Preliminary Phase 1/2 Efficacy Data of Lirilumab in Combination with Opdivo (Nivolumab) in Patients With Advanced Platinum Refractory Squamous Cell Carcinoma of the Head and Neck to be presented during SITC meeting
MARSEILLE, France, Nov. 08, 2016 (GLOBE NEWSWIRE) -- Innate Pharma SA (the "Company" - Euronext Paris: FR0010331421 - IPH) today announces the publication of the late-breaking abstract on an interim efficacy analysis from a Phase 1/2 study of the combination of lirilumab and Opdivo (nivolumab) in the cohort of advanced platinum refractory squamous cell carcinoma of the head and neck (SCCHN). The abstract is available on the Society for Immunotherapy of Cancer's (SITC) website.
In the abstract, data reports that among 29 evaluable patients with SCCHN, the objective response rate (ORR), as measured by Response Evaluation Criteria In Solid Tumors (RECIST), was 24 percent (n=7) and the disease control rate (DCR) was 52 percent (n=15). Seventeen percent (n=5) of these evaluable patients had deep responses, with reductions in tumor burden greater than 80 percent. Preliminary efficacy of lirilumab plus nivolumab in patients with advanced platinum-refractory SCCHN suggests clinical benefit with encouraging response rates and potential for deep and durable responses.
Lirilumab is directed against the inhibitory killer-cell immunoglobulin-like receptors (KIRs) expressed predominantly on natural killer (NK) cells, which belong to the innate immune system, while Opdivo blocks the inhibitory function of the PD-1 receptor on T cells.
Detailed data will be presented at a late-breaking oral presentation (Late-Breaking Abstract Session II) at SITC Annual Meeting on November 12 at 11:15 a.m. ET in National Harbor, Maryland, by Rom Leidner, Medical Oncologist, Earle A. Chiles Research Institute, Providence Cancer Center (Portland, OR, U.S.) and lead author of the study.
Innate Pharma will host a conference call to discuss these data for institutional investors and sell-side analysts on November 14th, 2016, at 2:00 p.m. CET (8:00 a.m. ET).
During the call, the Company's management team will discuss lirilumab and IPH4102 data published at the most recent scientific meetings
Conference call details will be communicated on Innate Pharma's website on November 10th,2016
The presentation will be available on the Company's website 15 minutes before the webcast begins
A replay will be available following the webcast on Innate Pharma's website
About CA223-001: A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-KIR (Lirilumab) Administered in Combination With Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors
CA223-001 is a Phase 1/2 dose escalation and cohort expansion study of lirilumab in combination with nivolumab in 159 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. The data reported at SITC pertain to an expansion cohort in SCCHN.
During dose escalation, patients with advanced solid tumors who progressed after at least 1 prior therapy received lirilumab 0.1-3.0 mg/kg once every 4 weeks (Q4W) plus nivolumab 3.0 mg/kg Q2W. Cohort expansion was initiated at the maximum dose of lirilumab 3.0 mg/kg Q4W plus nivolumab 3.0 mg/kg Q2W in patients with advanced solid tumors. Key study endpoints include safety (primary), objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and biomarker assessments.
The purpose of this Phase 1/2 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.
The safety profile associated with lirilumab in combination with Opdivo was as expected based on prior studies and was generally consistent with that observed with Opdivo monotherapy. The overall rate of treatment-related adverse events (TRAEs) was reported as 72 percent (114/159) and the rate of Grade 3-4 TRAEs was 15 percent (24/159). Discontinuations due to TRAEs occurred in 8 percent of patients (12/159). These safety data were reported at the 2016 European Society for Medical Oncology (ESMO) Congress.
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 Pharma 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 Head & Neck Cancer
Cancers that are known as head and neck cancers usually begin in the squamous cells that line the moist mucosal surfaces inside the head and neck, such as inside the mouth, the nose and the throat. Head and neck cancer is the seventh most common cancer globally, with an estimated 400,000 to 600,000 new cases per year and 223,000 to 300,000 deaths per year. The five-year survival rate is reported as less than 4% for metastatic Stage IV disease. Squamous cell carcinoma of the head and neck (SCCHN) accounts for approximately 90% of all head and neck cancers with global incidence expected to increase by 17% between 2012 and 2022. Risk factors for SCCHN include tobacco and alcohol consumption. The Human Papilloma Virus (HPV) infection is also a risk factor leading to rapid increase in oropharyngeal SCCHN in Europe and North America. Quality of life is often impacted for SCCHN patients, as physiological function (breathing, swallowing, eating, drinking), personal characteristics (appearance, speaking, voice), sensory function (taste, smell, hearing), and psychological/social function can be affected.
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 140 employees and is listed on Euronext Paris.
Learn more about Innate Pharma at www.innate-pharma.com.
Practical Information about Innate Pharma shares:
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 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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