TSC1 mutated metastatic bladder cancer | Primary Research (KOL's Insight) | Market Intelligence | Epidemiology & Market Forecast-2035

With 10% to 15% showing inactivating point mutations on 9q34, TSC1 is frequently mutated in bladder cancer. These mutations render TSC1 completely inactive when coupled with a sizable deletion or loss of chromosome 9. Additionally, if only one TSC1 allele is lost (haplo-insufficiency), bladder epithelial cells may have an advantage in terms of growth, which could contribute to the development of bladder cancer. In roughly 15% of bladder cancers, the tumor suppressor TSC1 has been found to be mutated or inactive, and in roughly 54% of bladder cancers, a region spanning the TSC1 locus at 9q34 has lost heterozygosity. The treatment landscape for advanced-stage, unresectable, or metastatic UC has undergone a significant change in a short period of time with the availability of six new therapeutic agents for clinical use.

Description

Inactivating point mutations on 9q34 are found in 10-15% of bladder cancers, which frequently have TSC1 mutations. These mutations make TSC1 totally inactive when they are coupled with a sizable deletion or loss of chromosome 9. In addition, bladder epithelial cells may grow more quickly if only one TSC1 allele is lost (haplo-insufficiency), which could promote the development of bladder cancer. A recent study also discovered a TSC1 mutation in a patient with metastatic bladder cancer who had a sustained complete response to treatment with the mTOR inhibitor everolimus. Up to 80% of bladder cancer cases have a connection to the environment. Since smoking is by far the most common cause of bladder cancer in developing countries, its significance is growing there. The frequency and duration of smoking are directly correlated with risk increases. Smokers are 2-6 times more likely to develop bladder carcinoma than nonsmokers. Both men and women appear to be at the same risk. There are a number of professions where bladder cancer risk-raising substances are exposed. Solvents, petroleum products, and diesel exhaust all have a variety of jobs associated with them (e. g., metal work, rubber work, leather, and apparel work) and have also been connected to a higher risk of bladder cancer. Arsenic exposure may have an impact on the development of bladder cancer.

TSC1 mutated metastatic bladder cancer (Epidemiology)

In roughly 15% of bladder cancers, the tumor suppressor TSC1 has been found to be mutated or inactive, and in roughly 54% of bladder cancers, there has been a loss of heterozygosity in a region that spans the TSC1 locus at 9q34. Globally, about 275,000 people receive a bladder cancer diagnosis each year, and 108,000 people die from the disease. In developed countries, TCC accounts for 90% of bladder cancer cases. In developing countries, particularly those in the Middle East and Africa, the majority of bladder cancers are SCCs, and Schistosoma haematobium infection is the primary cause of most of these cancers. Urothelial carcinoma is said to be the most common urologic cancer in China. In Africa, SCC accounts for between two thirds and three quarters of all malignant bladder tumors, with Sudan and Egypt having the highest incidence of the disease. A few studies from Egypt have recently shown a reversal of this trend due to better schistosomiasis control in the area, whereas in other parts of Africa the association is unchanged. Rising smoking rates are thought to have aided Egypt's transition to TCC, which has a stronger smoking association. The American Cancer Society predicts that in 2022, 81,180 new cases of bladder cancer will be identified in the nation, and 17,100 people will lose their lives to the disease. The median age at diagnosis is 73 years old, and bladder cancer is rarely diagnosed before the age of 40. Bladder cancer risk increases with age. Bladder cancer affects men about 4 times more frequently than it does women. The male predominance of bladder cancer in the US is a result of transitional cell carcinoma (TCC) being more prevalent in men. Small cell carcinoma has a 1:2 male to female incidence ratio, in contrast to TCC's 1:1 ratio. Despite not ranking among the top 10 cancers in women, bladder cancer is the fourth most prevalent cancer in men in the US, after colorectal, lung, and prostate cancer. Accordingly, it is predicted that 12,120 men rather than 4980 women will die of bladder cancer in 2022. However, women typically have a worse prognosis than men. Bladder cancer strikes White men in the US twice as often as Black men. Although they are less optimistic than Whites, Black people.

TSC1 mutated metastatic bladder cancer -Current Market Size & Forecast Trends

The market for TSC1-mutated metastatic bladder cancer is part of the broader metastatic bladder cancer treatment landscape, which was valued at approximately USD 10.83 billion in 2024 and is projected to exceed USD 29.1 billion by 2037, growing at a compound annual growth rate (CAGR) of 7.9% during this period. The focus on personalized medicine and targeted therapies is driving this growth, particularly for patients with specific genetic mutations like TSC1. Current research is exploring the use of mTOR inhibitors, such as nab-sirolimus, as potential treatments for TSC1-mutated cases, highlighting the importance of ongoing clinical trials. North America is expected to dominate the market due to high incidence rates and significant investment in research and development. Overall, the market for TSC1-mutated metastatic bladder cancer is well-positioned for substantial growth through 2035 as new therapies and treatment strategies continue to emerge.

The treatment landscape for advanced-stage, incurable, or metastatic UC has significantly changed over the past few years with the introduction of six new therapeutic agents for clinical use. Conventional chemotherapy and new immune checkpoint inhibitors (ICIs) that target programmed cell-death protein 1 (PD-1) or its ligand have been shown to improve survival in some patients with metastatic UC. According to data, anti-PD-1 ICIs are enhancing both the clinical outcomes and quality of life for second-line patients. Only patients with advanced UC who are ineligible for platinum therapy and who have PD-L1 positivity are approved for use of atezolizumab and pembrolizumab (both ICIs). The FDA recently granted accelerated approval to erdafintib, a pan-FGFR inhibitor, for the treatment of advanced metastatic UC that has undergone platinum pretreatment and has susceptible FGFR3 or FGFR2 genetic alterations. The FDA has granted Enfortumab vedotin, an antibody-drug conjugate, breakthrough status for the treatment of metastatic UC. The current immunotherapy landscape in metastatic UC is defined by the recent approval of pembrolizumab and atezolizumab for patients who are ineligible for platinum-based therapy or who are ineligible for cisplatin-containing therapy and whose tumors express PD-L1. Patients with tumors that are PD-L1 positive are included in this. Still, patient- and tumor-specific characteristics like renal function and PD-L1 status should be given high priority when thinking about front-line systemic therapy. Although more research is needed, dual immunotherapy regimens, alternative combined ICI, and targeted therapies, novel FGFR inhibitors, and antibody-drug conjugates all show great promise for treating metastatic bladder cancer. In the context of the evolving UC therapy paradigm, the development and validation of biomarkers that can identify patients who will likely benefit from a particular therapy are crucial.

Report Highlights

TSC1 mutated metastatic bladder cancer - Current Market Trends

TSC1 mutated metastatic bladder cancer - Current & Forecasted Cases across the G8 Countries

TSC1 mutated metastatic bladder cancer - Market Opportunities and Sales Potential for Agents

TSC1 mutated metastatic bladder cancer - Patient-based Market Forecast to 2035

TSC1 mutated metastatic bladder cancer - Untapped Business Opportunities

TSC1 mutated metastatic bladder cancer - Product Positioning Vis-a-vis Competitors' Products

TSC1 mutated metastatic bladder cancer - KOLs Insight