#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.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,200+ biopharma pros reading Endpoints daily — and it's free.

FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,200+ biopharma pros reading Endpoints daily — and it's free.

Al Sandrock, Biogen R&D chief (Biogen via YouTube)

UP­DAT­ED: Bio­gen push­es in a fresh stack of chips and starts prep­ping a glob­al R&D game plan af­ter watch­ing the cards turn on ear­ly throm­bolyt­ic da­ta

After patiently steering through a decade-long journey for its early-stage clinical work, a small Tokyo biotech has clinched a deal to out-license its lead thrombolytic agent to US heavyweight Biogen — which sees a potentially game-changing impact on the clot-busting field after taking a careful look at some upbeat Phase IIa data.

Three years after Biogen anted up $4 million to gain an option on the drug from TMS, the big US biotech is making a small bet to beef up its stroke portfolio. The BD team inked a deal to go ahead and grab rights to the drug for $18 million, with another $335 million in milestone cash on the table for a successful outcome.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,200+ biopharma pros reading Endpoints daily — and it's free.

Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,200+ biopharma pros reading Endpoints daily — and it's free.

A clos­er look at the FDA’s more than 700 pan­dem­ic-re­lat­ed record re­quests to re­place on­site in­spec­tions

As the pandemic constrained the FDA’s ability to travel for onsite manufacturing inspections, the agency increasingly turned to requesting records to fill the gap, even for hundreds of US-based facilities.

FDA explains in its guidance on manufacturing inspections during the pandemic that the agency can request records (not to be confused with the FDA’s remote interactive evaluations) directly from facilities “in advance of or in lieu of” certain onsite inspections. Companies are legally required to fulfill those requests because a denial may be considered limiting an inspection, which could lead to the FDA deeming a drug made at that site to be adulterated.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Stephen Squinto, Gennao Bio CEO (Gennao)

Alex­ion co-founder Stephen Squin­to is back in the game as CEO, this time for a small gene ther­a­py play­er

With his name already behind a rare disease success story in Alexion, Stephen Squinto was looking for a great story to drive him to jump back into the biotech game. He found that in a fledging non-viral gene therapy company, and now he’s got a few backers on board as well.

On Tuesday, Gennao Bio launched with a $40 million Series A co-led by OrbiMed and Logos Capital with participation by Surveyor Capital. The biotech, which is looking to use its cell-penetrating antibody platform to deliver nucleic acid “payloads” during into the nucleus, had to rush for its initial series — and had a name change along the way.

Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.