Innate Pharma acknowledged today that its cancer candidate lirilumab has failed a Phase II trial in elderly patients with acute myeloid leukemia (AML).
Lirilumab did not meet its primary efficacy endpoint of leukemia-free survival (LFS) in the EffiKIR trial (IPH2102-201), designed to assess the efficacy of the candidate as a single-agent maintenance treatment in seniors whose AML was in first complete remission.
EffiKIR found no statistically significant difference in LFS or other efficacy endpoints between the trial’s placebo arm and its two treatment arms—0.1 mg/kg q3months and 1 mg/kg q1month—the latter stopped in March 2015 by the trial’s data safety monitoring board after concluding “that treatment in the stopped arm cannot be superior to placebo,” according to a statement at the time.
“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,” Innate CMO Pierre Dodion said in a statement.
EffiKIR involved 150 patients in a trial based on the capacity of activated natural killer (NK) cells to directly kill tumor cells and trigger broad immune activation. That reasoning had been supported by clinical studies showing that NK cells can significantly lower the recurrence of AML following hematopoietic stem cell transplantation, Innate said.
Innate said that analyses of data generated by EffiKIR were ongoing, with full trial data set to be submitted to an unspecified future medical conference as well as for publication.
Adverse events encountered with lirilumab “were consistent with the previously reported safety profile of lirilumab,” the company added.
Lirilumab is being investigated in six trials sponsored by Bristol-Myers Squibb (BMS) across a variety of solid and hematological cancer indications in combination with other agents, including BMS’ marketed cancer drug Opdivo (nivolumab).
An up-to-$465 million-plus collaboration—trumpeted as the largest-ever biotech licensing deal signed in France—was launched in 2011, when BMS paid Innate $35 million upfront for exclusive worldwide rights to develop and commercialize lirilumab, then called IPH 2102. The collaboration also called for Innate to receive up to $430 million based on achieving development and commercialization milestones, plus tiered double-digit sales royalties.
“We saw encouraging early efficacy signals of lirilumab in combination with nivolumab at the 2016 SITC meeting,” Dodion added. “We are looking forward to the next data sets as well as the next steps for the program in 2017.”