Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Reg­u­la­tors didn’t keep As­traZeneca and Dai­ichi Sankyo wait­ing long at all for their lat­est En­her­tu ap­proval.

The part­ners pulled a win on Fri­day in HER2-low breast can­cer pa­tients who’ve al­ready failed on chemother­a­py, less than two weeks af­ter its sup­ple­men­tal BLA was ac­cept­ed. While this isn’t the FDA’s fastest ap­proval — Bris­tol My­ers Squibb won an OK for its block­buster check­point in­hibitor Op­di­vo in just five days back in March — it comes well ahead of En­her­tu’s orig­i­nal Q4 PDU­FA date.

En­her­tu is now the first ther­a­py ap­proved to treat pa­tients with HER2-low breast can­cer, a new­ly de­fined sub­set of HER-2 neg­a­tive breast can­cer pa­tients, ac­cord­ing to the FDA. About 60% of HER2-neg­a­tive pa­tients fall in­to the HER2-low buck­et, mean­ing they have some HER2 pro­teins, but not enough to be clas­si­fied as HER2-pos­i­tive, reg­u­la­tors said in a news re­lease.

Pa­tients can take the drug if they’ve re­ceived a pri­or chemother­a­py in the metasta­t­ic set­ting, or seen their can­cer re­turn with­in six months of com­plet­ing ad­ju­vant chemother­a­py.

Ash­ley Gaines

“This ap­proval in HER2-low breast can­cer is prob­a­bly one of the most mean­ing­ful ap­provals in the breast can­cer space in decades, both in terms of re­defin­ing the way breast can­cer pa­tients are clas­si­fied, as well as of­fer­ing a treat­ment op­tion in an area of such sig­nif­i­cant un­met need,” Ash­ley Gaines, As­traZeneca’s VP and US fran­chise head of the breast can­cer busi­ness, told End­points News. 

Gaines added that the com­pa­ny has an “ex­ten­sive ed­u­ca­tion­al plan” in place to start ed­u­cat­ing health­care providers and pa­tients on En­her­tu and how to clas­si­fy HER2-low pa­tients.

The ap­proval was based on da­ta from the DES­TINY-Breast04 study, which As­traZeneca and Dai­ichi un­veiled ear­li­er this year at AS­CO to a stand­ing ova­tion.

Of the 494 hor­mone re­cep­tor pos­i­tive (HR+) pa­tients, those on En­her­tu saw a 49% re­duc­tion in the risk of dis­ease pro­gres­sion or death com­pared to chemother­a­py (P<0.0001).  Across all pa­tients (in­clud­ing 63 hor­mone re­cep­tor neg­a­tive (HR-) pa­tients), re­searchers saw “a sim­i­lar 50% re­duc­tion in the risk of dis­ease pro­gres­sion or death,” com­pared to chemother­a­py, ac­cord­ing to a news re­lease.

Me­di­an pro­gres­sion-free sur­vival was 9.9 months in the En­her­tu pop­u­la­tion, com­pared to 5.1 months in the chemo arm.

The drug did, how­ev­er, get slapped with boxed warn­ings for in­ter­sti­tial lung dis­ease (ILD)/pneu­moni­tis and em­bryo-fe­tal tox­i­c­i­ty. Treat­ment-re­lat­ed ILD or pneu­moni­tis oc­curred in 12% of pa­tients, the ma­jor­i­ty of which were low-grade, ac­cord­ing to the part­ners. Three pa­tients in the tri­al died from ILD or pneu­moni­tis, as well as two pa­tients from sep­sis, and oth­ers from is­chemic col­i­tis, dis­sem­i­nat­ed in­travas­cu­lar co­ag­u­la­tion, dys­p­nea, febrile neu­trope­nia, gen­er­al phys­i­cal health de­te­ri­o­ra­tion, pleur­al ef­fu­sion and res­pi­ra­to­ry fail­ure.

“Ear­ly de­tec­tion and in­ter­ven­tion is key in en­sur­ing that pa­tients can be well-man­aged, and that has been and con­tin­ues to be a crit­i­cal ed­u­ca­tion pri­or­i­ty for us,” par­tic­u­lar­ly with ILD, Gaines said.

En­her­tu was first ap­proved back in De­cem­ber 2019 in HER2-pos­i­tive breast can­cer, and has since racked up in­di­ca­tions in ear­li­er breast can­cer set­tings and some types of gas­tric can­cer. As­traZeneca paid $1.35 bil­lion up­front for the col­lab­o­ra­tion rights back in 2019, and up­on the new ap­proval, the phar­ma gi­ant owes Dai­ichi Sankyo an­oth­er $200 mil­lion in mile­stone pay­ments.

It comes at a good time, as Dai­ichi lost a bid just a cou­ple weeks ago to es­cape a $42 mil­lion patent in­fringe­ment case. A ju­ry award­ed Seagen back in April af­ter find­ing that Dai­ichi in­fringed on a patent for its an­ti­body-drug con­ju­gate tech­nol­o­gy in the de­vel­op­ment of En­her­tu — and de­spite an ef­fort by Dai­ichi to ap­peal the de­ci­sion, a Texas fed­er­al judge up­held it last month.

Dai­ichi said at the time that it would con­tin­ue to ex­plore its op­tions to con­test the rul­ing.

Up­on an­nounc­ing En­her­tu’s new in­di­ca­tion, the FDA not­ed the Can­cer Moon­shot ini­tia­tive, an Oba­ma-era mis­sion reignit­ed by Pres­i­dent Joe Biden back in Feb­ru­ary with the goal of re­duc­ing the can­cer death rate by at least 50% over the next 25 years. Just weeks ago, the pres­i­dent tapped a Can­cer Cab­i­net to get things mov­ing.

“En­her­tu’s ap­proval fur­ther il­lus­trates how the FDA’s ef­forts align with the Can­cer Moon­shot goals of tar­get­ing the right treat­ments to the right pa­tients, speed­ing progress against the most dead­ly and rare can­cers, and learn­ing from the ex­pe­ri­ence of all pa­tients,” the FDA said in a news re­lease.

This ar­ti­cle has been up­dat­ed to clar­i­fy that En­her­tu’s ap­proval came less than two weeks af­ter the sBLA ac­cep­tance.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

No­var­tis un­veils 'US-first' strat­e­gy ahead of San­doz spin­off

Weeks after announcing the spinoff of generics arm Sandoz, Vas Narasimhan paints a picture of the new, slimmer Novartis — with a “US-first mindset,” he said at an investor event on Thursday.

The CEO unveiled ambitious plans to become a top-five player in the US by 2027 at Novartis’ “Meet the Management” event in Basel, Switzerland, which means ramping up clinical trials in the states and “building capability and talent, among other things.” The company’s also shooting for a top-three ranking in China.

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Pfiz­er sacks phar­ma com­pe­ti­tion in ear­ly NFL TV ad­ver­tis­ing sea­son

If pharma advertising had a fantasy football league, Pfizer would be crushing the competition. A dive into the National Football League’s TV commercial buys across early season games by iSpot shows a hefty lead with its Covid-19 Comirnaty vaccine ads.

More than 175 million impressions with $9.5 million in media spending put Pfizer in the top spot with a 65% share of voice across NFL pharma spending, according to the real-time TV ad tracker. In a distant second place is Bristol Myers Squibb’s Opdivo with 44 million impressions, $5.2 million in spending and a 16% share, followed by BMS’ Zeposia with 31 million impressions, $3.3 million in media buys and an 11% share.

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