Disease Analysis: Bladder Cancer
Author: Mike Ramirez
Publisher: Datamonitor Healthcare
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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. PD-1/PD-L1 inhibitor expansion into first-line patients eligible for platinum-based chemotherapy through development of combinations with platinum-based chemotherapy is expected to be a major source of market growth. Furthermore, 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.
- 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 as Keytruda in the bladder cancer market due to weaker clinical results. For example, the IMvigor211 and IMvigor130 studies failed to show overall survival benefit over chemotherapy in previously treated patients and in 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.
- Within the PD-1/PD-L1 class, Bavencio is expected to be the least commercially successful drug due to comparatively weaker clinical trial results, lack of development in first-line metastatic patients, and lack of geographic expansion.
- 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 (46.5%) and Phase II (43.3%) 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 60 trials.
- The overall likelihood of approval of a Phase I bladder cancer asset is 12.4%, and the average probability a drug advances from Phase III is 66.7%. Bladder cancer drugs, on average, take 8.5 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)
17 EPIDEMIOLOGY
21 MARKETED DRUGS
24 PIPELINE DRUGS
34 KEY REGULATORY EVENTS
34 Keytruda Dropped From England’s Cancer Drugs Fund For Bladder Cancer
34 Padcev/Keytruda Combo Earn BTD In First-Line Bladder Cancer
34 Astellas, Seattle Genetics Break Ground With US ADC Approval
34 Merck’s Keytruda Survives ‘Conflicted’ Adcom Vote For Bladder Cancer Indication
36 PROBABILITY OF SUCCESS
37 CLINICAL TRIAL LANDSCAPE
38 Sponsors by status
39 Sponsors by phase
40 Recent events
42 DRUG ASSESSMENT MODEL
44 MARKET DYNAMICS
45 FUTURE TRENDS
45 Label expansions will move PD-1/PD-L1 inhibitors into first-line treatment of platinum-ineligible patients
45 PD-1/PD-L1 inhibitors expected to move into earlier stages of bladder cancer
46 Several FGFR inhibitors are expected to enter the bladder cancer market
46 Antibody-drug conjugates may diversify treatment for metastatic bladder cancer
47 CONSENSUS FORECASTS
48 RECENT EVENTS AND ANALYST OPINION
48 Imfinzi for Bladder Cancer (March 6, 2020)
49 Tecentriq for Bladder Cancer (January 24, 2020)
50 Bavencio for Bladder Cancer (January 6, 2020)
52 Keytruda for Bladder Cancer (December 17, 2019)
53 Keytruda for Bladder Cancer (December 13, 2019)
54 Instiladrin for Bladder Cancer (December 5, 2019)
56 Sitravatinib for Bladder Cancer (November 9, 2019)
57 CV-301 for Bladder Cancer (October 18, 2019)
58 Tecentriq for Bladder Cancer (September 30, 2019)
60 Padcev for Bladder Cancer (September 28, 2019)
62 Sacituzumab Govitecan for Bladder Cancer (September 28, 2019)
64 VesiGel for Bladder Cancer (September 24, 2019)
65 Tecentriq for Bladder Cancer (August 4, 2019)
67 Magrolimab for Bladder Cancer (July 11, 2019)
68 Qapzola for Bladder Cancer (June 25, 2019)
69 Padcev for Bladder Cancer (June 3, 2019)
70 therascreen FGFR RGQ RT-PCR Kit for Bladder Cancer (May 10, 2019)
71 Sacituzumab Govitecan for Bladder Cancer (April 29, 2019)
72 Rubraca for Bladder Cancer (April 15, 2019)
73 therascreen FGFR RGQ RT-PCR for Bladder Cancer (April 12, 2019)
75 Balversa for Bladder Cancer (April 8, 2019)
75 Padcev for Bladder Cancer (March 28, 2019)
77 Vicinium for Bladder Cancer (March 4, 2019)
78 Bempegaldesleukin for Bladder Cancer (February 15, 2019)
80 Folotyn for Bladder Cancer (January 17, 2019)
81 Jelmyto for Bladder Cancer (January 8, 2019)
82 Cyramza for Bladder Cancer (October 20, 2018)
83 Opdivo for Bladder Cancer (October 20, 2018)
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
24 Figure 3: Overview of pipeline drugs for bladder cancer in the US
25 Figure 4: Pipeline drugs for bladder cancer, by company
25 Figure 5: Pipeline drugs for bladder cancer, by drug type
26 Figure 6: Pipeline drugs for bladder cancer, by classification
36 Figure 7: Probability of success in the bladder cancer pipeline
37 Figure 8: Clinical trials in bladder cancer
37 Figure 9: Top 10 drugs for clinical trials in bladder cancer
38 Figure 10: Top 10 companies for clinical trials in bladder cancer
38 Figure 11: Trial locations in bladder cancer
39 Figure 12: Bladder cancer trials status
40 Figure 13: Bladder cancer trials sponsors, by phase
42 Figure 14: Datamonitor Healthcare’s drug assessment summary for bladder cancer
44 Figure 15: Market dynamics for bladder cancer
45 Figure 16: Future trends in bladder cancer
49 Figure 17: Imfinzi for Bladder Cancer (March 6, 2020): Phase III – DANUBE (w/Tremelimumab)
50 Figure 18: Tecentriq for Bladder Cancer (January 24, 2020): Phase III – IMvigor010 (WO29636; Adjuvant)
52 Figure 19: Bavencio for Bladder Cancer (January 6, 2020): Phase III – JAVELIN Bladder 100
56 Figure 20: Instiladrin for Bladder Cancer (December 5, 2019): Phase III – BCG Unresponsive NMIBC
60 Figure 21: Tecentriq for Bladder Cancer (September 30, 2019): Phase III – IMvigor130
62 Figure 22: Padcev for Bladder Cancer (September 28, 2019): Phase Ib/II – EV-103 (w/CPIs)
64 Figure 23: Sacituzumab Govitecan for Bladder Cancer (September 28, 2019): Phase II – TROPHY U-01
65 Figure 24: VesiGel for Bladder Cancer (September 24, 2019): Phase IIb – OPTIMA (LG NMIBC)
67 Figure 25: Tecentriq for Bladder Cancer (August 4, 2019): Phase III – IMvigor130
70 Figure 26: Padcev for Bladder Cancer (June 3, 2019): Phase II – EV-201
77 Figure 27: Padcev for Bladder Cancer (March 28, 2019): Phase II – EV-201
78 Figure 28: Vicinium for Bladder Cancer (March 4, 2019): Phase III – VISTA
80 Figure 29: Bempegaldesleukin for Bladder Cancer (February 15, 2019): Phase I/II – PIVOT-02 (w/Opdivo)
82 Figure 30: Jelmyto for Bladder Cancer (January 8, 2019): Phase III – OLYMPUS
85 Figure 31: Opdivo for Bladder Cancer (October 20, 2018): Phase I/II – CheckMate 032 (w/Ipilimumab)
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
47 Table 7: Historical global sales, by drug ($m), 2015–19
47 Table 8: Forecasted global sales, by drug ($m), 2020–24
48 Table 9: Imfinzi for Bladder Cancer (March 6, 2020)
49 Table 10: Tecentriq for Bladder Cancer (January 24, 2020)
51 Table 11: Bavencio for Bladder Cancer (January 6, 2020)
52 Table 12: Keytruda for Bladder Cancer (December 17, 2019)
54 Table 13: Keytruda for Bladder Cancer (December 13, 2019)
55 Table 14: Instiladrin for Bladder Cancer (December 5, 2019)
57 Table 15: Sitravatinib for Bladder Cancer (November 9, 2019)
58 Table 16: CV-301 for Bladder Cancer (October 18, 2019)
59 Table 17: Tecentriq for Bladder Cancer (September 30, 2019)
61 Table 18: Padcev for Bladder Cancer (September 28, 2019)
63 Table 19: Sacituzumab Govitecan for Bladder Cancer (September 28, 2019)
64 Table 20: VesiGel for Bladder Cancer (September 24, 2019)
66 Table 21: Tecentriq for Bladder Cancer (August 4, 2019)
67 Table 22: Magrolimab for Bladder Cancer (July 11, 2019)
68 Table 23: Qapzola for Bladder Cancer (June 25, 2019)
69 Table 24: Padcev for Bladder Cancer (June 3, 2019)
71 Table 25: therascreen FGFR RGQ RT-PCR Kit for Bladder Cancer (May 10, 2019)
72 Table 26: Sacituzumab Govitecan for Bladder Cancer (April 29, 2019)
73 Table 27: Rubraca for Bladder Cancer (April 15, 2019)
74 Table 28: therascreen FGFR RGQ RT-PCR for Bladder Cancer (April 12, 2019)
75 Table 29: Balversa for Bladder Cancer (April 8, 2019)
76 Table 30: Padcev for Bladder Cancer (March 28, 2019)
77 Table 31: Vicinium for Bladder Cancer (March 4, 2019)
79 Table 32: Bempegaldesleukin for Bladder Cancer (February 15, 2019)
80 Table 33: Folotyn for Bladder Cancer (January 17, 2019)
81 Table 34: Jelmyto for Bladder Cancer (January 8, 2019)
83 Table 35: Cyramza for Bladder Cancer (October 20, 2018)
84 Table 36: Opdivo for Bladder Cancer (October 20, 2018
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