For patients with mNSCLC whose tumors express PD-L1 (TPS ≥1%) and who progressed on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
KEYNOTE-010 study design1: An open-label, multicenter, randomized, phase 2/3 trial of single-agent KEYTRUDA vs docetaxel in 1,033 patients with squamous or nonsquamous mNSCLC. The trial included patients whose tumors were PD-L1 positive based on a TPS ≥1%, as determined by the PD-L1 immunohistochemistry 22C3 pharmDx assay. Patients also had disease progression following platinum-containing chemotherapy and, if appropriate, targeted therapy for EGFR or ALK genomic tumor aberrations. Patients with an autoimmune disease; a medical condition that required immunosuppression; or who had received more than 30 Gy of thoracic radiation within 26 weeks were ineligible. Patients received KEYTRUDA 2 mg/kg (n=344) or 10 mg/kg (n=346) or docetaxel 75 mg/m2 (n=343) Q3W until unacceptable toxicity or disease progression or for up to 24 months. Tumor status was assessed every 9 weeks. Co-primary end points were OS and PFS, as assessed by blinded independent central review using Response Evaluation Criteria In Solid Tumors v1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.
aHazard ratio (KEYTRUDA compared with docetaxel) based on the stratified Cox proportional hazard model.
bAll responses were partial responses.
ALK = anaplastic lymphoma kinase; CI = confidence interval; DOR = duration of response; EGFR = epidermal growth factor receptor; HR = hazard ratio; mNSCLC = metastatic non–small cell lung cancer; NR = not reached; ORR = objective response rate; OS = overall survival; PD-L1 = programmed death ligand 1; PFS = progression-free survival; Q3W = every 3 weeks; TPS = tumor proportion score.