Innate Pharma SA (the “Company” – Euronext Paris: FR0010331421 – IPH) today announces top-line results from the randomized, double-blind, placebo-controlled Phase II trial testing the efficacy of lirilumab as a single agent maintenance treatment in elderly patients with acute myeloid leukemia (AML) in first complete remission (“EffiKIR” trial). The study did not meet its primary efficacy endpoint of leukemia-free survival (LFS).
Two arms of the trial tested single agent lirilumab at different doses and treatment intervals (0.1 mg/kg q3months or 1 mg/kg q1month) whereas in the third arm, patients received placebo. There was no statistically significant difference between either lirilumab arms and the placebo arm on the LFS nor on other efficacy endpoints. As announced in March 2015, one arm of the trial was discontinued upon DSMB recommendation. This arm has now been identified as the 1 mg/kg q1month arm of the trial. At the time of its decision, the DSMB assessed that the objective of achieving a superior LFS in this arm compared to placebo could not be reached. There was no concern with tolerance.
The adverse events encountered with lirilumab were consistent with the previously reported safety profile of lirilumab.
Data analyses are ongoing and the full trial data will be submitted to a future medical conference and for publication.
Lirilumab is being investigated in six trials sponsored by Bristol-Myers Squibb, across a range of solid and hematological cancer indications in combination with other agents, including nivolumab (see on clinicaltrials.gov).
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.”