As­traZeneca’s shares spike on a sur­prise coup in PhI­II lung can­cer da­ta

Sean Bo­hen, As­traZeneca

As­traZeneca $AZN shares popped more than 7% this morn­ing on pos­i­tive Phase III pro­gres­sion-free sur­vival da­ta for Imfinzi (dur­val­um­ab) in treat­ing ad­vanced, in­op­er­a­ble and chemo-re­sis­tant non-small cell lung can­cer.

An­a­lysts did a quick dou­ble take and im­me­di­ate­ly cheered it as a re­mark­able – and com­plete­ly un­ex­pect­ed – hit.

That’s the right tar­get for As­traZeneca, which re­cent­ly won its first ap­proval for the world’s fifth check­point in­hibitor. On Wednes­day Mer­ck moved to the front of that field with an ap­proval to use a com­bi­na­tion of Keytru­da with chemo as a first-line ther­a­py on NSCLC, putting it on top of the heap of ri­vals look­ing to carve out a big piece of the block­buster mar­ket.

This As­traZeneca tri­al wasn’t the big study an­a­lysts have been wait­ing for.

As­traZeneca has been bet­ting heav­i­ly on MYS­TIC, us­ing a com­bi­na­tion of dur­val­um­ab and the CT­LA-4 drug treme­li­mum­ab for NSCLC. That would cre­ate some ma­jor mar­ket op­por­tu­ni­ties for the phar­ma gi­ant, which has been mak­ing a rep for it­self in the on­col­o­gy field in re­cent years — even as it’s plagued by prat­falls and dis­ap­point­ments in oth­er ar­eas of R&D.

As­traZeneca bad­ly needs every shred of good news that it can find, and there were some high fives in the or­ga­ni­za­tion on this pos­i­tive read­out, which helps the com­pa­ny dis­tin­guish it­self in the most in­tense­ly com­pet­i­tive field in bio­phar­ma.

Sea­mus Fer­nan­dez, Leerink

Sea­mus Fer­nan­dez at Leerink gave it a big thumbs up, not­ing:

This news comes as an ear­ly up­side sur­prise, as we do not cur­rent­ly have fore­casts for this in­di­ca­tion in our mod­el nor do we be­lieve this op­por­tu­ni­ty is wide­ly ap­pre­ci­at­ed by in­vestors. Im­por­tant­ly, this puts AZN square­ly in the IO fight in with a unique NSCLC in­di­ca­tion for monother­a­py PD1/PDL1 agents not cur­rent­ly shared by oth­er mem­bers of the class. AZN es­ti­mates that it is at least 2-3 years ahead of oth­er com­peti­tors, and our search­es on­ly un­cov­ered rel­a­tive­ly small sin­gle-arm Ph 2 stud­ies un­der­way for po­ten­tial com­peti­tors.

Oth­er an­a­lysts at Deutsche Bank were al­so im­pressed, of­fer­ing some block­buster num­bers for As­traZeneca on this one in­di­ca­tion.

Look for the da­ta to make the short trip to reg­u­la­tors as As­traZeneca seeks to cap­i­tal­ize on fore­casts that this drug could be worth more than $2 bil­lion a year for the com­pa­ny.

Said R&D chief Sean Bo­hen:

We look for­ward to work­ing with reg­u­la­to­ry au­thor­i­ties around the world to bring Imfinzi to lung can­cer pa­tients as soon as pos­si­ble. Along­side this, we con­tin­ue to ex­plore Imfinzi’s full po­ten­tial as monother­a­py as well as in com­bi­na­tion with treme­li­mum­ab and oth­er med­i­cines in ar­eas of con­tin­ued un­met need across mul­ti­ple types of can­cer.

At a time when the check­point can­cer mar­ket would seem to be ripe for ma­tur­ing, with 5 ap­proved, there’s in­stead been a se­ries of star­tling re­ver­sals and ad­vances. Bris­tol-My­ers Squibb made the move to the lead, then blew it with a bad­ly de­signed Phase III on front­line use. Mer­ck leapfrogged its ri­val and then, just days ago, Roche’s Tecen­triq failed a con­fir­ma­to­ry Phase III in blad­der can­cer, af­ter it had been giv­en an ac­cel­er­at­ed ap­proval.

Big sur­pris­es are be­com­ing the or­der of the day in check­point in­hi­bi­tion, a field worth tens of bil­lions of dol­lars.

As­traZeneca trum­pets the good da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Paul Hudson, Sanofi CEO (Getty Images)

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As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

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Roger Perlmutter, Merck R&D chief (YouTube)

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