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KEYNOTE-057 showed that pembrolizumab could clear bladder cancer confined to the lining in a substantial minority of people whose disease had stopped responding to BCG, giving the first drug alternative to removing the bladder.
After BCG fails in high-risk non-muscle-invasive bladder cancer the standard is radical cystectomy, which many patients decline or cannot have. KEYNOTE-057 was a single-arm phase 2 study of pembrolizumab in BCG-unresponsive disease. Cohort A enrolled patients with carcinoma in situ with or without papillary tumours, with complete response rate as the primary endpoint; cohort B enrolled papillary-only high-grade disease, with disease-free survival as the endpoint.
In cohort A a substantial minority achieved a complete response at three months and about half of those responses lasted a year or more, with a systemic immunotherapy toxicity profile. Pembrolizumab was approved in the United States in January 2020 for BCG-unresponsive carcinoma in situ, the first systemic drug for this setting, followed by nadofaragene firadenovec and nogapendekin alfa inbakicept as bladder-sparing alternatives.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
296 enrolled.
95% CI 30.7 to 51.1; median follow-up 36.4 months
SourceShares Merck & Co. (MSD), Pembrolizumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Merck & Co. (MSD), Pembrolizumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Merck & Co. (MSD), Pembrolizumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Merck & Co. (MSD), Pembrolizumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Merck & Co. (MSD), Pembrolizumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Pembrolizumab, Immune checkpoint inhibitors and the tag subtype-trials.
Shares Immune checkpoint inhibitors and the tag subtype-trials.
Shares Immune checkpoint inhibitors and the tag subtype-trials.