Advancing Patient Care: Innovations in Bladder Cancer

Pfizer Prioritizes R&D for Patients with Early-Stage Bladder Cancer

For years, there have been limited advancements in the treatment of early-stage bladder cancer like non-muscle invasive bladder cancer (NMIBC)—cancer that has not reached the muscle wall of the bladder—which represents approximately 75% of people newly diagnosed with bladder cancer.^1-3 Behind these numbers are real people confronting a disease where treatment has remained frozen in time, waiting for innovative options that may help reduce the disease burden or help delay recurrence, progression, or more invasive treatments.

As is typically the case, the rate of survival in bladder cancer dramatically declines as the disease advances in stage, making early detection crucial to improve patient outcomes. Timely detection enables timely intervention, a key factor for those ~25% of patients with NMIBC that have high-risk disease, or disease that is associated with significant recurrence and progression rates, despite the decades-long availability of therapies like intravesical Bacillus Calmette-Guérin (BCG).^1,4-6 For these patients, understanding the best path to care before starting BCG is critical.

An Unmet Need: How Innovation Stalled in High-Risk NMIBC

Induction and maintenance with BCG has been the standard of care for NMIBC since its approval by the Food and Drug Administration (FDA) in 1990, but there are significant limitations to this approach.^7-9 While BCG has been shown to reduce the risk of tumor recurrence, up to 50% of patients with high-risk NMIBC are unresponsive to BCG intravesical immunotherapy, leaving them with few alternative approaches.^1,8 For many unresponsive patients, the recommended treatment is radical cystectomy, which is the surgical removal of the entire bladder. However, this treatment is associated with significant lifestyle changes due to the need to create a urinary diversion.¹⁰

Unfortunately, the heavy reliance on BCG therapy may have slowed the development and adoption of alternative treatments. Patients with BCG-naïve, high-risk NMIBC need more effective treatments that can help delay or avoid disease recurrence or progression and invasive bladder-removing surgery, while minimizing treatment-related discomfort and inconvenience.^1,11

Our Commitment to Early-Stage Bladder Cancer

At Pfizer, we are committed to prioritizing clinical development of innovative treatment options to reach early-stage bladder cancer patients. After decades of relatively minimal innovation in the field, the treatment landscape has advanced rapidly in the last few years with excitement around emerging treatments.¹ In particular, immune checkpoint inhibitors, also known as PD-(L)1 inhibitors, are breaking through as a potential remedy to improve patient outcomes in high-risk NMIBC.¹

PD-L1, expressed on tumor cells, binds to PD-1 on T cells, inhibiting the immune response and preventing tumor destruction.¹ Clinical investigation of PD-(L)1 inhibitors in high-risk NMIBC is underway and could represent a possible paradigm shift in the bladder cancer treatment landscape.¹

People with bladder cancer deserve transformative treatments that enable them to live longer and better lives. To that end, at Pfizer we are relentlessly driving scientific innovation through research and development to establish new benchmarks of meaningful clinical impact across disease stages. Our robust pipeline and breakthrough therapies aren't just advancing treatment—they're redefining what's possible for patients in need.

To learn more about early-stage bladder cancer and high-risk NMIBC, visit HighRiskNMIBC.com.

References

1. Bedke J, Black PC, Szabados, et al. Optimizing outcomes for high-risk, non-muscle-invasive bladder cancer: The evolving role of PD-(L)1 inhibition. Urol Oncol. 2023; 41(12):461-475.
2. Jiang Y, Zhu Y, Ren Y, et al. The optimal intravesical maintenance chemotherapy scheme for the intermediate-risk non-muscle invasive bladder cancer. BMC Cancer. 2023;23(1):1011.
3. Dobruch J, Oszczudłowski M. Bladder Cancer: Current Challenges and Future Directions. Medicina (Kaunas). 2021;57(8):749. Published 2021 Jul 24.
4. Thompson, I.M., Basler, J. (2004). Screening and Early Detection for Genitourinary Cancer. In: Potts, J.M. (eds) Essential Urology. Current Clinical Urology. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-59259-737-6_4
5. Cancer facts & figures 2024. American Cancer Society. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2024/2024-cancer-facts-and-figures-acs.pdf. Accessed January 25, 2024.
6. Grabe-Heyne K, Henne C, Mariappan P, et al. Intermediate and high-risk non-muscle-invasive bladder cancer: an overview of epidemiology, burden, and unmet needs. Front Oncol. 2023;13:1170124.
7. Morales A. BCG: A throwback from the stone age of vaccines opened the path for bladder cancer immunotherapy. Can J Urol. 2017;24(3):8788-8793.
8. JA Witjes, J Palou, M Soloway, D Lamm, AM Kamat, M Brausi, et al. Current clinical practice gaps in the treatment of intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC) with emphasis on the use of bacillus Calmette-Guérin (BCG): results of an international individual patient data survey (IPDS). BJU international. Published online September 13, 2013.
9. Aldousari S, Kassouf W. Update on the management of non-muscle invasive bladder cancer. Can Urol Assoc J. 2010 Feb;4(1):56-64.
10. Lidagoster S, Ben-David R, De Leon B, Sfakianos JP. BCG and Alternative Therapies to BCG Therapy for Non-Muscle-Invasive Bladder Cancer. Curr Oncol. 2024 Feb 16;31(2):1063-1078.
11. Kopenhafer L, Thompson A, Chang J, et al. Patient experience and unmet needs in high-risk nonmuscle-invasive bladder cancer: Insights from qualitative interviews and a cross-sectional survey. Urol Oncol. 2024;42(3):70.e1-70.e10. doi:10.1016/j.urolonc.2024.01.013