With up to 50% odds of recurrence within 1 year of treatment...

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...high-risk NMIBC has high stakes.1,2*

*Based on a combined analysis of individual patient data from 7 EORTC clinical trials including 2,596 patients. All of the included studies evaluated patients post-TURBT, at which point they received variable treatments.1

EORTC, European Organisation for Research and Treatment of Cancer; NMIBC, non-muscle–invasive bladder cancer; TURBT, transurethral resection of bladder tumor.

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01/

BCG monotherapy is essential to help protect against recurrence and progression3-5

>30 years

that BCG has been the standard of care for high-risk NMIBC6,7

~70% of patients

with CIS initially achieve complete response with BCG4,5,8

BCG, bacillus Calmette-Guérin; CIS, carcinoma in situ.

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But many patients do not achieve lasting remission1,8,9

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  • Image of a slot machine reel showing a tumor captioned by the word 'RECURRENCE
  • Image of a slot machine reel showing 2 tumors captioned by the word 'PROGRESSION
  • Image of a slot machine reel showing multiple tumors captioned by the word 'METASTASIS
  • Image of a slot machine reel showing a black ribbon captioned by the word 'DEATH
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  • UP TO 50% of patients with high-risk NMIBC are at risk of recurrence within 1 year of treatment1,2*
  • APPROXIMATELY 20% of patients with high-risk NMIBC may progress to MIBC within 4 years of diagnosis8,10†
  • APPROXIMATELY 50% of patients with MIBC may progress to metastatic disease11,12

  • 9% 5-year survival rate in patients who develop metastatic disease9

*Based on a combined analysis of individual patient data from 7 EORTC clinical trials including 2,596 patients. All of the included studies evaluated patients post-TURBT, at which point they received variable treatments.1

†Based on a systematic review of 19 clinical trials that included a total of 3,088 patients.10

MIBC, muscle-invasive bladder cancer.

Many patients treated for high-risk NMIBC may experience events such as recurrence or progression1,8
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Up to half of patients with high-risk NMIBC may undergo radical cystectomy13‡

In patients who received radical cystectomy:

APPROXIMATELY % experienced postoperative complications14,15

APPROXIMATELY % were readmitted within 1 month14,16

Patients who received radical cystectomy reported a decreased quality of life, including feeling17,18§||:

More negative emotions, such as anxiety and depression

Less able to perform daily activities

Less satisfied with sex life

‡Based on a meta-analysis of 31 studies. The analysis did not specify whether patients received treatment prior to radical cystectomy.13

§On the abbreviated World Health Organization Quality of Life questionnaire, compared with patients who received bladder-sparing treatment. Items included safety and security, physical environment, information acquiring, activities of daily living, and sexual activity.17

||Findings are based on an analysis conducted in Taiwan involving 343 patients with bladder cancer, including 52 patients who underwent radical cystectomy.18

New treatment approaches are needed in BCG-naive NMIBC

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03 /

Preclinical data have increased our understanding of how bladder cancer may respond to BCG19-22

In vitro data indicate that high-risk NMIBC can become resistant to BCG monotherapy—revealing potential strategies for future studies19-22

BCG monotherapy is effective in bladder cancer, a highly immunogenic disease. However, BCG response partially depends on host immune function.6,19-22

https://players.brightcove.net/1852113022001/JpBcT6sXX_default/index.html?videoId=6371805398112

  • BCG BCG
  • Tumor cell Tumor cell
  • T cell T cell
ACTIVATION: BCG infects bladder epithelial cells, triggering an immune response.23,24
TUMOR RESPONSE: Activated immune cells—particularly T cells—recognize bladder cancer cells and cause tumor cell death.23,24

IMMUNE EVASION: Over time, bladder cancer can adapt to the antitumor immune response and create an immunosuppressive tumor microenvironment, which may impede BCG treatment in several ways19-22:

Increased activation of the PD-1/PD-L1 pathway and T cell inactivation in response to BCG20,21,25

https://players.brightcove.net/1852113022001/JpBcT6sXX_default/index.html?videoId=6370463575112

Accumulation of myeloid-derived suppressor cells19,26

https://players.brightcove.net/1852113022001/JpBcT6sXX_default/index.html?videoId=6370464722112

Activation of regulatory T cells19,27

https://players.brightcove.net/1852113022001/JpBcT6sXX_default/index.html?videoId=6370465137112

Recruitment of tumor-associated macrophages19,28

https://players.brightcove.net/1852113022001/JpBcT6sXX_default/index.html?videoId=6370464059112

PD-1, programmed cell death protein 1; PD-L1, programmed cell death ligand 1.
Addressing these immune evasion mechanisms may be a potential strategy in high-risk NMIBC
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The Pfizer commitment

Pfizer is dedicated to addressing genitourinary malignancies and helping patients with bladder cancer.

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References

  1. Sylvester RJ, van der Meijden APM, Oosterlinck W, et al. Predicting recurrence and progression in individual patients with stage Ta T1 bladder cancer using EORTC risk tables: a combined analysis of 2596 patients from seven EORTC trials. Eur Urol. 2006;49(3):466-477. doi:10.1016/j.eururo.2005.12.031
  2. Ritch CR, Velasquez MC, Kwon D, et al. Use and validation of the AUA/SUO risk grouping for nonmuscle invasive bladder cancer in a contemporary cohort. J Urol. 2020;203(3):505-511. doi:10.1097/JU.0000000000000593
  3. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology. Bladder cancer. Version 5.2024. Published October 28, 2024.
  4. Lamm DL, Morales A. A BCG success story: from prevention of tuberculosis to optimal bladder cancer treatment. Vaccine. 2021;39(50):7308-7318. doi:10.1016/j.vaccine.2021.08.026
  5. Lamm DL, Blumenstein BA, Crawford ED, et al. A randomized trial of intravesical doxorubicin and immunotherapy with bacille Calmette-Guérin for transitional-cell carcinoma of the bladder. N Engl J Med. 1991;325(17):1205-1209. doi:10.1056/nejm199110243251703
  6. Song D, Powles T, Shi L, Zhang L, Ingersoll MA, Lu Y-J. Bladder cancer, a unique model to understand cancer immunity and develop immunotherapy approaches. J Pathol. 2019;249(2):151-165. doi:10.1002/path.5306
  7. Morales A, Eidinger D, Bruce AW. Intracavitary Bacillus Calmette-Guerin in the treatment of superficial bladder tumors. J Urol. 1976;116(2):180-183. doi:10.1016/s0022-5347(17)58737-6
  8. Shore ND, Redorta JP, Robert G, et al. Non-muscle-invasive bladder cancer: an overview of potential new treatment options. Urol Oncol. 2021;39(10):642-663. doi:10.1016/j.urolonc.2021.05.015
  9. National Cancer Institute. Cancer stat facts: bladder cancer. Accessed February 19, 2025. https://seer.cancer.gov/statfacts/html/urinb.html
  10. van den Bosch S, Alfred Witjes J. Long-term cancer-specific survival in patients with high-risk, non-muscle-invasive bladder cancer and tumour progression: a systematic review. Eur Urol. 2011;60(3):493-500. doi:10.1016/j.eururo.2011.05.045
  11. Patel VG, Oh WK, Galsky MD. Treatment of muscle-invasive and advanced bladder cancer in 2020. CA Cancer J Clin. 2020;70(5):404-423. doi:10.3322/caac.21631
  12. Stein JP, Lieskovsky G, Cote R, et al. Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol. 2001;19(3):666-675. doi:10.1200/jco.2001.19.3.666
  13. Musat MG, Kwon CS, Masters E, Sikirica S, Pijush DB, Forsythe A. Treatment outcomes of high-risk non-muscle invasive bladder cancer (HR-NMIBC) in real-world evidence (RWE) studies: systematic literature review (SLR). Clinicoecon Outcomes Res. 2022;14:35-48. doi:10.2147/ceor.s341896
  14. Lenis AT, Lec PM, Chamie K. Bladder cancer: a review. JAMA. 2020;324(19):1980-1991. doi:10.1001/jama.2020.17598
  15. Shabsigh A, Korets R, Vora KC, et al. Defining early morbidity of radical cystectomy for patients with bladder cancer using a standardized reporting methodology. Euro Urol. 2009;55(1):164-174. doi:10.1016/j.eururo.2008.07.031
  16. Hu M, Jacobs BL, Montgomery JS, et al. Sharpening the focus on causes and timing of readmission after radical cystectomy for bladder cancer. Cancer. 2014;120(9):1409-1416. doi:10.1002/cncr.28586
  17. World Health Organization. WHOQOL: measuring quality of life. Accessed February 19, 2025. https://www.who.int/tools/whoqol/whoqol-bref
  18. Tsai Y-S, Wu T-Y, Jou Y-C, Tzai T-S, Wang J-D. Determinants and dynamic changes of generic quality of life in human bladder cancer patients. J Clin Med. 2021;10(23):5472. doi:10.3390/jcm10235472
  19. Crispen PL, Kusmartsev S. Mechanisms of immune evasion in bladder cancer. Cancer Immunol Immunother. 2020;69(1):3-14. doi:10.1007/s00262-019-02443-4
  20. Kates M, Matoso A, Choi W, et al. Adaptive immune resistance to intravesical BCG in non-muscle invasive bladder cancer: implications for prospective BCG-unresponsive trials. Clin Cancer Res. 2020;26(4):882-891. doi:10.1158/1078-0432.ccr-19-1920
  21. Inman BA, Sebo TJ, Frigola X, et al. PD-L1 (B7-H1) expression by urothelial carcinoma of the bladder and BCG-induced granulomata: associations with localized stage progression. Cancer. 2007;109(8):1499-1505. doi:10.1002/cncr.22588
  22. Strandgaard T, Lindskrog SV, Nordentoft I, et al. Elevated T-cell exhaustion and urinary tumor DNA levels are associated with bacillus Calmette-Guérin failure in patients with non-muscle-invasive bladder cancer. Eur Urol. 2022;82(6):646-656. doi:10.1016/j.eururo.2022.09.008
  23. Li J, Zhan L, Qin C. The double-sided effects of Mycobacterium Bovis bacillus Calmette–Guérin vaccine. NPJ Vaccines. 2021;6(1):14. doi:10.1038/s41541-020-00278-0
  24. Böhle A, Gerdes J, Ulmer AJ, Hofstetter AG, Flad HD. Effects of local bacillus Calmette-Guerin therapy in patients with bladder carcinoma on immunocompetent cells of the bladder wall. J Urol. 1990;144(1):53-58. doi:10.1016/s0022-5347(17)39365-5
  25. Wang Y, Liu J, Yang X, et al. Bacillus Calmette–Guérin and anti-PD-L1 combination therapy boosts immune response against bladder cancer. Onco Targets Ther. 2018;11:2891-2899. doi:10.2147/OTT.S165840
  26. Yang G, Shen W, Zhang Y, et al. Accumulation of myeloid-derived suppressor cells (MDSCs) induced by low levels of IL-6 correlates with poor prognosis in bladder cancer. Oncotarget. 2017;8(24):38378-38388. doi:10.18632/oncotarget.16386
  27. Murai R, Itoh Y, Kageyama S, et al. Prediction of intravesical recurrence of non-muscle-invasive bladder cancer by evaluation of intratumoral Foxp3+ T cells in the primary transurethral resection of bladder tumor specimens. PLOS One. 2018;13(9):e0204745. doi:org/10.1371/journal.pone.0204745
  28. Suriano F, Santini D, Perrone G, et al. Tumor associated macrophages polarization dictates the efficacy of BCG instillation in non-muscle invasive urothelial bladder cancer. J Exp Clin Cancer Res. 2013;32(1):87. doi:10.1186/1756-9966-32-87
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