First 100 patients included in this planned interim
analysis
•
Evaluate ORR
•
Determine the PDL1-high expression cut point
KEYNOTE-052: study design
Balar et al. ESMO 2016
Pembrolizumab 200mg Q3W
•
Advanced urothelial cancer
•
No prior chemotherapy for metastatic disease
•
ECOG PS 0-2
•
Ineligible for cisplatin based on ≥1 of the following
–
CrCl <60 mL/min
–
ECOG PS 2
–
≥ Grade 2 neuropathy or hearing loss
–
NYHA class III CHF
N=350
Primary endpoints
•
ORR in all patients
•
ORR in patients with PD-L1–positive tumours
Secondary endpoints
•
DOR, PFS, OS, and ORR in all patients, PD-L1 positive and PD-L1–high expressing patients; safety and tolerability; establish an assay
cut point for high PD-L1 expression
