An investigational drug being developed by Innate Pharma in partnership with Bristol-Myers Squibb for elderly patients with acute myeloid leukaemia (AML) has failed to hit key targets in a Phase II trial.
The EffiKIR study was testing the efficacy of lirilumab as a single agent maintenance treatment in elderly patients with AML in first complete remission, but according to top-line data did not meet its primary efficacy endpoint of leukaemia-free survival.
Data analyses are ongoing and the full trial data will be submitted to a future medical conference and for publication, the firm noted, but stressed the findings confirm the safety profile of lirilumab as a monotherapy.
Pierre Dodion, Innate's chief medical officer, said the company is disappointed with the EffiKIR study results.
However, he also highlighted that Effikir is only one of seven studies currently investigating lirilumab, which is being assessed "in a broad and comprehensive combination programme in multiple indications" with "encouraging early efficacy signals" seen in tests of the drug plus Opdivo (nivolumab).
Lirilumab is being investigated in six trials sponsored by BMS, across a range of solid and blood cancer indications in combination with other agents.