Clinical Trials

Date: 2013-05-28

Type of information: Presentation of results at a congress

phase: 1

Announcement: presentation of a poster

Company: BMS (USA - NY) Innate Pharma (France)

Product: lirilumab or IPH2102/BMS-986015 in combination with 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. 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.

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.

Latest news:

• On May 28, 2013, Innate Pharma has announced that three posters on lirilumab (IPH2102/BMS-986015) will be presented at the ASCO (American Society of Clinical Oncology) 13th annual meeting, in Chicago, Illinois, May 31-June 4, 2013. “A phase I dose-escalation and cohort expansion study of lirilumab (anti-KIR; BMS-986015) administered in combination with nivolumab (anti-PD-1; BMS-936558; ONO-4538) in patients (Pts) with advanced refractory solid tumors” (Abstract TPS3110, Poster Board: #22E)
• On October 30, 2012, Innate Pharma has announced that a Phase I trial sponsored by BMS 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. 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.