Results

Bristol-Myers partner Innate concedes a PhII flop for I/O drug lirilumab in fighting AML

Mondher Mahjoubi, Innate Pharma CEO

More than five years ago Bristol-Myers Squibb heralded a $465 million deal to partner with Innate Pharma on its natural killer cell cancer drug lirilumab. But today the French biotech was forced to concede that its lead drug was no better than a placebo in fighting acute myeloid leukemia as a monotherapy.

Carrying out plans to handle development through Phase II, Marseilles-based Innate execs said that lirilumab flunked a Phase II trial testing the drug as a single agent. There was no evidence that the drug was any better than placebo in spurring a leukemia-free outcome for patients in a maintenance setting.

Shares of Innate (Euronext Paris: IPH) dropped 14% on the news, which must have come as an unwelcome surprise to new CEO Mondher Mahjoubi, who recently took the helm after he was wooed from a top-level job at AstraZeneca.

Investigators had already halted work on one of two doses — the 1 mg/kg q1month group — close to two years ago after the data safety monitoring board concluded that it wasn’t working to patients’ advantage. The final readout came on the 0.1 mg/kg q3months group.

The drug is an antibody designed to interfere with the interaction of killer-cell immunoglobulin-like receptors on NK cells with their ligands, hopefully spurring a more effective natural killer cell attack on cancer cells. Bristol-Myers saw that as a natural combination approach with Opdivo and the two companies launched six other studies for various combination approaches. Those combo trials will proceed.

This is the latest in a series of clinical setbacks for Bristol-Myers’ Opdivo, which has been pummeled by the swift advance of Merck’s Keytruda in frontline lung cancer. Checkpoint inhibitors have been put into dozens of combination studies as developers look for better results in fighting cancer.

Investigators recruited 150 patients for the study.

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.”


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RAPS Regulatory Convergence 2017