Innate Pharma, based in Marseille, France, today reported the failure of a phase II Lirilumab study in AML, called the EffiKIR trial. The study was designed as a randomized, double-blind, placebo-controlled Phase II trial testing the efficacy of lirilumab in elderly patients with AML in first complete remission.
The original EffiKIR study had two active arms, one with 0.1 mg/kg q3months and one with 1 mg/kg q1month. It now turned out that is was the higher dose arm which was discontinued already in 2015 due to a lack of efficiency. The second, lower dose arm unfortunately did not do any better in the end. As per press release:
Pierre Dodion, Chief Medical Officer of Innate Pharma, said: “Although we knew that this setting was challenging, we are disappointed by the results of the EffiKIR study and will investigate further to better understand the data in its entirety. However, Effikir is only one of seven studies currently investigating lirilumab. Lirilumab is tested in a broad and comprehensive combination program in multiple indications and we saw encouraging early efficacy signals of lirilumab in combination with nivolumab at the 2016 SITC meeting. We are looking forward to the next data sets as well as the next steps for the program in 2017.
While EffiKIR was a monotherapy study, Innate also is testing Lirilumab in combination with nivolumab (Opdivo) where results in a head and neck cancer study showed more promising results.
Making use of natural killer cells to target cancer remains a promising and fast evolving branch of cancer research with companies like Innate Pharma, Celyad or NantKwest pursuing different approaches.