Bristol Myers Squibb (BMY)

[chmcnfunds]

Bristol-Myers’ tarnished checkpoint star Opdivo beats out Yervoy in surprise PhIII

by john carroll — on July 5, 2017 09:47 AM EDT
Updated: 01:24 PM

Bris­tol-Myers got a much-needed boost with the ear­lier-than-ex­pected news that Op­divo beat out Yer­voy in a Phase III study fo­cused on a par­tic­u­lar niche for ad­ju­vant melanoma ther­apy. And an an­a­lyst who’s been fol­low­ing the data says it could be worth a bil­lion dol­lars in added an­nual sales.

The big biotech says an in­terim analy­sis of Check­mate-238 pro­vided re­searchers with proof that the PD-1 drug out­per­formed Yer­voy, Bris­tol-Myers’ CTLA-4 drug, among ad­vanced Stage IIIb or IV pa­tients, cut­ting the re­cur­rence rate for those who have un­der­gone surgery. There are no bot­tom line num­bers in the state­ment, but Bris­tol-Myers says they’ll be able to re­lease data at an up­com­ing con­fer­ence to show that Op­divo pro­vided a sig­nif­i­cantly lower risk of dis­ease re­cur­rence.

Sea­mus Fer­nan­dez notes that the re­sults are likely to can­ni­bal­ize Bris­tol’s Yer­voy rev­enue, but will likely de­liver a $1 bil­lion boost to Op­divo as physi­cians steer away from the higher doses of highly toxic Yer­voy. He noted:

This comes as a sur­prise, as top-line data were not ex­pected until the final read­out in 2H:18. While there were no de­tails in the press re­lease re­gard­ing the mag­ni­tude of ben­e­fit for Op­divo, we would ex­pect it to be­come the stan­dard of care in high-risk pa­tients fol­low­ing sur­gi­cal re­sec­tion given its su­pe­rior safety and tol­er­a­bil­ity pro­file rel­a­tive to Yer­voy. We es­ti­mate the ad­ju­vant melanoma mar­ket will ex­pand PD1 sales by ap­prox­i­mately $3B glob­ally. Al­though this likely will can­ni­bal­ize sales of Yer­voy in the set­ting (we es­ti­mate cur­rent ad­ju­vant Yer­voy sales at $300-400M), the ex­pan­sion of the mar­ket should add ap­prox­i­mately $1B to BMY’s net im­muno-on­col­ogy (IO) sales de­spite as­sumed com­pe­ti­tion from MRK’s (MP) Keytruda (pem­brolizumab; anti-PD-1).


Vicki Good­man
Op­divo’s rocky road at Bris­tol has led to end­less spec­u­la­tion that the com­pany could find it­self on the auc­tion block be­fore it gets a chance to re­or­ga­nize in the clinic and come back in its head-to-head show­down with Merck’s Keytruda. But it is also rack­ing up bil­lions in an­nual sales of Op­divo, with a slate of new tri­als un­der­way.

“These topline re­sults sup­port the po­ten­tial promise of Op­divo as a treat­ment op­tion for pa­tients with high-risk sur­gi­cally re­sected melanoma. There re­mains an unmet need for ad­di­tional op­tions as the ma­jor­ity of stage III and re­sected stage IV high-risk melanoma pa­tients ex­pe­ri­ence dis­ease re­cur­rence after surgery,” said Vicki Good­man, de­vel­op­ment lead, melanoma and gen­i­touri­nary can­cers, Bris­tol-Myers Squibb. “We are com­mit­ted to re­search­ing ther­a­pies that may bet­ter meet the needs of this pa­tient pop­u­la­tion and look for­ward to shar­ing these data with health au­thor­i­ties soon.”


Jef­frey Weber
Physi­cians in the field, in­clud­ing the high pro­file Jef­frey Weber at NYU Lan­gone, have been wait­ing to see how this one will shake out. And they’re get­ting the read­out a year ahead of sched­ule. In a panel chat with ex­perts in the field in the spring of 2016, he noted:

On the basis of my own ex­pe­ri­ence with both drugs in pilot ad­ju­vant tri­als, I have a sus­pi­cion that nivolumab is going to look bet­ter than ip­il­i­mumab. And the next fron­tier is what we’ve al­ready pi­loted when I was at Mof­fitt and we’ll con­tinue at NYU, which is com­bi­na­tion ad­ju­vant ther­apy. But be­cause of the tox­i­c­ity, we flipped the doses giv­ing one of ip­il­i­mumab and three of nivolumab, which is very well-tol­er­ated with a pretty good track record, ad­mit­tedly, in a small study. So, I think that we’ve gone from in­ter­feron, we’ll go to ip­il­i­mumab, we’ll go to nivolumab, and even­tu­ally end up at ip­il­i­mumab plus nivolumab, over the next five years, which brings us to where we’re going in metasta­tic treat­ment. I think we’re going to see triple com­bi­na­tions. On the one hand, it’s sci­en­tif­i­cally fas­ci­nat­ing, ex­tremely com­plex with para­dox­i­cally a bar that’s now so high, it’s going to be very dif­fi­cult to get com­bi­na­tions ap­proved. You’re going to need to see major in­cre­men­tal ad­van­tages, which I think you prob­a­bly will see with some of the drugs my col­leagues have men­tioned. But they’re also going to be very ex­pen­sive, so phar­ma­coeco­nom­ics is also going to play a huge role in what we do. Right now, I would es­ti­mate that the cost of ip­il­i­mumab plus nivolumab ther­apy for a year is about $250,000. So, I would ask where does this all end?

https://endpts.com/bristol-myers-tarnished-checkpoint-star-opdivo-beats-out-yervoy-in-surprise-phiii/?utm_medium=email&utm_campaign=257%20Wednesday%207517%20Surprise%20PhIII%20success%20bolsters%20Bristol-Myers%20Opdivo%20plans%20Judge%20tells%20Shkreli%20to%20zip%20it%20as%20Twitter%20clamps%20down%20-%20again&utm_content=257%20Wednesday%207517%20Surprise%20PhIII%20success%20bolsters%20Bristol-Myers%20Opdivo%20plans%20Judge%20tells%20Shkreli%20to%20zip%20it%20as%20Twitter%20clamps%20down%20-%20again+CID_50858b30d4f444f687fe9368c425236b&utm_source=ENDPOINTS%20emails&utm_term=Bristol-Myers%20tarnished%20checkpoint%20star%20Opdivo%20beats%20out%20Yervoy%20in%20surprise%20PhIII

BMY