The combination of lirilumab and nivolumab
in a Phase I study of advanced solid tumors showed no added
toxicity over nivolumab monotherapy;
Data supports ongoing Phase I cohort
expansion of lirilumab in combination with nivolumab;
Efficacy data will be presented at the
Society for Immunotherapy of Cancer 2016 conference.
Bristol-Myers Squibb Company (NYSE:BMY) and Innate Pharma SA
(Euronext Paris: FR0010331421 – IPH) today announced safety data
for two Phase I studies conducted by Bristol-Myers Squibb, testing
lirilumab in combination with nivolumab or ipilimumab,
respectively, in patients with advanced refractory solid tumors.
Lirilumab is a first-in-class antibody directed against the
inhibitory killer-cell immunoglobulin-like receptors (KIRs)
expressed predominantly on natural killer (NK) cells and some T
cells. It was licensed by Innate to Bristol-Myers Squibb and is
being studied for its potential to complement nivolumab or
ipilimumab, which act on different cell types and via different
mechanisms of action.
The safety profile of the combination of lirilumab and nivolumab
therapy was similar to that of nivolumab monotherapy, with the
exception of an increased frequency of low grade infusion-related
reactions in patients treated with the lirilumab combinations.
These reactions were clinically managed and similar to those seen
with lirilumab alone. In the limited population (22 patients)
studied for the combination of lirilumab and ipilimumab, there did
not appear to be additional safety concerns compared to ipilimumab
monotherapy.
Based on these data, further evaluation of lirilumab in
combination with nivolumab is warranted. Efficacy data from the
lirilumab and nivolumab combination study will be reported
separately.
“We are very pleased by these safety results. They add to an
existing body of data that support our scientific platform
targeting NK receptors and the rationale for the development of
lirilumab, our anti-KIR antibody licensed to Bristol-Myers Squibb,
in various combinations,” said Pierre Dodion, Chief Medical Officer
of Innate Pharma. “We are now looking forward to the efficacy data
that will be presented at the Society for Immunotherapy of Cancer
2016 conference.”
“These studies are part of Bristol-Myers Squibb's ongoing
efforts to explore innovative and complementary combinations of
immunotherapies with the ultimate goal of achieving quality
long-term survival for patients living with different types of
cancer,” said Timothy Reilly, Vice President & Head of Oncology
Early Assets Development at Bristol-Myers Squibb. “The preliminary
safety data of this novel anti-KIR antibody, lirilumab, in
combination with nivolumab or ipilimumab, provide support for this
approach. Through ongoing collaborations and extensive
translational research programs, Bristol-Myers Squibb is working to
develop and understand the next generation of transformational
Immuno-Oncology combinations with the potential to impact the
standard of care in oncology for patients with unmet needs.”
The results were presented by Dr. Neil H. Segal, Memorial
Sloan-Kettering Cancer Center, at the European Society for Medical
Oncology (ESMO) 2016 congress (October 7 – 11, 2016) in Copenhagen,
Denmark, in a poster entitled “Safety of the natural killer (NK)
cell-targeted anti-KIR Antibody, lirilumab (liri), in combination
with nivolumab (nivo) or ipilimumab (ipi) in two phase I studies in
advanced refractory solid tumors” (poster number 1086P).
About the Phase I trial of lirilumab in combination with
nivolumab (anti-PD-1) in solid tumors (CA223-001):
CA223-001 is a Phase I dose escalation and cohort expansion
study of lirilumab in combination with nivolumab in patients with
advanced solid tumors. In this trial, patients received lirilumab
(0.1, 0.3, 1.0, or 3.0 mg/kg) once every 4 weeks and nivolumab
(3 mg/kg) once every 2 weeks, in 8-week treatment cycles for a
maximum of 12 cycles.
The purpose of this Phase I open label study is to determine the
safety of the combination of lirilumab and nivolumab and to explore
the preliminary anti-tumor activity of the combination in patients
with a range of advanced solid tumors.
In the escalation and expansion phases, 159 patients were
treated. No dose-limiting toxicities (DLTs) were reported with
lirilumab and nivolumab treatment. The overall rate of
treatment-related adverse events (TRAEs) was reported as 71.7
percent (114/159) and the rate of Grade 1-2 TRAEs was 56.6 percent
(90/159), with the most common being fatigue (20.8 percent),
pruritus (18.9 percent), and infusion-related reaction (17.6
percent). The rate of Grade 3-4 TRAEs was 15.1 percent (24/159).
Discontinuations due to TRAEs occurred in 7.5 percent
(12/159), with only treatment related pneumonitis (3/159; Grade 2)
and diarrhea (2/159; Grade 2) occurring in more than one
patient.
About the Phase I trial of lirilumab in combination with
ipilimumab (anti-CTLA4) in solid tumors (CA223-002):
CA223-002 was a Phase I dose escalation and cohort expansion
study of lirilumab in combination with ipilimumab in patients with
advanced solid tumors. In this trial, patients received lirilumab
(0.1, 0.3, 1.0, or 3.0 mg/kg) + ipilimumab (3 mg/kg) once every 3
weeks for 4 doses (induction phase) and then every 12 weeks
for 4 doses (maintenance phase).
The purpose of this Phase I open label study was to determine
the safety of the combination of lirilumab and ipilimumab and to
provide preliminary information on the anti-tumor activity of the
combination.
The study enrolled 22 patients. The overall rate of
treatment-related adverse events (TRAEs) was reported as 68.2
percent (15/22) and the rate of Grade 1-2 TRAEs was 59.1 percent
(13/22), with fatigue (27.3 percent) and diarrhea (22.7 percent)
being the most common. The rate of Grade 3-4 TRAEs was 9.1 percent
(2/22) and included erythematous rash and pruritus (1/22) and
hypopituitarism (1/22). This study is complete and the combination
of lirilumab with ipilimumab is no longer being evaluated.
Poster details:
Category: Immunotherapy of cancerPoster:
1086PDate: Sunday, October 9, 2016Presentation
Time: 1:00 - 2:00 p.m.Location: Bella Center, Hall E,
CopenhagenPresenter: Dr. Neil H. Segal, Memorial
Sloan-Kettering Cancer Center
About lirilumab (IPH2102/BMS-986015):
Lirilumab is a fully human monoclonal antibody that is designed
to act as a checkpoint inhibitor by blocking the interaction
between KIR2DL-1,-2,-3 inhibitory receptors and their ligands.
Blocking these receptors facilitates activation of NK cells and,
potentially some subsets of T cells, ultimately leading to
destruction of tumor cells.
Lirilumab is licensed to Bristol-Myers Squibb Company. As part
of the agreement with Innate Pharma, Bristol-Myers Squibb holds
exclusive worldwide rights to develop, manufacture and
commercialize lirilumab and related compounds blocking KIR
receptors, for all indications. Under the agreement, Innate Pharma
conducts the development of lirilumab through Phase II in acute
myeloid leukemia (“AML”).
Innate is currently testing lirilumab in a randomized,
double-blind, placebo-controlled Phase II trial as maintenance
treatment in elderly patients with AML in first complete remission
(“EffiKIR” trial). In addition, lirilumab is also being evaluated
by Bristol-Myers Squibb in clinical trials in combination with
other agents in a variety of tumor types.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines
that help patients prevail over serious diseases. For more
information about Bristol-Myers Squibb, visit us at BMS.com or
follow us on LinkedIn, Twitter, YouTube and Facebook.
Bristol-Myers Squibb: At the Forefront of Immuno-Oncology
Science & Innovation
At Bristol-Myers Squibb, patients are at the center of
everything we do. Our vision for the future of cancer care is
focused on researching and developing transformational
Immuno-Oncology (I-O) medicines that will raise survival
expectations in hard-to-treat cancers and will change the way
patients live with cancer.
We are leading the scientific understanding of I-O through our
extensive portfolio of investigational and approved agents,
including the first combination of two I-O agents in metastatic
melanoma, and our differentiated clinical development program,
which is studying broad patient populations across more than 20
types of cancers with 11 clinical-stage molecules designed to
target different immune system pathways. Our deep expertise and
innovative clinical trial designs uniquely position us to advance
the science of combinations across multiple tumors and potentially
deliver the next wave of I-O combination regimens with a sense of
urgency. We also continue to pioneer research that will help
facilitate a deeper understanding of the role of immune biomarkers
and inform which patients will benefit most from I-O therapies.
We understand making the promise of I-O a reality for the many
patients who may benefit from these therapies requires not only
innovation on our part but also close collaboration with leading
experts in the field. Our partnerships with academia, government,
advocacy and biotech companies support our collective goal of
providing new treatment options to advance the standards of
clinical practice.
Bristol-Myers Squibb Forward Looking Statement
This press release contains "forward-looking statements" as that
term is defined in the Private Securities Litigation Reform Act of
1995 regarding the research, development and commercialization of
pharmaceutical products. Such forward-looking statements are based
on current expectations and involve inherent risks and
uncertainties, including factors that could delay, divert or change
any of them, and could cause actual outcomes and results to differ
materially from current expectations. Among other risks, there can
be no guarantee that lirilumab either as a monotherapy or in
combination with nivolumab or ipilimumab will receive regulatory
approval for the treatment of cancer. No forward-looking statement
can be guaranteed. Forward-looking statements in this press release
should be evaluated together with the many uncertainties that
affect Bristol-Myers Squibb's business, particularly those
identified in the cautionary factors discussion in Bristol-Myers
Squibb's Annual Report on Form 10-K for the year ended December 31,
2015 in our Quarterly Reports on Form 10-Q and our Current Reports
on Form 8-K. Bristol-Myers Squibb undertakes no obligation to
publicly update any forward-looking statement, whether as a result
of new information, future events or otherwise.
About Innate Pharma
Innate Pharma S.A. is a clinical-stage biotechnology company
with a focus on discovering and developing first-in-class
therapeutic antibodies that harness the innate immune system to
improve cancer treatment and clinical outcomes for patients.
Innate Pharma specializes in immuno-oncology, a new therapeutic
field that is changing cancer treatment by mobilizing the power of
the body’s immune system to recognize and kill cancer cells.
The Company’s aim is to become a commercial stage
biopharmaceutical company in the area of immunotherapy and focused
on serious unmet medical needs in cancer. Innate Pharma has
pioneered the discovery and development of checkpoint inhibitors to
activate the innate immune system. Innate Pharma's innovative
approach has resulted in three first-in-class, clinical-stage
antibodies targeting natural killer cell receptors that may address
a broad range of solid and hematological cancer indications as well
as additional preclinical product candidates and technologies.
Targeting receptors involved in innate immunity also creates
opportunities for the Company to develop therapies for inflammatory
diseases.
The Company's expertise and understanding of natural killer cell
biology have enabled it to enter into major alliances with leaders
in the biopharmaceutical industry including AstraZeneca,
Bristol-Myers Squibb, Novo Nordisk A/S and Sanofi.
Based in Marseille, France, Innate Pharma has more than 130
employees and is listed on Euronext Paris.
Learn more about Innate Pharma at www.innate-pharma.com.
About Innate Pharma shares:ISIN code
FR0010331421Ticker code IPH
Innate Pharma Forward-Looking Statements:
This press release contains certain forward-looking statements.
Although the company believes its expectations are based on
reasonable assumptions, these forward-looking statements are
subject to numerous risks and uncertainties, which could cause
actual results to differ materially from those anticipated. For a
discussion of risks and uncertainties which could cause the
company's actual results, financial condition, performance or
achievements to differ from those contained in the forward-looking
statements, please refer to the Risk Factors (“Facteurs de Risque")
section of the Document de Reference prospectus filed with the AMF,
which is available on the AMF website (http://www.amf-france.org)
or on Innate Pharma’s website.
This press release and the information contained herein do not
constitute an offer to sell or a solicitation of an offer to buy or
subscribe to shares in Innate Pharma in any country.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20161009005024/en/
Bristol-Myers SquibbInvestors:Tim Power,
609-252-7509timothy.power@bms.comorBill Szablewski,
609-252-5894william.szablewski@bms.comorMedia:Sarah Koenig,
609-252-4145sarah.koenig@bms.comorInnate
PharmaInvestors:Laure-Hélène Mercier, +33 (0)4 30 30 30
87investors@innate-pharma.comorMedia:ATCG Press
(France)Marie Puvieux, +33 (0)6 10 54 36
72presse@atcg-partners.comorConsilium Strategic Communications
(ROW)Mary-Jane Elliott / Sue Stuart / Jessica Hodgson / Hendrik
Thys, +44 (0)20 3709 5700InnatePharma@consilium-comms.com
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