As­traZeneca chief is bet­ting the com­pa­ny’s fu­ture on a sin­gle roll of the dice

Bioreg­num
The view from End­points
As­traZeneca CEO Pas­cal So­ri­ot

Near­ly five years in­to his stint at the helm of As­traZeneca, CEO Pas­cal So­ri­ot has now reached his year of liv­ing dan­ger­ous­ly.

This morn­ing the phar­ma chief out­lined a steadi­ly de­clin­ing rate of rev­enue. Core EPS is ex­pect­ed to slide in the low to mid teens as gener­ics con­tin­ue to chop away at their Crestor fran­chise. All their old block­busters are be­ing dis­en­fran­chised, in a man­ner of speak­ing.

So­ri­ot, not known to wa­ver in times of a cri­sis, wasn’t about to break down now. He an­nounced: “It is an ex­cit­ing time as we rapid­ly ap­proach the in­flec­tion point for our an­tic­i­pat­ed re­turn to long-term growth, built on the sol­id foun­da­tions of a sci­ence-led pipeline.”

In­vestors weren’t very ex­cit­ed by the num­bers, though, send­ing the com­pa­ny’s shares down by close to 3% this morn­ing.

Af­ter a whole slate of clin­i­cal set­backs in 2016, the fi­nan­cial ero­sion at As­traZeneca has fo­cused an un­wa­ver­ing spot­light on the com­pa­ny’s com­bi­na­tion study for the PD-L1 check­point dur­val­um­ab and treme­li­mum­ab, a CT­LA-4, dubbed MYS­TIC.

A late­com­er to the check­point in­hi­bi­tion field, As­traZeneca is mak­ing a high-risk at­tempt at cut­ting in­to the line of heavy­weights com­pet­ing on lung can­cer, look­ing for ev­i­dence that they have a com­bo that can ri­val the ad­vanc­ing for­tunes of Mer­ck’s Keytru­da/chemo com­bi­na­tion, now un­der re­view.

As­traZeneca re­cent­ly tweaked MYS­TIC, adding months to the time­line as the phar­ma com­pa­ny awaits pro­gres­sion-free sur­vival da­ta this year and over­all sur­vival da­ta in 2018. And the move was wide­ly viewed as sig­nal­ing some un­der­ly­ing con­cerns about how the fi­nal da­ta read­out will look.

De­lays of any kind, though, are poi­son to As­traZeneca, as faster com­pa­nies con­tin­ue to cap­i­tal­ize on the first wave of check­points and more com­pa­nies mus­cle in along­side them. Pfiz­er, al­lied with Mer­ck KGaA, al­so has a check­point now un­der re­view at the FDA. Mer­ck, Bris­tol-My­ers and Roche are al­ready well in­to the mar­ket, with their own fol­low-up plans. And Bris­tol-My­ers’ de­ci­sion not to pur­sue an ac­cel­er­at­ed ap­proval for Op­di­vo (PD-1)/Yer­voy (CT­LA-4) in lung can­cer raised even more doubts about the ap­proach at As­traZeneca.

The stakes for As­traZeneca keep get­ting high­er, cre­at­ing a re­mark­able high-wire act for a Big Phar­ma play­er.

Not on­ly does As­traZeneca have to gain an ap­proval now, the com­pa­ny al­so has to be rec­og­nized as a leader in the field, po­si­tioned to grab bil­lions of dol­lars in new sales. Just falling short of ex­pec­ta­tions will be enough to quash hopes for the near-term turn­around that As­traZeneca needs.

“Rarely has a sin­gle tri­al re­sult been so cru­cial to a com­pa­ny the size of As­traZeneca,” said Mick Coop­er of Trin­i­ty Delta.

And how.

Rev­enue in 2016 hit $23 bil­lion in 2016, down from $24.7 bil­lion. But So­ri­ot promised $45 bil­lion in rev­enue by 2023, now just six years away. The com­pa­ny has al­ready start­ed back­ing away from that num­ber, blam­ing cur­ren­cy val­u­a­tions. But even their new goals will rapid­ly evap­o­rate with­out a big score on the I/O front.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

Roger Perl­mut­ter lines up deals, fresh fund­ing at Eikon; Sec­ond RSV vac­cine ap­proved; Sev­er­al biotechs flash­ing red; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As you come back to our website this weekend for ASCO news, don’t forget to check out our updated event lineup at BIO, which will cover everything from the current state of VC investing in biotech to top pharma R&D chiefs discussing how to make pipeline decisions.

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Full TIG­IT da­ta from Gilead, Ar­cus show low­er PFS rates than De­cem­ber read­out: #AS­CO23

CHICAGO — Gilead and Arcus unveiled a fuller snapshot of a Phase II study testing their experimental cancer immunotherapy combo that showed lower progression-free survival rates than its previous update, results that are likely to spark further debate over the closely-watched clinical trial.

Last December, the anti-TIGIT/anti-PD-L1 combo, positioned as a first-line treatment for non-small cell lung cancer, recorded data that drew mixed reactions. The latest analysis, presented Saturday afternoon at ASCO, included only a handful more patients than the previous update, but PFS rates fell — in one cohort by nearly three months.

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Bris­tol My­er­s' Op­di­vo keeps can­cer at bay in more lym­phoma pa­tients than Seagen's Ad­cetris in PhI­II: #AS­CO23

CHICAGO — In a study pitting Seagen’s Adcetris against Bristol Myers Squibb’s Opdivo in newly diagnosed patients with advanced classic Hodgkin lymphoma, a greater proportion of those who received Opdivo saw no cancer growth at one year compared to those who got Adcetris.

In addition, patients in the Opdivo arm of the Phase III trial reported reduced toxicities, according to lead investigator Alex Herrera, a hematologist-oncologist at City of Hope’s cancer cancer in Duarte, CA. Notably, the trial included more than 200 children across both arms. Generally, more than half of children with advanced Hodgkin lymphoma receive radiation therapy, but in this trial, dubbed SWOG S1826, only a handful of patients in the two arms received radiotherapy, sparing many children from long-term side effects of radiation.

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Servi­er’s vo­rasi­denib stalls pro­gres­sion of brain can­cer by 61% in piv­otal PhI­II IN­DI­GO study: #AS­CO23

An experimental pill from Servier Pharmaceuticals showed potentially practice-changing results in a narrow group of brain cancer patients, cutting the risk of their cancers progressing by 61%, according to a late-stage clinical trial.

The drug, vorasidenib, is a precision medicine that only works in certain people whose cancer carries mutations in one of two genes called IDH1/2. Doctors hope that the therapy will delay the need for chemotherapy or radiation, which are often used to combat relapses in patients who’ve previously undergone surgery to remove brain tumors.

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Take­da ax­es gene ther­a­py deal with Po­sei­da Ther­a­peu­tics amid broad­er re­think

Less than two years after Takeda inked a collaboration with Poseida Therapeutics to develop six liver-directed and hematopoietic stem cell-directed in vivo gene therapies, Takeda will end the partnership on July 30, the company confirmed to Endpoints News.

The breakup is not unexpected, coming on the heels of Takeda’s April announcement that it planned to stop discovery and preclinical work in AAV gene therapy, as well as research and preclinical work on rare hematology. A representative for Takeda confirmed that the partnership ended because of the company’s decision to stop that work.

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Who's con­fi­dent­ly in­vest­ing in biotech star­tups dur­ing these tense days? We've got some an­swers

We’ve got a changeup to our event schedule in Boston next week, where we’ll be doing a mix of live/streaming events at our base at The Seaport Hotel as part of a two-day lineup of webinars, virtual firesides and a cocktail hour Q&A with a veteran of the biotech financing scene.

The 9:30-10:30 am ET live slot on Tuesday, June 6, will now feature a panel conversation on the current state of affairs for VC investing in biotech, focusing on what startups are getting cash — and how. Alaa Halawa, head of US ventures at Mubadala, is confirmed, along with Brian Goodman at MPM and Geoff von Maltzahn, a general partner at Moderna-buoyed Flagship. I have a couple of other invites out and will let you know how that plays out.

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As­traZeneca tri­al shows mod­est ben­e­fit in ovar­i­an can­cer, but doc­tors say it's hard to ap­ply find­ings: #AS­CO23

CHICAGO — Adding AstraZeneca’s Imfinzi and Lynparza to the treatment regimen for patients with advanced ovarian cancer and no BRCA mutation extended progression-free survival (PFS) by five months, according to interim data released at the ASCO annual meeting Saturday morning.

However, the design of the Phase III study obscures how much Imfinzi is contributing to the PFS extension, doctors said, making it difficult to apply the findings to clinical practice.

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Keytru­da be­fore and af­ter lung can­cer surgery cuts re­lapse risk by 42%, but doesn’t im­prove sur­vival: #AS­CO23

CHICAGO — Merck has found partial success with its latest effort to more aggressively treat earlier stages of lung cancer.

On Saturday the pharma giant announced results from a large trial in which patients received Merck’s immunotherapy Keytruda plus chemotherapy before surgeons removed their tumors, followed by another course of Keytruda afterward.

The Phase III study, called KEYNOTE-671, enrolled 800 people with the early stages of the most common kind of lung cancer: non-small cell lung cancer, or NSCLC. Everyone got chemo before surgery, and half also got Keytruda before and after. At two years, 62.4% of those who got Keytruda kept their cancer at bay, compared to 40.6% who got a placebo.

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