Phase III study of pembrolizumab in high-risk early stage triple negative breast cancer (KEYNOTE-522) meets dual primary endpoint
Use of pembrolizumab with chemotherapy as neoadjuvant treatment and then continuing as single-agent adjuvant treatment after surgery showed a statistically significant and clinically meaningful improvement in event-free survival compared with neoadjuvant chemotherapy alone
Source:
Biospace Inc.
SPS commentary:
As previously published in the New England Journal of Medicine, KEYNOTE-522 met its other dual primary endpoint of pathological complete response (pCR). Merck submitted a supplemental Biologics License Application seeking approval of pembrolizumab in this setting, based on the pCR results and on early interim data on event-free survival. The FDA committee reviewing the application ruled that a regulatory decision be deferred until further data were available from this study.