...
September 01 2016 - 4:05PM
ChemoCentryx, Inc., (Nasdaq:CCXI) today announced initial 12 week
overall response rate (ORR) results from an ongoing open label,
single arm Phase Ib clinical trial with CCX872 in patients with
advanced pancreatic cancer. CCX872 is a selective inhibitor of the
chemokine receptor known as CCR2.
The ongoing Phase Ib clinical study aims to evaluate the safety
and effects of orally administered CCX872 when added to standard of
care FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan and
oxaliplatin) in patients with advanced non-resectable pancreatic
cancer. 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. The Company expects to report
progression-free survival (PFS) by the end of 2016.
Patients enrolled in the study 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. In order to assess the initial
treatment effect of CCX872, the study provided for assessment of
overall response rate (ORR) based on computerized tomography (CT)
imaging following 12 weeks of treatment.
The pre-specified evaluable ORR population consists of all
patients who have at least one post-baseline disease CT assessment.
Response rate results at 12 weeks of treatment were as follows:
|
Pre-Specified Evaluable Patient Population1 (N=41) |
ITT Patient Population (N=50) |
Tumor control rate2 |
32/41 (78%) |
32/50 (64%) |
Overall response rate3 |
15/41 (37%) |
15/50 (30%) |
Stable disease |
17/41 (41%) |
17/50 (34%) |
Progressive disease |
9/41 (22%) |
9/50 (18%) |
Not evaluable4 |
|
9/50 (18%) |
1 Pre-specified as the primary efficacy population =
pre-defined as all patients who have a least one post baseline CT
scan. ITT = all patients randomized, including those with no post
baseline CT scan. 2 Tumor control rate includes stable
disease, partial response and complete response.3 Overall
response rate measured by Response Evaluation Criteria for Solid
Tumors version 1.1 (RECIST 1.1). All responses included in ORR
were partial responses (PRs).4 Not evaluable due to no
post baseline CT scan due to early withdrawal.
CCX872 was well tolerated by advanced pancreatic cancer
patients. The incidence and rate of adverse events were consistent
with data reported historically for FOLFIRINOX alone, suggesting no
apparent additional safety burdens of combining CCX872 with
FOLFIRINOX.
“Advanced pancreatic cancer is particularly challenging to
treat, and represents a very high unmet medical need,” said Pirow
Bekker, M.D., Ph.D., Chief Medical Officer of ChemoCentryx. “While
some earlier work with this mechanism looked at non-metastatic
pancreatic cancer patients, we were keen on examining the effects
of CCR2 inhibition in non-operable, metastatic disease in a
multi-center setting. Given patients in our study may continue to
receive treatment with CCX872 for as long as they are in a
progression-free state, we will continue the study according to
plan and evaluate progression-free survival later this year. Those
data, as well as the potential longer term survival beyond that
time, will help us in determining how best to proceed with CCR2
inhibition for pancreatic cancer.”
About CCX872 Phase Ib Trial DesignThe
open-label, multi-center, ongoing Phase Ib clinical trial is
designed to evaluate the safety and efficacy of orally administered
CCX872 plus FOLFIRINOX in 50 patients with non-resectable
pancreatic cancer. Patients receive 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), are eligible to continue on study for at
least an additional 12 weeks unless disease progression occurs. Per
protocol, the Eastern Cooperative Oncology Group (ECOG) performance
status of patients in the trial is 0, 1 or 2. The primary efficacy
measurement of the trial is progression-free survival (PFS)
following at least 24 weeks of treatment.
About Pancreatic CancerIt is estimated that
over 337,000 cases of pancreatic cancer are diagnosed worldwide
every year. In the United States, the annual incidence of
pancreatic cancer is approximately 45,000; 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 ChemoCentryxChemoCentryx, Inc. is a
clinical-stage biopharmaceutical company focused on discovering,
developing and commercializing orally-administered therapeutics
that target the chemokine and chemoattractant systems in order to
treat autoimmune diseases, inflammatory disorders and cancer. The
chemokine system is a biological network that regulates
inflammation via a collection of secreted chemokine molecules, or
ligands, and their specific cell surface receptors. Based on its
proprietary drug discovery and drug development platform,
ChemoCentryx has generated multiple clinical and preclinical-stage
programs, each targeting distinct chemokine and chemoattractant
receptors with different small molecule compounds. CCX168, a C5aR
inhibitor, is in Phase II development for the treatment of
anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV).
CCX168 appears to be safe, well tolerated and successful in
allowing reduction and elimination of high-dose steroids, part of
standard of care for AAV patients, without compromising efficacy or
safety in clinical studies to date. CCX168 is also in Phase II
studies for the treatment of atypical hemolytic uremic syndrome
(aHUS) and immunoglobulin A nephropathy, or IgA nephropathy (IgAN).
ChemoCentryx has licensed exclusive rights to Vifor Pharma to
commercialize CCX168 in Europe and certain other markets outside of
the U.S. and most of Asia. CCX872, a CCR2 inhibitor, successfully
completed Phase I development and is in development for the
treatment of non-resectable pancreatic cancer. CCX140, a distinct
CCR2 inhibitor, successfully completed a Phase II clinical trial
where it was shown to be safe and well tolerated while
demonstrating statistically significant improvement in albuminuria
in patients with diabetic nephropathy. Other clinical programs
include CCX507, a next generation CCR9 inhibitor, which has
successfully completed Phase I development, vercirnon (also known
as Traficet-EN or CCX282) a specific CCR9 inhibitor for the
treatment of inflammatory bowel disease, and CCX354, a CCR1
inhibitor which successfully completed a Phase II clinical trial
for the treatment of rheumatoid arthritis. ChemoCentryx also has
several programs in advanced preclinical development.
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 the timing of additional
data including progression-free survival results from the ongoing
Phase Ib clinical trial with CCX872 in patients with advanced
pancreatic cancer. 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
Senior Vice President, Finance and Chief Financial 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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