ASCO GU 2017: Pembrolizumab as first-line therapy in cisplatin-ineligible advanced urothelial cancer: Results from the total KEYNOTE-052 study population.

Orlando, Florida USA (UroToday.com) Until 2016, cisplatinum ineligible patients with advanced bladder cancer had poor outcomes due to limited effective therapies. This has been recognized as an effective disease space for immunotherapies since recent FDA approval of checkpoint blockade for bladder cancer. KEYNOTE-052 addresses this gap by assessing the role of pembrolizumab as first line therapy in cisplatinum ineligible patients. Previously, interim results from the first 100 patients in the phase 2, open-label KEYNOTE-052 (ClinicalTrials.gov, NCT02335424) study had been presented. The findings suggested that first-line pembrolizumab has effective antitumor activity and acceptable safety. The authors were able to present confirmatory results from the fully enrolled study at this year's genitourinary cancer symposium.

370 patients with advanced urothelial cancer of the renal pelvis, ureter, bladder, or urethra were included in the study. All patients were cisplatin-ineligible and had not received prior systemic therapy. The main reasons for cisplatin ineligibility were poor renal function and poor performance status. Response rates to pembrolizumab were consistent with other checkpoint inhibitors at 27%. More than ¾ of responders had a response of more than 6 months. At a median of 14 months follow up, the median response rate was not reached. Survival outcomes were promising at 6 months with 31% and 67% progression-free and overall survival rates, respectively. Adverse events were moderate with 16% of patients having a grade 3 AE and 5% of patients discontinuing therapy due to adverse events. Results from the fully enrolled KEYNOTE-052 phase II study confirmed that pembrolizumab has a good response in cisplatin-ineligible patients and is reasonably tolerated. We wait for more phase III clinical trials as competition in this disease space is getting significant. Clinical trial information: NCT02335424

Author: Arjun Vasant Balar

Written By: Michael J Metcalfe, MD, Fellow of Urologic Oncology Urology, MD Anderson Cancer Center, Houston TX
Ashish M. Kamat, MD, MBBS, FACS, President, International Bladder Cancer Network Chair, Society of Immunotherapy for Cancer (SITC), BCTF, Director of Urologic Oncology Fellowship, Professor of Urology, Attending Surgeon, Division of Surgery, The University of Texas, MD Anderson Cancer Center, Houston TX

at the 2017 Genitourinary Cancers Symposium - February 16 - 18, 2017 – Orlando, Florida USA

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