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, 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 expansions as part of a combination with chemotherapy in metastatic patients and into NMIBC highlight its broad utility.
- Tecentriq is not expected to fare as well commercially in bladder cancer as Keytruda due to weaker clinical results. The IMvigor010 trial in postoperative MIBC did not meet its primary endpoints, while IMvigor211 and IMvigor130 failed to show overall survival benefit over chemotherapy in second- and first-line mUC, respectively. These latter findings resulted in Roche withdrawing Tecentriq from the second-line setting following a reappraisal by the FDA, and though front-line use remains unaffected, this represents a significant setback for Roche’s flagship checkpoint inhibitor.
- Following the failure of the Phase III DANUBE trial in first-line mUC, AstraZeneca has similarly 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 appears to be final, and Imfinzi’s previously ambitious R&D 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 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 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 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 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
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
37 KEY REGULATORY EVENTS
37 Accelerated Approval: US FDA Review Of Expedited Program Could Bring More Withdrawals
37 Keeping Track: Padcev, Vicineum Seek Bladder Cancer Approvals
37 First-Line Bavencio Bladder Cancer OK Boosts Merck KGaA
38 Keytruda Dropped From England’s Cancer Drugs Fund For Bladder Cancer
39 PROBABILITY OF SUCCESS
40 LICENSING AND ASSET ACQUISITION DEALS
40 U. Of Texas Research Branch Maintains Hectic Partnering Pace
40 NantKwest/ImmunityBio To Merge In All-Stock Deal
40 Hikma Adds Sesen’s Vicineum To MENA Brands
41 Gilead’s Immunomedics Buy: Five Things To Worry About
41 Prokarium Options Bladder Cancer Candidate From Swiss University
41 PhotoCure Regains Global Rights For Hexvix From Ipsen
42 CLINICAL TRIAL LANDSCAPE
43 Sponsors by status
44 Sponsors by phase
45 Recent events
47 DRUG ASSESSMENT MODEL
50 MARKET DYNAMICS
51 FUTURE TRENDS
51 Platinum-eligible first-line mUC remains out of reach for PD-1/PD-L1 antibodies
51 Regulatory reviews threaten use of PD-1/PD-L1 antibodies in mUC
52 PD-1/PD-L1 inhibitors move to earlier, more localized bladder tumors
52 Multiple novel agents are targeting the lucrative NMIBC setting
53 Development of FGFR inhibitors sees mixed fortunes
53 Antibody-drug conjugates may diversify treatment for metastatic bladder cancer
55 CONSENSUS FORECASTS
57 RECENT EVENTS AND ANALYST OPINION
57 Eganelisib for Bladder Cancer (February 11, 2021)
58 Anktiva for Bladder Cancer (December 21, 2020)
59 Padcev for Bladder Cancer (October 12, 2020)
60 Opdivo for Bladder Cancer (September 24, 2020)
62 Padcev for Bladder Cancer (September 18, 2020)
63 Keytruda for Bladder Cancer (June 9, 2020)
65 Bavencio for Bladder Cancer (May 31, 2020)
66 Tecentriq for Bladder Cancer (May 31, 2020)
68 Imfinzi for Bladder Cancer (March 6, 2020)
69 Tecentriq for Bladder Cancer (January 24, 2020)
71 Bavencio for Bladder Cancer (January 6, 2020)
72 Keytruda for Bladder Cancer (December 17, 2019)
74 Instiladrin for Bladder Cancer (December 5, 2019)
75 Sitravatinib for Bladder Cancer (November 9, 2019)
76 CV-301 for Bladder Cancer (October 18, 2019)
77 Tecentriq for Bladder Cancer (September 30, 2019)
79 Padcev for Bladder Cancer (September 28, 2019)
81 Trodelvy for Bladder Cancer (September 28, 2019)
83 VesiGel for Bladder Cancer (September 24, 2019)
85 KEY UPCOMING EVENTS
86 KEY OPINION LEADER INSIGHTS
87 BIBLIOGRAPHY
88 Prescription information
90 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
39 Figure 6: Probability of success in the bladder cancer pipeline
42 Figure 7: Clinical trials in bladder cancer
42 Figure 8: Top 10 drugs for clinical trials in bladder cancer
43 Figure 9: Top 10 companies for clinical trials in bladder cancer
43 Figure 10: Trial locations in bladder cancer
44 Figure 11: Bladder cancer trials status
45 Figure 12: Bladder cancer trials sponsors, by phase
47 Figure 13: Datamonitor Healthcare’s drug assessment summary for bladder cancer
50 Figure 14: Market dynamics for bladder cancer
51 Figure 15: Future trends in bladder cancer
58 Figure 16: Eganelisib for Bladder Cancer (February 11, 2021): Phase II – MARIO-275 (w/Nivolumab)
60 Figure 17: Padcev for Bladder Cancer (October 12, 2020): Phase II – EV-201
62 Figure 18: Opdivo for Bladder Cancer (September 24, 2020): Phase III – CheckMate 274
63 Figure 19: Padcev for Bladder Cancer (September 18, 2020): Phase III – EV-301
65 Figure 20: Keytruda for Bladder Cancer (June 9, 2020): Phase III – KEYNOTE-361
66 Figure 21: Bavencio for Bladder Cancer (May 31, 2020): Phase III – JAVELIN Bladder 100
68 Figure 22: Tecentriq for Bladder Cancer (May 31, 2020): Phase III – IMvigor010 (WO29636; Adjuvant)
69 Figure 23: Imfinzi for Bladder Cancer (March 6, 2020): Phase III – DANUBE (w/Tremelimumab)
71 Figure 24: Tecentriq for Bladder Cancer (January 24, 2020): Phase III – IMvigor010 (WO29636; Adjuvant)
72 Figure 25: Bavencio for Bladder Cancer (January 6, 2020): Phase III – JAVELIN Bladder 100
75 Figure 26: Instiladrin for Bladder Cancer (December 5, 2019): Phase III – BCG Unresponsive NMIBC
79 Figure 27: Tecentriq for Bladder Cancer (September 30, 2019): Phase III – IMvigor130
81 Figure 28: Padcev for Bladder Cancer (September 28, 2019): Phase Ib/II – EV-103 (w/CPIs)
83 Figure 29: Trodelvy for Bladder Cancer (September 28, 2019): Phase II – TROPHY U-01
84 Figure 30: VesiGel for Bladder Cancer (September 24, 2019): Phase IIb – OPTIMA (LG NMIBC)
85 Figure 31: 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
55 Table 8: Historical global sales, by drug ($m), 2015–19
56 Table 9: Forecasted global sales, by drug ($m), 2021–25
57 Table 10: Eganelisib for Bladder Cancer (February 11, 2021)
58 Table 11: Anktiva for Bladder Cancer (December 21, 2020)
59 Table 12: Padcev for Bladder Cancer (October 12, 2020)
61 Table 13: Opdivo for Bladder Cancer (September 24, 2020)
62 Table 14: Padcev for Bladder Cancer (September 18, 2020)
64 Table 15: Keytruda for Bladder Cancer (June 9, 2020)
65 Table 16: Bavencio for Bladder Cancer (May 31, 2020)
67 Table 17: Tecentriq for Bladder Cancer (May 31, 2020)
68 Table 18: Imfinzi for Bladder Cancer (March 6, 2020)
70 Table 19: Tecentriq for Bladder Cancer (January 24, 2020)
71 Table 20: Bavencio for Bladder Cancer (January 6, 2020)
73 Table 21: Keytruda for Bladder Cancer (December 17, 2019)
74 Table 22: Instiladrin for Bladder Cancer (December 5, 2019)
76 Table 23: Sitravatinib for Bladder Cancer (November 9, 2019)
77 Table 24: CV-301 for Bladder Cancer (October 18, 2019)
78 Table 25: Tecentriq for Bladder Cancer (September 30, 2019)
80 Table 26: Padcev for Bladder Cancer (September 28, 2019)
82 Table 27: Trodelvy for Bladder Cancer (September 28, 2019)
83 Table 28: VesiGel for Bladder Cancer (September 24, 2019)
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