|The following article features coverage from the American Society of Clinical Oncology (ASCO) 2018 meeting.|
Updated findings from a clinical trial show that first-line pembrolizumab therapy for cisplatin-ineligible advanced urothelial carcinoma (UC) continues to elicit clinically meaningful and durable anti-tumor activity, investigators concluded in a presentation at the 2019 American Society of Clinical Oncology annual meeting in Chicago.
The effect was more pronounced among patients with PD-L1 expression combined positive scores (CPS) of 10 or higher.
Peter H. O’Donnell, MD, of the University of Chicago, and colleagues presented longer follow-up data from the phase 2 KEYNOTE-052 trial, which led to FDA approval of pembrolizumab for cisplatin-ineligible patients with advanced UC. The updated analysis included assessment of 370 patients with a median age of 74 years. Of these, 85% had visceral metastases and 30% were PD-L1 positive (CPS 10 or higher).
The median follow-up duration was 11.4 months (range 0.1 to 41.2 months) for all patients and 29.3 months (range 7 to 41.2 months) for responders. The analysis revealed a confirmed objective response rate (ORR) of 29% and complete response and partial response rates of 9% and 20%, respectively. The median duration of response was 30.1 months, with 67% and 52% of patients experiencing a DOR of 12 months or more and 24 months or more, respectively. The median overall survival time (OS) was 11.3 months; the 12- and 24-month OS rates were 47% and 31%, respectively.
The median OS time was 9.7 months for patients with a CPS less than 10 compared with 18.5 months for those with a CPS of 10 or higher. The 24-month OS rates were 24% and 47% respectively.
A total of 67% of patients experienced treatment-related adverse events. The most common of these events were fatigue and pruritus (18% each), the investigators reported.
O’Donnell PH, Balar AV, Vuky J, et al. KEYNOTE-052: Phase 2 study evaluating first-line pembrolizumab (pembro) in cisplatin-ineligible advanced urothelial cancer (UC)—Updated response and survival results. Presented at the 2019 American Society of Clinical Oncology annual meeting in Chicago, May 31 to June 4. Abstract 4546.