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.

Illustration: Assistant Editor Kathy Wong for Endpoints News

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