Am­gen hit with a set­back as Kypro­lis fails a key front­line tri­al for mul­ti­ple myelo­ma

Sean Harp­er, Ex­ec­u­tive Vice Pres­i­dent, Re­search and De­vel­op­ment

Am­gen re­port­ed ear­ly Tues­day that Kypro­lis has failed a Phase III tri­al for front­line use against mul­ti­ple myelo­ma, a set­back that can on­ly fur­ther sharp­en the dis­ap­point­ment an­a­lysts have felt for this ther­a­py in light of weak sales.

In­ves­ti­ga­tors say that Kypro­lis com­bined with mel­pha­lan and pred­nisone es­sen­tial­ly matched a triple com­bo us­ing Take­da’s Vel­cade. The PFS for Kypro­lis was 22.3 months com­pared to 22.1 months for the Vel­cade arm.

Am­gen’s shares slid 2.3% in pre-mar­ket trad­ing Tues­day.

The over­all sur­vival da­ta have yet to ma­ture for a read out, ac­cord­ing to Am­gen. But the big biotech didn’t have any­thing pos­i­tive to re­port this morn­ing.

Am­gen had been hop­ing to use this study to help jus­ti­fy the $10.4 bil­lion ac­qui­si­tion of Onyx Phar­ma­ceu­ti­cals back in 2013, af­ter Onyx had pushed the treat­ment through to an ap­proval. Last year, Am­gen had been bull­ish about its prospects in the blood can­cer field af­ter Kypro­lis proved more ef­fec­tive in help­ing mul­ti­ple myelo­ma pa­tients who had failed at least one pri­or treat­ment com­pared to Vel­cade. And it fol­lowed up with a new ap­proval for use against re­lapsed mul­ti­ple myelo­ma in com­bi­na­tion with Vel­cade.

Front­line use, though, would have opened up a ma­jor mar­ket op­por­tu­ni­ty to Am­gen that the com­pa­ny bad­ly need­ed. Kypro­lis earned $512 mil­lion last year, up 55% from the year be­fore. But you’ll find it at the tail end of the drugs Am­gen re­ports on, leav­ing the big biotech look­ing for new ways to add rev­enue. Vel­cade, mean­while, brings in block­buster cash for Take­da, earn­ing more than $2.5 bil­lion a year.

Cel­gene is the leader in mul­ti­ple myelo­ma, though, dom­i­nat­ing the field with Revlim­id and Po­m­a­lyst while J&J and Bris­tol-My­ers Squibb have jumped in with Darza­lex and Em­plic­i­ti.

Look­ing over the field and weigh­ing the set­back at Am­gen, Leerink’s Ge­of­frey Porges con­clud­ed that gener­ic Vel­cade will be the dom­i­nant drug in use. He con­clud­ed:

“With the mul­ti­ple myelo­ma field search­ing for the op­ti­mum com­bi­na­tion treat­ment com­bi­na­tion it seems like­ly that soon-to-be-gener­ic Vel­cade will be the pro­tea­some in­hibitor of choice in front line pa­tients with the back­bone of J&J’s (JNJ, [OP]) Darza­lex (dara­tu­mum­ab)‎, Cel­gene’s (CELG, [MP]) Revlim­id (lenalido­mide), and dex­am­etha­sone (aka Darza­lex/ Rev/ Dex). Vel­cade’s patent is set to ex­pire in 2017. A num­ber of Kypro­lis stud­ies are still on­go­ing – and we are cau­tious about the out­comes. These tri­als in­clude AR­ROW, a phase 3 tri­al of Kypro­lis (with dex) re­lapsed and re­frac­to­ry MM, set to read-out mid- 2017; a phase 3 com­par­ing Kypro­lis vs. Vel­cade (both with rev/ dex) in new­ly di­ag­nosed MM, set to read-out 2H 2017; and the over­all sur­vival da­ta of phase 3 EN­DEAV­OR study of Kypro­lis vs. Vel­cade (both with dex) in re­lapsed MM ex­pect­ed 2018.”

Said R&D chief Sean Harp­er:

“The CLAR­I­ON re­sults, gen­er­at­ed in the con­text of a mel­pha­lan-con­tain­ing reg­i­men, are dis­ap­point­ing, es­pe­cial­ly giv­en the ro­bust da­ta we’ve seen in the sec­ond-line set­ting. How­ev­er, the myelo­ma land­scape has changed dra­mat­i­cal­ly since the de­sign of the CLAR­I­ON study with very few new­ly di­ag­nosed pa­tients treat­ed with mel­pha­lan-based reg­i­mens, par­tic­u­lar­ly in the U.S.  We re­main com­mit­ted to ex­plor­ing Kypro­lis in com­bi­na­tion with oth­er agents to ad­vance the treat­ment of mul­ti­ple myelo­ma.”


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Merck is cutting 500 jobs in its US sales and headquarters commercial teams in its latest effort to find new ways to streamline the operation.

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Alice Shaw, Lung Cancer Foundation of America

Top ALK ex­pert and can­cer drug re­searcher Al­ice Shaw bids adieu to acad­e­mia, hel­lo to No­var­tis

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Mirati has been experiencing the full effect of a rival’s initial success at targeting the G12C pocket found on KRAS, offering the biotech some support on the concept they’re after — and biotech fans a race to the top. Amgen made a big splash with its first positive snapshot on lung cancer, but deflated sky-high expectations as it proved harder to find similar benefits in other types of cancers.

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Sean Parker, AP

Sean Park­er helps cre­ate a CRISPRed cell ther­a­py 2.0 play — and he’s got a high-pro­file set of lead­ers on the team

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Today it’s Ken Drazan and the team at South San Francisco-based ArsenalBio that are coming from behind the curtain for a public bow, backed by billionaire Sean Parker and a collection of investors that includes Beth Seidenberg’s new venture investment operation based in LA.
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Med­ical an­i­ma­tion: Mak­ing it eas­i­er for the site and the pa­tient to un­der­stand

Medical animation has in recent years become an increasingly important tool for conveying niche information to a varied audience, particularly to those audiences without expertise in the specialist area. Science programmes today, for example, have moved from the piece-to-camera of the university professor explaining how a complex disease mechanism works, to actually showing the viewer first-hand what it might look like to shrink ourselves down to the size of an ant’s foot, and travel inside the human body to witness these processes in action. Effectively communicating a complex disease pathophysiology, or the novel mechanism of action of a new drug, can be complex. This is especially difficult when the audience domain knowledge is limited or non-existent. Medical animation can help with this communication challenge in several ways.
Improved accessibility to visualisation
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Hal Barron, GSK's president of R&D and CSO, speaks to Endpoints News founder and editor John Carroll in London at Endpoints' #UKBIO19 summit on October 8, 2019

[Video] Cel­e­brat­ing tri­al fail­ures, chang­ing the cul­ture and al­ly­ing with Cal­i­for­nia dream­ers: R&D chief Hal Bar­ron talks about a new era at GSK

Last week I had a chance to sit down with Hal Barron at Endpoints’ #UKBIO19 summit to discuss his views on R&D at GSK, a topic that has been central to his life since he took the top research post close to 2 years ago. During the conversation, Barron talked about changing the culture at GSK, a move that involves several new approaches — one of which involves celebrating their setbacks as they shift resources to the most promising programs in the pipeline. Barron also discussed his new alliances in the Bay Area — including his collaboration pact with Lyell, which we covered here — frankly assesses the pluses and minuses of the UK drug development scene, and talks about his plans for making GSK a much more effective drug developer.

This is one discussion you won’t want to miss. Insider and Enterprise subscribers can log-in to watch the video.

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Flu Virus (Source: CDC)

FDA ex­pands Xofluza ap­proval as Roche strug­gles to catch loom­ing flu mar­ket

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The drugmaker $MRK began developing the vaccine, christened Ervebo, during the West African outbreak that occurred between 2014 and 2016, killing more than 11,000.

The current outbreak in the Democratic Republic of Congo (DRC) has shown case fatality rates of approximately 67%, the agency estimated. Earlier this year, the WHO declared the outbreak — which so far has infected more than 3,000 people — a public health emergency of international concern.