Infinity
Pharmaceuticals, Inc. (NASDAQ:INFI) today announced new clinical
data for duvelisib
(IPI-145), an oral, dual inhibitor of phosphoinositide-3-kinase
(PI3K)-delta and PI3K-gamma in patients with treatment-naïve chronic
lymphocytic leukemia (CLL), a potentially fatal hematologic malignancy
(blood cancer). Data from the Phase 1 study showed that duvelisib was
highly active in this patient population cohort, with an overall
response rate of 88 percent as defined by the International Workshop on
Chronic Lymphocytic Leukemia (iwCLL) criteria, including 15 partial
responses among 17 efficacy evaluable patients. These data will be
presented at the 2015 Annual Meeting of the American Society of Clinical
Oncology (ASCO) in Chicago, Ill. on Sunday, May 31, 2015.
“It is encouraging to see such a high monotherapy response rate reported
in treatment-naïve patients with chronic lymphocytic leukemia, the
majority of whom in this study were identified as high-risk and with a
less favorable prognosis,” commented Manish R. Patel, MD, Florida Cancer
Specialists/Sarah Cannon Research Institute and an investigator for the
trial. “These data support further evaluating duvelisib as a front-line
treatment option for patients with CLL, including novel combinations
with other emerging targeted treatments.”
Today Infinity also announced new translational data demonstrating that
treatment with duvelisib resulted in a decrease in key mediators known
to be involved in the communication between CLL cells and the tumor
microenvironment. These data further support the investigation of dual
inhibition of PI3K-delta and PI3K-gamma with duvelisib as a therapeutic
strategy for the treatment of CLL.
Clinical Data for Duvelisib in Treatment-Naïve CLL Patients (Abstract
#7074)
New clinical data from the Phase 1 study of duvelisib will be reported
at ASCO 2015 on Sunday, May 31, from 8:00 a.m. – 11:30 a.m. CDT (9:00
a.m. – 12:30 p.m. EDT) in a poster presentation, “Early clinical
activity and pharmacodynamic effects of duvelisib, a PI3K-δ,γ inhibitor,
in patients with treatment-naïve CLL.” The study included 18
treatment-naïve CLL patients, with 17 evaluable for response who
received duvelisib dosed at 25 mg dose twice daily (BID), which is the
dose being administered in ongoing registration studies. All patients in
this study were age 65 or over or high-risk, defined as having 17p
deletions or p53 mutations. Patients with CLL with 17p deletions or p53
mutations generally have a poor response to chemotherapy and worse
prognosis.1
Data showed that duvelisib is clinically active in patients with
treatment-naïve CLL, with an 88 percent overall response rate (15
partial responses out of 17 evaluable patients) as defined by the iwCLL
criteria. Additionally, two patients exhibited stable disease. The
median time to response was 3.7 months. The median progression free
survival (PFS) and median overall survival (OS) have not yet been
reached, with a 92 percent PFS rate and 94 percent OS rate at 18 months.
The majority of adverse events were grade 1 or grade 2 and clinically
manageable. The most common grade 3 side effects among the 18 enrolled
patients were diarrhea (22 percent, 4 patients), increases in alanine
aminotransferase (ALT) and aspartate aminotransferase (AST) (17 percent,
3 patients), and rash (11 percent, 2 patients). Twenty-eight percent (5
patients) had grade 4 neutropenia or decreases in neutrophil count.
There were no grade 4 events of diarrhea, increases in ALT/AST or rash.
Six patients discontinued treatment due to an adverse event.
Research also showed that duvelisib treatment inhibited the PI3K pathway
and CLL cell proliferation in treatment-naïve CLL patients, and also
reduced serum levels of chemokines and cytokines produced by both CLL
cells and the tumor microenvironment. Taken together, these Phase 1
clinical and translational data support further development of duvelisib
in treatment-naïve CLL, including combination studies with other
targeted therapies.
New Translational CLL Data from the Phase 1 Study of Duvelisib
(Abstract #7072)
New translational data will be reported at ASCO 2015 on Sunday, May 31,
from 8:00 a.m. – 11:30 a.m. CDT in a poster presentation, “Serum
chemokines and cytokines in CLL patients treated with duvelisib, a
PI3K-delta,gamma inhibitor.”
Data from translational studies demonstrated that in patients with
relapsed/refractory CLL, treatment with duvelisib resulted in a decrease
in key chemokines and cytokines known to be involved in the
communication between CLL cells and the tumor microenvironment,
including stromal cells, T-cells and myeloid cells. This research
provides further insight into the mechanism by which duvelisib disrupts
communication between the tumor cells and the supporting
microenvironment in CLL and supports the development of duvelisib for
the treatment of CLL.
Additional Duvelisib Presentations at ASCO 2015
In total, four duvelisib presentations will take place on Sunday, May
31, 2015, during a poster session from 8:00 a.m. to 11:30 a.m. CDT in
South Hall A at McCormick Place. In addition to the clinical and
translational data reported today, duvelisib presentations at ASCO 2015
will include the following:
-
Preclinical data for duvelisib demonstrating synergy with
standards-of-care and emerging targeted therapeutics in development
for hematologic malignancies, including duvelisib in combination with
venetoclax (Abstract #8559)
-
A “trials in progress” poster highlighting SYNCHRONY, a Phase 1b study
of duvelisib in CLL patients whose disease is refractory to or has
relapsed while receiving a BTK inhibitor (Abstract # TPS7100)
About Duvelisib
Duvelisib is an investigational, oral, dual inhibitor of
phosophoinositide-3-kinase (PI3K)-delta and PI3K-gamma that is being
jointly developed by Infinity Pharmaceuticals, Inc. and AbbVie Inc. in
oncology. The PI3K pathway is known to play a critical role in
regulating the growth and survival of certain types of blood cancers.
Duvelisib is designed to block the growth and survival of tumor cells by
inhibiting PI3K-delta and PI3K-gamma signaling.
Duvelisib is being evaluated in registration-focused studies, including
DYNAMOTM, a Phase 2 study in patients with refractory
indolent non-Hodgkin lymphoma, DYNAMO+R, a Phase 3 study in patients
with previously treated follicular lymphoma, and DUOTM, a
Phase 3 study in patients with relapsed/refractory chronic lymphocytic
leukemia. Duvelisib is also being evaluated in CONTEMPO, a Phase 1b/2
study in treatment-naïve patients with follicular lymphoma and
SYNCHRONY, a Phase 1b study in CLL patients whose disease is refractory
to or has relapsed while receiving a BTK inhibitor.
Duvelisib is an investigational compound and its safety and efficacy
have not been evaluated by the U.S. Food and Drug Administration or any
other health authority.
About Infinity Pharmaceuticals, Inc.
Infinity is an innovative biopharmaceutical company dedicated to
discovering, developing and delivering best-in-class medicines to people
with difficult-to-treat diseases. Infinity combines proven scientific
expertise with a passion for developing novel small molecule drugs that
target emerging disease pathways. For more information on Infinity,
please refer to the company’s website at www.infi.com.
Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995. Such
forward-looking statements include those regarding the Company’s
expectations about: the presentation of clinical, preclinical and
translational data; and the therapeutic potential of PI3K- delta, gamma
inhibition and of duvelisib, alone or in combination with other agents.
Such statements are subject to numerous important factors, risks and
uncertainties that may cause actual events or results to differ
materially from the company’s current expectations. For example, there
can be no guarantee that Infinity will report data in the time frames it
has estimated, that any product candidate Infinity is developing will
successfully complete necessary preclinical and clinical development
phases, or that development of any of Infinity’s product candidates will
continue. Further, there can be no guarantee that Infinity’s strategic
collaboration with AbbVie will continue or that any positive
developments in Infinity’s product portfolio will result in stock price
appreciation. Management’s expectations and, therefore, any
forward-looking statements in this press release could also be affected
by risks and uncertainties relating to a number of other factors,
including the following: Infinity’s results of clinical trials and
preclinical studies, including subsequent analysis of existing data and
new data received from ongoing and future studies; a failure of Infinity
and/or AbbVie to fully perform under the strategic collaboration and/or
an early termination of the collaboration and license agreement; the
content and timing of decisions made by the U.S. FDA and other
regulatory authorities, investigational review boards at clinical trial
sites and publication review bodies; Infinity’s ability to obtain and
maintain requisite regulatory approvals and to enroll patients in its
clinical trials; unplanned cash requirements and expenditures;
development of agents by Infinity’s competitors for diseases in which
Infinity is currently developing or intends to develop its product
candidates; and Infinity’s ability to obtain, maintain and enforce
patent and other intellectual property protection for any product
candidates it is developing. These and other risks which may impact
management’s expectations are described in greater detail under the
caption “Risk Factors” included in Infinity’s quarterly report on Form
10-Q filed with the Securities and Exchange Commission (SEC) on May 6,
2015, and other filings filed by Infinity with the SEC. Any
forward-looking statements contained in this press release speak only as
of the date hereof, and Infinity expressly disclaims any obligation to
update any forward-looking statements, whether as a result of new
information, future events or otherwise.
1 Grever et al. (2007) Comprehensive assessment of genetic
and molecular features predicting outcome in patients with chronic
lymphocytic leukemia: Results from the US intergroup phase III trial
E2997. J Clin Oncol 25:799-804.
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