#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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s latest projects is headed to Harvard.

Resilience, a company started with the goal of establishing itself as a “one-stop-shop” for companies looking to scale manufacturing, including for hard-to-develop cell and gene therapies, is less than a year old. Friday, it announced a five-year R&D deal with Harvard University that includes $30 million to develop biologics, including vaccines, nucleic acids and cell and gene therapies.

Susan Galbraith speaking at Endpoints News' virtual EUBIO21 summit

Imfinzi/treme­li­mum­ab com­bo scores As­traZeneca an­oth­er OS win — this time in liv­er can­cer

Is the tide turning on AstraZeneca’s battered PD-L1/CTLA4 combo?

A single priming dose of the experimental tremelimumab, followed by Imfinzi every four weeks, beat Nexavar (sorafenib) in helping a group of liver cancer patients live longer in a Phase III study, the company reported, meeting the primary endpoint.

Specifically, the two drugs extended overall survival for patients with unresectable hepatocellular carcinoma who had not received prior systemic therapy and were not eligible for localized treatment.

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FDA+ roundup: Marks on Wood­cock­'s tenure as act­ing com­mis­sion­er; FDA lead­ers of­fer per­spec­tive on bar­ri­ers to di­ver­si­ty in re­search

CBER director Peter Marks praised Janet Woodcock’s work as acting FDA commissioner, and while noting that Biden needs to nominate someone to fill the role permanently by Nov. 16, he said he has “no idea” when that actually might occur.

“Dr. Woodcock has been at the agency for over three decades and she, during that time, has proven herself to be a remarkably capable manager,” Marks said at the Alliance for Regenerative Medicine’s meeting Tuesday. “And she’s been managing as if she’s commissioner, unlike some previous acting [commissioners] who are afraid to actually do things. She doesn’t appear to be afraid to do things. I have not felt any different now from when we had a commissioner in place,” he added.

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