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
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
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.
Category: Immunotherapy of cancer
October 9, 2016
Presentation Time: 1:00 - 2:00 p.m.
Bella Center, Hall E, Copenhagen
Presenter: 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
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,
Bristol-Myers Squibb: At the Forefront of Immuno-Oncology Science &
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
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
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:
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.
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