Table Info

Table 1.

Select studies on UC utilizing ctDNA-guided treatment responses

Trial name/study cohort	Phase of trial/patient population	N of patients	Primary endpoint	Results/Comments
IMvigor010	Phase III/ypT2/pT3/pT4 or pN+ or > pT3pN+	500	DFS on adjuvant atezolizumab vs. placebo	Primary endpoint negative DFS atezolizumab vs. placebo; 37% were ctDNA+; ctDNA+ with improved OS in atezolizumab arm (HR 0.59)
Sfakianos et al. [17]	Retrospective/stage I–IV UC	167	Real-world data on DFS with ctDNA, WES, NGS	No DFS benefit from adjuvant atezolizumab if ctDNA– (P = 0.34); ctDNA+ shorter DFS (HR = 6.93, P < 0.001)
IMvigor011	Phase III/ypT2/pT3/pT4 (if +NAC) or pN+ or > pT3pN+ (if no NAC)	405	DFS for ctDNA+ ≤ 20 weeks after cystectomy	No results yet
MODERN	Phases II and III/ypT2/pT3/pT4 (if +NAC) or pN+ or > pT3pN+ (if no NAC)	1,000	ctDNA clearance proportion; DFS for cohort B and OS for cohort A (phase III nivolumab vs. nivolumab/relatlimab)	No results yet

pT2: pathologic T2 stage; pT3: pathologic T3 stage; DFS: disease-free survival; PFS: progression-free survival; pN+: pathologic node positive; NAC: neoadjuvant chemotherapy; ctDNA: circulating tumor DNA; HR: hazard ratio; NGS: next-generation sequencing; OS: overall survival; UC: urothelial cancer

Declarations

Author contributions

JBAC: Conceptualization, Investigation, Writing—original draft, Writing—review & editing.

Conflicts of interest

JBAC has served on the Speakers’ Bureau of BMS, Astellas, SeaGen, EMD Serono and the Advisory Board of Merck, Pfizer, EMD Serono, AZD. In addition to what has been mentioned, the author declares no other conflicts of interest.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

Not applicable.

Funding

This work was supported by the David Wohlscheid Fund. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright

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