#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.

Paul Hudson, Getty Images

UP­DAT­ED: Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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De­vel­op­ment of the Next Gen­er­a­tion NKG2D CAR T-cell Man­u­fac­tur­ing Process

Celyad’s view on developing and delivering a CAR T-cell therapy with multi-tumor specificity combined with cell manufacturing success
Overview
Transitioning potential therapeutic assets from academia into the commercial environment is an exercise that is largely underappreciated by stakeholders, except for drug developers themselves. The promise of preclinical or early clinical results drives enthusiasm, but the pragmatic delivery of a therapy outside of small, local testing is most often a major challenge for drug developers especially, including among other things, the manufacturing challenges that surround the production of just-in-time and personalized autologous cell therapy products.

Large advertisements for the drug Vivitrol decorate the walls of Grand Central Station on June 15, 2017 in New York City. (Photo: Andrew Lichtenstein via Getty)

FDA slaps down Alk­er­mes for mis­lead­ing Viv­it­rol ads — don't for­get vul­ner­a­bil­i­ty to opi­oid over­dose

The ads piqued interest as soon as they started appearing in 2016: at Grand Central Station, on the Red Line in Cambridge, and on a billboard off the New Jersey Turnpike. All showed a young person, generally with his or her arms crossed, and the question, “what is Vivitrol?”

Vivitrol’s maker, Alkermes, was in the midst of a marketing and lobbying campaign to promote the anti-opioid addiction drug — a campaign that would face significant backlash for tarnishing competitors despite little evidence for Vivitrol’s superiority.

What does $6.9B buy these days in on­col­o­gy R&D? As­traZeneca has a land­mark an­swer

Given the way the FDA has been whisking through new drug approvals months ahead of their PDUFA date, AstraZeneca and their partners Daiichi Sankyo may not have to wait until Q2 of next year to get a green light on trastuzumab deruxtecan (DS-8201).

The pharma giant this morning played their ace in the hole, showing off why they were willing to commit to a $6.9 billion deal — with $1.35 billion in a cash upfront — to partner on the drug.

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FDA in-house re­view spot­lights an is­sue with one of Hori­zon's end­points but notes ef­fi­ca­cy for lead drug

The FDA in-house review highlights a disagreement of investigators’ use of a key endpoint by Horizon Pharma in the late-stage trial for the top drug in its pipeline, but largely agreed that the antibody was effective.

Horizon submitted a BLA for thyroid eye disease (TED) drug teprotumumab in March, less than two years after they bought the drug (and the rest of a division) from Narrow River for $145 million upfront. With breakthrough status, priority review, orphan designation and in-house sales projections of up to $750 million, the one-time Roche reject became the marquee pipeline asset for a company that’s developed some of the world’s most expensive drugs.

Seat­tle Ge­net­ics de­tails pos­i­tive OS and PFS da­ta for tu­ca­tinib in breast can­cer

Seattle Genetics $SGEN is showing off more positive data around tucatinib, its pivotal-stage drug for HER2 positive breast cancer.

A month after hearing about solidly upbeat hazard ratios, we learned today that the estimated progression-free survival rate at one year was 33% in the tucatinib arm compared to 12% for patients taking trastuzumab and capecitabine alone.

Median PFS was 7.8 months (95% CI: 7.5, 9.6) in the tucatinib arm, compared to 5.6 months (95% CI: 4.2, 7.1) in the control arm.

Bat­tered, cash hun­gry In­tec feels the burn of No­var­tis re­jec­tion

It’s a case of some bad timing for Intec.

Just when a key trial testing the company’s Accordion drug delivery tech imploded in Parkinson’s disease, they handed Novartis data from a successful PK study of a custom Accordion pill engineered to deliver a Novartis compound to entice the Swiss drugmaker into signing a licensing agreement.

Novartis said thanks, but no thanks.

For the cash-strapped Israeli drug developer, the failure to clinch the deal marks a big blow. As of the third quarter, the company has $15.7 million in cash and equivalents, which HC Wainwright analysts estimate will keep the lights on into mid-2020.

Bris­tol-My­ers shows off a low-pro­file AML con­tender it gained from Cel­gene buy­out — and they’re tak­ing it straight to the FDA

Bristol-Myers Squibb reaped an enormous pipeline with its much-criticized $64 billion megadeal to buy Celgene. And it got a few hidden gems in the deal.

One of those gems was brought out for display on Tuesday, with a late-breaker at ASH on CC-486, which is now being prepped for regulatory filings at the FDA and elsewhere.

Celgene top-lined the positive results in a maintenance setting for acute myeloid leukemia a few months ago, but at ASH investigators pulled back the curtains on the all-important data they believe will give them an advantage in the commercial wars to come.

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De­sert­ed by Astel­las and Mer­ck, lit­tle Cor­re­vio still can't win over FDA pan­el con­cerned with its AFib drug's safe­ty

When the FDA spurned Astellas’ pitch for atrial fibrillation drug vernakalant in 2008, regulators made it abundantly clear that it wasn’t the efficacy they had a problem with — two Phase III trials had shown the drug successfully restored 52% of patients’ heartbeat from irregular to normal — but the cardio safety issues for a drug that was to compete with well established, low-risk options. One licensing deal, one clinical hold and several studies later, the chances of approval aren’t looking any better.