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Keytruda TNBC Approval Now More Likely, But Data Is Bad News For pCR Surrogate Endpoint

 
• By Alaric DeArment

Merck unveiled event-free survival results for Keytruda in triple-negative breast cancer following failure earlier this year to gain approval on a surrogate endpoint.

Keytruda's TNBC claim appears on a solid launch trajectory, but the pCR surrogate endpoint may not make the rest of the trip to approval. • Source: Alamy

Merck & Co., Inc. has bolstered its chances of winning US Food and Drug Administration approval for Keytruda (pembrolizumab) in neoadjuvant triple-negative breast cancer (TNBC) with Phase III trial data showing a benefit in event-free survival. But the data do not support the use of a surrogate endpoint the company unsuccessfully tried to use before.

In May, Merck had announced that the KEYNOTE-522 study testing Keytruda and chemotherapy before surgical resection followed by the PD-1 checkpoint inhibitor alone showed a statistically significant improvement in event-free...

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