UNMET NEED IN BLADDER CANCER
84,870
Non-muscle invasive bladder cancer (NMIBC) represents
75%
60%-70%
within 5 years3
10%-45%
6TH
Bladder cancer is the 6th most common form of cancer in the US,4 and men account for three-quarters of newly diagnosed cases.1 Although bladder cancer is more common in men, women are often diagnosed with more advanced disease and have worse survival than men.5 Bladder cancer patients are generally from high-risk populations,1 with 77% of patients aged 65 or older and a median age of 73 years old.4
NMIBC includes 3 stages: CIS-containing tumors, Ta and T1. T2 through T4 stages make up MIBC and are indicative of more aggressive locally advanced and metastatic disease.2 Bladder cancer has metastasized in an estimated 5% of patients with newly diagnosed disease.6
Bladder cancer is the 6th most common form of cancer in the US,4 and men account for three-quarters of newly diagnosed cases.1 Although bladder cancer is more common in men, women are often diagnosed with more advanced disease and have worse survival than men.5 Bladder cancer patients are generally from high-risk populations,1 with 77% of patients aged 65 or older and a median age of 73 years old.4
NMIBC includes 3 stages: CIS-containing tumors, Ta and T1. T2 through T4 stages make up MIBC and are indicative of more aggressive locally advanced and metastatic disease.2 Bladder cancer has metastasized in an estimated 5% of patients with newly diagnosed disease.6
THE POTENTIAL OF A DUAL-ACTING MECHANISM OF ACTION
Cretostimogene grenadenorepvec is an oncolytic immunotherapy with a dual mechanism of action that selectively replicates in and lyses bladder cancer cells while amplifying the immune response against bladder tumors.
Tumor selectivity and potent anti-tumor activity
Cretostimogene works in 2 important and complementary ways to find, attack and destroy bladder cancer cells. First, it replicates inside the tumor’s cells, causing tumor cell lysis and immunogenic cell death. Then, the rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, that can stimulate a systemic anti-tumor immune response that involves the body’s immune system.
BCG=Bacillus Calmette-Guérin; GM-CSF=granulocyte-macrophage colony stimulation factor; NMIBC=non-muscle invasive bladder cancer.
REFERENCES:
- Cancer Facts and Figures. American Cancer Society. Updated 2025. Accessed October 24, 2025. https://www.cancer.org/cancer/types/bladder- cancer/about/key-statistics.html
- Holzbeierlein JM, Bixler BR, Buckley DI, et al. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline: 2024 Amendment. J Urol. Published online January 24, 2024. doi:https://doi.org/10.1097/ju.0000000000003846
- Sylvester RJ, van der Meijden APM, Oosterlinck W, et al. Eur Urol. 2006;49(3):466-477. doi:10.1016/j.eururo.2005.12.031
- Cancer Stat Facts: Bladder Cancer. National Cancer Institute. Surveillance, Epidemiology and End Results Program (SEER). Accessed October 24, 2025. https://seer.cancer.gov/statfacts/html/urinb.html
- Weiner AB, Keeter MK, Manjunath A, Meeks JJ. Discrepancies in staging, treatment, and delays to treatment may explain disparities in bladder cancer outcomes: An update from the National Cancer Data Base (2004-2013). Urol Oncol. 2018;36(5):237.e9-237.e17. doi: 10.1016/j.urolonc.2017.12.015. Epub 2018 Jan 12. PMID: 29338913
- Stecca C, Abdeljalil O, Sridhar SS. Metastatic urothelial cancer: a rapidly changing treatment landscape. Ther Adv Med Oncol. 2021;30(13):1-18. doi: 10.1177/17588359211047352