Keytruda To Enjoy First-To-Market Advantage As TNBC Approval Now More Likely

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, meaning that it will likely benefit from a first-to-market advantage in the setting. But the data do not support the use of a surrogate endpoint the company unsuccessfully tried to use before.

The Kenilworth, NJ-based firm reported in May 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 survival (EFS), which was the study’s co-primary endpoint, with pathological complete response (pCR). (Also see "Merck & Co.’s Keytruda Gets Fighting Chance In TNBC" - Scrip, 13 May, 2021