On January 9, 2017 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that, per the licensing agreement for lirilumab, Bristol-Myers Squibb has paid Innate Pharma a US$15 million milestone payment for the continued exploration of lirilumab in combination with Opdivo (nivolumab) (Press release, Innate Pharma, JAN 9, 2017, View Source [SID1234517308]). Schedule your 30 min Free 1stOncology Demo! This milestone payment follows the presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) annual meeting (November 2016) of encouraging preliminary activity results from the cohort of patients with Squamous Cell Cancer of the Head and Neck (SCCHN) of a Phase I/II trial. These interim efficacy results – the first report for the combination of an anti-KIR antibody and an anti-PD-1 therapy – indicate that targeting both pathways with lirilumab and nivolumab respectively may provide enhanced clinical activity, particularly in PD-L1 positive tumors, with deep and durable responses in some patients.
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Pierre Dodion, Chief Medical Officer at Innate Pharma, said: "The combination of lirilumab with nivolumab showed encouraging early efficacy signals in the initial part of the trial which support the strategy of simultaneously targeting the KIR and PD-1 pathways with lirilumab and nivolumab, respectively; the reported data point to broader potential for lirilumab. We look forward to further investigation of the combination in the Phase II part of this trial."
In total, Bristol-Myers Squibb is currently investigating lirilumab in six trials, across a range of solid and hematological cancer indications, in monotherapy and in combination with other agents, and Innate Pharma is responsible for conducting the EffiKIR trial, a randomized Phase II trial evaluating lirilumab as a single agent in patients with acute myeloid leukemia (see on clinicaltrials.gov).
About CA223-001: A Phase I/II 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 I/II dose escalation and cohort expansion study of lirilumab in combination with nivolumab in patients with advanced solid tumors.
During the dose escalation, patients with advanced solid tumors who progressed after ≥ 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. The data reported at SITC (Free SITC Whitepaper) pertain to an expansion cohort in SCCHN. 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 I/II 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.