Wel­come Imfinzi: As­traZeneca crash­es the check­point par­ty late with a green light for dur­val­um­ab

And then there were 5.

The FDA hand­ed out its lat­est ap­proval for a PD-L1 check­point in­hibitor on Mon­day af­ter­noon, giv­ing a green light to As­traZeneca to start sell­ing dur­val­um­ab as Imfinzi as a sec­ond-line ther­a­py for metasta­t­ic urothe­lial car­ci­no­ma.

Pas­cal So­ri­ot

The reg­u­la­to­ry OK comes in the wake of ap­provals for Mer­ck, Bris­tol-My­ers Squibb, Roche/Genen­tech and Pfiz­er/Mer­ck KGaA. The bi­ol­o­gy of these new check­point drugs is well un­der­stood now, and the FDA is­sued its ap­proval af­ter a rel­a­tive­ly small, sin­gle-arm study.

Reg­u­la­tors waved this one through af­ter giv­ing dur­val­um­ab a break­through drug des­ig­na­tion and pri­or­i­ty re­view, even though its the third ap­proval for a check­point ther­a­py in blad­der can­cer.

Dur­val­um­ab’s longterm suc­cess is cru­cial to the fu­ture of As­traZeneca and CEO Pas­cal So­ri­ot. Billed as a block­buster-to-be, fol­low­ing a com­mer­cial trail al­ready clear­ly laid out, the big show­down for As­traZeneca comes lat­er in the year, when it rolls out late-stage da­ta on a com­bi­na­tion of its check­point com­bo in its MYS­TIC study, which match­es dur­val­um­ab with treme­li­mum­ab, a CT­LA-4 sim­i­lar to Yer­voy, for lung can­cer.

The ju­ry is still out, though, on how well a CT­LA-4 drug — with all its at­ten­dant tox­i­c­i­ty — will do in this field. That’s one rea­son why Bris­tol-My­ers Squibb re­cent­ly inked a deal with Cy­tomX on a next-gen CT­LA-4 that might prove far bet­ter for pa­tients.

Sea­mus Fer­nan­dez at Leerink not­ed some mod­est ex­pec­ta­tions on this first ap­proval. The up­side lies fur­ther down the road.

Al­though this in­di­ca­tion rep­re­sents a rel­a­tive­ly small op­por­tu­ni­ty for AZN (we fore­cast Imfinzi cap­tur­ing 10% of our es­ti­mat­ed ~$2.3B WW blad­der can­cer mar­ket), the ap­proval will al­low the agent to be­come more fa­mil­iar with on­col­o­gists and should help fa­cil­i­tate fu­ture sBLAs for drug. The ma­jor in­di­ca­tion for Imfinzi re­mains first-line (1L) non-small cell lung can­cer (NSCLC) and we await top-line da­ta from the Phase 3 MYS­TIC tri­al in com­bi­na­tion with treme­li­mum­ab (an­ti-CT­LA-4) ex­pect­ed in mid-2017.

As­traZeneca, mean­while, raised a red flag last week when it de­layed its third-line read­out in the ARC­TIC study of the duo, spurring some sus­pi­cions that it was on track to a trou­bling fail­ure that would have raised se­ri­ous doubts about its fu­ture in the field.

The oth­er ques­tion that many of us have is how many of these PD-1/PD-L1 check­points can be ap­proved be­fore they start slic­ing and dic­ing this mar­ket in­to ever small­er bites. A range of sec­ond-wave check­points are in de­vel­op­ment now, with every­one that’s fi­nanced well enough and in­ter­est­ed in it go­ing af­ter one of their own.

That group in­cludes In­cyte, which has been part­ner­ing with the main­stream check­points in nonex­clu­sive arrange­ments. And the main play­ers, like Mer­ck and Bris­tol-My­ers, are al­ready well along with their own com­bi­na­tion tri­als. Hun­dreds of them.

The ap­proval, though, marks a big win for As­traZeneca, which has made sig­nif­i­cant progress on the on­col­o­gy front in the last few years. They had to have this one to re­main a cred­i­ble ri­val. And they got it.

The FDA has been on a drug ap­proval spree over the last few days. This is the fifth OK for a new chem­i­cal en­ti­ty in the last three work­ing days, bring­ing the year-to-date to­tal to 19. Last year, which saw a big dip in ap­provals, the FDA ap­proved a to­tal of 22 new drugs.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

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