Bladder Cancer Coverage from Every Angle

ASCO 2021: KEYNOTE-052 Survival Update on First-Line Pembrolizumab in Advanced Urothelial Cancer

By: Joseph Cupolo
Posted: Thursday, June 10, 2021

According to updated data from the KEYNOTE-052 phase II study, after up to 5 years of follow-up, pembrolizumab continued to elicit clinically meaningful, durable antitumor activity in cisplatin-ineligible patients with advanced urothelial cancer. Of note, these effects seemed to be more pronounced in patients with a combined positive score (CPS) of ≥ 10, according to Peter H. O’Donnell, MD, of the University of Chicago. These findings were presented during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 4508).

Patients in the study received pembrolizumab at 200 mg every 3 weeks until disease progression, unacceptable toxicity, withdrawal, or 24 months of therapy, whichever occurred first. Among 370 enrolled patients, the median age was 74 years, 315 (85.1%) had visceral disease, and 43 (11.6%) completed 24 months of therapy. The median time from enrollment to data cutoff in September 2020 was 56.3 months for all patients; it was 56.0 months for the 110 patients (29.7%) with a CPS ≥ 10.

The confirmed overall response rate for all patients was 28.9%; the complete response rate was 9.5%; and the partial response rate was 19.5%. The median duration of response rate was 33.4 months (range, 1.4+ to 60.7+); 44.8% and 39.4% of patients had a median duration of response of ≥ 36 and ≥ 48 months, respectively. As for median overall survival, it was 11.3 months, with 24-month and 36-month rates of 31.5% and 22.1%, respectively.

In terms of toxicity, about two-thirds of patients (67.3%) experienced treatment-related adverse events. In addition, grade ≥ 3 treatment-related toxicity was reported in 21.2% of patients.

Disclosure: For full disclosures of the study authors, visit

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