ODAC votes to keep Keytru­da and Tecen­triq ac­cel­er­at­ed ap­provals in blad­der can­cer

The FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee is con­tin­u­ing to find it dif­fi­cult to say no to can­cer pa­tients, es­pe­cial­ly as blad­der can­cer pa­tients af­fect­ed by Wednes­day’s votes have few oth­er treat­ment op­tions.

Pe­ter Kang

On Wednes­day morn­ing, ODAC vot­ed 5-3 in fa­vor of keep­ing Keytru­da’s (pem­brolizum­ab) ac­cel­er­at­ed ap­proval alive as a first line blad­der can­cer treat­ment for those who are cis­platin-in­el­i­gi­ble and car­bo­platin-in­el­i­gi­ble, even af­ter a Mer­ck con­fir­ma­to­ry tri­al failed.

And on Wednes­day af­ter­noon, ODAC vot­ed 10-1 in fa­vor of keep­ing Genen­tech’s Tecen­triq (ate­zolizum­ab) as a first-line treat­ment of cis­platin-in­el­i­gi­ble pa­tients with ad­vanced/metasta­t­ic blad­der can­cer pend­ing fi­nal over­all sur­vival re­sults from a con­fir­ma­to­ry tri­al, known as IMvig­or130.

Among those vot­ing in fa­vor of Keytru­da — Mer­ck’s mega-block­buster drug, with 19 full ap­provals, in­clud­ing a full ap­proval as a sec­ond-line blad­der can­cer treat­ment, and 10 ac­cel­er­at­ed ap­provals — sev­er­al physi­cians point­ed to the lack of oth­er treat­ments for cer­tain pa­tients.

While the con­fir­ma­to­ry tri­al did not show a ben­e­fit for Keytru­da as a first-line treat­ment, much of the dis­cus­sion cen­tered on these sub­groups of pa­tients who might have no treat­ment op­tions with­out Keytru­da.

“Ac­cess to pem­brolizum­ab re­mains im­por­tant for these pa­tients, and FDA ap­proval should be main­tained un­til ad­di­tion­al con­fir­ma­to­ry da­ta are avail­able,” Pe­ter Kang, VP of clin­i­cal re­search at Mer­ck, told the com­mit­tee.

Laleh Amiri-Ko­rdestani

As far as how Mer­ck might still con­firm ben­e­fit in this in­di­ca­tion, Kang point­ed to one study that would look at Keytru­da in com­bi­na­tion with Ei­sai’s Lenvi­ma, com­pared with Keytru­da and place­bo. That tri­al is ex­pect­ed to be com­plet­ed in Oc­to­ber 2023. But the FDA said it would be chal­leng­ing to use this tri­al as it does not iso­late the ef­fect of Keytru­da. Two oth­er po­ten­tial con­fir­ma­to­ry tri­als from Mer­ck may al­so be used to con­firm its ben­e­fit, and are ex­pect­ed to fin­ish in mid-2025 and 2027.

Lay­ing out the case for FDA, Laleh Amiri-Ko­rdestani, di­vi­sion di­rec­tor in FDA’s Of­fice of On­co­log­ic Dis­eases, not­ed that the clin­i­cal tri­al ev­i­dence does not sup­port con­tin­ued ap­proval for Keytru­da in this set­ting.

Ronac Mam­tani

She al­so ex­plained how the treat­ment land­scape has changed, as last June, FDA ap­proved EMD Serono’s Baven­cio (avelum­ab) for those with blad­der can­cer who have not pro­gressed with first-line plat­inum-con­tain­ing chemother­a­py.

But Ronac Mam­tani, blad­der can­cer doc­tor at the Uni­ver­si­ty of Penn­syl­va­nia, took to the pub­lic fo­rum at the meet­ing and stressed what oth­er pan­elists had been hint­ing at — that re­tain­ing this in­di­ca­tion could be crit­i­cal for some pa­tients who are cis­platin-in­el­i­gi­ble.

For the af­ter­noon ses­sion, pan­elists were over­whelm­ing­ly in fa­vor of wait­ing for the over­all sur­vival re­sults from a con­fir­ma­to­ry tri­al to read out for Tecen­triq be­fore de­cid­ing on whether to pull the blad­der can­cer in­di­ca­tion.

Mo­hum­mad Sid­diqui, di­rec­tor of uro­log­ic on­col­o­gy at the Uni­ver­si­ty of Mary­land Med­ical Cen­ter, vot­ed to keep this ac­cel­er­at­ed ap­proval for Tecen­triq and said the in­ter­im analy­sis looks promis­ing and the FDA should wait for the fi­nal analy­sis from IMvig­or130. And Rick Paz­dur, FDA’s top on­col­o­gy head, sweet­ened the of­fer for Roche/Genetech, not­ing that if the com­pa­ny hits on the over­all sur­vival in the tri­al, they’ll be able to con­vert the Tecen­triq monother­a­py ac­cel­er­at­ed ap­proval to full ap­proval and the com­pa­ny will win a new in­di­ca­tion for Tecen­triq in com­bi­na­tion with chemo.

Mo­hum­mad Sid­diqui

Philip Hoff­man, chair of ODAC, was the on­ly com­mit­tee mem­ber to vote against keep­ing this Tecen­triq ac­cel­er­at­ed ap­proval, and he said he was con­cerned by with­draw­al of the Roche/Genen­tech drug in the sec­ond line set­ting as the pri­ma­ry end­point of over­all sur­vival was not met.

The votes on Wednes­day fol­lowed Tues­day’s meet­ing, in which com­mit­tee mem­bers vot­ed 7-2 to keep alive the ac­cel­er­at­ed ap­proval for Genen­tech’s Tecen­triq (ate­zolizum­ab) plus Abrax­ane (nab-pa­cli­tax­el) in metasta­t­ic triple neg­a­tive breast can­cer (mTNBC) while ad­di­tion­al con­fir­ma­to­ry tri­als are on­go­ing.

Three more ac­cel­er­at­ed ap­provals (in­clud­ing two for Keytru­da and one for Bris­tol My­ers Squibb’s Op­di­vo) are set for votes on Thurs­day. While the FDA does not have to fol­low the ad­vice of ODAC, it gen­er­al­ly does.

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