Disease Analysis: Bladder Cancer
Author: Tom Tyler
Publisher: Datamonitor Healthcare
- Description
- Contents
- Enquire
Disease Overview
Bladder cancer is the fifth most common cancer in Europe and the ninth most common cancer globally. Symptoms include hematuria, dysuria, increased urinary frequency, and frequent urinary tract infections.
Latest key takeaways
- Bladder cancer is the fifth most common cancer in the US and Europe, and the ninth most common cancer worldwide. Datamonitor Healthcare estimates that in 2018, there were 546,400 incident cases of bladder cancer globally, and expects that number to increase 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 10 years across the US, Japan, and five major European markets (France, Germany, Italy, Spain, and the UK). The primary drivers for this growth are label expansions of the established PD-1/PD-L1 drug class and the approval and subsequent uptake of new targeted therapies.
- PD-1/PD-L1 inhibitors remain the dominant class in the bladder cancer market in terms of patient share, and label expansion into earlier disease stages such as non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC) will further grow the overall bladder cancer market.
- Despite the solid performance of PD-1/PD-L1 inhibitors in other settings, poor results from investigations of Keytruda, Imfinzi, and Tecentriq with chemotherapy combinations in front-line platinum-eligible metastatic urothelial carcinoma (mUC) have dampened the likelihood of expansion into this setting of substantial market opportunity.
- Keytruda remains a key therapy across patient segments. Guideline recommendations for use at first line and subsequent lines of therapy, physician familiarity, and a recent expansion into NMIBC highlight its broad utility. Though its approval in front-line cisplatin-ineligible mUC was narrowly retained by the FDA, uncertainty persists over the robustness of the data justifying its use in this setting.
- Tecentriq is another PD-1/PD-L1 inhibitor that has encountered regulatory difficulties. The IMvigor010 trial in postoperative MIBC did not meet its primary endpoints, while IMvigor211 failed to show an overall survival benefit over chemotherapy in second-line mUC. These latter findings resulted in Roche withdrawing Tecentriq from the second-line setting following a reappraisal by the FDA. By contrast, Tecentriq’s front-line cisplatin-ineligible label remains unaffected, and positive data from IMvigor130 provide stronger evidence for its use than exists for Keytruda.
- Following the failure of the Phase III DANUBE trial in first-line mUC, AstraZeneca has withdrawn Imfinzi from the bladder cancer indication in line with the conditions imposed by the FDA on its initial approval for previously treated disease. Unlike Tecentriq, this withdrawal removes Imfinzi from the mUC market entirely, and future research is focusing on localized tumors like NMIBC.
- Though Bavencio was initially expected to be the least commercially successful drug in the PD-1/PD-L1 inhibitor class, its use as a maintenance therapy following first-line chemotherapy in mUC satisfies a major unmet need and grants it access to a large and uncontested market. Conversely, the drug’s overall sales will be stymied by a lack of development in other settings.
- With three ongoing registration-enabling trials, Opdivo could potentially supplement its currently modest sales within the bladder cancer space with label expansions.
- Antibody-drug conjugates (ADCs) are also expected to contribute to growth of the overall bladder cancer market through continued uptake of Padcev, a label expansion for Padcev in the first-line setting, and approval of pipeline ADC Trodelvy.
- Padcev is the first ADC to be approved for use in bladder cancer. The drug will experience substantial 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 of the US. Furthermore, Padcev is being investigated in combination with Keytruda in first-line patients, a larger population that will further the drug’s commercial prospects.
- Pipeline ADC Trodelvy is expected to have less commercial success than Padcev due to less impressive overall response rate results and a lack of clinical development in previously treated bladder cancer.
- Datamonitor Healthcare expects market growth will be supplemented by the fibroblast growth factor receptor (FGFR) inhibitor drug class, with continued uptake of Balversa – the first drug in this class to be launched – as well as prospective approvals of the pipeline FGFR inhibitors Pemazyre and Truseltiq. However, an FGFR biomarker restriction, as well as the lack of routine FGFR alteration screening, will limit growth within the drug class.
- If positive results are obtained in pivotal trials, bempegaldesleukin in combination with Opdivo may be viewed as a favorable chemotherapy-free option in first-line patients with low PD-L1 expression. However, bempegaldesleukin sales in bladder cancer will be limited by its lack of development outside of the combination with Opdivo.
- If approved, the combination of IDO1 inhibitor linrodostat and Opdivo may experience uptake as a peri-adjuvant regimen in MIBC. However, uncertainty surrounding the IDO1 inhibitor class tempers expectations for this combination. Furthermore, linrodostat sales in bladder cancer will be limited due to a lack of development outside of the combination with Opdivo.
- Following Keytruda’s recent launch in the setting, the large and unaddressed market of BCG-resistant NMIBC is set to become highly contested with a suite of novel approvals expected in the coming years including the gene therapy Instiladrin, the recombinant immunocytokine Anktiva, the anti-CD116 viral therapy CG0070, and the EpCAM-targeting ADC Vicineum.
CONTENTS
7 OVERVIEW
7 Latest key takeaways
9 DISEASE BACKGROUND
9 Risk factors
9 Symptoms
10 Diagnosis
11 Patient segmentation
11 Prognosis
13 TREATMENT
13 Referral patterns
13 Non-muscle invasive bladder cancer (Stage 0–I)
13 Muscle invasive bladder cancer (Stage II–III)
14 Metastatic (Stage IV)
19 EPIDEMIOLOGY
23 MARKETED DRUGS
27 PIPELINE DRUGS
38 KEY REGULATORY EVENTS
38 Bladder Cancer Accelerated Approvals: Merck, Genentech PD-1/L1 Inhibitors Prevail At US FDA Panel, But For Different Reasons
38 Bladder Cancer Accelerated Approvals: Merck’s Keytruda and Genentech’s Tecentriq Each May Have One Last Lifeline
38 Bladder Cancer Space Churns With Accelerated Approvals
39 Accelerated Approval: US FDA Review Of Expedited Program Could Bring More Withdrawals
39 Keeping Track: Padcev, Vicineum Seek Bladder Cancer Approvals
39 First-Line Bavencio Bladder Cancer OK Boosts Merck KGaA
41 PROBABILITY OF SUCCESS
42 LICENSING AND ASSET ACQUISITION DEALS
42 CytoImmune Acquires City Of Hope Cell Therapy IP
42 Helsinn And BridgeBio Ink Infigratinib Cancer Pact
42 U. Of Texas Research Branch Maintains Hectic Partnering Pace
42 NantKwest/ImmunityBio To Merge In All-Stock Deal
43 Hikma Adds Sesen’s Vicineum To MENA Brands
43 Gilead’s Immunomedics Buy: Five Things To Worry About
44 CLINICAL TRIAL LANDSCAPE
45 Sponsors by status
46 Sponsors by phase
47 Recent events
48 DRUG ASSESSMENT MODEL
51 MARKET DYNAMICS
52 FUTURE TRENDS
52 Platinum-eligible first-line mUC remains out of reach for PD-1/PD-L1 antibodies
52 Regulatory reviews threaten use of PD-1/PD-L1 antibodies in mUC
53 PD-1/PD-L1 inhibitors move to earlier, more localized bladder tumors
53 Multiple novel agents are targeting the lucrative NMIBC setting
54 Development of FGFR inhibitors sees mixed fortunes
54 Antibody-drug conjugates may diversify treatment for metastatic bladder cancer
56 CONSENSUS FORECASTS
58 RECENT EVENTS AND ANALYST OPINION
58 Keytruda for Bladder Cancer (April 28, 2021)
59 Tecentriq for Bladder Cancer (April 28, 2021)
61 Keytruda for Bladder Cancer (April 23, 2021)
62 Tecentriq for Bladder Cancer (April 23, 2021)
63 Eganelisib for Bladder Cancer (February 11, 2021)
64 Anktiva for Bladder Cancer (December 21, 2020)
65 Padcev for Bladder Cancer (October 12, 2020)
67 Opdivo for Bladder Cancer (September 24, 2020)
69 Padcev for Bladder Cancer (September 18, 2020)
70 Keytruda for Bladder Cancer (June 9, 2020)
72 Bavencio for Bladder Cancer (May 31, 2020)
73 Tecentriq for Bladder Cancer (May 31, 2020)
75 Imfinzi for Bladder Cancer (March 6, 2020)
76 Tecentriq for Bladder Cancer (January 24, 2020)
78 Bavencio for Bladder Cancer (January 6, 2020)
79 Keytruda for Bladder Cancer (December 17, 2019)
81 Instiladrin for Bladder Cancer (December 5, 2019)
83 KEY UPCOMING EVENTS
84 KEY OPINION LEADER INSIGHTS
85 BIBLIOGRAPHY
87 APPENDIX
LIST OF FIGURES
21 Figure 1: Trends in incident cases of bladder cancer, 2018–27
27 Figure 2: Overview of pipeline drugs for bladder cancer in the US
27 Figure 3: Pipeline drugs for bladder cancer, by company
28 Figure 4: Pipeline drugs for bladder cancer, by drug type
28 Figure 5: Pipeline drugs for bladder cancer, by classification
41 Figure 6: Probability of success in the bladder cancer pipeline
44 Figure 7: Clinical trials in bladder cancer
44 Figure 8: Top 10 drugs for clinical trials in bladder cancer
45 Figure 9: Top 10 companies for clinical trials in bladder cancer
45 Figure 10: Trial locations in bladder cancer
46 Figure 11: Bladder cancer trials status
47 Figure 12: Bladder cancer trials sponsors, by phase
48 Figure 13: Datamonitor Healthcare’s drug assessment summary for bladder cancer
51 Figure 14: Market dynamics for bladder cancer
52 Figure 15: Future trends in bladder cancer
64 Figure 16: Eganelisib for Bladder Cancer (February 11, 2021): Phase II – MARIO-275 (w/Nivolumab)
67 Figure 17: Padcev for Bladder Cancer (October 12, 2020): Phase II – EV-201
69 Figure 18: Opdivo for Bladder Cancer (September 24, 2020): Phase III – CheckMate 274
70 Figure 19: Padcev for Bladder Cancer (September 18, 2020): Phase III – EV-301
72 Figure 20: Keytruda for Bladder Cancer (June 9, 2020): Phase III – KEYNOTE-361
73 Figure 21: Bavencio for Bladder Cancer (May 31, 2020): Phase III – JAVELIN Bladder 100
75 Figure 22: Tecentriq for Bladder Cancer (May 31, 2020): Phase III – IMvigor010 (WO29636; Adjuvant)
76 Figure 23: Imfinzi for Bladder Cancer (March 6, 2020): Phase III – DANUBE (w/Tremelimumab)
78 Figure 24: Tecentriq for Bladder Cancer (January 24, 2020): Phase III – IMvigor010 (WO29636; Adjuvant)
79 Figure 25: Bavencio for Bladder Cancer (January 6, 2020): Phase III – JAVELIN Bladder 100
82 Figure 26: Instiladrin for Bladder Cancer (December 5, 2019): Phase III – BCG Unresponsive NMIBC
83 Figure 27: Key upcoming events in bladder cancer
LIST OF TABLES
11 Table 1: Bladder cancer staging
12 Table 2: Five-year survival rates for bladder cancer by stage at diagnosis
16 Table 3: Preferred branded treatment regimens for patients with Stage IV bladder cancer
20 Table 4: Incident cases of bladder cancer, 2018–27
22 Table 5: Incident cases of bladder cancer, by gender, 2018
24 Table 6: Marketed drugs for bladder cancer
29 Table 7: Pipeline drugs for bladder cancer in the US
56 Table 8: Historical global sales, by drug ($m), 2016–20
57 Table 9: Forecasted global sales, by drug ($m), 2021–25
58 Table 10: Keytruda for Bladder Cancer (April 28, 2021)
60 Table 11: Tecentriq for Bladder Cancer (April 28, 2021)
61 Table 12: Keytruda for Bladder Cancer (April 23, 2021)
62 Table 13: Tecentriq for Bladder Cancer (April 23, 2021)
63 Table 14: Eganelisib for Bladder Cancer (February 11, 2021)
65 Table 15: Anktiva for Bladder Cancer (December 21, 2020)
66 Table 16: Padcev for Bladder Cancer (October 12, 2020)
68 Table 17: Opdivo for Bladder Cancer (September 24, 2020)
69 Table 18: Padcev for Bladder Cancer (September 18, 2020)
71 Table 19: Keytruda for Bladder Cancer (June 9, 2020)
72 Table 20: Bavencio for Bladder Cancer (May 31, 2020)
74 Table 21: Tecentriq for Bladder Cancer (May 31, 2020)
75 Table 22: Imfinzi for Bladder Cancer (March 6, 2020)
77 Table 23: Tecentriq for Bladder Cancer (January 24, 2020)
78 Table 24: Bavencio for Bladder Cancer (January 6, 2020)
80 Table 25: Keytruda for Bladder Cancer (December 17, 2019)
81 Table 26: Instiladrin for Bladder Cancer (December 5, 2019)
© Informa UK Ltd. This document is a licensed product and is not to be reproduced or redistributed
Do you have a subscription to Datamonitor Healthcare, Biomedtracker or Meddevicetracker? You may already have access to these reports, contact your account manager or email pharma@informabi.com for further help or assistance.
Market Spotlight: Thyroid Cancer 
Sign up to the