Bris­tol My­er­s' Op­di­vo scores pri­or­i­ty re­view in com­mon blad­der can­cer, mark­ing lat­est win in PD-1 bat­tle with Keytru­da

Two months af­ter Bris­tol My­ers Squibb an­nounced Op­di­vo near­ly dou­bled the av­er­age length of time pa­tients with a com­mon blad­der can­cer lived with­out dis­ease re­cur­rence, reg­u­la­tors have said they’ll give the PD-1 block­buster an ex­pe­dit­ed look.

The FDA has grant­ed pri­or­i­ty re­view to Op­di­vo as an ad­ju­vant treat­ment in mus­cle-in­va­sive urothe­lial can­cer, Bris­tol My­ers said on Fri­day, mark­ing the lat­est win in the phar­ma’s bid to out­shine Mer­ck’s su­per­star I/O Keytru­da. The agency tapped Sept. 3 for a PDU­FA date.

Dana Walk­er

Urothe­lial car­ci­no­ma fre­quent­ly be­gins in the cells that line the in­side of the blad­der, but can al­so oc­cur in oth­er parts of the uri­nary tract, in­clud­ing the ureters and re­nal pelvis. While the ma­jor­i­ty of cas­es are di­ag­nosed ear­ly, the chance of re­cur­rence and dis­ease pro­gres­sion is high.

“Af­ter pa­tients un­der­go surgery for mus­cle-in­va­sive urothe­lial car­ci­no­ma, they con­tin­ue to face un­cer­tain­ties giv­en the high rate of dis­ease re­cur­rence and the lack of safe and ef­fec­tive treat­ment op­tions,” Dana Walk­er, Bris­tol My­ers’ VP and de­vel­op­ment lead for gen­i­touri­nary can­cers, said in a state­ment. “We look for­ward to work­ing with the FDA to­wards the goal of bring­ing the first ad­ju­vant im­munother­a­py op­tion to these pa­tients in the U.S.”

The FDA’s de­ci­sion was based on re­sults from the Phase III Check­Mate -274 tri­al, in which Op­di­vo came close to dou­bling dis­ease-free sur­vival, with a me­di­an of 21 months in the treat­ment arm and 10.9 months in the place­bo arm. And for pa­tients whose tu­mors ex­press PD-L1 ≥1%, Op­di­vo re­duced the risk of dis­ease re­cur­rence or death by 47%, ac­cord­ing to BMS.

In ad­di­tion to meet­ing both pri­ma­ry end­points — dis­ease-free sur­vival in all pa­tients and in the sub­set whose tu­mors ex­pressed PD-L1 ≥1% — Op­di­vo met key sec­ondary end­points, in­clud­ing the time pa­tients lived with­out re­cur­rence out­side the blad­der, ureters or re­nal pelvis (al­so called non-urothe­lial tract re­cur­rence-free sur­vival, or NU­TRFS.) Those giv­en Op­di­vo achieved a me­di­an NU­TRFS of 24.6 months com­pared to 13.7 months for those who got the place­bo.

Since snag­ging its first ap­proval in 2014, Op­di­vo has built up a long list of in­di­ca­tions, rang­ing from metasta­t­ic non-small cell lung can­cer to metasta­t­ic squa­mous cell car­ci­no­ma of the head and neck, and sev­er­al oth­ers in com­bi­na­tion with Yer­voy. But set­backs over the last few years have left it trail­ing be­hind Mer­ck. While Keytru­da raked in $14.4 bil­lion in sales last year, Op­di­vo took home just un­der $7 bil­lion.

Back in De­cem­ber, BMS agreed to stop mar­ket­ing  Op­di­vo in third-line-or-lat­er small-cell lung can­cer af­ter con­fir­ma­to­ry tri­als for an ac­cel­er­at­ed nod failed to show ben­e­fit in ex­tend­ing pa­tients’ lives. And just a week be­fore that, the phar­ma  did the same for its pro­gram for brain tu­mor pa­tients af­ter Op­di­vo failed to pro­long the lives of pa­tients with new­ly di­ag­nosed MGMT-pos­i­tive glioblas­toma mul­ti­forme.

Ear­li­er this year, though, Op­di­vo picked up an­oth­er pri­or­i­ty re­view to treat first-line pa­tients with ad­vanced or metasta­t­ic gas­tric can­cer, gas­troe­sophageal junc­tion can­cer or esophageal ade­no­car­ci­no­ma in com­bi­na­tion with chemother­a­py. The agency set an ac­tion date of May 25 for that ap­pli­ca­tion.

Keytru­da scored an ap­proval in non-mus­cle-in­va­sive blad­der can­cer last Jan­u­ary.

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Robert Califf, FDA commissioner (Tom Williams/CQ Roll Call via AP Images)

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