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Pembrolizumab extends survival in urothelial cancer
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MADRID — Pembrolizumab significantly prolonged median OS compared with chemotherapy among patients with recurrent, advanced urothelial cancer, according to phase 3 study results presented at the European Society for Medical Oncology Congress.
“Pembrolizumab was associated with substantially better overall survival and a longer duration of progression-free survival than chemotherapies in patients with advanced urothelial cancer,” Ronald de Wit, MD, PhD, urological oncologist at Erasmus University Medical Center in the Netherlands, said during his presentation. “Pembrolizumab also continues to have a superior safety profile. These data support pembrolizumab as a new standard of care in this population.”
The open-label KEYNOTE-045 trial included 542 patients with histologically or cytologically confirmed urothelial cancer that progressed after platinum therapy. Eligible patients underwent up to two prior lines of systemic therapy, had measurable disease, and had ECOG performance status of 0 to 2.
Researchers randomly assigned 270 patients to the anti-PD-1 antibody pembrolizumab (Keytruda, Merck) 200 mg every 3 weeks. The other 272 patients received investigator’s choice of chemotherapy. Options were paclitaxel 175 mg/m2 every 3 weeks, docetaxel 75 mg/m2 every 3 weeks, or vinflunine 320 mg/m2 every 3 weeks.
OS and PFS served as the primary endpoints. Secondary endpoints included objective response rate and safety. Investigators assessed efficacy in all patients, as well as those with PD-L1 combined positive score of 10% or higher.
Baseline characteristics appeared generally similar between treatment groups.
Initial results showed pembrolizumab was associated with significantly longer OS compared with investigator’s choice of chemotherapy. At ESMO, de Wit presented mature results.
After median follow-up of 22.5 months, researchers reported significantly longer median OS among patients assigned pembrolizumab (10.3 months vs 7.4months; HR = 0.7; P=0.0003). They also reported significantly longer median OS among pembrolizumab-treated patients who met the PD-L1 expression threshold (8 months vs. 5.2months; HR = 0.58; P=0.003).
The OS benefit with pembrolizumab persisted when researchers assessed results by patient age, liver metastases, hemoglobin, visceral disease and choice of chemotherapy.
Eighteen-month OS rates were 33.2% (95% CI, 27.5-38.9) with pembrolizumab and 19.7% (95% CI, 14.7-24.8) with chemotherapy.
Researchers reported no significant difference in median PFS between groups (2.1 months vs. 3.3months; HR = 0.96).
A higher percentage of pembrolizumab-treated patients achieved a response (21.1% vs. 11%), and median duration of response was longer in the pembrolizumab group (not reached vs. 4.4 months).
Chemotherapy-treated patients appeared more likely to experience any-grade adverse events (90.6% vs. 62%), as well as grade 3 or higher treatment-related adverse events (50.2% vs. 16.5%).
“With additional follow-up, OS with pembrolizumab vs. chemotherapy continues to improve, and responses continue to be more durable with pembrolizumab,” de Wit and colleagues wrote.
– by Chuck Gormley
Reference:
De Wit R, et al. Abstract LBA37. Presented at European Society for Medical Oncology Congress; Sept. 8-12, 2017; Madrid.
Disclosures: Merck funded this study. De Wit reports advisory board roles with Merck, Roche, Sanofi and Eli Lilly. Please see the abstract for a list of all other researchers’ relevant financial disclosures.