Bristol Myers Squibb (BMY)

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Bristol-Myers shares sink after another setback for its immuno-oncology franchise drugs

by john carroll — on August 15, 2017 05:22 PM EDT
Updated: August 16, 2017 08:13 AM

Once again un­der­min­ing con­fi­dence in its all-im­por­tant im­muno-on­col­ogy pipeline, Bris­tol-Myers Squibb con­ceded Tues­day evening that a com­bi­na­tion of Op­divo and Yer­voy failed to hit a key co-pri­mary end­point in a Phase III study for front­line renal cell car­ci­noma.

Com­par­ing the combo against suni­tinib (Su­tent) in CHECK­MATE-214, re­searchers said that Op­divo/Yer­voy failed to sig­nif­i­cantly im­prove pro­gres­sion-free sur­vival for pa­tients. They did note, though, that the combo hit a co-pri­mary end­point on the ob­jec­tive re­sponse rate, achiev­ing a 41.6% ORR ver­sus 26.5% for suni­tinib. In their words: “The me­dian PFS was 11.56 months (95% CI 8.71 – 15.51) for the Op­divo and Yer­voy com­bi­na­tion ver­sus 8.38 months (95% CI 7.03-10.81) for suni­tinib.”

Com­ing fast on the heels of As­traZeneca’s woe­ful fail­ure on PFS for its PD-L1/CTLA4 combo in lung can­cer, in­vestors clearly didn’t like the lat­est set­back for Bris­tol-Myers, dri­ving shares $BMY down 3.5% in pre-mar­ket trad­ing. In­ves­ti­ga­tors will con­tinue to fol­low pa­tients to see how the combo works on over­all sur­vival.

An­a­lysts of­fered two key opin­ions on the re­sults. A few noted that the PFS num­bers only nar­rowly missed their tar­get on sta­tis­ti­cal sig­nif­i­cance, mean­ing the combo isn’t out for the count. And Michael Schmidt at Leerink noted that Ex­elixis $EXEL in­vestors are likely to be re­lieved as one near-term threat to cabo’s fran­chise for Ex­elixis at least got de­layed by the late-stage miss.

Un­der­scor­ing that point, Ex­elixis re­ported this morn­ing that it had filed a sup­ple­men­tal NDA for cabo in front­line RCC. Ex­elixis’ shares jumped 3.5% overnight.

Bris­tol-Myers has been work­ing hard to over­come sus­pi­cions about the fu­ture of Op­divo and I/O in gen­eral after a major blow was lev­eled by a fail­ure in front­line lung can­cer. This lat­est flop won’t help, but it also won’t deter the com­pany from its come­back mis­sion.

“We are en­cour­aged by the to­tal­ity of the CHECK­MATE-214 data. The over­all re­sponse rate and dura­bil­ity of re­sponse fa­vored the com­bi­na­tion of Op­divo and Yer­voy, and the trend for PFS sup­ports the po­ten­tial of the com­bi­na­tion in in­ter­me­di­ate and poor-risk ad­vanced renal cell car­ci­noma, the most com­mon type of kid­ney can­cer. This is an im­por­tant study in first-line renal can­cer as these pa­tients need new op­tions,” said Vicki Good­man, de­vel­op­ment lead, melanoma and gen­i­touri­nary can­cers, Bris­tol-Myers Squibb. “We look for­ward to pre­sent­ing the full re­sults from this study at an up­com­ing med­ical meet­ing.”
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