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 ipilimumab (Yervoy®)
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.
Ipilimumab (Yervoy®) is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4).
- 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 (melanoma, non-small cell lung cancer - squamous and non-squamous histology, and castrate resistant prostate cancer)
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
- This Phase I open label study will assess the safety and tolerability, characterize the dose-limiting toxicities (DLTs), and identify the maximally tolerated dose (MTD) of BMS-986015/IPH2102 given in combination with ipilimumab in subjects with select advanced (metastatic and/or unresectable) solid tumors. The primary outcome will be safety. Secondary outcomes will include a preliminary assessment of efficacy, as measured by tumor assessment. The study will be conducted in two parts - dose escalation and cohort expansion - and is expected to enroll approximately 150 patients. Tumor types will be restricted to the following advanced (metastatic and/or unresectable) tumor types: melanoma, non-small cell lung cancer - squamous and non-squamous histology, and castrate resistant prostate cancer. (NCT01750580)
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 ipilimumab in patients with advanced refractory solid tumors. 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. 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 1086P).
- • On May 28, 2013, Innate Pharma, the innate immunity company developing first-in-class drugs for cancer and inflammatory diseases, has announces 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.
- • On December 19, 2012, Innate PHarma has announced the publication of a Phase I trial sponsored by BMS on the NIH website Clinicaltrials.gov. This second Phase I combination trial follows the Phase I trial of IPH2102/BMS-986015 in combination with anti-PD-1 nivolumab (BMS-936558) announced in October and published on the NIH website.
Is
general: Yes
