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The standard treatment for high-risk non-muscle invasive bladder cancer is transurethral bladder tumor resection followed by intravesical BCG immunotherapy .
immunity
The KEYNOTE-057 study evaluated the efficacy and safety of the PD-1 inhibitor pembrolizumab for BCG-non-responsive non-muscle invasive bladder cancer.
The KEYNOTE-057 study evaluated the efficacy and safety of the PD-1 inhibitor pembrolizumab for BCG-non-responsive non-muscle invasive bladder cancer.
This is an open-label, single-arm, multi-center Phase 2 study conducted in 54 medical centers in 14 countries.
From December 9, 2015 to April 1, 2018, a total of 334 patients were screened , of which 186 were not eligible for inclusion, and 47 patients were assigned to cohort B (BCG-non-responsive high Ta stage or no cause Any T1 stage papilloma with cancer; the results were not included in this analysis).
Screening FDA
Duration of response after the first dose of pembrolizumab
Duration of response after the first dose of pembrolizumabThe median follow-up was 36.
Of the 96 BCG-non-responsive bladder carcinoma in situ patients with or without papilloma, 39 patients (41%, 95% CI 30.
Treatment-related adverse reactions
Treatment-related adverse reactionsThirteen (13%) patients experienced the most common phase 3/4 treatment-related adverse reactions; the most common were arthralgia (2%) and hyponatremia (3%).
In summary, pembrolizumab is well tolerated as a single-agent treatment of BCG-non-responsive non-muscle invasive bladder cancer, and it has shown promising anti-tumor activity, or it may become such a difficult-to-treat population Non-surgical treatment options .
Pembrolizumab is well tolerated as a single agent in the treatment of BCG-non-responsive non-muscle invasive bladder cancer, and it has shown promising anti-tumor activity, and may be a non-surgical treatment option for this type of difficult-to-treat population Pembrolizumab is well tolerated as a single agent in the treatment of BCG-non-responsive non-muscle invasive bladder cancer, and it has shown promising anti-tumor activity, and may be a non-surgical treatment option for this type of difficult-to-treat population
Original source:
Original source:Arjun V Balar, et al.
org/10.
1016/S1470-2045(21)00147-9" target="_blank" rel="noopener">Pembrolizumab monotherapy for the treatment of high- risk non-muscle-invasive bladder cancer unresponsive to BCG (KEYNOTE-057): an open-label, single-arm, multicentre, phase 2 study
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