The combination of lirilumab and nivolumab in a phase I study of advanced solid tumors showed no added toxicity over nivolumab monotherapy;
Data supports ongoing Phase I cohort expansion of lirilumab in combination with nivolumab;
Efficacy data will be presented at the Society for Immunotherapy of Cancer 2016 conference.
(PRINCETON, N.J., and MARSEILLE, France, October 9, 2016) – Bristol-Myers 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, BMS 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 unmet needs.”
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).