KEYNOTE-010 Update: Long-Term Benefits Continue With Pembrolizumab in NSCLC
Posted: Tuesday, November 23, 2021
A 5-year follow up to the phase III KEYNOTE-010 trial supports the clinical benefits of treatment with the PD-1 inhibitor pembrolizumab for patients with non–small cell lung cancer (NSCLC), according to Paul Bass, MD, of The Netherlands Cancer Institute, Amsterdam, and colleagues. In particular, pembrolizumab improved treatment outcomes compared with docetaxel for previously treated patients with PD-L1–positive advanced disease. The updated results of this multicenter, international study were published in the Journal of Thoracic Oncology.
“Notably, in the first-line setting, pembrolizumab has been reported to improve overall survival in patients with NSCLC as monotherapy (in patients with PD-L1–expressing tumors) and when combined with platinum-based chemotherapy (irrespective of tumor PD-L1 expression), suggesting first-line pembrolizumab options may provide greater benefit,” stated the study investigators.
Patients with stage IIIB or IV NSCLC with at least one measurable lesion who exhibited disease progression following two or more cycles of chemotherapy and tyrosine kinase inhibition for EGFR or ALK alterations were enrolled (n = 1,034). Patients were randomly assigned to receive either pembrolizumab or docetaxel once every 3 weeks. PD-L1 expression was assessed via immunohistochemistry, and samples with a Tumor Proportion Score (TPS) of 1% or greater were considered PD-L1–positive. Patients were stratified into groups with high or low PD-L1 tumor status (≥ 175 or ≤ 175 mut/exome, respectively).
At the median follow-up of 67.4 months, the overall survival hazard ratio for patients with high PD-L1 scores appeared to be significantly lower than patients with low PD-L1 scores. Further, the 5-year overall survival rates were found to be more than three times higher in patients with high PD-L1 scores treated with pembrolizumab (25%) versus docetaxel (8.2%). Overall survival rates for patients with low PD-L1 scores were more than doubled following pembrolizumab (15.6%) compared with docetaxel (6.5%) treatment. Three years following pembrolizumab treatment, the average overall survival was 83%. No new safety signals were identified.
Disclosure: For full disclosures of the study authors, visit jto.org.