Summary
KEYNOTE-057 was a phase 2 trial investigating pembrolizumab monotherapy as a treatment option for patients with high-risk non-muscle-invasive bladder cancer lacking carcinoma in situ and refractory to BCG immunotherapy. As suggested by the trial design and journal, the study provides efficacy and safety data to support clinical decision-making in this difficult-to-treat patient population. The findings may inform treatment sequencing and immunotherapy approaches in BCG-unresponsive bladder cancer.
UK applicability
The findings are relevant to UK urological oncology practice, as BCG-unresponsive bladder cancer represents a significant clinical challenge in the National Health Service. Pembrolizumab approval and reimbursement for this indication would depend on Health Technology Assessment review, cost-effectiveness analysis relative to other options (such as radical cystectomy), and alignment with National Institute for Health and Care Excellence guidance.
Key measures
Complete response rate, recurrence-free survival, disease-free survival, adverse events, tolerability
Outcomes reported
The study evaluated the efficacy and safety of pembrolizumab monotherapy in patients with high-risk non-muscle-invasive bladder cancer who had failed BCG treatment. Primary outcomes likely included complete response rates, recurrence-free survival, and adverse event profiles.
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