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 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. The publisher 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.
- The publisher 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.
Table of Contents
OVERVIEW
DISEASE BACKGROUND
TREATMENT
KEY REGULATORY EVENTS
LICENSING AND ASSET ACQUISITION DEALS
CLINICAL TRIAL LANDSCAPE
FUTURE TRENDS
RECENT EVENTS AND ANALYST OPINION
BIBLIOGRAPHY
LIST OF FIGURES
LIST OF TABLES
