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Merck’s checkpoint star Keytruda grabs another FDA OK, steering past wreckage of a Roche disaster

Merck’s Keytruda continues to make a rapid advance to new approvals for expanded use. This time the FDA is approving their PD-1 drug for second-line as well as some first-line cases of bladder cancer — while Roche’s landmark OK for the rival Tecentriq (atezolizumab) in the same indication has been threatened by a stunning Phase III failure.

Regulators came up with an accelerated approval for Keytruda for patients whose advanced cases of urothelial cancer have progressed after chemotherapy as well as any frontline patients who aren’t eligible for cisplatin-containing chemotherapy. KEYNOTE-045 provided the data for the second-line OK, with an objective response rate of 21% for Keytruda, close to twice that achieved by chemotherapy. Those numbers underscore the promise for this field, as well as the need for combination therapies that can do much better. And Merck has hundreds of those underway now.

Those combos will be telling as the PD-1/PD-L1 checkpoint field continues to get more and more crowded. AstraZeneca already has an approval for Imfinzi (durvalumab) in bladder cancer, alongside Merck KGaA/Pfizer’s Bavencio (avelumab) and Bristol-Myers Squibb’s Opdivo. And a whole tsunami of new checkpoints from other players are coming along in the pipeline as well.

While Keytruda goes from advance to advance — most recently highlighted with a frontline OK for a combination of Keytruda and chemo for firstling use against lung cancer — this field has been roiled by startling setbacks. Roche was stunned when its confirmatory Phase III for Tecentriq failed in bladder cancer, unable to significantly improve the overall survival rate of patients after the FDA had offered an early approval. That failure may well force the FDA to yank the approval, putting the blockbuster contender under a cloud. Bristol-Myers Squibb has also felt the heat after stumbling badly in lung cancer, giving Merck the opportunity to leapfrog its lead position.


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