#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.

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Joshua Liang, Clover Biopharmaceuticals CEO

With world still in sore need of dos­es, Clover says its Covid-19 vac­cine is 67% ef­fec­tive in Phase III

With concerns about the Delta variant rising and much of the world still in desperate need of vaccine doses, a Chinese biotech announced Wednesday that a new shot has shown positive results in a large trial against Covid-19, including new variants.

Clover Biopharmaceuticals announced Wednesday that its vaccine candidate showed 79% efficacy against the Delta variant in a Phase II/III trial dubbed Spectra, and 67% effective against Covid-19 overall.