#AACR18 round 1: Mer­ck takes a di­rect swing at Bris­tol-My­ers with ad­ju­vant melanoma da­ta for Keytru­da

CHICA­GO — Mer­ck $MRK came out of its cor­ner swing­ing Sun­day morn­ing, tak­ing a few di­rect jabs at the de­fend­ing cham­pi­on in check­point in­hi­bi­tion as the phar­ma gi­ant en­tered the lat­est I/O ti­tle fight with Bris­tol-My­ers Squibb $BMY at the an­nu­al meet­ing of AACR in Chica­go.

Roger Perl­mut­ter, Mer­ck

Re­searchers for Mer­ck were in Chica­go for the cur­tain open­er in what promis­es to be a bruis­ing brawl be­tween the lead­ers in the PD-1 field over a mar­ket one an­a­lyst has said is worth $3 bil­lion.

In KEYNOTE-054, Mer­ck de­ter­mined that 18 dos­es of Keytru­da pushed post-surgery pa­tients with stage 3 melanoma to a re­cur­rence-free rate of 75.4% com­pared to 61% for a com­par­i­son group get­ting a place­bo. A 43% drop in re­cur­rence rate was some­thing Mer­ck tout­ed as a ma­jor ad­vance for pa­tients.

Mer­ck is look­ing to carve away mar­ket share from Bris­tol-My­ers any way it can. And they’ll have their work cut out in Stage 3 melanoma. Bris­tol-My­ers won an ap­proval to use Yer­voy in this group three years ago, and fol­lowed up with an OK for Op­di­vo last year, mak­ing them the go-to play­er for ad­ju­vant ther­a­py.

Mer­ck, though, didn’t hes­i­tate to make its case in their out­line of the re­sults Sun­day morn­ing. Yer­voy, they note, is no­to­ri­ous­ly tox­ic for pa­tients, who may well pre­fer an al­ter­na­tive. And Op­di­vo? They have an ar­gu­ment there as well.

“Nivolum­ab was more ef­fec­tive and had few­er side ef­fects than ip­il­i­mum­ab, but it is giv­en at a dose of 3 mil­ligrams per kilo­gram every two weeks for up to a year, which is 26 dos­es in to­tal,” not­ed Alexan­der Eg­ger­ment, di­rec­tor gen­er­al of Gus­tave Roussy Can­cer Cam­pus Grand Paris, mak­ing Mer­ck’s case. “Pem­brolizum­ab may prove con­ve­nient to pa­tients and hos­pi­tals be­cause it re­quires few­er out­pa­tient hos­pi­tal vis­its and is giv­en at a flat dose.”

Mer­ck is hunt­ing ap­provals in the US and Eu­rope so they can take that pitch di­rect­ly to physi­cians.

A spokesper­son for Bris­tol-My­ers, though, fol­lowed up with me to note that “the ad­ju­vant melanoma dos­ing for nivolum­ab was up­dat­ed with the Q4W ap­proval and is now ap­proved for flat dos­ing 240 mg every two weeks or 480 mg every four weeks.”

Bris­tol-My­ers won an FDA ap­proval af­ter Check­mate-238 demon­strat­ed that Op­di­vo was bet­ter than Yer­voy in hold­ing back melanoma for post-surgery stage 3 and 4 pa­tients. In that study, the re­cur­rence rate for Op­di­vo at a me­di­an fol­low-up of 18.5 months was 66.4% for Op­di­vo and 52.7% for Yer­voy.

Whats at stake? Ac­cord­ing to Sea­mus Fer­nan­dez at Leerink, about $3 bil­lion. Here’s his com­ment on the -238 re­sults from last sum­mer:

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).

It’s not just about mon­ey, though. Ever since Bris­tol-My­ers rolled out in front of Mer­ck, Roger Perl­mut­ter’s team has been fo­cused on claim­ing the lead. A key mis­step on lung can­cer at Bris­tol-My­ers gave them an ad­van­tage they’ve been ex­ploit­ing ever since — which we’ll al­so hear more about over the next two days.

This par­tic­u­lar show­down has just be­gun.

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.