Clo­vis' Rubra­ca wins prostate can­cer ap­proval, but da­ta from ri­val Lyn­parza damp­en com­mer­cial ex­pec­ta­tions

While As­traZeneca and Mer­ck’s mar­ket-lead­ing Lyn­parza seem­ing­ly pipped Clo­vis On­col­o­gy’s ri­val Rubra­ca in help­ing prostate can­cer pa­tients, Rubra­ca has, as ex­pect­ed, made it across the fin­ish line first.

On Fri­day, the FDA ap­proved Rubra­ca in pa­tients with BR­CA mu­ta­tion-as­so­ci­at­ed metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer (mCR­PC) who have been treat­ed pre­vi­ous­ly with an­dro­gen re­cep­tor-di­rect­ed ther­a­py as well as chemother­a­py. The ap­proval marks the first ever for a PARP in­hibitor in the prostate can­cer set­ting.

The ap­proval was based on a sin­gle-arm TRI­TON2 study, with a 44% con­firmed ob­jec­tive re­sponse rate in 62 sec­ond-line pa­tients. A late-stage study eval­u­at­ing the im­pact of Rubra­ca on over­all sur­vival in prostate can­cer pa­tients is on­go­ing.

“While Clo­vis has an on­go­ing ran­dom­ized tri­al with OS as a key sec­ondary end­point, TRI­TON3, we would not ex­pect this ben­e­fit to be demon­strat­ed in time to have a sig­nif­i­cant com­mer­cial im­pact, as Lyn­parza may have al­ready ad­vanced to the front­line, based on the Phase 3 PRO­pel tri­al with ini­tial da­ta ex­pect­ed in 2021,” SVB Leerink an­a­lyst An­drew Berens wrote in a note in late April.

In April, Lyn­parza eclipsed the an­ti-an­dro­gen ther­a­pies Pfiz­er and Astel­las’ Xtan­di and John­son & John­son’s Zyti­ga by help­ing men with metasta­t­ic, cas­tra­tion-re­sis­tant prostate can­cer with BR­CA or ATM gene mu­ta­tions live longer. Pre­vi­ous­ly un­veiled da­ta al­so showed the PARP in­hibitor su­per­seded the im­pact of the an­dro­gen ther­a­pies at re­duc­ing the risk of dis­ease pro­gres­sion or death — by a sharp 66%.

An­drew Berens

“While Rubra­ca re­quires pri­or treat­ment with both an an­dro­gen-re­cep­tor and tax­ane ther­a­py, Lyn­parza’s reg­is­tra­tional PRO­found study on­ly re­quires pri­or treat­ment with an an­dro­gen-re­cep­tor treat­ment…as such, while Rubra­ca is ap­proved as a 3L ther­a­py, Lyn­parza could ob­tain ap­proval as a 2L + agent,” Berens wrote in a note on Mon­day. “Fur­ther­more, AZN’s PRO­pel study, which would ex­pand the Lyn­parza la­bel in­to 1L mCR­PC treat­ment in com­bi­na­tion with abi­raterone, is ex­pect­ed to an­nounce da­ta in 2021, po­ten­tial­ly mov­ing Lyn­parza to the front­line. In com­par­i­son, CLVS’ TRI­TON3 study in­ves­ti­gat­ing Rubra­ca ver­sus physi­cian’s choice of an­dro­gen-re­cep­tor or chemother­a­py in 1L mCR­PC will not read out da­ta un­til 2022.”

Berens has ad­just­ed his peak Rubra­ca prostate rev­enue to $130 mil­lion glob­al­ly.

Akin to Lyn­parza, Clo­vis’ Rubra­ca and GSK’s Ze­ju­la are poly (ADP-ri­bose) poly­merase (PARP) in­hibitors. PARP is a pro­tein used by dam­aged cells to ini­ti­ate re­pair, and by thwart­ing it, the class of drugs is en­gi­neered to pre­vent can­cer cells from re­pair­ing them­selves, there­by cat­alyz­ing their de­struc­tion.

While drug de­vel­op­ers have pri­mar­i­ly re­lied on BR­CA mu­ta­tions to iden­ti­fy pa­tients who can ben­e­fit from this fam­i­ly of ther­a­pies, sci­en­tists have sug­gest­ed that de­fects in oth­er genes in­volved in DNA re­pair — which ren­der cells can­cer­ous — could be prime tar­gets too.

M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

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Joe Wiley, Amryt Pharma CEO

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