Disease Analysis: Bladder Cancer
Author: Tom Tyler
Publisher: Datamonitor Healthcare
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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 and Tecentriq with chemotherapy combinations in front-line platinum-eligible bladder cancer 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 expansions as part of a combination with chemotherapy in metastatic patients and into NMIBC highlight its broad utility.
- Though approved in first-line and previously treated patients, Tecentriq is not expected to fare as well commercially in bladder cancer as Keytruda due to weaker clinical results. For example, IMvigor211 and IMvigor130 failed to show overall survival benefit over chemotherapy in subsequent- and first-line patients, respectively. Furthermore, the recent failure of the IMvigor010 trial ends Tecentriq’s development in MIBC, limiting the drug’s commercial outlook.
- Though Imfinzi currently lacks approvals outside of the US and in the first-line setting, an ambitious development program in bladder cancer may help drive uptake in the coming years.
- Bavencio is expected to be the least commercially successful drug in the PD-1/PD-L1 inhibitor class due to comparatively weaker clinical trial results, lack of development in first-line metastatic patients, and lack of geographic expansion. However, its prospective use as a maintenance therapy grants it a small but largely unchallenged niche.
- 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 (ORR) 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 infigratinib. 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 BMS-986205 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, BMS-986205 sales in bladder cancer will be limited due to 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, and the EpCAM-targeting ADC Vicineum.
- A relatively high proportion of trials for bladder cancer have been in Phase I (46.3%) and Phase II (43.7%) compared to other indications. The US, Spain, and the UK have seen the greatest number of bladder cancer trials globally, while South Korea has the top spot within Asia. Eli Lilly has the highest number of completed clinical trials for bladder cancer, with 61 trials.
- The overall likelihood of approval of a Phase I bladder cancer asset is 13%, and the average probability a drug advances from Phase III is 66.7%. Bladder cancer drugs, on average, take 9.0 years from Phase I to approval, compared to 9.2 years in the overall oncology space.
CONTENTS
8 OVERVIEW
8 Latest key takeaways
10 DISEASE BACKGROUND
10 Risk factors
10 Symptoms
11 Diagnosis
12 Patient segmentation
12 Prognosis
14 TREATMENT
14 Referral patterns
14 Non-muscle invasive bladder cancer (Stage 0–I)
14 Muscle invasive bladder cancer (Stage II–III)
15 Metastatic (Stage IV)
19 EPIDEMIOLOGY
23 MARKETED DRUGS
26 PIPELINE DRUGS
36 KEY REGULATORY EVENTS
36 Keytruda Dropped From England’s Cancer Drugs Fund For Bladder Cancer
36 Padcev/Keytruda Combo Earn BTD In First-Line Bladder Cancer
36 Astellas, Seattle Genetics Break Ground With US ADC Approval
36 Merck’s Keytruda Survives ‘Conflicted’ Adcom Vote For Bladder Cancer Indication
38 PROBABILITY OF SUCCESS
39 LICENSING AND ASSET ACQUISITION DEALS
39 Gilead’s Immunomedics Buy: Five Things To Worry About
39 Prokarium Options Bladder Cancer Candidate From Swiss University
39 PhotoCure Regains Global Rights for Hevvix from Ipsen
40 CLINICAL TRIAL LANDSCAPE
41 Sponsors by status
42 Sponsors by phase
43 Recent events
45 DRUG ASSESSMENT MODEL
48 MARKET DYNAMICS
49 FUTURE TRENDS
49 Disappointing trial results cast doubt on future of PD-1/PD-L1 inhibitors in front-line metastatic disease
49 PD-1/PD-L1 inhibitors move to earlier, more localized bladder tumors
50 Multiple novel agents move in on lucrative NMIBC setting
50 Several FGFR inhibitors are expected to enter the bladder cancer market
51 Antibody-drug conjugates may diversify treatment for metastatic bladder cancer
52 CONSENSUS FORECASTS
54 RECENT EVENTS AND ANALYST OPINION
54 Anktiva for Bladder Cancer (December 21, 2020)
55 Padcev for Bladder Cancer (October 12, 2020)
56 Opdivo for Bladder Cancer (September 24, 2020)
58 Padcev for Bladder Cancer (September 18, 2020)
59 Keytruda for Bladder Cancer (June 9, 2020)
61 Bavencio for Bladder Cancer (May 31, 2020)
62 Tecentriq for Bladder Cancer (May 31, 2020)
64 Imfinzi for Bladder Cancer (March 6, 2020)
65 Tecentriq for Bladder Cancer (January 24, 2020)
67 Bavencio for Bladder Cancer (January 6, 2020)
68 Keytruda for Bladder Cancer (December 17, 2019)
70 Instiladrin for Bladder Cancer (December 5, 2019)
71 Sitravatinib for Bladder Cancer (November 9, 2019)
72 CV-301 for Bladder Cancer (October 18, 2019)
73 Tecentriq for Bladder Cancer (September 30, 2019)
75 Padcev for Bladder Cancer (September 28, 2019)
77 Trodelvy for Bladder Cancer (September 28, 2019)
79 VesiGel for Bladder Cancer (September 24, 2019)
80 Tecentriq for Bladder Cancer (August 4, 2019)
82 Magrolimab for Bladder Cancer (July 11, 2019)
83 Qapzola for Bladder Cancer (June 25, 2019)
84 Padcev for Bladder Cancer (June 3, 2019)
86 KEY UPCOMING EVENTS
87 KEY OPINION LEADER INSIGHTS
88 BIBLIOGRAPHY
89 Prescription information
91 APPENDIX
LIST OF FIGURES
21 Figure 1: Trends in incident cases of bladder cancer, 2018–27
26 Figure 2: Overview of pipeline drugs for bladder cancer in the US
26 Figure 3: Pipeline drugs for bladder cancer, by company
27 Figure 4: Pipeline drugs for bladder cancer, by drug type
27 Figure 5: Pipeline drugs for bladder cancer, by classification
38 Figure 6: Probability of success in the bladder cancer pipeline
40 Figure 7: Clinical trials in bladder cancer
40 Figure 8: Top 10 drugs for clinical trials in bladder cancer
41 Figure 9: Top 10 companies for clinical trials in bladder cancer
41 Figure 10: Trial locations in bladder cancer
42 Figure 11: Bladder cancer trials status
43 Figure 12: Bladder cancer trials sponsors, by phase
45 Figure 13: Datamonitor Healthcare’s drug assessment summary for bladder cancer
48 Figure 14: Market dynamics for bladder cancer
49 Figure 15: Future trends in bladder cancer
56 Figure 16: Padcev for Bladder Cancer (October 12, 2020): Phase II – EV-201
58 Figure 17: Opdivo for Bladder Cancer (September 24, 2020): Phase III – CheckMate 274
59 Figure 18: Padcev for Bladder Cancer (September 18, 2020): Phase III – EV-301
61 Figure 19: Keytruda for Bladder Cancer (June 9, 2020): Phase III – KEYNOTE-361
62 Figure 20: Bavencio for Bladder Cancer (May 31, 2020): Phase III – JAVELIN Bladder 100
64 Figure 21: Tecentriq for Bladder Cancer (May 31, 2020): Phase III – IMvigor010 (WO29636; Adjuvant)
65 Figure 22: Imfinzi for Bladder Cancer (March 6, 2020): Phase III – DANUBE (w/Tremelimumab)
67 Figure 23: Tecentriq for Bladder Cancer (January 24, 2020): Phase III – IMvigor010 (WO29636; Adjuvant)
68 Figure 24: Bavencio for Bladder Cancer (January 6, 2020): Phase III – JAVELIN Bladder 100
71 Figure 25: Instiladrin for Bladder Cancer (December 5, 2019): Phase III – BCG Unresponsive NMIBC
75 Figure 26: Tecentriq for Bladder Cancer (September 30, 2019): Phase III – IMvigor130
77 Figure 27: Padcev for Bladder Cancer (September 28, 2019): Phase Ib/II – EV-103 (w/CPIs)
79 Figure 28: Trodelvy for Bladder Cancer (September 28, 2019): Phase II – TROPHY U-01
80 Figure 29: VesiGel for Bladder Cancer (September 24, 2019): Phase IIb – OPTIMA (LG NMIBC)
82 Figure 30: Tecentriq for Bladder Cancer (August 4, 2019): Phase III – IMvigor130
85 Figure 31: Padcev for Bladder Cancer (June 3, 2019): Phase II – EV-201
86 Figure 32: Key upcoming events in bladder cancer
LIST OF TABLES
12 Table 1: Bladder cancer staging
13 Table 2: Five-year survival rates for bladder cancer by stage at diagnosis
17 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
28 Table 7: Pipeline drugs for bladder cancer in the US
52 Table 8: Historical global sales, by drug ($m), 2015–19
52 Table 9: Forecasted global sales, by drug ($m), 2020–24
54 Table 10: Anktiva for Bladder Cancer (December 21, 2020)
55 Table 11: Padcev for Bladder Cancer (October 12, 2020)
57 Table 12: Opdivo for Bladder Cancer (September 24, 2020)
58 Table 13: Padcev for Bladder Cancer (September 18, 2020)
60 Table 14: Keytruda for Bladder Cancer (June 9, 2020)
61 Table 15: Bavencio for Bladder Cancer (May 31, 2020)
63 Table 16: Tecentriq for Bladder Cancer (May 31, 2020)
64 Table 17: Imfinzi for Bladder Cancer (March 6, 2020)
66 Table 18: Tecentriq for Bladder Cancer (January 24, 2020)
67 Table 19: Bavencio for Bladder Cancer (January 6, 2020)
69 Table 20: Keytruda for Bladder Cancer (December 17, 2019)
70 Table 21: Instiladrin for Bladder Cancer (December 5, 2019)
72 Table 22: Sitravatinib for Bladder Cancer (November 9, 2019)
73 Table 23: CV-301 for Bladder Cancer (October 18, 2019)
74 Table 24: Tecentriq for Bladder Cancer (September 30, 2019)
76 Table 25: Padcev for Bladder Cancer (September 28, 2019)
78 Table 26: Trodelvy for Bladder Cancer (September 28, 2019)
79 Table 27: VesiGel for Bladder Cancer (September 24, 2019)
81 Table 28: Tecentriq for Bladder Cancer (August 4, 2019)
82 Table 29: Magrolimab for Bladder Cancer (July 11, 2019)
83 Table 30: Qapzola for Bladder Cancer (June 25, 2019)
84 Table 31: Padcev for Bladder Cancer (June 3, 2019)
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