On January 26, 2023, the #FDA has approved #pembrolizumab for adjuvant treatment of NSCLC patients following complete resection and platinum-based chemotherapy (if indicated) for stage IB (T2a ≥4 cm), II, or IIIA with any histology or PD-L1 expression level.

The approval was based on the phase III KEYNOTE-091 (PEARLS) trial which randomized patients (1:1) to pembrolizumab 200 mg or placebo, both administered IV every 3 weeks for up to 18 cycles. Results demonstrated a statistically significant improvement in DFS, with median DFS of 53·6 months in the pembrolizumab group versus 42·0 months in the placebo group (HR 0·76, p=0·0014).