Merck Keytruda sBLA for Non-small Cell Lung Cancer

FDA has accepted for review a Merck supplemental BLA seeking approval for Keytruda (pembrolizumab) for the adjuvant treatment of patients with Stage IB, II or IIIA non-small cell lung cancer following complete surgical resection. The submission is based on data from the pivotal Phase 3 KEYNOTE-091 trial.

Merck says that the study’s interim analysis found adjuvant treatment with Keytruda demonstrated a significant improvement in disease-free survival (DFS) for patients regardless of PD-L1 expression compared to placebo. DFS in patients whose tumors express PD-L1 (tumor proportion score [TPS] greater than 50%) did not reach statistical significance under a pre-specified statistical plan, according to the company, adding that the trial will continue to analyze DFS in patients whose tumors express high levels of PD-L1 as well as other secondary endpoints.

The agency has set a user fee review action target date of 1/29/2023.