Increased scope to explore additional cohorts of Opdivo (nivolumab) plus lirilumab in solid tumors, including a cohort exploring Opdivo with or without lirilumab in squamous cell carcinoma of the head and neck
Initial testing of the triplet combination of Opdivo, Yervoy (ipilimumab) and lirilumab
Innate Pharma SA (the “Company” - Euronext Paris: FR0010331421 – IPH) today announces that its partner Bristol-Myers Squibb has amended the clinical trial protocol for its ongoing Phase I/II trial evaluating the safety and tolerability of lirilumab in combination with Opdivo in patients with advanced refractory solid tumors. Under the amended protocol, updated on clinicaltrials.gov, the study will expand in scope to include additional cohorts of Opdivo plus lirilumab in solid tumors, including a randomized cohort exploring Opdivo with or without lirilumab in platinum refractory recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), and initial testing of the triplet combination of Opdivo, Yervoy and lirilumab in solid tumors.
The protocol amendment follows the presentation at the Society for Immunotherapy of Cancer annual meeting (SITC, November 2016) of an interim efficacy analysis, which showed encouraging preliminary clinical benefit in the cohort of patients with advanced platinum refractory SCCHN in this Phase I/II trial.
Pierre Dodion, MD, Chief Medical Officer at Innate Pharma, said: “This trial expansion builds on the promising preliminary signs of efficacy which we have seen in lirilumab in the initial cohort of patients in the Phase I/II study, announced at the SITC annual meeting last year. We are very encouraged by these signs and are delighted that our partner Bristol-Myers Squibb is exploring lirilumab’s potential further through this large scale and broad-ranging trial.”
Lirilumab is directed against the inhibitory killer-cell immunoglobulin-like receptors (KIRs) expressed predominantly on natural killer (NK) cells, which belong to the innate immune system. It is licensed to Bristol-Myers Squibb and is being studied for its potential in combination with Opdivo and/or Yervoy, which are immune checkpoint inhibitors that respectively block the PD-1 and CTLA-4 receptors on T cells.
Lirilumab is being investigated in a broad exploratory program sponsored by Bristol-Myers Squibb, in various combinations with other agents across a range of solid and hematological cancer indications (see on clinicaltrials.gov).
About the Study
CA223-001 is a Phase I/II trial designed to assess the safety, tolerability and preliminary anti-tumor activity of the combination of lirilumab (anti-KIR) and Opdivo (anti-PD-1) or lirilumab and Opdivo with Yervoy (anti-CTLA-4) in advanced refractory solid tumors. The study cohorts include dose escalation and initial signal detection in multiple solid tumors; safety and preliminary efficacy data were presented at the 2016 ESMO* and SITC meetings.
Key study endpoints include safety and tolerability, best overall response (BOR), objective response rate (ORR), duration of response (DOR) and biomarker assessments.
* European Society for Medical Oncology