Keytruda TNBC Approval Now More Likely, But Data Is Bad News For pCR Surrogate Endpoint
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.
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The company previously was unsuccessful securing accelerated approval based on complete response data, but event-free survival results may be more persuasive.
Although US FDA panelists said that ideally a new confirmatory trial would be conducted in the same triple-negative breast cancer population, they acknowledged the sponsor’s feasibility concerns and suggested instead that the IMpassion132 trial, expected to report in 2023, might suffice.