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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Vas Narasimhan. Getty Images

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David Liu, Liu Group

David Liu un­veils newest ad­vance­ment in CRISPR tech: Prime edit­ing

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Fra­zier Health­care Part­ner­s' der­ma­tol­ogy up­start at­tracts a mar­quee syn­di­cate, $94M+ for 'in-be­tween' top­i­cal drug

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IM­brave150: Roche’s reg­u­la­to­ry crew plans a glob­al roll­out of Tecen­triq com­bo for liv­er can­cer as PhI­II scores a hit

Just weeks after Bristol-Myers Squibb defended its failed pivotal study pitting Opdivo against Nexavar in liver cancer, Roche says it’s beat the frontline challenge with a combination of their PD-L1 Tecentriq with Avastin. And now they’re rolling their regulatory teams in the US, Europe and China in search of a new approval — badly needed to boost a trailing franchise effort.
Given their breakthrough and Big Pharma status as well as the use of two approved drugs, FDA approval may well prove to be something of a formality. And the Chinese have been clear that they want new drugs for liver cancer, where lethal disease rates are particularly high.
Researchers at their big biotech sub, Genentech, say that the combo beat Bayer’s Nexavar on both progression-free survival as well as overall survival — the first advance in this field in more than a decade. We won’t get the breakdown in months of life gained, but it’s a big win for Roche, which has lagged far, far behind Keytruda and Opdivo, the dominant PD-1s that have captured the bulk of the checkpoint market so far.
Researchers recruited hepatocellular carcinoma — the most common form of liver cancer — patients for the IMbrave150 study who weren’t eligible for surgery ahead of any systemic treatment of the disease.
Roche has a fairly low bar to beat, with modest survival benefit for Nexavar, approved for this indication 12 years ago. But they also plan to offer a combo therapy that could have significantly less toxicity, offering patients a much easier treatment regimen.
Cowen’s Steven Scala recently sized up the importance of IMbrave150, noting:

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