Grivas on the KEYNOTE-057 Trial in BCG-Unresponsive Papillary NMIBC

Petros Grivas, MD, PhD, clinical director of the genitourinary cancers program at the University of Washington Medicine and professor in the clinical research division of the Fred Hutch Cancer Center, discusses the design and end points of the phase 2 KEYNOTE-057 trial (NCT02625961).

Findings from the KEYNOTE-057 trial showed that pembrolizumab (Keytruda) is an effective treatment option for patients with bacillus Calmette-Guérin (BCG)-unresponsive, papillary high-risk non–muscle-invasive bladder cancer (NMIBC).

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0:10 | Here we were focusing specifically on cohort B [of the study]. [These were] patients with papillary high-risk NMIBC without [carcinoma in situ]. Patients should have had a TURBT within 3 months prior to the first pembrolizumab dose on the trial, and they were continued on treatment with pembrolizumab on the standard dose of 200 milligrams [given intravenously] every 3 weeks for up to 2 years. The first assessment was at 3 months, and the second assessment at 6 months, and in that particular [part of the] study, when it was designed, there were no mandatory biopsies.

0:45 | These assessments were done with urine cytology, cystoscopy every 3 months for the first couple of years, and then every 6 months through year 5, and of course, CAT scan imaging [was done] every 6 months for the first 2 years, and then yearly thereafter. The other relevant point to make is that, as I mentioned, pembrolizumab was continued up to 2 years and if someone did not achieve a complete response regarding progression of high-risk disease, at any time, they were discontinued from treatment.

1:22 | The efficacy analysis [looked at] assigned patients who received at least 1 dose for pembrolizumab, and the same was the case for safety. The primary end point was the disease-free survival rate for higher-risk non-muscle-invasive disease in 1 year, and safety [along with] many secondary end points.