Mature results from the KEYNOTE-045 trial were presented at ESMO 2017.
The phase 3 study KEYNOTE-045 randomly assigned patients whose urothelial cancer had recurred or progressed after platinum-based chemotherapy, to either pembrolizumab (n=272) or the investigator’s choice of paclitaxel, docetaxel, or vinflunine chemotherapy (n=270).
Now the 22.5 months of follow-up data confirmed a significantly longer survival in patients with advanced urothelial cancer who receive the checkpoint inhibitor pembrolizumab after initial chemotherapy, compared to an alternative chemotherapy regimen. Pembrolizumab resulted in an approximately 3 month advantage in overall survival (OS compared to that of a second-line of chemotherapy (median 10.3 months vs. 7.4 months), with a further improvement in the hazard ratio [HR] from 0.73 to 0.70 (P = 0.0003) since the interim analysis.
The progression-free survival was not superior with pembrolizumab: median progression-free survival (PFS) was not significantly different (2.1 months for pembrolizumab vs 3.3; HR, 0.96; P = 0.32).
Quality of life (QOL), measured at week 15 and reported earlier this year, showed better results in the pembrolizumab arm.