Date: 2016-10-09
Type of
information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the European Society for Medical Oncology (ESMO) 2016 Congress
Company: BMS (USA - NY) Innate Pharma (France)
Product: lirilumab or IPH2102/BMS-986015 in combination with nivolumab or Anti-PD-1 (BMS-936558)
Action
mechanism:
- monoclonal antibody/immune checkpoint inhibitor. Lirilumab or IPH2102/BMS-986015 is a fully human monoclonal antibody blocking interaction between Killercell immunoglobulin-like receptors (KIR) on NK cells with their ligands. Blocking these receptors facilitates activation of NK cells and, potentially, destruction of tumor cells by the latter.
- Nivolumab or Anti-PD-1 is a fully-human antibody that targets the inhibitory receptor expressed on activated T-cells called PD-1 or programmed death-1. The two compounds are checkpoint inhibitors.
- IPH2102/BMS-986015 is licensed to BMS. As part of their agreement, BMS holds exclusive worldwide rights to develop, manufacture and commercialize IPH2102/BMS-986015 and related compounds blocking KIR receptors, for all indications. Under the agreement, Innate Pharma will conduct the development of IPH2102/BMS-986015 through Phase II in acute myeloid leukemia.
Disease: advanced solid tumors
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
- The purpose of this Phase I open label study is to determine whether the combination of IPH2102/BMS-986015 and BMS-936558 is safe and provide preliminary information on the clinical activity of the combination. The primary outcome will be safety. Secondary outcomes will include a preliminary assessment of efficacy, as measured by tumor assessment.
- It will be conducted in two parts - dose escalation and cohort expansion - and is expected to enroll approximately 150 patients, with up to 48 patients in dose escalation and up to 96 patients in cohort expansion. During dose escalation, patients with any advanced tumor type (with the exception of primary central system tumors and hematologic malignancies) will be eligible to enroll. During cohort expansion, tumor type will be restricted to the following advanced malignancies: non-small cell lung cancer – squamous and non-squamous histology, Renal Cell Carcinoma, Melanoma, Colorectal Cancer and Serous Ovarian Carcinoma. (NCT01714739)
Latest
news:
- • On October 9, 2016, BMS and Innate Pharma announced safety data for two Phase I studies conducted by BMS, testing lirilumab in combination with nivolumab or ipilimumab, respectively, in patients with advanced refractory solid tumors. 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. 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 presented at the Society for Immunotherapy of Cancer 2016 conference. The results were presented by Dr. Neil H. Segal, Memorial Sloan-Kettering Cancer Center, at the European Society for Medical Oncology (ESMO) 2016 congress 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 1086P ).
- • On March 31, 2014, Innate Pharma has announced the start of the cohort expansion portion of the Phase I clinical trial testing the combination of the two investigational checkpoint inhibitors lirilumab (anti-KIR) and nivolumab (anti-PD-1) in selected solid tumors.
- • On October 30, 2012, Innate Pharma has announced that a Phase I trial sponsored by Bristol-Myers Squibb was published on the NIH website ClinicalTrials.gov for IPH2102/BMS-986015 and is currently recruiting. IPH2102/BMS-986015 will be tested in a variety of solid tumors, in combination with BMD's anti-PD-1 which has shown promising single agent results in Phase I/II trials.
Is
general: Yes
