KEYNOTE-057: Pembrolizumab in Patients With High-Risk NMIBC


An overview of the study design, patient populations, and eligibility of the KEYNOTE-057 trial, which studied pembrolizumab in patients with high-risk NMIBC.


Eric A. Singer, MD, MA, FACS: The KEYNOTE-057 study was looking at pembrolizumab for patients who had already had 2 induction courses of intravesical BCG [Bacillus Calmette-Guerin]. This was a patient population who had been pretty heavily pretreated, and they still had high-grade non-muscle-invasive bladder cancer present.

This was broken up into 2 groups, cohort A and cohort B. Cohort A is the group I mentioned earlier, they had non-muscle-invasive bladder cancer. They could have papillary bladder tumors or carcinoma in situ, which we call CIS. Those patients received intravenous pembrolizumab, so it went systemically throughout the body. We found that it met its primary end point of patients having disease-free survival, meaning that the bladder cancer didn’t come back. That study ended up being published and got FDA approval.

More recently, what we just presented at the AUA [American Urological Association] Annual Meeting in Chicago was talking about cohort B. That’s the group with the same inclusion criteria, but [those patients] had papillary tumors only, no carcinoma in situ. We were talking a bit about how they did. Again, the primary end point for both groups was 12-month disease-free survival rate, [meaning] how many people did not have any bladder cancer come back at 12 months. They got the IV [intravenous] pembrolizumab every 3 weeks for up to 2 years. Essentially, we’d be looking at them regularly, looking inside their bladder with cystoscopy and doing cytologies as well. If anything seemed abnormal, we would do a biopsy for that. As long as there was no evidence of disease coming back, the biopsies were negative, the cytology was negative, they could continue for up to 2 years with that.

Transcript edited for clarity.

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