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10/14/2025
The Association Between Tumor Immunogenomic Features and First-Line (1L) Therapeutic Outcomes in Advanced Biliary Tract Cancer (BTC)
ESMO 2025
PRESENTATION
Authors
N. Shah, J. Symons, B. Rhead, Y. Yu, J. Mercer, J. Gong, Q. Kimana, T. Patel, G. King, M. Javle
Background – Recent advanced BTC clinical trials reported an overall survival (OS) benefit with 1L immunotherapy (ICI) added to gemcitabine + cisplatin (G+C). Real world (rw) confirmation of 1L ICI benefit is limited and predictive ICI biomarkers are lacking. We investigated the relationship between pt outcomes, BTC subtype, immunologic phenotype, and genomic alterations (gAlt) in pts with BTC treated with 1L G+C+ICI.
Methods – We used Tempus Lens to analyze a cohort of de-identified pts with BTC sequenced with xT (DNA seq) + xR (RNA-seq). Pts were stratified by subtype (intrahepatic, iCCA; extrahepatic, eCCA; gallbladder, GBC), median %CD8 T cells (%CD8T) High (H)/Low (L), and gAlt: IDH1, KRAS, TP53, ARID1A, HRR (23 genes) alt, FGFR2 fusions and MTAP loss. Immunologic phenotype was assessed by TMB (m/MB). Immune infiltration was estimated by quanTIseq (RNA). rwOS was defined as time from the start of 1L G+C±ICI to death from any cause. Median rwOS (mOS) was estimated using the Kaplan-Meier method and hazard ratios (HR) estimated with Cox proportional hazard models.
Results – The mOS between G+C+ICI vs G+C in pts with BTC did not differ. GBC was the only subtype that showed a trend towards improved rwOS with G+C+ICI (table). GBC was associated with the highest %CD8T (p=0.002) and TMB (p<0.001) among subtypes. The GBCCD8T-H cohort maintained a rwOS benefit with G+C+ICI; the trend was blunted in the GBCCD8T-L group (table). With G+C+ICI and G+C, rwOS was improved in pts with FGFR2 fusions (HR, 0.4, p<0.001; 0.6, p=0.07) and HRR alt (HR, 0.80, p=0.2; 0.7, p=0.06), and worse rwOS was associated with KRAS alt (HR, 1.29, p=0.1; 1.55, p=0.03) vs pts without the respective gAlt.
Conclusions – Our study shows similar rwOS with G+C+ICI in BTC. However, in GBC, higher %CD8T was linked to better rwOS with G+C+ICI, while gAlts in FGFR2, HRR, and KRAS genes appeared prognostic. In clinical trials, immunogenomic analyses with %CD8T may help define predictive ICI biomarkers for pts with BTC.