Abstract 1776P
Background
Biomarkers such as fibroblast growth factor receptor (FGFR) and programmed death-ligand 1 (PD-L1) have been incorporated into the treatment paradigm of metastatic urothelial cancer (mUC). However, there are no data on the FGFR alteration rate and clinical burden of mUC patients in Taiwan. In addition, the association between FGFR status and PD-L1 expression in mUC is rarely studied.
Methods
This is a retrospective, multicenter, non-interventional study to evaluate the association between biomarkers of archived tumor and clinical outcomes including objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) in unresectable locally advanced or mUC patients between 2015-2019. FGFR alterations were detected by therascreen FGFR RGQ RT-PCR kit. PD-L1 expression was assessed by the combined positive score (CPS) in DAKO 22C3.
Results
Of the 196 patients, median age was 71, 62% were male, and more than one-third had stage III or IV tumors. FGFR alterations were detected in 13 (6.6%) patients: five patients had FGFR3 translocations and eight had FGFR3 mutations. Among FGFR (+) patients, 15 % (2/13) were PD-L1 CPS≥10, compared with 32 % (58/182) in FGFR (-) ones (Table). A negative association between FGFR status and PD-L1 expression was observed at a CPS cutoff of 5. In general, ORR was 12.2% (95% CI 8.01-17.67) among patients at any 1L treatment. It was 7.7% (95% CI 0.19-36.03) for FGFR (+) patients and 12.6% (95% CI 8.14-18.26) for FGFR (-) ones. Median PFS and OS were 3.58 months (mos) (95% CI 2.92-4.60) and 7.39 mos (95% CI 5.95-8.34) for 1L treatment, and 2.3 mos (95% CI 1.45-3.32) and 5.03 mos (95% CI 3.55-7.06) for 2L treatment. Survival outcomes were similar irrespective of FGFR status. Table: 1776P
FGFR status versus PD-L1 expression in mUC
| FGFR (+)(N=13) | FGFR (-)(N=183) | Overall (N=196) | Chi-Square (Nominal p value) | |
| PD-L1 level, n (%) | 13 | 182 | 195 | |
| PD-L1≥10 | 2 (15) | 58 (32) | 60 (31) | |
| PD-L1<10 | 11 (85) | 124 (68) | 135 (69) | 0.3511 |
| PD-L1≥5 | 2 (15) | 79 (43) | 81 (42) | |
| PD-L1<5 | 11 (85) | 103 (57) | 114 (58) | 0.0476 |
| PD-L1≥1 | 5 (38) | 111 (61) | 116 (59) | |
| PD-L1<1 | 8 (62) | 71 (39) | 79 (41) | 0.1099 |
| Missing | 0 | 1 | 1 |
Conclusions
This retrospective study showed high unmet needs under SoC in mUC in Taiwan, irrespective of FGFR status. The negative association between FGFR status and PD-L1 expression might be considered when deciding personalized treatment based on biomarker profiles.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Janssen Taiwan.
Funding
Janssen Taiwan.
Disclosure
Y-H. Feng: Financial Interests, Personal, Other, Consultant: Roche, Novartis, AbbVie. H-L. Huang: Financial Interests, Personal, Full or part-time Employment: Janssen. All other authors have declared no conflicts of interest.