Dive Brief:
- A combination study of Innate Pharma SA and Bristol-Myers Squibb's lirilumab with Bristol's blockbuster Immunotherapy Opdivo (nivolumab) in squamous cell carcinoma of the head and neck has failed to reach its primary endpoint, with "no clear evidence of benefit to patients or an obvious development path."
- According to the company, full data from EffiKIR, to be presented at the ASH Annual Meeting 2017, suggests that alternate dosing regimens may have potential for improved patient benefit.
- Bristol-Myers paid $35 million upfront in 2011 to Innate for the rights to lirilumab and related compounds, agreeing to $430 million in potential milestones. Discussions are ongoing regarding the next steps for the program.
Dive Insight:
In January this year, French company Innate Pharma SA received a $15 million milestone payment for the continued evaluation of lirilumab in combination with Opdivo (nivolumab). This followed "encouraging preliminary activity results" from a cohort of patients with squamous cell cancer of the head and neck (SCCHN) in a Phase I/II trial. There had also been data presented in December 2016 of activity in relapsed/refractory cutaneous T-cell lymphomas. At the time, lirilumab was in seven studies across a range of solid and blood cancers.
Innate has been clinging to the idea that lirilumab boosts the activity of Opdivo, but there have been multiple instances that could indicate the drug is a dud. The idea is that by combining Opdivo's PD-1 blocking potential with lirilumab's KIR2DL-1,-2,-3 inhibitory abilities, the combo could unleash immune cells and natural killer cells to better attack tumors.
Back in February, results from a study of lirilumab as a single agent in elderly patients with acute myeloid leukemia showed that the drug didn't meet the primary efficacy endpoint. Prior to the flop, a Data Safety Monitoring Board indicated it wasn't seeing enough efficacy from the trial and shut down one arm of the study.
"Together with Bristol-Myers Squibb, our partner, we will further examine these data to better understand the results and explore whether other combinations should be investigated," said Mondher Mahjoubi, CEO at Innate Pharma.