Innate Pharma and Bristol-Myers Squibb have modified 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.
According to the protocol, 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, said Innate.
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.”
As the company explained, 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, the company explained .