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 in the established PD-1/PD-L1 drug class and the approval and subsequent uptake of new targeted therapies.
- The PD-1/PD-L1 drug class remains the dominant class in the bladder cancer market in terms of patient share, and label expansions for PD-1/PD-L1 inhibitors 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 as well as the substantial market opportunity presented by expansion to front-line platinum-eligible bladder cancer, recent results from investigations of Keytruda and Tecentriq chemotherapy combinations in this setting have dampened hopes for such a move.
- Keytruda remains a key therapy across patient segments. Guideline recommendations for use at first line and subsequent lines of therapy, physician familiarity, and expansion 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 for MIBC, limiting the drug’s commercial viability.
- Though Imfinzi currently lacks an approval 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.
- Though 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, 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 if positive results are obtained.
- 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 sacituzumab govitecan.
- 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 sacituzumab govitecan 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 approved, as well as approvals of pipeline FGFR inhibitors pemigatinib and rogaratinib. However, the requirement for FGFR alteration for use of these drugs, as well as the lack of routine FGFR alteration screening, will restrict growth within the drug class.
- Bempegaldesleukin in combination with Opdivo may be viewed as a favorable chemotherapy-free option in first-line patients with low PD-L1 expression if positive results are obtained. However, bempegaldesleukin sales in bladder cancer will be limited due to lack of development outside of the combination with Opdivo.
- IDO1 inhibitor BMS-986205 in combination with Opdivo may experience uptake as a peri-adjuvant regimen in MIBC if approved. 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.
- A relatively high proportion of trials for bladder cancer have been in Phase I (46.7%) and Phase II (43.2%) 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 12.2%, and the average probability a drug advances from Phase III is 66.7%. Bladder cancer drugs, on average, take 8.6 years from Phase I to approval, compared to 9.4 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)
17 EPIDEMIOLOGY
21 MARKETED DRUGS
25 PIPELINE DRUGS
35 KEY REGULATORY EVENTS
35 Keytruda Dropped From England’s Cancer Drugs Fund For Bladder Cancer
35 Padcev/Keytruda Combo Earn BTD In First-Line Bladder Cancer
35 Astellas, Seattle Genetics Break Ground With US ADC Approval
35 Merck’s Keytruda Survives ‘Conflicted’ Adcom Vote For Bladder Cancer Indication
37 PROBABILITY OF SUCCESS
38 LICENSING AND ASSET ACQUISITION DEALS
38 Prokarium Options Bladder Cancer Candidate From Swiss University
38 PhotoCure Regains Global Rights for Hevvix from Ipsen
39 CLINICAL TRIAL LANDSCAPE
40 Sponsors by status
41 Sponsors by phase
42 Recent events
44 DRUG ASSESSMENT MODEL
46 MARKET DYNAMICS
47 FUTURE TRENDS
47 Disappointing trial results cast doubt on future of PD-1/PD-L1 inhibitors in front-line chemotherapy combinations
47 PD-1/PD-L1 inhibitors expected to move into earlier stages of bladder cancer
48 Several FGFR inhibitors are expected to enter the bladder cancer market
48 Antibody-drug conjugates may diversify treatment for metastatic bladder cancer
49 CONSENSUS FORECASTS
50 RECENT EVENTS AND ANALYST OPINION
50 Keytruda for Bladder Cancer (June 9, 2020)
51 Bavencio for Bladder Cancer (May 31, 2020)
53 Tecentriq for Bladder Cancer (May 31, 2020)
54 Imfinzi for Bladder Cancer (March 6, 2020)
56 Tecentriq for Bladder Cancer (January 24, 2020)
57 Bavencio for Bladder Cancer (January 6, 2020)
59 Keytruda for Bladder Cancer (December 17, 2019)
60 Keytruda for Bladder Cancer (December 13, 2019)
61 Instiladrin for Bladder Cancer (December 5, 2019)
63 Sitravatinib for Bladder Cancer (November 9, 2019)
64 CV-301 for Bladder Cancer (October 18, 2019)
65 Tecentriq for Bladder Cancer (September 30, 2019)
67 Padcev for Bladder Cancer (September 28, 2019)
69 Trodelvy for Bladder Cancer (September 28, 2019)
71 VesiGel for Bladder Cancer (September 24, 2019)
72 Tecentriq for Bladder Cancer (August 4, 2019)
74 Magrolimab for Bladder Cancer (July 11, 2019)
75 Qapzola for Bladder Cancer (June 25, 2019)
76 Padcev for Bladder Cancer (June 3, 2019)
77 therascreen FGFR RGQ RT-PCR Kit for Bladder Cancer (May 10, 2019)
78 Trodelvy for Bladder Cancer (April 29, 2019)
79 Rubraca for Bladder Cancer (April 15, 2019)
80 therascreen FGFR RGQ RT-PCR Kit for Bladder Cancer (April 12, 2019)
82 Balversa for Bladder Cancer (April 8, 2019)
82 Padcev for Bladder Cancer (March 28, 2019)
84 Vicineum for Bladder Cancer (March 4, 2019)
86 KEY UPCOMING EVENTS
87 KEY OPINION LEADER INSIGHTS
88 BIBLIOGRAPHY
89 Prescription information
90 APPENDIX
LIST OF FIGURES
16 Figure 1: Preferred branded treatment regimens for patients with Stage IV bladder cancer
19 Figure 2: Trends in incident cases of bladder cancer, 2018–27
25 Figure 3: Overview of pipeline drugs for bladder cancer in the US
25 Figure 4: Pipeline drugs for bladder cancer, by company
26 Figure 5: Pipeline drugs for bladder cancer, by drug type
26 Figure 6: Pipeline drugs for bladder cancer, by classification
37 Figure 7: Probability of success in the bladder cancer pipeline
39 Figure 8: Clinical trials in bladder cancer
39 Figure 9: Top 10 drugs for clinical trials in bladder cancer
40 Figure 10: Top 10 companies for clinical trials in bladder cancer
40 Figure 11: Trial locations in bladder cancer
41 Figure 12: Bladder cancer trials status
42 Figure 13: Bladder cancer trials sponsors, by phase
44 Figure 14: Datamonitor Healthcare’s drug assessment summary for bladder cancer
46 Figure 15: Market dynamics for bladder cancer
47 Figure 16: Future trends in bladder cancer
51 Figure 17: Keytruda for Bladder Cancer (June 9, 2020): Phase III – KEYNOTE-361
53 Figure 18: Bavencio for Bladder Cancer (May 31, 2020): Phase III – JAVELIN Bladder 100
54 Figure 19: Tecentriq for Bladder Cancer (May 31, 2020): Phase III – IMvigor010 (WO29636; Adjuvant)
56 Figure 20: Imfinzi for Bladder Cancer (March 6, 2020): Phase III – DANUBE (w/Tremelimumab)
57 Figure 21: Tecentriq for Bladder Cancer (January 24, 2020): Phase III – IMvigor010 (WO29636; Adjuvant)
59 Figure 22: Bavencio for Bladder Cancer (January 6, 2020): Phase III – JAVELIN Bladder 100
63 Figure 23: Instiladrin for Bladder Cancer (December 5, 2019): Phase III – BCG Unresponsive NMIBC
67 Figure 24: Tecentriq for Bladder Cancer (September 30, 2019): Phase III – IMvigor130
69 Figure 25: Padcev for Bladder Cancer (September 28, 2019): Phase Ib/II – EV-103 (w/CPIs)
71 Figure 26: Trodelvy for Bladder Cancer (September 28, 2019): Phase II – TROPHY U-01
72 Figure 27: VesiGel for Bladder Cancer (September 24, 2019): Phase IIb – OPTIMA (LG NMIBC)
74 Figure 28: Tecentriq for Bladder Cancer (August 4, 2019): Phase III – IMvigor130
77 Figure 29: Padcev for Bladder Cancer (June 3, 2019): Phase II – EV-201
84 Figure 30: Padcev for Bladder Cancer (March 28, 2019): Phase II – EV-201
85 Figure 31: Vicineum for Bladder Cancer (March 4, 2019): Phase III – VISTA
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
18 Table 3: Incident cases of bladder cancer, 2018–27
20 Table 4: Incident cases of bladder cancer, by gender, 2018
22 Table 5: Marketed drugs for bladder cancer
27 Table 6: Pipeline drugs for bladder cancer in the US
49 Table 7: Historical global sales, by drug ($m), 2015–19
49 Table 8: Forecasted global sales, by drug ($m), 2020–24
50 Table 9: Keytruda for Bladder Cancer (June 9, 2020)
52 Table 10: Bavencio for Bladder Cancer (May 31, 2020)
53 Table 11: Tecentriq for Bladder Cancer (May 31, 2020)
55 Table 12: Imfinzi for Bladder Cancer (March 6, 2020)
56 Table 13: Tecentriq for Bladder Cancer (January 24, 2020)
58 Table 14: Bavencio for Bladder Cancer (January 6, 2020)
59 Table 15: Keytruda for Bladder Cancer (December 17, 2019)
61 Table 16: Keytruda for Bladder Cancer (December 13, 2019)
62 Table 17: Instiladrin for Bladder Cancer (December 5, 2019)
64 Table 18: Sitravatinib for Bladder Cancer (November 9, 2019)
65 Table 19: CV-301 for Bladder Cancer (October 18, 2019)
66 Table 20: Tecentriq for Bladder Cancer (September 30, 2019)
68 Table 21: Padcev for Bladder Cancer (September 28, 2019)
70 Table 22: Trodelvy for Bladder Cancer (September 28, 2019)
71 Table 23: VesiGel for Bladder Cancer (September 24, 2019)
73 Table 24: Tecentriq for Bladder Cancer (August 4, 2019)
74 Table 25: Magrolimab for Bladder Cancer (July 11, 2019)
75 Table 26: Qapzola for Bladder Cancer (June 25, 2019)
76 Table 27: Padcev for Bladder Cancer (June 3, 2019)
78 Table 28: therascreen FGFR RGQ RT-PCR Kit for Bladder Cancer (May 10, 2019)
79 Table 29: Trodelvy for Bladder Cancer (April 29, 2019)
80 Table 30: Rubraca for Bladder Cancer (April 15, 2019)
81 Table 31: therascreen FGFR RGQ RT-PCR Kit for Bladder Cancer (April 12, 2019)
82 Table 32: Balversa for Bladder Cancer (April 8, 2019)
83 Table 33: Padcev for Bladder Cancer (March 28, 2019)
84 Table 34: Vicineum for Bladder Cancer (March 4, 2019)
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