Roche racks up an­oth­er check­point win as Tecen­triq scores in lat­est PhI­II lung can­cer study

Com­ing fast on the heels of Bris­tol-My­ers Squibb’s sting­ing set­back with its star can­cer ther­a­py Op­di­vo, Roche says that its PD-L1 check­point drug Tecen­triq (ate­zolizum­ab) hit its key goals in a Phase III study for non-small cell lung can­cer, ex­tend­ing the lives of pa­tients in the tri­al.

San­dra Horn­ing, Roche CMO

The phar­ma gi­ant’s big Genen­tech unit re­port­ed that Tecen­triq met its co-pri­ma­ry end­points on im­prov­ing sur­vival rates for the over­all pop­u­la­tion of lung can­cer pa­tients as well as a spe­cif­ic sub­group se­lect­ed by PD-L1 ex­pres­sion, a cru­cial bio­mark­er for this treat­ment. In­ves­ti­ga­tors gath­ered the da­ta among 1,225 pa­tients whose lung can­cer had spread on or af­ter chemo.

The phar­ma gi­ant was stick­ing with top-line da­ta on­line in this first analy­sis, hold­ing back the spe­cif­ic re­sults for an up­com­ing sci­en­tif­ic con­fer­ence — stan­dard prac­tice in R&D, at least for pos­i­tive stud­ies.  And Roche says it plans to hus­tle the new da­ta to the FDA as it works in­tent­ly on grow­ing the mar­ket.

The suc­cess lands just weeks af­ter Bris­tol-My­ers man­aged to stun just about every­one in the on­col­o­gy field with the news that its Phase III for its PD-1 drug Op­di­vo in first-line lung can­cer pa­tients had failed, in­stant­ly giv­ing Mer­ck a big edge in a huge mar­ket. Op­di­vo’s fail­ure star­tled a big crowd of in­vestors who had be­come used to con­sid­er­ing Op­di­vo as the dom­i­nant play­er, dis­rupt­ing a field that is de­liv­er­ing megablock­buster re­turns.

Roche has been play­ing catch-up with Bris­tol-My­ers — the dom­i­nant play­er — and Mer­ck. But it has at­tract­ed con­sid­er­able at­ten­tion for its com­ple­men­tary PD-L1 ap­proach, which is carv­ing out its own place in the mar­ket af­ter gain­ing its first ap­proval for blad­der can­cer back in May.

Bris­tol-My­ers’ set­back in the check­point field — where drugs dis­man­tle a mech­a­nism that hides can­cer cells from an im­mune sys­tem at­tack — spurred some sig­nif­i­cant crit­i­cism that the com­pa­ny had tried to tack­le a pa­tient pop­u­la­tion too big to de­liv­er pos­i­tive re­sults, forc­ing in­ves­ti­ga­tors to re­think how they de­sign and ex­e­cute Phase III stud­ies for a check­point pro­gram. Re­searchers on the Bris­tol-My­ers study had re­cruit­ed a broad pop­u­la­tion of 541 pre­vi­ous­ly un­treat­ed first line pa­tients whose tu­mors ex­pressed PD-L1 at a low lev­el of ≥ 5%.

Genen­tech, mean­while, has eight late-stage stud­ies on­go­ing for var­i­ous stages of lung can­cer, high­light­ing its sig­nif­i­cance in a boom­ing field. And with break­through sta­tus at the FDA, it ex­pects to hus­tle up a whole slate of ap­pli­ca­tions to ex­pand its use.

Sea­mus Fer­nan­dez at Leerink sees tougher head­winds ahead for Op­di­vo now:

At a min­i­mum, we have to as­sume that this re­sult will in­crease the view that PD-1 & PD-L1 an­ti­bod­ies have very sim­i­lar ef­fi­ca­cy pro­files, re­sult­ing in in­creased com­pe­ti­tion in 2L lung can­cer – Op­di­vo’s cur­rent strong­hold. In our view, this places even greater im­por­tance on a pos­i­tive out­come in the Check­Mate-227 (CM-227) tri­al of Op­di­vo + Yer­voy (ip­il­i­mum­ab; CT­LA-4 in­hibitor) in 1L NSCLC. While full re­sults of the OAK tri­al will de­ter­mine if physi­cians will dis­tin­guish Tecen­triq com­mer­cial­ly, we be­lieve the top line re­sults sug­gest less ef­fi­ca­cy dif­fer­en­ti­a­tion be­tween Tecen­triq, Op­di­vo, and Mer­ck’s (MP) Keytru­da (pem­brolizum­ab; PD-1 in­hibitor), and near-term, MRK is like­ly to main­tain the most unique op­por­tu­ni­ty in 1st line NSCLC.

San­dra Horn­ing, Roche’s chief med­ical of­fi­cer and head of Glob­al Prod­uct De­vel­op­ment, had this to say:

“These re­sults add to the grow­ing body of ev­i­dence that sup­ports the role of Tecen­triq as a po­ten­tial new treat­ment for spe­cif­ic types of ad­vanced NSCLC. This is very en­cour­ag­ing news for peo­ple liv­ing with this dis­ease be­cause lung can­cer is the lead­ing cause of can­cer deaths around the world. We hope to bring this treat­ment op­tion to pa­tients as soon as pos­si­ble.”

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