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FDA Brief: Application Accepted for Pembrolizumab as Adjuvant Therapy Early-Stage NSCLC

By: Lauren Velentzas
Posted: Thursday, June 16, 2022

Merck recently announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental biologics license application seeking approval for pembrolizumab (Keytruda) for the adjuvant treatment of patients with stage IB (≥ 4 cm), II, or IIIA non–small cell lung cancer (NSCLC) after complete surgical resection. Pembrolizumab has already been approved for several indications in NSCLC. The FDA has set a target action date of January 29, 2023.

The application is based on data from the phase III KEYNOTE-091 trial, a study with dual primary endpoints of disease-free survival regardless of PD-L1 expression and disease-free survival in patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥ 50%). The results were presented as part of the European Society for Medical Oncology (ESMO) 2022 Virtual Plenary series. During the interim analysis, pembrolizumab demonstrated improvement in disease-free survival for patients regardless of PD-L1 expression when compared with placebo. In patients whose tumors expressed PD-L1 (TPS ≥ 50%), disease-free survival did not reach statistical significance. The trial will continue to analyze disease-free survival in patients whose tumors express high levels of PD-L1 (TPS ≥ 50%) as well as other secondary endpoints.


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