Bristol Myers Squibb (BMY)

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

by john carroll
February 6, 2017 06:27 AM EST
Updated: 08:23 AM


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.

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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https://endpts.com/bristol-myers-partner-innate-concedes-a-phii-flop-for-io-drug-lirilumab-in-fighting-aml/?utm_medium=email&utm_campaign=Monday%20%20Feb%206%202017&utm_content=Monday%20%20Feb%206%202017+CID_ccdf8b1631ec999dc209823d5340b64e&utm_source=ENDPOINTS%20emails&utm_term=Bristol-Myers%20partner%20Innate%20concedes%20a%20PhII%20flop%20for%20IO%20drug%20lirilumab%20in%20fighting%20AML

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