KEYNOTE-045: Pembrolizumab benefit maintained over 2 years in urothelial cancer
medwireNews: Patients with advanced urothelial cancer continue to derive a significant overall survival (OS) benefit with second-line pembrolizumab over chemotherapy, indicates an analysis of KEYNOTE-045 with more than 2 years of follow-up.
After a median follow-up of 27.7 months, the 1- and 2-year OS rates were 44.2% and 26.9% for the 270 patients who were randomly assigned to receive pembrolizumab 200 mg every 3 weeks after progressing on first-line platinum-based chemotherapy.
This was higher than the corresponding rates of 29.8% and 14.3% for their 272 counterparts who instead received investigator’s choice of paclitaxel, docetaxel, or vinflunine, and equated to a significant 30% reduction in the median risk for death with the PD-1 inhibitor.
As reported in Annals of Oncology, progression-free survival rates were also higher with pembrolizumab than chemotherapy, as was the objective response rate.
Of note, even “after this extended follow-up” the median duration of response was not reached in the pembrolizumab group (vs 4.4 months with chemotherapy), and the rates of any-grade (62.0 vs 90.6%) and grade 3 or worse (16.5 vs 50.2%) adverse events were lower, say the researchers.
And Yves Fradet (CHU de Québec-Université Laval, Québec City, Canada) and co-authors conclude that these “[l]ong-term results (>2 years’ follow-up) were consistent with those of previously reported analyses, demonstrating continued clinical benefit of pembrolizumab” in this patient population.
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