Conference abstracts

81 abstracts

• Level 3neutralAACR Annual Meeting 2026

  Abstract 3845: Enhancing MRD detection through an ultrasensitive ctDNA test: Insights from real-world clinical data

  Pyke, Rachel Marty · Abstract 3845 · more than 5,000 patients across 15 cancer types, as stated in the abstract (a single exact n is not given)

  NeXT Personal Dx (Personalis), bespoke panel of up to about 1,800 variants

  Median limit of detection across timepoints was 1.90 PPM (IQR 1.53-2.70) at a median cfDNA input of 12 ng. 45.3% of tests were ctDNA-positive. 40.2% of detections were below 100 PPM, and 14.7% of all detections were below 10 PPM. Among patients who became sustainably positive after a negative timepoint, 49% had a first MRD-positive result below 10 PPM. Two case examples (NSCLC and colorectal cancer) describe low-PPM detections that preceded imaging-confirmed recurrence. This is a real-world analytical and descriptive series, not a prospective outcomes trial.

• Level 2positiveASCO Annual Meeting 2026

  Safety and performance results from PATHFINDER 2, a registrational study of a multi-cancer early detection (MCED) test in an intended-use population.

  Giridhar, Karthik · Abstract LBA10509 · LBA · PATHFINDER 2 · 35,878 enrolled; 32,007 with a 12-month cancer assessment analyzable for performance; 35,335 analyzable for safety

  Galleri multi-cancer early detection test (targeted methylation cfDNA), as evaluated in PATHFINDER 2

  Of 287 (0.9%) participants with a positive test, 173 were diagnosed with cancer within 12 months (detection rate 0.5%; PPV 60.3%, 95% CI 54.5-65.8%; specificity 99.6%). Twelve-month episode sensitivity was 69.8% in a prespecified 12-cancer subgroup, 66.2% in 6 aggressive cancers, and 39.3% across all cancers. Cancer-signal-origin accuracy was 91.3%. Of 151 MCED-detected new primaries, 80 (53.0%) were stage I-II. Five study-related adverse events occurred during diagnostic workup; none were serious. Median time from result to diagnostic resolution was 48 days.

• Level 1mixedASCO Annual Meeting 2026

  NHS-Galleri: Primary results from a randomised controlled trial to assess the clinical utility of a multi-cancer early detection (MCED) test in population screening.

  Swanton, Robert Charles · Abstract LBA100 · LBA · NHS-Galleri · 142,924 enrolled participants in England, aged 50-79 years, randomized 1:1 after the year-0 blood draw

  Galleri MCED test (cfDNA cancer-signal test)

  The primary endpoint, a reduction in stage III/IV incidence among 12 prespecified cancers, was not met (706 vs 688 events; IRR 1.03, 95% CI 0.92-1.14; P=0.6324). A 14% reduction in stage IV cancers was observed after 3 years (342 vs 397; overall IRR 0.86, 95% CI 0.744-0.998). Stage I/II cancers increased by 16% (RR 1.16) and stage I-III by 19% (RR 1.19). Screen-detected cancers were 1,173 vs 290. Aggregate specificity was 99.55% and PPV 52.0%. No related serious adverse events were reported.

• Level 1positiveASCO Annual Meeting 2026

  Patient-reported outcomes from IMvigor011: A phase 3 study of circulating tumor (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer (MIBC).

  Bellmunt, Joaquim · Abstract 4627 · IMvigor011 · 250 ctDNA-positive patients randomized (167 atezolizumab, 83 placebo)

  not named in the abstract

  Time to confirmed deterioration in physical functioning, role functioning, and global health status/quality of life showed no evidence of a difference between atezolizumab and placebo. More than 90% of patients in both arms reported little or no treatment side-effect burden through cycle 11. The abstract concludes ctDNA-guided adjuvant atezolizumab improved DFS and OS without negatively affecting patient-reported quality of life.

  Full paper

• Level 2mixedASCO Annual Meeting 2026

  ctDNA analysis in participants with renal cell carcinoma treated with adjuvant pembrolizumab or placebo in the KEYNOTE-564 trial.

  Choueiri, Toni K. · Abstract 4502 · KEYNOTE-564 · 994 randomized (496 pembrolizumab, 498 placebo); baseline ctDNA in 736; cycle 5 day 1 ctDNA in 641

  Natera Signatera RUO tissue-exome-based 16-plex and 64-plex assays

  Baseline ctDNA was detectable in only 5.4% (16-plex) and 8.2% (64-plex) of 736 analyzed patients. ctDNA positivity was associated with worse DFS in both arms (P<0.05 for both assays), but sensitivity to predict DFS events was low and specificity was high. Among patients detectable at baseline and evaluable at cycle 5 day 1, clearance occurred in 6/10 vs 3/14 (16-plex) and 10/18 vs 9/25 (64-plex) with pembrolizumab vs placebo. The abstract concludes these data highlight limitations of these assays in clear-cell RCC.

• Level 1mixedASCO Genitourinary Cancers Symposium 2026

  Circulating tumor DNA (ctDNA) to guide response-adapted bladder preservation in muscle invasive bladder cancer (MIBC).

  Ghatalia, Pooja · Abstract LBA632 · LBA · RETAIN-2 (and combined RETAIN-1/2) · 71 evaluable RETAIN-2 patients; combined ctDNA analysis across RETAIN-1/2: 274 timepoints from 111 patients

  Signatera (named in the abstract)

  Estimated 2-year metastasis-free survival was 79.8% in the RETAIN-2 ITT population; the abstract states RETAIN-2 is expected to meet its primary MFS endpoint. Among 22 active-surveillance patients, 16 (73%) remained metastasis-free with an intact bladder. Post-treatment ctDNA negativity or clearance predicted lower recurrence (34.8% and 43.8%) than persistent positivity or non-clearance (85.7% and 91.7%). Among active-surveillance patients who were ctDNA-negative after treatment, 24-month MFS was 82.4% but 24-month RFS was 50.7%, driven by local recurrences: 19 of 22 who recurred on active surveillance were ctDNA-negative after treatment.

• Level 3prognosticASCO Genitourinary Cancers Symposium 2026

  Whole genome–based ultrasensitive circulating tumor DNA clearance as a biomarker of exceptional outcomes with enfortumab vedotin and pembrolizumab in urothelial carcinoma: Preliminary real-world results.

  Zerey, Mehmet Murat · Abstract 866 · 27 patients, 118 plasma samples; single-institution retrospective

  Next Personal Dx tumor-informed whole-genome sequencing assay (up to 1,800 patient-specific variants; detection down to about 1 part per million), as stated in the abstract

  Among evaluable patients, 11 (48%) achieved ctDNA clearance after a median of 3 EVP cycles and 12 (52%) had persistent positivity. The abstract states clearance correlated with exceptional clinical and radiographic outcomes, and persistent positivity identified residual or progressive disease. Median follow-up 13.8 months; 19 of 27 remained under surveillance, including 9 with metastatic disease.

• Level 2positiveASCO Genitourinary Cancers Symposium 2026

  Urinary tumor DNA (utDNA) and circulating tumor DNA (ctDNA) in patients (pts) with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA.

  Van Der Heijden, Michiel S. · Abstract 636 · NIAGARA · 265 biomarker-evaluable (25% of 1063 randomized)

  Signatera for ctDNA (named in the related NIAGARA ASCO 2025 abstract). utDNA as described in this abstract.

  utDNA-positive rate fell from 85% at baseline to 55% pre-cystectomy. Clearance was associated with longer EFS (HR 0.24, 95% CI 0.09-0.62) and was 12 percentage points higher with durvalumab (39% vs 27%). Pre-cystectomy utDNA-negative status was associated with pCR (72% [55/76] vs 18% [17/96] if utDNA-positive). Estimated 24-month EFS was 90% if dual-negative, 75% if utDNA-positive only, and 55% if dual-positive.

• Level 1positiveASCO Genitourinary Cancers Symposium 2026

  Circulating tumor (ct)DNA-guided adjuvant atezolizumab (atezo) in muscle-invasive bladder cancer (MIBC): Exploratory analysis of ctDNA dynamics in the IMvigor011 trial.

  Powles, Thomas · Abstract 633 · IMvigor011 · 379 patients who tested ctDNA-positive during surveillance; on-treatment dynamics in 165 atezolizumab and 83 placebo

  not named in the abstract (results reported as mean tumor molecules/mL)

  Of patients first testing ctDNA-positive, 74.1% (281/379) did so within 24 weeks of radical cystectomy; early positivity and higher baseline concentration (median 0.27 MTM/mL) were associated with shorter investigator-assessed DFS. Atezolizumab decreased ctDNA levels between cycle 1 and 3 (log2 fold-change -0.4) while levels increased on placebo (log2 fold-change 0.5; Wilcoxon P=0.009). Clearance at cycle 3 or 5 was associated with improved DFS and OS.

  Full paper

• Level 3prognosticASCO Genitourinary Cancers Symposium 2026

  Use of ultra-sensitive whole genome circulating tumor DNA detection to predict early recurrence in high-risk localized RCC after nephrectomy: Preliminary real-world findings.

  Amaral, Paulo Siqueira do · Abstract 516 · 22 patients, 42 plasma samples; single-center retrospective

  Next Personal Dx whole-genome tumor-informed assay (Personalis)

  At a median follow-up of 7.0 months, 3 of 22 patients (14%) were ctDNA-positive at any timepoint (all <100 ppm); 2 of those 3 developed radiographic recurrence. Only 1 of 20 patients negative at the 3-month landmark recurred, and 0 of 16 with persistent ctDNA negativity recurred during follow-up.

• Level 2positiveASCO Genitourinary Cancers Symposium 2026, Abstract 537 2026

  Circulating KIM-1 and ctDNA as prognostic markers in oligometastatic clear cell renal cell carcinoma (ccRCC): The K-COMPASS model.

  Tang C · Abstract 537 · NCT03575611 · 112 patients with KIM-1 measurements; median baseline KIM-1 127.0 pg/mL (IQR 71.5–228.0)

  Personalized ctDNA detection panels (≤2000 somatic variants) from tumor whole-genome sequencing (Myriad Genetics); plasma KIM-1

  ASCO GU 2026 abstract 537: among 112 patients, baseline and 3-month KIM-1 and ctDNA MRD were each associated with STFS in univariable and multivariable analyses; K-COMPASS (baseline KIM-1, baseline ctDNA MRD, and four clinical variables) had C-index 0.76 and calibration slope 1.

• Level 2ESMO Breast Cancer 2026

  416O - SMART: On-treatment ctDNA dynamics predicts response and progression in metastatic breast cancer

  Pedram Razavi · Abstract 416O · Proffered Paper (oral) · SMART

  SlidesWebcastSlides + webcast. An ASCO or ESMO member login may be required.

• Level 3ESMO Congress 2026

  Novel error-corrected tumor-informed whole-genome sequencing ctDNA analysis improves postoperative MRD detection in stage II-III colorectal cancer

  Maria Honholt Jorgensen · Abstract 4273P · Poster

  PosterPoster PDF. An ASCO or ESMO member login may be required.

• Level 3ESMO Congress 2026

  Postoperative TAV16 ctDNA detects molecular residual disease and predicts relapse after pancreatic cancer resection

  Miguel García Bartolomé · Abstract 3192eP · ePoster

  PosterPoster PDF. An ASCO or ESMO member login may be required.

• Level 3ESMO Congress 2026

  MUTE-Seq enables efficient single-digit-ppm tumor-informed ctDNA MRD monitoring in colorectal cancer

  Junseok W Hur · Abstract 2446P · Poster

  PosterPoster PDF. An ASCO or ESMO member login may be required.

• Level 3ESMO Congress 2026

  Clinical utility of ultra-sensitive ctDNA MRD monitoring in advanced NSCLC

  Srushti Borkar · Abstract 2728eP · ePoster

  PosterPoster PDF. An ASCO or ESMO member login may be required.

• Level 2ESMO Gastrointestinal Cancers Congress 2026

  ctDNA status and adjuvant chemotherapy after resection of colorectal liver metastases: An overall survival analysis of the GALAXY study

  Kozo Kataoka · Abstract 8O · Proffered Paper (oral) · GALAXY

  SlidesWebcastSlides + webcast. An ASCO or ESMO member login may be required.

• Level 2positiveESTRO 2026, Abstract 846 2026

  Optimizing oligometastatic disease management with circulating tumor DNA: a correlative analysis from the phase II randomized EXTEND trial

  Sherry AD · Abstract 846 · EXTEND (NCT03599765)

  ESTRO 2026 abstract 846 (Sherry first, Tang last) is a correlative ctDNA analysis of the phase 2 randomized EXTEND trial. Title, authorship, DOI, and pagination were verified on CrossRef; the abstract body was not deposited, so no ESTRO-only numeric results are filed. Exploratory ctDNA findings are taken from the subsequent JCO paper (PMID 42142259), not from institutional news releases.

• Level 2positiveAACR Annual Meeting 2025, Abstract CT132 2025

  Phase 2 trial of metastasis directed radiotherapy without systemic therapy (MRWS) for oligometastatic clear cell renal cell carcinoma (ccRCC) and investigation of circulating tumor DNA (ctDNA) as a personalized biomarker

  Tang C · Abstract CT132 · NCT03575611 · 121 patients enrolled July 2018–May 2023 (NCT03575611)

  Individualized ctDNA panels (Myriad Genetics) from tumor whole-genome sequencing; MRD+ if ctDNA detected

  AACR 2025 abstract CT132 of NCT03575611: median PFS 18 months and median STFS 34 months in 121 patients; baseline ctDNA MRD+ in 56%, with shorter STFS (HR 2.9, 27 vs 54 months); 31% of baseline-MRD+ patients converted to MRD– at 3 months, and 3-month MRD+ was associated with shorter STFS (HR 4.3).

• Level 2prognosticASCO Annual Meeting 2025

  Circulating tumor DNA and late recurrence in high-risk, hormone receptor-positive, HER2-negative breast cancer: An updated analysis of the CHiRP study.

  Yoo, Tae-Kyung Robyn · Abstract 3055 · CHiRP · same 83-patient analytic cohort as the 2022 abstract; median follow-up from first sample 4.4 years; 214 plasma samples before known recurrence

  RaDaR (tumor-informed, whole-exome-based)

  With longer follow-up, all 8/8 patients with ctDNA detected at any timepoint developed distant recurrence (median lead time 1.39 years, range 0.01-4.24). A negative test had a negative predictive value for remaining recurrence-free of 100% at more than 1 year (0/196), 98.4% at more than 2 years (3 events among 185 samples), and 96.6% at more than 3 years (5/147).

• Level 1negativeASCO Annual Meeting 2025

  ctDNA-guided adjuvant chemotherapy escalation in stage III colon cancer: Primary analysis of the ctDNA-positive cohort from the randomized AGITG dynamic-III trial (intergroup study of AGITG and CCTG).

  Tie, Jeanne · Abstract 3503 · DYNAMIC-III · 961 eligible randomized; 259 (27%) ctDNA-positive (this analysis). 115/129 in the ctDNA-informed arm received escalation (65 FOLFOXIRI).

  tumor-informed (commercial name not stated in this abstract)

  2-year RFS with ctDNA-informed escalation was 52% vs 61% with standard of care (HR 1.11, 90% CI 0.83-1.48; P=0.6). 3-year RFS was similar for FOLFOXIRI vs FOLFOX/CAPOX (47% vs 51%; HR 1.09, P=0.7). Recurrence risk increased with ctDNA burden (3-year RFS 78%, 63%, 36%, and 22% across MTM/mL quartiles; P<0.01). Escalation, including to FOLFOXIRI, did not improve RFS.

  Full paper

• Level 2positiveASCO Annual Meeting 2025

  Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA.

  Powles, Thomas · Abstract 4503 · NIAGARA · 462 biomarker-evaluable of 1063 randomized (237 durvalumab arm, 225 control)

  Signatera (named in the abstract)

  ctDNA-positive rate was 57% (260/460) at baseline and fell to 22% (94/422) after neoadjuvant treatment, pre-cystectomy. Clearance from baseline to pre-cystectomy was 41% with durvalumab plus NAC vs 31% with NAC alone. Pre-cystectomy ctDNA-positive status was associated with non-pCR in 97% (86/89). Event-free survival benefit of perioperative durvalumab was observed in both baseline ctDNA-positive and ctDNA-negative groups. Post-cystectomy ctDNA-positive rate was 9% (31/345).

• Level 3prognosticASCO Annual Meeting 2025

  Association of tumor-informed ctDNA-based molecular residual disease (MRD) with clinical outcomes for upper tract urothelial cancer (UTUC).

  Ayanambakkam, Adanma · Abstract 4565 · 45 patients with stage I-IV UTUC, 349 plasma samples

  Signatera (tumor-informed)

  ctDNA detection was 70.8% in the MRD window (n=24) and 68.8% during surveillance (n=32). Positivity was associated with inferior RFS (MRD window HR 13.4, P=0.012; surveillance HR 14.46, P=0.01). 12-month RFS was 32.1% and 45.5% if positive vs 100% if negative in those windows. On multivariate analysis during surveillance, ctDNA positivity was the only factor significantly associated with poor RFS (HR 17.6, P=0.011).

• Level 2prognosticASCO Annual Meeting 2025

  Association of post-surgical MRD status with neoadjuvant ctDNA dynamics, genomic mutations, and clinical outcomes in patients with resectable NSCLC (R-NSCLC) from the phase 3 AEGEAN trial.

  Reck, Martin · Abstract 8009 · AEGEAN · 168 MRD-evaluable patients at a landmark a median of 6.9 weeks after surgery; 17 (10%) MRD-positive (10 durvalumab, 7 placebo)

  patient-specific tumor-informed assays (brand not named in the abstract)

  12-month DFS was 14.3% if MRD-positive vs 89.3% if MRD-negative. MRD positivity was associated with worse DFS in both arms (durvalumab HR 21.28, 95% CI 7.70-58.83; placebo HR 14.29, 95% CI 4.94-41.36). No MRD-positive patient in the durvalumab arm had a pathologic complete or major pathologic response. DFS trends favored durvalumab especially among MRD-negative patients (HR 0.56, 95% CI 0.26-1.20). KEAP1 and KMT2C mutations were associated with MRD-positive status in the durvalumab arm in this small exploratory analysis.

• Level 2prognosticASCO Annual Meeting 2025

  Longitudinal ctDNA monitoring for post-surgical molecular residual disease in patients with stage I-IIIb melanoma.

  Ansstas, George · Abstract 9571 · 197 patients; 1,718 plasma samples; retrospective real-world series; median 7 tests per patient over a median 24.7 months

  Signatera (personalized tumor-informed 16-plex mPCR-NGS)

  ctDNA positivity at any postoperative timepoint was associated with shorter RFS (HR 15.0, 95% CI 7.3-31.0, P<0.0001), particularly for distant or regional recurrence (HR 27.0). In a multivariate analysis (n=163), ctDNA positivity remained associated with RFS (HR 10.50, 95% CI 3.891-28.32, P<0.001). The abstract states ctDNA positivity influenced treatment-management changes in 28/38 (73.7%) of patients in whom that question was assessed.

• Level 2positiveASCO Annual Meeting 2025, Abstract 5502 2025

  Ultrasensitive detection and tracking of circulating tumor DNA (ctDNA) and association with relapse and survival in locally advanced cervical cancer (LACC): Phase 3 CALLA trial analyses.

  Mayadev J · Abstract 5502 · CALLA (NCT03830866) · Biomarker-evaluable population 185 / 186 / 130 at baseline (C1D1) / C3D1 / 6 months; parent trial 770 randomized

  NeXT Personal (Personalis), ultrasensitive tumor-informed MRD assay with up to 1,800 patient-specific variants from WGS

  ASCO 2025 abstract 5502 of the CALLA NeXT Personal analysis: baseline ctDNA detection 99%; 6-month detection 23% with durvalumab+CRT vs 36% with CRT; baseline median ctDNA 5,268.2 ppm; PFS HRs for low vs high baseline ctDNA 0.57 (0.26–1.26) with D+CRT and 0.62 (0.31–1.23) with CRT.

• Level 2prognosticASCO Gastrointestinal Cancers Symposium 2025

  Circulating tumor DNA for detection of molecular residual disease (MRD) in patients (pts) with stage II/III colorectal cancer (CRC): Final analysis of the BESPOKE CRC sub-cohort.

  Shah, Purvi K. · Abstract 15 · BESPOKE CRC · 1,001 in the sub-cohort; 625 (62.4%) received ACT; MRD-window results in 420 stage II and 505 stage III

  Signatera (tumor-informed)

  MRD-window ctDNA positivity was 8.1% (34/420) in stage II and 24.9% (126/505) in stage III, with DFS HR 10.4 and 10.1, respectively (both P<0.0001). Combined 24-month DFS was 91.7% if MRD-negative vs 41.4% if MRD-positive. During surveillance, conversion to ctDNA-positive was associated with markedly worse DFS in both observation and ACT-treated patients (stage II observation HR 34.9; stage III ACT HR 54.6).

• Level 1negativeASCO Gastrointestinal Cancers Symposium 2025

  A randomized, double-blind, phase III study comparing trifluridine/tipiracil (FTD/TPI) versus placebo in patients with molecular residual disease following curative resection of colorectal cancer (CRC): The ALTAIR study.

  Bando, Hideaki · Abstract LBA22 · LBA · ALTAIR (CIRCULATE-Japan) · 243 randomized (122 FTD/TPI, 121 placebo); 96.3% had received standard-of-care postoperative therapy

  Signatera (Natera), personalized tumor-informed

  Median DFS was 9.30 vs 5.55 months (HR 0.79, 95% CI 0.60-1.05; P=0.107); the primary endpoint was not met. The abstract reports a more pronounced benefit in resected oligometastatic stage IV disease and a trend toward greater DFS benefit at higher baseline MTM/mL. Grade >=3 adverse events occurred in 73.0% vs 3.3%. OS data were immature (24 events).

  Full paper

• Level 2mixedESMO Congress 2025

  LBA68 CCTG BR.31: Adjuvant durvalumab (D) in resected non-small-cell lung cancer (NSCLC): Final overall survival (OS) and minimal residual disease (MRD) analyses

  Goss, G. · Abstract LBA68 · LBA · CCTG BR.31 · 1,415 randomized; MRD available in 1,131 (80%), of whom 116 (10%) were positive; median follow-up 81 months

  Invitae Personalized Cancer Monitoring (tumor-informed), tested on plasma at randomization

  Adjuvant durvalumab did not improve OS versus placebo in any prespecified analysis group (all-randomized HR 1.02, 95% CI 0.84-1.25; PD-L1 TC >=25% and EGFR/ALK-negative HR 0.98). MRD positivity was strongly prognostic for worse OS in the placebo arm (HR 6.50 to 8.74 across groups). Durvalumab improved OS among MRD-positive, EGFR/ALK-negative patients with PD-L1 TC >=25% (HR 0.30, 95% CI 0.11-0.80; P=0.011; n=29) and PD-L1 TC >=1% (HR 0.49, P=0.024; n=55); treatment-by-MRD interaction P values were all <0.05.

  SlidesWebcastSlides + webcast. An ASCO or ESMO member login may be required.

• Trial in progressESMO Congress 2025

  HEROES: De-escalation of anti-HER2 therapies in HER2-positive metastatic breast cancer with long-term persistent response and undetectable MRD in ctDNA

  Benjamin Verret (with Thibault De La Motte Rouge) · Abstract 620TiP · Poster / trial-in-progress · HEROES

  Trial in progress

  PosterPoster PDF. An ASCO or ESMO member login may be required.

• Trial in progressESMO Congress 2025

  The SURVIVE HERoes study: Targeting molecular relapse in breast cancer; trastuzumab deruxtecan versus standard-of-care treatment in ctDNA-positive HER2-positive/HER2-low early breast cancer

  Kerstin Pfister · Abstract 464eTiP · Poster / trial-in-progress · SURVIVE HERoes

  Trial in progress

  PosterPoster PDF. An ASCO or ESMO member login may be required.

• Level 2ESMO Congress 2025

  Safety and performance of a multi-cancer early detection (MCED) test in an intended-use population: Initial results from the registrational PATHFINDER II study

  Nima Nabavizadeh · Abstract LBA64 · Proffered Paper / late-breaking oral · PATHFINDER II

  SlidesWebcastSlides + webcast. An ASCO or ESMO member login may be required.

• Level 2ESMO Congress 2025

  Molecular residual disease (MRD) analysis from the LAURA study of osimertinib in unresectable stage III EGFR-mutated NSCLC

  Edurne Arriola Aperribay · Abstract 1817MO · Mini oral · LAURA

  SlidesWebcastSlides + webcast. An ASCO or ESMO member login may be required.

• Level 2positiveESMO Congress 2025

  3068O Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274

  Galsky, M.D. · Abstract 3068O · oral · CheckMate 274 · 709 randomized (353 nivolumab, 356 placebo); ctDNA evaluable at cycle 1 day 1 in 133 (18.8%), of whom 54 (40.6%) were ctDNA-positive

  Natera Signatera (exploratory)

  With median follow-up 43.4 months, adjuvant nivolumab improved DFS versus placebo in the ITT population (median 21.9 vs 11.0 months; HR 0.74, 95% CI 0.61-0.90). In the exploratory Signatera analysis, DFS HR was 0.35 (95% CI 0.2-0.7) in patients who were ctDNA-positive at cycle 1 day 1 (median 7.4 vs 2.8 months) and 0.99 (95% CI 0.5-1.9) in those who were ctDNA-negative.

  Full paperSlidesWebcastSlides + webcast. An ASCO or ESMO member login may be required.

• Level 1positiveESMO Congress 2025

  LBA8 IMvigor011: A phase III trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer

  Powles, T.B. · Abstract LBA8 · LBA · IMvigor011 · 761 enrolled in surveillance; 250 ctDNA-positive patients randomized (167 atezolizumab, 83 placebo); 357 persistently ctDNA-negative

  not named in the abstract

  Among 250 eligible ctDNA-positive patients after cystectomy, adjuvant atezolizumab improved investigator-assessed DFS versus placebo (median 9.9 vs 4.8 months; HR 0.64, 95% CI 0.47-0.87; P=0.0047) and OS (median 32.8 vs 21.1 months; HR 0.59, 95% CI 0.39-0.90; P=0.0131). In 357 patients who remained ctDNA-negative, DFS was 95.4% at the end of 1-year monitoring and 88.4% at 2 years.

  Full paperSlidesWebcastSlides + webcast. An ASCO or ESMO member login may be required.

• Level 1mixedESMO Congress 2025

  LBA9 ctDNA-guided adjuvant chemotherapy de-escalation in stage III colon cancer: Primary analysis of the ctDNA-negative cohort from the randomized AGITG DYNAMIC-III trial (Intergroup study of AGITG and CCTG)

  Tie, J. · Abstract LBA9 · LBA · DYNAMIC-III · 702 ctDNA-negative of 968 evaluable (72.5%); 353 ctDNA-guided, 349 standard; median follow-up 45 months

  tumor-informed (testing 5-6 weeks post-surgery; commercial name not stated in the abstract)

  Protocol de-escalation occurred in 90.4%. Oxaliplatin-based chemotherapy use fell (34.8% vs 88.6%, P<0.001), as did grade 3+ adverse events of special interest (6.2% vs 10.6%, P=0.037) and treatment-related hospitalization (8.5% vs 13.2%, P=0.048). Non-inferiority of 3-year RFS was not confirmed (85.3% vs 88.1%; difference -2.8%; 97.5% lower CI -8.0%; NI margin 7.5%). A pre-planned subgroup of clinically low-risk T1-3N1 tumors had difference -2.2% (97.5% lower CI -7.2%), within the NI margin.

  Full paperSlidesWebcastSlides + webcast. An ASCO or ESMO member login may be required.

• Level 1mixedESMO Congress 2025

  723O Post-surgical liquid biopsy-guided treatment of stage III and high-risk stage II colon cancer patients: Final results of the PEGASUS trial

  Marsoni, S. · Abstract 723O · oral · PEGASUS · 135 patients (100 liquid-biopsy-negative, 35 positive); median follow-up 33.5 months

  Guardant Reveal (v L1.2)

  Among patients with two consecutive post-surgical negative tests, 12 relapses occurred, for a 2-year no-evidence-of-disease rate of 88% (90% CI 81-93). The predefined feasibility threshold (fewer than 14 relapses among 134 negative patients to exclude 85% in favor of 92%) was not met, though the point estimate exceeded 85%. In the 35 positive patients, 13 (37%) relapsed; 2-year time-to-relapse was 87.6% vs 61.5% (HR 3.22, P=0.0013).

  SlidesWebcastSlides + webcast. An ASCO or ESMO member login may be required.

• Level 1negativeESMO Gastrointestinal Cancers Congress 2025

  3O Association of ctDNA clearance with disease-free survival, safety, and quality of life from ctDNA-directed therapy: Findings from the ALTAIR study

  Kotaka, M. · Abstract 3O · oral · ALTAIR (CIRCULATE-Japan) · n=243

  Signatera (Natera)

  ctDNA clearance at treatment completion was 17.2% with FTD/TPI vs 12.4% with placebo (P=0.367), a non-significant difference. Grade >=3 neutropenia occurred in 56.6% on FTD/TPI; 37.7% required dose reduction. Global health status declined at week 8 on FTD/TPI (P=0.028) but arms did not differ from week 24 onward. DFS results match the ASCO GI primary report (HR 0.79, P=0.107).

  Full paper

• Level 1positiveESMO Gastrointestinal Cancers Congress 2025

  LBA1 Dynamic circulating tumor DNA methylation monitoring guiding postoperative surveillance in non-metastatic colorectal cancer: Interim analysis of FIND trial

  Peng, J. · Abstract LBA1 · LBA · FIND · 728 randomized (363 ctDNA-guided, 365 standard); interim, median follow-up 12 months

  single-tube methylation-specific quantitative PCR (mqMSP) targeting 10 methylation markers (stated detection to 0.01% allelic fraction)

  Cumulative recurrence rates did not differ (P=0.671 ITT). ctDNA-guided surveillance increased the proportion of recurrent patients who received curative-intent therapy (50.0% vs 22.6%; relative risk 2.214, 95% CI 1.060-4.780; P=0.034), the trial's primary endpoint. This is an interim analysis.

• Level 2prognosticSan Antonio Breast Cancer Symposium 2025

  Abstract RF3-05: Tissue-free circulating tumour DNA detection in patients with early triple negative breast cancer from the c-TRAK-TN trial

  Cunningham, N. · Abstract RF3-05 · c-TRAK TN · 1,062 timepoints from 159 patients; 1,012 (95.3%) successfully analyzed with the tissue-free assay; 1,005 timepoints compared with ddPCR

  Guardant Reveal (tissue-free methylation) compared with digital droplet PCR (1-2 patient-specific variants)

  ctDNA was detected by Reveal in 54/159 (34.0%) patients at least once and was associated with relapse (HR 20.62, P<0.0001). Of patients who relapsed by 24 months, 34/38 (89.5%) had prior ctDNA detection. Agreement with ddPCR was 94.5% (950/1005 timepoints). Among detections, 44.8% were first found by the tissue-free assay and 6.9% by ddPCR. Median time from first detection to relapse was 7.9 months with Reveal vs 5.7 months with ddPCR (HR 0.6, P=0.0574).

  Full paper

• Level 2positiveThe Oncologist, 2025, abstract 7 2025

  Phase 2 trial of metastasis directed radiotherapy without systemic therapy (MRWS) for oligometastatic clear cell renal cell carcinoma (ccRCC) and investigation of circulating tumor DNA (ctDNA)

  Tang C · Abstract 7 · NCT03575611 · 121 patients (NCT03575611)

  Individualized ctDNA panels (Myriad Genetics) from tumor whole-genome sequencing

  The Oncologist abstract 7 reports the same NCT03575611 ctDNA analysis as AACR CT132, with baseline MRD+ in 56% (STFS HR 2.9, 27 vs 54 months) and 3-month MRD+ STFS HR 4.3; a few clinical tallies differ slightly from CT132 and are not pooled.

• Level 2prognosticASCO Annual Meeting 2024

  Ultra-sensitive ctDNA mutation tracking to identify molecular residual disease and predict relapse in patients with early breast cancer.

  Garcia-Murillas, Isaac · Abstract 1010 · ChemoNEAR · 76 patients with early breast cancer (23 TNBC, 33 HER2-positive, 16 HR-positive, 4 unknown); 598 plasma samples

  NeXT Personal (Personalis), tumor-informed whole-genome personalized panels of up to about 1,800 variants

  At a median follow-up of 76 months, ctDNA detection was associated with relapse (HR undefined, P<0.0001) and shorter OS (P<0.0001), with a median lead time of 12.5 months (range 1-60). MRD was identified in 10/10 patients who relapsed (median 18.5 PPM at first detection). None of 58 patients who remained ctDNA-undetected relapsed. Of patients undetected at the post-surgical landmark, 31/33 (94%) did not relapse. Forty percent of all detections were below 100 PPM.

• Level 1prognosticASCO Annual Meeting 2024

  The potential role of serial circulating tumor DNA (ctDNA) testing after upfront surgery to guide adjuvant chemotherapy for early stage pancreatic cancer: The AGITG DYNAMIC-Pancreas trial.

  Lee, Belinda · Abstract 107 · DYNAMIC-Pancreas (AGITG) · 102 enrolled; 40 ctDNA-positive, 54 negative, 4 ineligible (no tumor mutation); median follow-up 36 months

  tumor-informed (brand not named in the extracted results)

  A tumor-informed approach was feasible (first draw at a median of 5 weeks). 40% were ctDNA-positive after resection, independent of usual clinicopathologic risk factors. Of 54 ctDNA-negative patients, 24 (44%) were de-escalated to a planned 3 months of adjuvant chemotherapy. Median RFS was 13 months if ctDNA-positive vs 22 months if negative (HR 0.52, P=0.003).

• Level 1positiveASCO Annual Meeting 2024

  Circulating tumor DNA analysis guiding adjuvant therapy in stage II colon cancer: Overall survival and updated 5-year results from the randomized DYNAMIC trial.

  Tie, Jeanne · Abstract 108 · DYNAMIC · same randomized cohort; median follow-up 59.6 months

  tumor-informed Safe-SeqS (as in the primary DYNAMIC report)

  5-year RFS was 88% vs 87% (difference 1.1%, 95% CI -5.8% to 8.0%). 5-year OS was 93.8% vs 93.3% (HR 1.05, 95% CI 0.47-2.37; P=0.887). In treated ctDNA-positive patients, end-of-treatment clearance occurred in 35/40 (87.5%); 5-year RFS was 85.2% with clearance vs 20.0% with persistence (HR 15.4, P<0.001). Higher post-surgery mutant tumor molecules (>=0.38 MTM/mL) were associated with lower clearance and worse RFS.

• Level 2prognosticASCO Annual Meeting 2024

  Molecular residual disease (MRD) analysis from the ADAURA trial of adjuvant (adj) osimertinib in patients (pts) with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC).

  John, Tom · Abstract 8005 · ADAURA · 245 of 682 randomized patients had samples to produce MRD panels; 220 (32%) were evaluable (112 osimertinib, 108 placebo)

  RaDaR (NeoGenomics), personalized panels of up to 50 tumor-specific variants from whole-exome sequencing of resected tumor

  Baseline MRD was detected in 5/112 (4%) on osimertinib vs 13/108 (12%) on placebo; 4 of 5 became MRD-negative on osimertinib vs 0 of 13 on placebo. On-treatment MRD detection had 65% clinical sensitivity and 95% specificity for DFS events and preceded a DFS event by a median of 4.7 months. At 36 months, MRD/DFS event-free rates were 86% vs 36% (HR 0.23, 95% CI 0.15-0.36). Most MRD/DFS events on osimertinib occurred after treatment completion (19/28), 11 of those 19 within 12 months of stopping.

• Level 3neutralASCO Annual Meeting 2024, Abstract 3039 2024

  Comparison of primary versus metastatic tumor tissue sources when designing panels for whole genome–based tumor-informed ctDNA assays in clear cell renal cell carcinoma.

  Seo A · Abstract 3039 · 5 patients; 13 primary-tumor, 24 metastatic-lesion, and matched buffy-coat samples; baseline plasma before radiotherapy

  Myriad Genetics High-Definition MRD assay: tumor/normal WGS (median coverage 30x); a sub-panel of up to 1,000 somatic variants designed for each lesion subsite; hybridization capture from plasma cfDNA

  ASCO 2024 methods abstract (Seo first, Tang last): in 5 oligometastatic ccRCC patients, baseline MRD calls from Myriad High-Definition MRD sub-panels designed from primary-tumor vs metastatic subsites were fully concordant in 3 of 5 patients, at tumor fractions from 0.0004% to 0.027%.

• Level 1mixedASCO Gastrointestinal Cancers Symposium 2024

  Circulating tumor DNA analysis informing adjuvant chemotherapy in locally advanced rectal cancer: The randomized AGITG DYNAMIC-Rectal study.

  Tie, Jeanne · Abstract 12 · DYNAMIC-Rectal · 230 eligible (155 ctDNA-guided, 75 standard); recruitment stopped early because of COVID-19 and uptake of total neoadjuvant therapy

  tumor-informed (same program as DYNAMIC; commercial name not re-stated in the extracted results)

  In the ctDNA-guided arm, 42/150 (28%) with successful testing were ctDNA-positive. Adjuvant chemotherapy was used in 46% vs 77% (P<0.001). 3-year RFS was 76% vs 82% (difference 6%, 95% CI -6% to 17%). The abstract states the sample size precludes conclusions about non-inferiority. Recurrence in untreated ctDNA-negative patients was often lung-only (12/15, 80%).

• Level 2prognosticASCO Gastrointestinal Cancers Symposium 2024

  Circulating tumor DNA (ctDNA) for informing adjuvant chemotherapy (ACT) in stage II/III colorectal cancer (CRC): Interim analysis of BESPOKE CRC study.

  Kasi, Pashtoon Murtaza · Abstract 9 · BESPOKE CRC · 154 stage II and 196 stage III in this interim subset; MRD results in 295; median follow-up 24.8 months

  Signatera (tumor-informed)

  MRD positivity was 15.6% (46/295; 6.9% stage II, 22.4% stage III) and was associated with inferior DFS (HR 20.8, 95% CI 10.0-43.4). Within the MRD-positive group, patients who received ACT had longer DFS than those observed (median 18.7 vs 6.7 months; HR 3.9, P=0.01). No ACT benefit was observed in MRD-negative patients (HR 1.1, P=0.89). Treatment was not randomized.

• Level 2prognosticASCO Gastrointestinal Cancers Symposium 2024

  Circulating tumor DNA (ctDNA) dynamics in patients with colorectal cancer (CRC) with molecular residual disease: Updated analysis from GALAXY study in the CIRCULATE-JAPAN.

  Yukami, Hiroki · Abstract 6 · GALAXY (CIRCULATE-Japan) · 2,518 analyzed of 3,034 enrolled; MRD-window results in 2,093 (309 [14.8%] positive)

  Signatera (tumor-informed)

  MRD-positive patients had inferior DFS (HR 15.75, 95% CI 12.59-19.68, P<0.0001). Those who remained positive 3 months after MRD detection were more than 5 times as likely to recur as those with clearance (HR 5.4, P<0.0001). Of 181 MRD-positive patients who received adjuvant therapy, 72.9% had clearance; 54% of those with later samples had sustained clearance, which was associated with far better outcomes than transient clearance (HR 32.57). A 50% or greater drop in MTM/mL at 6 months among treated MRD-positive patients was associated with better DFS (HR 2.39, P=0.004).

  Full paper

• Level 1negativeASCO Gastrointestinal Cancers Symposium 2024

  Phase II results of circulating tumor DNA as a predictive biomarker in adjuvant chemotherapy in patients with stage II colon cancer: NRG-GI005 (COBRA) phase II/III study.

  Morris, Van K. · Abstract 5 · NRG-GI005 (COBRA) · 635 randomized (318 observation, 317 ctDNA-directed); phase II clearance analysis used the first 16 patients with baseline ctDNA detected

  Guardant LUNAR (mutations plus colon cancer-specific methylation)

  Clearance of ctDNA at 6 months was observed in 3/7 (43%) in the observation arm and 1/9 (11%) in the chemotherapy arm (P=0.98). The phase II endpoint was not met; enrollment was halted under prespecified stopping rules based on the original assay. No improvement in clearance was seen after 6 months of chemotherapy in ctDNA-detected resected stage IIA colon cancer. The abstract notes future integral-biomarker trials must account for assay specificity in this population.

• Level 3prognosticASCO Genitourinary Cancers Symposium 2024

  Longitudinal circulating tumor DNA monitoring for detection of molecular residual disease in patients with penile squamous cell carcinoma.

  Patel, Mukti · Abstract 11 · 7 patients with advanced HPV-unassociated penile squamous cell carcinoma; single-center retrospective

  Signatera (personalized tumor-informed)

  Assays were designed for all 7 patients, and ctDNA was detectable at least once in all. Rising ctDNA prompted imaging that showed progression in 3 patients. Two of 7 remained alive with sustained clearance and 3 with persistent positivity had died at the time of the report.

• Level 2ESMO Congress 2024

  IMpower010: ctDNA status and 5-year disease-free survival follow-up in resected NSCLC after adjuvant chemotherapy followed by atezolizumab or best supportive care

  Heather Wakelee · Abstract 1211P · Poster · IMpower010

  PosterPoster PDF. An ASCO or ESMO member login may be required.

• Level 2ESMO Congress 2024

  Association of ctDNA-based MRD detection and MRD clearance with short-term overall survival in resectable colorectal cancer: Updated analysis of CIRCULATE-Japan GALAXY

  Jun Nagata · Abstract 553P · Poster · CIRCULATE-Japan GALAXY

  PosterPoster PDF. An ASCO or ESMO member login may be required.

• Level 2ESMO Congress 2024

  Association between copy number aberration and ctDNA MRD in colorectal cancer: CIRCULATE-Japan GALAXY

  Tomoya Harima · Abstract 555P · Poster · CIRCULATE-Japan GALAXY

  PosterPoster PDF. An ASCO or ESMO member login may be required.

• Level 2ESMO Congress 2024

  Survival benefit of adjuvant chemotherapy based on MRD detection in resected colorectal liver metastases: Subgroup analysis from CIRCULATE-Japan GALAXY

  Kozo Kataoka · Abstract 558P · Poster · CIRCULATE-Japan GALAXY

  PosterPoster PDF. An ASCO or ESMO member login may be required.

• Level 1mixedSan Antonio Breast Cancer Symposium 2024

  Abstract GS3-01: Circulating tumor DNA surveillance in ZEST, a randomized, phase 3, double-blind study of niraparib or placebo in patients w/ triple-negative breast cancer or HER2+ BRCA-mutated breast cancer with molecular residual disease after definitive therapy

  Turner, Nicholas · Abstract GS3-01 · oral · ZEST · 2,746 prescreened; 1,901 with at least one ctDNA result; 147 (8%) ctDNA-positive; 40 randomized (18 niraparib, 22 placebo) before early termination

  Signatera (personalized tumor-informed, whole-exome-based)

  Enrollment was stopped early because of a low ctDNA-positivity rate (8% of 1,901 tested; 5.2% on the first test) and a high rate of radiographic recurrence already present at first ctDNA positivity (72/147, 49%). Among the 40 randomized patients, median DFS was 11.4 months with niraparib vs 5.4 months with placebo (HR 0.64, 95% CI 0.30-1.39), a comparison the sample size cannot support as a conclusive efficacy result. No new safety signals for niraparib were reported.

• Level 2prognosticASCO Annual Meeting 2023

  Minimal residual disease by circulating tumor DNA as a biomarker of recurrence free survival in resected high-risk melanoma patients treated with mRNA-4157/V940, a personalized cancer vaccine, and pembrolizumab.

  Carlino, Matteo S. · Abstract LBA9515 · LBA · KEYNOTE-942 (mRNA-4157-P201) · 125 patients with evaluable baseline ctDNA; 110 (88%) ctDNA-negative at start of treatment

  RaDaR (as stated in prior reports of this analysis; confirm brand is named in this abstract body if cited as such)

  Baseline ctDNA-negativity was associated with longer RFS than positivity (event rate 20.9% [23/110] vs 80.0% [12/15]; HR 0.150, 95% CI 0.073-0.306). In the mRNA-4157/V940 plus pembrolizumab arm, RFS event rates were 10.4% (8/77) if negative vs 76.9% (10/13) if positive (HR 0.087). The pembrolizumab monotherapy comparison used only 2 ctDNA-positive patients.

• Level 3prognosticASCO Annual Meeting 2023

  Longitudinal circulating tumor DNA monitoring for detection of molecular residual disease in patients with surgically resected stage II/III melanoma.

  Kollipara, Revathi · Abstract 9582 · 45 patients; assays designed for 42/45 (93%); 159 plasma samples; single-center real-world series

  Signatera (bespoke mPCR-NGS)

  ctDNA was detectable at one or more timepoints in 15/42 (36%), including 11/20 (55%) with stage III and 4/22 (18%) with stage II disease. Radiographic recurrence occurred in 7/42 patients, 6 of whom were ctDNA-positive. 26/27 (96%) patients with persistent ctDNA negativity remained clinically and radiographically progression-free. Twelve of 15 ctDNA-positive patients received adjuvant immunotherapy or treatment escalation after a positive result; 6 had sustained clearance.

• Level 2prognosticASCO Annual Meeting 2023

  Circulating tumor DNA dynamics as an early predictor of recurrence in patients with radically resected colorectal cancer: Updated results from GALAXY study in the CIRCULATE-Japan.

  Oki, Eiji · Abstract 3521 · GALAXY (CIRCULATE-Japan) · 2,083 analyzed of 3,615 enrolled; median follow-up 16.3 months

  Signatera (tumor-informed)

  286/2,083 (14%) were ctDNA-positive at the 4-week MRD timepoint and had inferior DFS (HR 12, 95% CI 9.1-15; P<0.0001). Versus patients who stayed negative (n=1,529), conversion from negative to positive (n=112) had HR 14.5 and persistent positivity (n=124) had HR 25.4. Median lead time from ctDNA to radiographic recurrence was 142 days among protocol-imaged recurrences.

  Full paper

• Level 3prognosticASCO Annual Meeting 2023

  Association of tumor-informed minimal residual disease (MRD) with clinical outcomes for muscle invasive bladder cancer (MIBC): A multicenter retrospective real-world analysis.

  Kommalapati, Ajitha · Abstract 3050 · 109 patients, 545 plasma samples; multicenter retrospective

  Signatera (tumor-informed)

  ctDNA positivity at the first post-surgical timepoint was associated with shorter DFS (HR 9.9, 95% CI 4.1-24; 65.79% of positive patients had recurred vs 8.45% of negative). Anytime post-cystectomy positivity: HR 25 (95% CI 5.9-103); 96.83% of persistently negative patients had no recurrence. Median lead time to imaging recurrence was 61 days. In multivariate analysis, anytime ctDNA positivity was the only significant factor associated with shorter DFS (HR 23.07).

• Level 3positiveASCO Annual Meeting 2023

  Clinical evaluation of cancer signal origin prediction and diagnostic resolution following multi-cancer early detection testing.

  Klein, Eric A. · Abstract 10520 · PATHFINDER · 39 participants with a cancer signal detected by both test versions

  targeted methylation MCED test with cancer-signal-origin prediction (PATHFINDER / Galleri lineage)

  Diagnostic evaluations were consistent with the predicted cancer signal origin in 30/39 (77%) cases. Diagnostic resolution was reached after initial evaluation in 32/39 (82%); the remaining 7 reached resolution after additional workup (3 with cancer, 4 without). Whole-body imaging was used in 27 cases and was equivocal or had no impact on resolution in 8/27 (30%).

• Level 3prognosticASCO Genitourinary Cancers Symposium 2023

  Longitudinal detection of circulating tumor DNA in patients with advanced renal cell carcinoma.

  Basu, Arnab · Abstract 715 · 41 patients with advanced RCC

  Signatera (tumor-informed)

  ctDNA was detected at any time point in 70% (29/41). All 14 patients who progressed had ctDNA detected ahead of radiographic progression (100% sensitivity in this series) with a median lead time of 13.6 weeks (range 1-39.7). Concordance between clinical outcome and ctDNA status was 78% (32/41).

  Full paper

• Level 1mixedESMO Congress 2023

  LBA28 The PEGASUS trial: Post-surgical liquid biopsy-guided treatment of stage III and high-risk stage II colon cancer patients

  Lonardi, S. · Abstract LBA28 · LBA · PEGASUS · 135 patients; median follow-up 20.8 months at this report

  Guardant Reveal (v L1.2)

  Post-surgery ctDNA was detected in 35/135 (26%). Relapse occurred in 12/35 (34%) ctDNA-positive vs 9/100 (9%) ctDNA-negative patients (HR 4.37, P=0.0003); the 9 negative relapses were the prespecified false-negative count. After 3 months of CAPOX, 11/35 positive patients converted to negative, but 8/11 later relapsed or re-positivized. Of 23 who received FOLFIRI after CAPOX, 11 converted and were relapse-free at analysis.

  SlidesWebcastSlides + webcast. An ASCO or ESMO member login may be required.

• Trial in progressESMO Congress 2023

  GUIDE.MRD: A consortium guiding multimodal therapies against minimal residual disease by liquid biopsy and ctDNA implementation in clinical practice

  Klaus Pantel · Abstract 237TiP · Poster / trial-in-progress · GUIDE.MRD

  Trial in progress

  PosterPoster PDF. An ASCO or ESMO member login may be required.

• Level 1positiveASCO Annual Meeting 2022

  Adjuvant chemotherapy guided by circulating tumor DNA analysis in stage II colon cancer: The randomized DYNAMIC trial.

  Tie, Jeanne · Abstract LBA100 · LBA · DYNAMIC · 455 randomized (302 ctDNA-guided, 153 standard management)

  tumor-informed Safe-SeqS (named in the abstract)

  Fewer patients in the ctDNA-guided arm received adjuvant chemotherapy (15.3% vs 27.9%; odds ratio 2.14; P=0.002). ctDNA-guided management was non-inferior for 2-year RFS (93.5% vs 92.4%; difference 1.1%, 95% CI -4.1% to 6.2%). After chemotherapy, 3-year RFS in ctDNA-positive patients was 86.4%; without chemotherapy, 3-year RFS in ctDNA-negative patients was 92.5% (96.7% in clinically low-risk disease).

  Full paper

• Level 3prognosticASCO Annual Meeting 2022

  Liquid Biopsy for Minimal Residual Disease Detection in Head and Neck Squamous Cell Carcinoma (LIONESS): A personalized cell-free tumor DNA analysis for patients with HNSCC.

  Flach, Susanne · Abstract 6017 · LIONESS · 35 patients, 236 longitudinal plasma samples; prospective observational; median follow-up 9.5 months at this report

  RaDaR (personalized panels targeting a median of 48 somatic variants, range 20-60)

  Baseline (pre-surgery) ctDNA detection was 94.28%. Recurrence occurred in 8/11 (72.7%) patients who were ctDNA-positive during follow-up vs 0/24 who were ctDNA-negative (P=7e-7). In all 8 clinical recurrences, ctDNA was detected first, with lead times of 56 to 265 days. Post-surgery ctDNA was detected at variant allele fractions as low as 0.0005%.

• Level 2prognosticASCO Annual Meeting 2022

  Circulating tumor DNA (ctDNA) and late recurrence in high-risk, hormone receptor–positive, HER2-negative breast cancer (CHiRP).

  Lipsyc-Sharf, Marla · Abstract 103 · CHiRP · 103 enrolled; 83 with successful whole-exome sequencing and personalized assays; 219 plasma samples

  RaDaR (personalized, tumor-informed; 12-51 variants, median 36)

  At a median of 8.4 years from diagnosis to first sample, 8/83 (10%) were MRD-positive at any timepoint and 4/83 (5%) were positive at study entry. All 5 patients with distant metastatic recurrence were MRD-positive, with ctDNA lead times up to 37.6 months. Two of 8 MRD-positive patients had not recurred at latest follow-up.

• Level 2prognosticASCO Gastrointestinal Cancers Symposium 2022

  Association of circulating tumor DNA dynamics with clinical outcomes in the adjuvant setting for patients with colorectal cancer from an observational GALAXY study in CIRCULATE-Japan.

  Kotaka, Masahito · Abstract 9 · GALAXY (CIRCULATE-Japan) · 1,365 patients enrolled June 2020-April 2021 (this analysis); median follow-up 6.6 months

  Signatera (tumor-informed)

  6-month DFS by 4-to-12-week ctDNA dynamics: 98% if negative-to-negative (n=618), 100% if positive-to-negative (n=58), 59% if negative-to-positive (n=32), and 45% if positive-to-positive (n=78); HR 52.3 comparing conversion to clearance vs persistent positivity (P<0.001). Among 4-week MRD-positive patients, 12-week clearance was 57% (54/95) with adjuvant chemotherapy vs 8% (7/93) without (P<0.001). 6-month DFS in 4-week MRD-positive patients was 84% vs 34% with vs without ACT (HR 0.15, P<0.001).

  Full paper

• Level 2prognosticASCO Genitourinary Cancers Symposium 2022

  Molecular residual disease (MRD) detection with a tissue comprehensive genomic profiling (CGP)-informed personalized monitoring assay: An exploratory analysis of the IMvigor-010 observation arm.

  Young, Amanda · Abstract 448 · IMvigor010 (observation arm) · 182 patients on the observation arm evaluated at the MRD timepoint

  tissue comprehensive genomic profiling-informed personalized monitoring assay (Foundation Medicine approach, as described in the abstract)

  ctDNA was detected at the MRD timepoint in 66/182 (36%). Of those 66, 58 (88% PPV) had relapsed at analysis. Median DFS from randomization was 3 months if ctDNA-positive versus not reached if negative (HR 5.7, 95% CI 3.8-8.6); median OS 13 months vs not reached (HR 5.7, 95% CI 3.4-9.7).

  Full paper

• Level 2prognosticASH Annual Meeting 2022

  Risk Profiling of Patients with Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) By Measuring Circulating Tumor DNA (ctDNA): Results from the POLARIX Study

  Herrera, Alex F. · Abstract 1297 · POLARIX · paired baseline and Cycle 2 Day 1 results in 319/440 (Pola-R-CHP) and 299/439 (R-CHOP) patients

  AVENIO NHL CAPP-Seq; results as mean mutant molecules per mL

  Baseline ctDNA above the median MMPM was associated with shorter PFS and OS in both arms (Pola-R-CHP PFS HR 1.96, OS HR 2.17; R-CHOP PFS HR 1.43, OS HR 2.10). A log-fold change of at least 2.0 or undetectable ctDNA at C2D1 was reached by 66.8% and 65.6% of patients in the two arms and was prognostic (PFS HR 1.86 and 2.21). In Pola-R-CHP, a 2.5-log reduction (PFS HR 2.89) and C2D1 clearance (PFS HR 2.98, OS HR 2.74) remained prognostic independent of baseline risk factors.

• Trial in progressESMO Asia Congress 2022

  Minimal residual disease-guided adjuvant tislelizumab after adjuvant chemotherapy in resected stage IIA-IIIB NSCLC: A single-arm phase II study (Seagull)

  Feng Li · Abstract 304TiP · Poster / trial-in-progress · Seagull

  Trial in progress

  PosterPoster PDF. An ASCO or ESMO member login may be required.

• Level 3ESMO Congress 2022

  A tumor-informed, hybrid-capture ctDNA assay for MRD detection in colorectal cancer after curative surgery

  Sae-Won Han · Abstract 381P · Poster

  PosterPoster PDF. An ASCO or ESMO member login may be required.

• Level 2ESMO Congress 2022

  Tumour-naïve ctDNA analysis in resected colorectal cancer in the phase III ASCOLT trial

  Daphne Day · Abstract 380P · Poster · ASCOLT

  PosterPoster PDF. An ASCO or ESMO member login may be required.

• Level 2prognosticSan Antonio Breast Cancer Symposium 2022

  Abstract PD5-03: PD5-03 Comparison of a personalized sequencing assay and digital PCR for circulating tumor DNA based Molecular Residual Disease detection in early-stage triple negative breast cancer in the cTRAK-TN trial

  Coakley, Maria · Abstract PD5-03 · poster discussion · c-TRAK TN · Agreement and lead-time comparison on c-TRAK TN samples; exact patient n is given in rates (9 patients RaDaR-only positive, 3 dPCR-only) but a single total n is not restated as a standalone figure in the extracted results beyond the agreement analysis

  RaDaR (personalized multi-mutation sequencing) compared with digital PCR mutation tracking

  Overall test agreement was 92.7% (95% CI 90.7-94.4%). From a patient-level view, 58.7% were negative on both assays, 32.9% positive on both, and 8.6% discordant (ctDNA detected by RaDaR but not dPCR in 9 patients, and the reverse in 3). Among ctDNA-positive patients, 55.2% were first detected by RaDaR, 5.2% by dPCR, and 39.6% at the same timepoint (P<0.001). Median lead time to relapse was 7.1 months with RaDaR vs 5.7 months with dPCR.

  Full paper

• Level 2positiveASCO Annual Meeting 2021

  A prespecified interim analysis of the PATHFINDER study: Performance of a multicancer early detection test in support of clinical implementation.

  Beer, Tomasz M. · Abstract 3070 · PATHFINDER · 4,011 of 4,047 participants analyzable in this interim cohort enrolled as of 6 October 2020

  targeted methylation-based cfDNA MCED test (Galleri lineage; a more recent classifier than the version returned to investigators), predicting cancer signal origin

  A cancer signal was detected in 38/4011 (0.95%). Using a conservative minimal PPV that treated all discordant positives as false positives, PPV was 43.3% (13/30, 95% CI 27.4-60.8%). Among 13 detected cancers, top cancer-signal-origin accuracy was 92.3% (12/13). Nine cancer types were represented among those 13 cases.

• Level 2positiveASCO Annual Meeting 2021

  Phase II study of anti-EGFR rechallenge therapy with panitumumab driven by circulating tumor DNA molecular selection in metastatic colorectal cancer: The CHRONOS trial.

  Sartore-Bianchi, Andrea · Abstract 3506 · CHRONOS · 52 screened by liquid biopsy; 36 (69%) negative for RAS/BRAF/EGFR mutations; 27 enrolled and treated

  ctDNA genotyping for RAS/BRAF/EGFR mutations (assay brand not named in the extracted results)

  The primary endpoint was met: partial response in 8/27 (ORR 30%, 95% CI 12-47%). Disease control (PR plus SD lasting more than 4 months) was 59%. Median PFS was 16 weeks. This is metastatic anti-EGFR rechallenge guided by ctDNA resistance mutations, not adjuvant MRD.

• Level 3prognosticASCO Annual Meeting 2021

  Personalized, ctDNA analysis to detect minimal residual disease and identify patients at high risk of relapse with multiple myeloma.

  Dhakal, Binod · Abstract 8029 · 28 patients after upfront autologous transplant; 80 plasma timepoints; median follow-up 92.4 months; single-center retrospective

  Signatera (personalized tumor-informed mPCR-NGS), assessed about 3 months after transplant; bone-marrow comparison used multiparameter flow cytometry at 10^-4

  ctDNA was detectable in 17/24 (70.8%) before transplant, 15/28 (53.6%) at about 3 months after transplant, and 11/28 (39.2%) during later surveillance. Of 15 patients MRD-positive at 3 months, 14 (93.3%) later relapsed (HR 5.64, 95% CI 1.8-17, P=0.0003). Median PFS was 84 months if ctDNA-negative at 3 months vs 31 months if positive (P=0.003). The 3-month positive predictive value for relapse was 93.3%, higher than marrow flow cytometry (68.4%) in this series.

• Level 2prognosticASCO Annual Meeting 2021

  Residual ctDNA after treatment predicts early relapse in patients with early-stage NSCLC.

  Gale, Davina · Abstract 8517 · LUCID · 88 patients, 363 plasma samples; landmark analysis in 62 patients (2 weeks to 4 months after initial treatment); 69 surgery, 19 chemoradiotherapy

  RaDaR personalized tumor-informed assay (up to 48 tumor-specific variants)

  Landmark post-treatment ctDNA detection was associated with relapse (HR 20.7, 95% CI 7.7-55.5, P<0.0001). All 11 patients with landmark detection progressed, at a median of 121 days after detection, including all 8 who relapsed within 300 days of treatment. Among 27 patients who progressed, post-treatment ctDNA was detected in 17, with a median lead time of 203 days (up to 741 days).

• Level 3prognosticASCO Annual Meeting 2021

  Leveraging phased variants for personalized minimal residual disease detection in localized non-small cell lung cancer.

  Kurtz, David Matthew · Abstract 8518 · Personalized PhasED-Seq applied in 5 patients with localized NSCLC (14 plasma samples); methodologic series

  PhasED-Seq (personalized phased-variant sequencing after tumor/normal whole-genome sequencing)

  Phased variants had a lower background rate than SNVs, including duplex SNVs (1.2e-6 vs 3.8e-5 and 1.0e-5). PhasED-Seq detected all 5 SNV-positive samples and 5 additional samples at tumor fractions as low as 0.000094%. In one patient with stage III adenocarcinoma, PhasED-Seq detected MRD in three on-treatment samples that were undetectable by SNVs, including a sample 8 months before progression.

• Level 2prognosticESMO Immuno-Oncology Congress 2021

  2O IMpower010: Biomarkers of disease-free survival (DFS) in a phase III study of atezolizumab (atezo) vs best supportive care (BSC) after adjuvant chemotherapy in stage IB-IIIA NSCLC

  Zhou, C. · Abstract 2O · oral · IMpower010 · 600 ctDNA-evaluable of 1,005 randomized; 534 with stage II-IIIA disease

  Natera Signatera RUO (plasma after surgery and before adjuvant chemotherapy)

  ctDNA positivity rose with stage (IB 9%, II 14%, IIIA 29%) and was associated with worse DFS. In stage II-IIIA disease, atezolizumab improved DFS versus BSC in both ctDNA-positive and ctDNA-negative patients, with clearer benefit when PD-L1 TC was >=1% (ctDNA-negative HR 0.57, 95% CI 0.36-0.90; ctDNA-positive HR 0.54, 95% CI 0.31-0.93). Among PD-L1 TC <1% patients, HRs were 0.95 (ctDNA-negative) and 0.88 (ctDNA-positive).

• Level 1mixedSan Antonio Breast Cancer Symposium 2021

  Abstract GS3-06: Primary results of the cTRAK TN trial: A clinical trial utilising ctDNA mutation tracking to detect minimal residual disease and trigger intervention in patients with moderate and high risk early stage triple negative breast cancer

  Turner, Nicholas · Abstract GS3-06 · oral · c-TRAK TN · 208 registered; 171 with trackable mutations; 161 entered ctDNA surveillance

  digital PCR mutation tracking (1-2 patient-specific variants), as described in the companion full paper and later assay-comparison abstracts from the same trial

  The 12-month ctDNA detection rate was 27.3% (44/161). Seven patients relapsed without prior ctDNA detection. Of patients allocated to pembrolizumab, 23/32 (72%) already had metastatic disease on staging at the time of ctDNA detection. Only 5 patients started pembrolizumab; none achieved sustained ctDNA clearance, and 4 had recurred at analysis. In the observation group, median time to recurrence was 4.1 months. The therapeutic activity endpoint could not be assessed.

  Full paper