- Merck (NYSE:MRK) announces that the FDA has approved KEYTRUDA, an anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery, based on the Phase 3 KEYNOTE-522 trial.
- KEYNOTE-522 showed that KEYTRUDA in combination with chemotherapy significantly prolonged event-free survival versus the same neoadjuvant chemotherapy regimens alone – there was a 37% reduction in the risk of disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause (HR=0.63 [95% CI, 0.48-0.82]; p=0.00031).
- With this approval, KEYTRUDA is now approved in the U.S. for 30 indications.
- Additionally, the FDA converted the accelerated approval of KEYTRUDA in combination with chemotherapy recurrent unresectable or metastatic TNBC to a full (regular) approval based on confirmatory data from KEYNOTE-522.
- This approval was originally granted in November 2020 based on results from the Phase 3 KEYNOTE-355 trial.