aA CR was defined by negative results for cystoscopy (with transurethral resection of bladder tumor/biopsies, as applicable), urine cytology, and computed tomography urography.
bDOR was based on patients (n=39) who achieved a CR; reflects period from the time CR was achieved.
- The median follow-up time was 28.0 months (range: 4.6–40.5 months).
- Median DOR: 16.2 months (range: 0.0+ – 30.4+ months).
NMIBC = non‑muscle invasive bladder cancer; BCG = Bacillus Calmette-Guerin; CIS = carcinoma in situ; CI = confidence interval.
Pembrolizumab (KEYTRUDA) is the only systemic immuno-oncology therapy recommended in NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a treatment option for patients with BCG-unresponsive, high-risk NMIBC with CIS with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.1
National Comprehensive Cancer Network® (NCCN®) makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
In the treatment of patients with high-risk NMIBC
A multicenter, open-label, single-arm trial in 96 patients with high-risk NMIBC with CIS with or without papillary tumors who were BCG unresponsive and who were ineligible for or elected not to undergo cystectomy. BCG-unresponsive, high-risk NMIBC was defined as persistent disease despite adequate BCG therapy, disease recurrence after an initial tumor-free state following adequate BCG therapy, or T1 disease following a single induction course of BCG. Adequate BCG therapy was defined as administration of at least 5 of 6 doses of an initial induction course plus either of: at least 2 of 3 doses of maintenance therapy or at least 2 of 6 doses of a second induction course.
- Prior to treatment, all patients had undergone transurethral resection of bladder tumor (TURBT) to remove all resectable disease (Ta and T1 components). Residual CIS (Tis components) not amenable to complete resection was allowed.
- The trial excluded patients with muscle-invasive (ie, T2, T3, T4) locally advanced nonresectable or metastatic urothelial carcinoma, concurrent extravesical (ie, urethra, ureter, or renal pelvis) non-muscle invasive transitional cell carcinoma of the urothelium, or autoimmune disease or a medical condition that required immunosuppression.
Q3W = every 3 weeks; IV = intravenous; CTU = computed tomography urography.
Baseline high-risk NMIBC disease status
Persistent
27%
Baseline high-risk NMIBC disease status
Recurrent
73%
- Additional study population characteristics: median age 73 years (range: 44–92 years); 44% aged ≥75 years; 84% male; and 67% white.
- Tumor pattern at study entry was CIS with T1 (13%), CIS with high-grade Ta (25%), and CIS (63%).
- The median number of prior instillations of BCG was 12.
ECOG PS = Eastern Cooperative Oncology Group performance status.
Give your patients a key to the first and only anti–PD-1 approved for certain patients with high-risk NMIBC.
PD-1 = programmed death receptor-1.