#ES­MO17: As­traZeneca salves sting­ing set­back with a big win in a block­buster seg­ment of the lung can­cer mar­ket

MADRID — Just weeks af­ter As­traZeneca was ham­mered by a round-one fail­ure for its check­point com­bo on non-small cell lung can­cer, the phar­ma gi­ant re­paired some of that dam­age at ES­MO with an im­pres­sive hit for a block­buster mar­ket seg­ment.

Tack­ling stage 3 lung can­cer, As­traZeneca’s top ex­ecs turned up in Madrid to un­veil da­ta from their PA­CIF­IC tri­al which re­vealed a pro­gres­sion-free sur­vival ad­van­tage of more than 11 months for a group of pa­tients tak­ing Imfinzi (dur­val­um­ab) over place­bo— 16.8 ver­sus 5.6 months. That rep­re­sents a 48% drop in the risk of pro­gres­sion.

Re­searchers treat­ed pa­tients whose can­cer was in­op­er­a­ble and had not ad­vanced wide­ly in the body fol­low­ing stan­dard chemo ther­a­py in stage 3. That wasn’t the big score they have been look­ing for with a com­bo of Imfinzi and treme­li­mum­ab for first-line ther­a­py, but it rep­re­sents a block­buster prize for a com­pa­ny that has been mak­ing some ma­jor ad­vances in on­col­o­gy in re­cent years.

“We’re go­ing to be first in half the pool in lung can­cer,” As­traZeneca CEO Pas­cal So­ri­ot told a small group of re­porters on Fri­day.

As­traZeneca’s shares surged 2% in af­ter-mar­ket trad­ing on Fri­day af­ter the num­bers hit.

Sean Bo­hen

Stage 3 it­self rep­re­sents a third of NSCLC in­ci­dence, and So­ri­ot with chief med­ical of­fi­cer Sean Bo­hen ex­plained that it po­si­tioned Imfinzi as the lead check­point in the front half of the mar­ket for stages 1 through 3, with a strate­gic ad­van­tage for mov­ing in­to stage 4 cas­es.

So­ri­ot de­murred on giv­ing his own es­ti­mate of what that is worth, stick­ing with the com­pa­ny’s ball­park fig­ure of $1 bil­lion-plus. But he al­so cit­ed a mar­ket con­sen­sus that a win in this group could spur sales of more than $2 bil­lion a year.

So­ri­ot added that he felt that look­ing over the mar­ket, As­traZeneca has a wide open shot at seiz­ing the ad­van­tage for two years be­fore a ri­val could come along in that par­tic­u­lar are­na.

The phar­ma gi­ant has al­ready sent in its mar­ket­ing ap­pli­ca­tion on this, with a break­through ther­a­py des­ig­na­tion at the FDA which could be swift­ly act­ed on by reg­u­la­tors who have been quick to wave through new ap­provals for these ap­proved check­points.

“Hav­ing stage 3 to our­selves is re­al­ly crit­i­cal,” says So­ri­ot, who need­ed this win. “I think in lung can­cer we can be a leader.”

Mer­ck is still out front in the field with its OK for Keytru­da with chemo in front-line lung can­cer, af­ter leapfrog­ging a dam­aged Bris­tol-My­ers Squibb. But the As­traZeneca ad­vance at ES­MO un­der­scores just how much near-term po­ten­tial is still at stake as the lead­ers in the PD-(L)1 field con­tin­ue to jock­ey for top spots in var­i­ous seg­ments of the can­cer mar­ket.

With an OK here, So­ri­ot and Bo­hen un­der­scored that the in­tro­duc­tion of Imfinzi was “prac­tice-chang­ing” — with physi­cians able to sim­ply add it to the stan­dard of care. A new treat­ment op­tion like this should al­so help im­prove ear­li­er screen­ing prac­tices, they said, get­ting to more of the pa­tients be­fore they fall in­to the ad­vanced stage 4 pool, which rep­re­sents the oth­er half the mar­ket, and po­ten­tial­ly tip­ping more of the mar­ket in their fa­vor.

A win here po­si­tions As­traZeneca to stake out more block­buster ter­ri­to­ry in on­col­o­gy af­ter mak­ing sol­id progress in es­tab­lish­ing Lyn­parza and Tagris­so in their re­spec­tive fields. To­geth­er those three drugs rep­re­sents So­ri­ot’s com­mit­ment to cre­at­ing a ma­jor can­cer drug fran­chise that will be es­sen­tial for turn­ing around the com­pa­ny af­ter years of wan­ing rev­enue.

As­traZeneca is not out of the woods yet, but things are look­ing up for So­ri­ot this week­end af­ter some bleak set­backs ear­li­er in the year.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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UP­DAT­ED: Stay tuned: Bio­gen’s num­bers are great — it’s their wor­ri­some fu­ture that leaves an­a­lysts skit­tish

Biogen came out with an upbeat assessment of their Q2 numbers today, discounting the arrival of a key rival for its blockbuster Spinraza franchise. But the top execs remain grimly determined to not say much anything new about the sore points that have dragged down its stock, including the future of its big investment in Alzheimer’s or how it plans to invest the considerable cash that the big biotech continues to reap.

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Why wait? Cel­gene re­struc­tures a big Jounce pact — ze­ro­ing in on new I/O path­way with $530M deal and bump­ing ICOS

Celgene’s business team isn’t waiting for the big merger with Bristol-Myers Squibb to go through before syncing its strategy with the new mother ship.

Tuesday evening the big biotech unveiled a $530 million deal — $50 million in upfront cash — to amend their alliance with Jounce Therapeutics $JNCE to gain worldwide rights to JTX-8064, an antibody that targets the LILRB2 receptor on macrophages. Their old, $2.6 billion deal is being scrapped, leaving Jounce with a pipeline that includes the lead drug, the ICOS-targeting vopratelimab.

PACT Phar­ma says it's per­fect­ed the tech to se­lect neoanti­gens for per­son­al­ized ther­a­py — now on­to the clin­ic

At PACT Pharma, the lofty goal to unleash a “tsunami” of T cells personalized for each patient has hinged on the ability to correctly identify the neoantigens that form something of a fingerprint for each tumor, and extract the small group of T cells primed to attack the cancer. It still has a long way to go testing a treatment in humans, but the biotech says it has nailed that highly technical piece of the process.

UP­DAT­ED: My­ovan­t's uter­ine fi­broid drug looks com­pet­i­tive in PhI­II — but can they van­quish mighty Ab­b­Vie?

Vivek Ramaswamy’s Myovant $MYOV has closely matched its positive first round of Phase III data for their uterine fibroid drug relugolix, setting up a head-to-head rivalry with pharma giant AbbVie as the little biotech steers to the market with a planned filing in Q4.

Here’s how Myovant plans to prevail over the AbbVie $ABBV empire.

In the study, 71.2% of women receiving once-daily relugolix combination therapy achieved the clinical response they were looking for, compared to only 14.7% in the control arm. The data comfortably reflected the same outcomes in the first Phase III — 73.4% of women receiving once-daily oral relugolix combination therapy achieved the responder criteria compared with 18.9% of women receiving placebo — which will reassure regulators that they are getting the carefully randomized data that qualifies for the FDA’s gold standard for success.

Lit­tle Mar­i­nus sees its shares eclipsed as the Sage ri­val fails to com­pare on PPD in PhII

The executive team at Sage $SAGE have skirted another potential pitfall on its way to racking up a big future for its depression drug Zulresso.

Little Marinus Pharmaceuticals $MRNS had sought to challenge the Sage drug with an IV formulation — followed by an oral version — of ganaxolone for postpartum depression. But researchers say their Phase II study failed to positively differentiate itself from a placebo at 28 days — leaving them to hold up “clinically meaningful” data within the first day of administration compared to the control arm.

Roche cuts loose Tam­i­flu OTC rights, hand­ing Sanofi the keys as the phar­ma gi­ant dou­bles down on Xofluza

Roche set out to make a better flu medicine than Tamiflu as that franchise was headed to a generic showdown. Now they’ll see just how well Xofluza stacks up against the mainstay drug after handing off over-the-counter rights in the US to Sanofi.

Sanofi $SNY says it will now step in to negotiate a deal with the FDA to steer Tamiflu into the OTC market, a role that could well involve new studies to ease passage of the drug out of doctor’s hands and into the consumer end of the market. And the French pharma giant will have first dibs over “selected” OTC markets around the world as they push ahead.

Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.