Bladder cancer is the fifth most common cancer in Europe and the ninth most common cancer worldwide. Symptoms include hematuria, dysuria, increased frequency of urination, and frequent urinary tract infections.
Bladder cancer is the fifth most common cancer in the United States and Europe, and the ninth most common cancer globally. The publisher estimates that in 2018, there were 546,400 cases of bladder cancer globally, and expects this number to rise to 605,300 incident cases by 2027.
The majority of bladder cancer diagnoses (77.2%) worldwide are in males, ranging from 70.1% to 78.4% across regions.
The bladder cancer market will experience rapid growth over the next ten years across the United States, Japan, and five major European markets (France, Germany, Italy, Spain, and the United Kingdom). The primary drivers for this growth are the label expansions of the PD-1/PD-L1 drug class and the approval and subsequent utilization of new targeted therapies.
PD-1/PD-L1 inhibitors remain the dominant category in the bladder cancer market in terms of patient share, and expansion of the nomenclature in early disease stages such as non-muscular invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC) will further increase the growth of the cancer market. The bladder in general.
Despite the strong performance of PD-1/PD-L1 inhibitors elsewhere, poor results from investigations of Keytruda, Imfinzi and Tecentriq with chemotherapy combinations in metastatic urothelial carcinoma (MUC) have reduced the potential for expansion of this Prepare for significant market opportunities.
Keytruda remains a major treatment across patient segments. Guideline recommendations for use in the first and later lines of treatment, physician knowledge, and dilations as part of combination with chemotherapy in patients with metastases and in NMIBC highlight their broad benefit.
Centric is not expected to have commercial success in bladder cancer as Keytruda due to poor clinical outcomes. The IMvigor010 trial in postoperative MIBC did not achieve the primary end points, while IMvigor211 and IMvigor130 failed to show an overall survival benefit over chemotherapy in the second and first MUC lines, respectively. These latest findings have led Roche to withdraw Tecentriq from its second-line setting after a re-evaluation by the Food and Drug Administration, and although front-line use remains unaffected, this represents a significant setback for Roche’s major checkpoint inhibitor.
Following the failure of the phase III trial of DANUBE in its first-line MUC, AstraZeneca similarly withdrew Imfinzi from its bladder cancer indication in line with the terms the Food and Drug Administration had imposed on its initial approval of the previously treated disease. Unlike Tecentriq, this withdrawal appears to be final, and Imfinzi’s ambitious research and development program in bladder cancer has now been suspended.
Bavencio is expected to be the least commercially successful drug in the PD-1/PD-L1 inhibitor class due to relatively weaker clinical trial results, lack of development in metastatic first-line patients, and lack of geographic expansion. However, its potential use as a maintenance treatment gives it a small but largely unchallenged stature.
With three trials underway to enable registration, Opdivo could supplement its currently modest sales within the bladder cancer space with label expansions.
The drug and antibody consortia (ADCs) are also expected to contribute to the growth of the overall bladder cancer market through continued uptake of Padcev, label expansion of Padcev in a first-line setup, and approval of the ADC Trodelvy pipeline.
Padcev is the first ADC to be approved for use in bladder cancer. The drug will experience significant uptake in patients previously treated with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor due to strong clinical data in this population and ongoing development outside the United States. Furthermore, Padcev is being investigated in combination with Keytruda in first-line patients, a larger population that will enhance the drug’s commercial prospects.
Pipeline ADC Trodelvy is expected to have less commercial success than Padcev because of its less impressive overall response rate results and the lack of clinical development in previously treated bladder cancer.
The publisher anticipates that market growth will be complemented by the class of fibroblast growth factor (FGFR) inhibitor drugs, with continued uptake of Balversa – the first drug in this class to be launched – as well as potential pipeline approvals for the FGFR inhibitors Pemazyre and infigratinib. However, restriction of FGFR biomarkers, as well as the lack of routine screening for FGFR alteration, will limit growth within the drug class.
If positive results are obtained in the pivotal trials, bempegaldesleukin in combination with Opdivo could be considered as an appropriate chemotherapy-free option in first-line patients with low PD-L1 expression. However, sales of bempegaldesleukin in bladder cancer will be limited due to its lack of out-of-group development with Opdivo.
If approved, the combination of the IDO1 inhibitor linrodostat and Opdivo may be subject to uptake as a semi-adjuvant system in MIBC. However, the uncertainty surrounding the class of IDO1 inhibitor dampens expectations for this group. Furthermore, sales of Linrodostat in bladder cancer will be limited due to lack of development outside of integration with Opdivo.
With Keytruda recently launched into the setting, the large, untreated market for BCG-resistant NMIBC is set to become highly contentious with a host of new approvals expected in the coming years, including the gene therapy Instiladrin, Anktiva recombinant immunoglobulin, anti-CD116 viral therapy CG0070 , and EpCAM targeting ADC Vicineum.
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Ignalisib for Bladder Cancer (Feb 11, 2021)
Anktiva for Bladder Cancer (December 21, 2020)
Padcev for Bladder Cancer (October 12, 2020)
Opdivo for Bladder Cancer (September 24, 2020)
Padcev for Bladder Cancer (September 18, 2020)
Keytruda for Bladder Cancer (June 9, 2020)
Bavencio for Bladder Cancer (May 31, 2020)
Tecentriq for Bladder Cancer (May 31, 2020)
Imfinzi for Bladder Cancer (March 6, 2020)
Tecentriq for Bladder Cancer (January 24, 2020)
Bavencio Bladder Cancer (January 6, 2020)
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