Prevalence of PD-L1 Expression in Patients With Advanced Urothelial Carcinoma

Advanced urothelial carcinoma (UC) (locally advanced/unresectable or metastatic UC) is a
fatal disease with 5-year survival rate of 5%. The most frequently studied diagnostic for
advanced UC is the programmed death-ligand 1 (PD-L1) protein expression in tumor tissue. A
better understanding of PD-L1 expression in a "real world" setting could help understand its
clinical utility in the management and decision making in advanced UC and clinical trial
design.

Inclusion Criteria:

- Provision of written informed consent

- Age ≥18 years old

- Patients with histologically-confirmed diagnosis of UC and healthcare provider
(HCP)-confirmed advanced UC prior to or during 1L therapy (primary histology UC; mixed
histologies are allowed).

Where the 1L therapy setting is defined as:

- Patients with no prior systemic therapy given for advanced UC; 1L is the first
systemic therapy given for advanced UC

- Patients who received neoadjuvant or adjuvant platinum-based chemotherapy with
recurrence more than 12 months from the last chemotherapy dose

- Patients with available tumor tissue sample (fresh or archival - up to 3 years
old) that was collected as part of SoC any time prior to 1L treatment for
advanced UC with a target of 18 slides available for biomarker testing (PD-L1 and
tTMB).

Exclusion Criteria:

- Patients concurrently enrolled in other clinical trials that prohibit their
participation in a non-interventional study

- Patients with history of non-urothelial active malignancy that completed therapy
within 2 years from study enrollment except:

- Any resected in situ carcinoma or non-melanoma skin cancer

- Localized (early stage) cancer treated with curative intent (without evidence of
recurrence and intent for further therapy) and in which no systemic therapy was
indicated