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KEYNOTE-010 (P:10 mg/kg), 2016 NCT01905657

pembrolizumab (10mg/kg) (n=346) vs. docetaxel (n=343)

randomized controlled trial

Studied treatment

pembrolizumab 10 mg/kg
pembrolizumab 2 mg/kg intravenously over 30 min every 3 weeks for 24 months

Control treatment

docetaxel
docetaxel 75 mg/m² every 3 weeks for 24 months

patients in the docetaxel group were not permitted to cross over

Patients

mNSCLC - L2 - PDL1 positive

patients with appropriate tyrosine kinase inhibitor for those with an EGFR-sensitising mutation or ALK gene rearrangement were included

Method

open-label

202 academic medical centres in 24 countries

P3-2/ one sided and two interim analysis. Repartition,reallocation and hierarchy between coprimary endpoints (4 in each arm)

Remark

Pembrolizumab prolongs overall survival and has a favourable benefit-to-risk profile in patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer. (5 years results pooled 10 and 2mg)

KEYNOTE-010 (P:10 mg/kg ; PDL1>50%), 2016 NCT01905657

pembrolizumab (10mg/kg) (n=151) vs. docetaxel (n=152)

randomized controlled trial

Studied treatment

pembrolizumab 10 mg/kg
pembrolizumab 2 mg/kg intravenously over 30 min every 3 weeks for 24 months

Control treatment

docetaxel
docetaxel 75 mg/m² every 3 weeks for 24 months

patients in the docetaxel group were not permitted to cross over

Patients

mNSCLC - L2 - PDL1 positive

patients with appropriate tyrosine kinase inhibitor for those with an EGFR-sensitising mutation or ALK gene rearrangement were included

Method

open-label

202 academic medical centres in 24 countries

P3-2/ one sided and two interim analysis. Repartition,reallocation and hierarchy between coprimary endpoints (4 in each arm)

Remark

Pembrolizumab prolongs overall survival and has a favourable benefi t-to-risk profi le in patients with previously treated, PD-L1-positive, advanced non-small-cell lung cancer (5 years results pooled 10 and 2mg)