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Long-Term Outcomes With Pembrolizumab for Cisplatin-Ineligible Advanced Urothelial Cancer


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As reported in the Journal of Clinical Oncology by Jacqueline Vuky, MD, of Oregon Health & Science University, Portland, and colleagues, long-term follow-up in the phase II KEYNOTE-052 study has shown durable responses with first-line pembrolizumab in cisplatin-ineligible locally advanced or metastatic urothelial cancer, with higher response rates and longer survival in patients with a PD-L1 combined positive score (CPS) of at least 10 or lymph node–only metastasis.1

Study Details

Jacqueline Vuky, MD

Jacqueline Vuky, MD

In the study, 370 patients received pembrolizumab at 200 mg every 3 weeks for up to 24 months. Positive PD-L1 expression was defined as a CPS of at least 10. Response was assessed by independent central review using Response Evaluation Criteria in Solid Tumors, version 1.1.

Key Findings

At data cutoff, the minimum follow-up was 2 years since enrollment of the last patient. Among all patients, the objective response rate was 28.6%, with a median duration of response of 30.1 months (95% confidence interval [CI] = 18.1 months to not reached); responses lasted at least 12 and at least 24 months in 67% and 52% of responders, respectively. Of 40 responding patients completing 2 years of treatment, 32 had an ongoing response at completion. Median overall survival was 11.3 months (95% CI = 9.7–13.1 months), with 12- and 24-month rates of 46.9% and 31.2%.

Among 110 patients with a CPS of at least 10 vs 251 patients with a CPS up to 10, the objective response rates were 47.3% vs 20.3%, and the median duration of response was not reached  (95% CI = 18.1 months to not reached) vs 18.2 months (95% CI = 9.7 months to not reached), with 57% vs 45% of responders having a response lasting 24 months or longer. Median overall survival was 18.5 months (95% CI = 12.2–28.5 months) vs 9.7 months (95% CI = 7.6–11.5 months), with a 24-month rate of 47% vs 24%.

“First-line pembrolizumab confers meaningful and durable clinical response in cisplatin-ineligible patients with advanced urothelial carcinoma and is associated with prolonged overall survival, particularly with PD-L1 CPS ≥ 10 and lymph node–only disease.”
— Jacqueline Vuky, MD, and colleagues

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Among 51 patients with lymph node–only metastasis vs 315 with visceral metastasis, the objective response rates were 49.0% vs 25.1%, and the median overall survival was 27.0 months (95% CI = 12.4 months to not reached) vs 10.6 months (95% CI = 8.7–11.7 months). No new safety signals were identified.

The investigators concluded: “First-line pembrolizumab confers meaningful and durable clinical response in cisplatin-ineligible patients with advanced urothelial carcinoma and is associated with prolonged overall survival, particularly with PD-L1 CPS ≥ 10 and lymph node–only disease.” 

Disclosure: Dr. Vuky has served in a consulting or advisory role for Seattle Genetics/Astellas; and has received institutional research funding from Roche/Genentech, Pharma, Celldex, Novartis, and Fortis Therapeutics.

REFERENCE

1. Vuky J, Balar AV, Castellano D, et al: Long-term outcomes in KEYNOTE-052: Phase II study investigating first-line pembrolizumab in cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer. J Clin Oncol. June 17, 2020 (early release online).


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