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Bladder Cancer Market Wide Open As Tecentriq Fails Confirmatory 2L Trial

 
• By Sukaina Virji

A cloud hangs over the approval of Roche's Tecentriq in the second line treatment of bladder cancer following the failure of a confirmatory Phase III trial. Meanwhile, rival product Bavencio from Merck KGaA and Pfizer has been granted accelerated approval by the FDA.

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Shark-infested waters: Roche failure highlights competitive risks • Source: Shutterstock

A Phase III trial ‒ IMVigor211 ‒ in second-line urothelial (bladder) cancer of Roche's anti-PD-L1 immuno-oncology drug Tecentriq (atezolizumab) has failed to show a survival benefit. This study was required to confirm full approval with the US FDA following Tecentriq's accelerated approval last year based on the IMvigor210 study.

"This comes as a surprise to us, considering Merck & Co. Inc.Keytruda (pembrolizumab) showed an OS (overall survival) benefit in its pivotal Keynote-045 trial," said Leerink Research analyst Seamus...

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