Abstract 756P
Background
We aimed to determine whether a similar ICI-based approach could be used by considering selected cT1 HG and cT2 bladder UC as optimal candidates for single-agent ICI.
Methods
Data from transurethral resection of the bladder tumor (TURBT) specimens from 2 studies was evaluated. The MOL cohort included 206 patients (pts) with HG cT1N0M0 (N=87) or cT2N0M0 (N=119) bladder UC who underwent radical cystectomy (RC) without any neoadjuvant therapy. The PURE-01 cohort (NCT02736266, N=102), was used as a neoadjuvant pembrolizumab-treated UC reference. Specimen collection and processing were conducted using a clinical-grade whole-transcriptome assay (Decipher® assay). Immune-signatures scores (ISS) and molecular subtyping were evaluated. Kaplan-Meier curves and log-rank tests were used for exploratory analyses of the outcomes in relation to the molecular signatures and ISS.
Results
In the MOL cohort, luminal tumors (LT) were less frequently upstaged at RC vs non-LT (p=0.02). However, organ-confined (OC; pT
Conclusions
In further analyzing the MOL cohort we identified a population of cT1-T2N0M0 tumors that shared molecular features with tumors included in PURE-01. These profiles were consistent regardless of whether the tumor was ultimately identified as OC or NOC, suggesting that treatment with ICI could be proposed to more selected cT1 HG. Clinical trials will be required to confirm the clinical utility of these observations.
Clinical trial identification
NCT02609269.
Editorial acknowledgement
Legal entity responsible for the study
Andrea Necchi.
Funding
Decipher Biosciences.
Disclosure
All authors have declared no conflicts of interest.