Pembrolizumab Improves OS, ORR After 2 Years vs Chemotherapy in Urothelial Cancer
Of 542 enrolled patients, 270 were randomly assigned to pembrolizumab and 272 were assigned to chemotherapy. All patients progressed after platinum therapy.
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Pembrolizumab may improve overall survival (OS), with fewer adverse events (AEs), vs chemotherapy among patients with advanced or metastatic urothelial cancer, according to research being presented at the 2018 Genitourinary Cancers Symposium in San Francisco, California.1
Interim results of KEYNOTE-045 (ClinicalTrials.gov Identifier: NCT02256436), a randomized phase 3 study of pembrolizumab vs investigator's choice of paclitaxel, docetaxel, or vinflunine, led to the US Food and Drug Administration (FDA) approval of pembrolizumab for advanced/metastatic urothelial cancer. Two-year follow-up results from KEYNOTE-045 are reported here.
Of 542 enrolled patients, 270 were randomly assigned to pembrolizumab and 272 were assigned to chemotherapy. All patients progressed after platinum therapy. The primary endpoints were progression-free survival (PFS) and OS.
The median follow-up was 27.7 months. No PFS benefit was seen with pembrolizumab (2.1 months vs 3.3 months in the chemotherapy group; hazard ratio [HR], 0.96; P = .32). The objective response rate was, however, nearly doubled in the pembrolizumab group (21.1% vs 11%, respectively), and OS was significant improved with pembrolizumab (median OS, 10.3 vs 7.3 months, respectively; HR, 0.70; P < .0002). The OS benefit was seen regardless of PD-L1 expression.
The duration of response was not reached with pembrolizumab vs 4.4 months with chemotherapy.
Any-grade AEs were noted in 62% of patients in the pembrolizumab group vs 90.6% of patients in the chemotherapy group; grade 3 or worse AEs were seen in 16.5% and 50.2% of patients, respectively.
The authors concluded that these results “were consistent with the interim analyses that led to the approval of [pembrolizumab] in locally advanced or metastatic [urothelial cancer] that progressed during or after platinum-based chemotherapy.”
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- Bellmunt J, De Wit R, Vaughn DJ, et al. Two-year follow-up from the phase 3 KEYNOTE-045 trial of pembrolizumab (pembro) vs investigator's choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (UC). Oral presentation at: 2018 Genitourinary Cancers Symposium; February 8-10, 2018; San Francisco, CA.