Keytruda has received two sBLA acceptances from FDA for the treatment of triple negative breast cancer:
FDA has accepted and granted priority review for a new sBLA seeking accelerated approval for Keytruda in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10), based on the phase 3 KEYNOTE-355 trial. FDA has set a target action date of Nov. 28, 2020.
FDA also accepted for standard review a new sBLA for Keytruda for the treatment of patients with high-risk early-stage TNBC, in combination with chemotherapy as neoadjuvant treatment, and then as a single agent as adjuvant treatment after surgery, based on the phase 3 KEYNOTE-522 trial. The target action date for this application is March 29, 2021.
Keytruda is sponsored by Merck. These are the first U.S. applications for Keytruda in breast cancer.
The applications are based on data from the KEYNOTE-355 and KEYNOTE-522 trials, respectively. In KEYNOTE-355, Keytruda plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared with chemotherapy alone in patients whose tumors expressed PD-L1 at CPS ≥10.
Approximately 38% of patients enrolled in KEYNOTE-355 had tumors expressing PD-L1 at CPS ≥10. As previously announced, the trial will continue without changes to evaluate the other dual primary endpoint of overall survival.
In KEYNOTE-522—the first randomized trial of an anti-PD-1 therapy in the neoadjuvant/adjuvant setting for TNBC—neoadjuvant Keytruda plus chemotherapy resulted in a statistically significant increase in pathologic complete response in patients with early-stage TNBC, regardless of PD-L1 expression.
The Keytruda regimen also demonstrated a favorable trend for the other dual primary endpoint of event-free survival. As previously announced, Keytruda plus chemotherapy was granted Breakthrough Therapy designation by FDA for the neoadjuvant treatment of patients with high-risk early-stage TNBC.
