On May 22, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported that data from more than 25 Signatera studies will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from May 30 – June 3, 2025 in Chicago, IL (Press release, Natera, MAY 22, 2025, View Source [SID1234653342]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Together with its collaborators, Natera will showcase the clinical utility of Signatera across 10 different cancer types. This extraordinary breadth of data includes analyses of thousands of patients, demonstrating Natera’s leadership in circulating tumor DNA (ctDNA) monitoring and molecular residual disease (MRD) assessment.

"The depth and breadth of Natera’s research at ASCO (Free ASCO Whitepaper) is our most significant to date, with multiple impactful datasets in several histologies," said Alexey Aleshin, M.D., corporate chief medical officer and general manager of oncology at Natera. "The interim analysis from the DARE trial shows a possible first signal in a randomized setting that treating high-risk breast cancer patients based on Signatera results can impact clearance rates. We also look forward to sharing results on our ultra-sensitive Signatera Genome assay, along with numerous other presentations underscoring our commitment to advance the way cancer is managed."

Highlights include:

DARE Clinical Trial: Oral Presentation
DARE is a prospective, randomized study, launched in 2021, to investigate the utility of Signatera for guiding adjuvant endocrine therapy in 585 women with high-risk, estrogen receptor-positive, HER2-negative (ER+/HER2-) breast cancer. It assesses the novel concept of "treatment on molecular recurrence" (TOMR). Patients who were Signatera-positive and imaging-negative were randomized into two arms: the standard-of-care (SOC) arm with endocrine therapy vs. the escalated arm with fulvestrant+palbociclib (CDK 4/6i). This interim analysis of 507 women and 2,208 plasma samples demonstrates the exceptional clinical performance of Signatera, and the early feasibility of both this treatment escalation approach and the TOMR trial strategy, including:
Strong test sensitivity and NPV: Among patients who remained persistently Signatera-negative during screening (>400 pts), 99% remained recurrence free with a median follow up of 27.4 months.
High randomization rate: Of patients who tested Signatera-positive, 73% were negative on imaging, and 93% were willing to be randomized.
2x higher ctDNA clearance: Patients in Arm A had a 2x higher rate of ctDNA clearance at 3 months vs. Arm B.
Signatera Monitoring in Metastatic Breast Cancer: Oral Presentation
This real-world analysis of over 600 metastatic breast cancer (mBC) patients across all disease subtypes and a wide range of therapeutic regimens (e.g., chemo, ADCs, CDK4/6) shows the utility of metastatic monitoring with Signatera:
Serial ctDNA testing done at an appropriate cadence (6 weeks) can inform treatment response and clinical decisions in metastatic breast cancer.
Signatera ctDNA dynamics were the strongest predictor of treatment benefit in a multivariate analysis, based on measuring time to next treatment (TTNT).
Nearly 75% of patients with favorable dynamics remained on the same treatment for over 4 months, including those receiving antibody drug conjugates (ADCs) where therapy response can be challenging to evaluate on imaging.
Pan-Cancer Performance of Signatera Genome: Poster Presentation
Large-scale presentation of Signatera’s Genome assay, analyzing more than 3,000 samples from over 300 patients across 5 major cancer types.
The study includes analysis of patients with breast cancer, colorectal cancer, non-small cell lung cancer, melanoma, and renal cell carcinoma.
Signatera Performance in Post-Surgical Stage I-IIIb Melanoma: Poster Presentation
This study includes 197 patients and 1,681 plasma samples, tested for a median period of 2 years. This is one of the most comprehensive MRD/monitoring datasets thus far in early melanoma, demonstrating the ability of Signatera to identify patients who may benefit from escalated imaging or earlier treatment initiation.
Post-surgical Signatera-positivity was the most significant predictor of recurrence free survival (RFS).
In the surveillance setting, Signatera-positivity was predictive of shorter RFS (HR: 24.0, P < 0.001).
Full list of oral presentations at ASCO (Free ASCO Whitepaper):

May 30, 2:45 PM CT | 3008 | Breast
Presenter: Silver Alkhafaji
Circulating tumor DNA (ctDNA) in patients with stage 2/3 HR+HER2-negative breast cancer (BC) treated with neoadjuvant endocrine therapy (NET) in the I-SPY2 endocrine optimization pilot (EOP) trial

June 1, 9:45 AM CT | 4503 | Genitourinary
Presenter: Thomas Powles, MBBS, MRCP, M.D.
Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA

June 1, 11:30 AM CT | 3518 | Gastrointestinal
Presenter: Aron Bercz, M.D.
Circulating Tumor DNA Provides an Early Response Assessment in Anal Squamous Cell Carcinoma Treated With Definitive Chemoradiation

June 1, 4:30 PM CT | 1010 | Breast
Presenter: Lajos Pusztai, M.D., DPhil
Circulating tumor (ct)DNA monitoring of ER+/HER2- high-risk breast cancer (BC) during adjuvant endocrine therapy (ET) (DARE)

June 1, 4:30 PM CT | 1011 | Breast
Presenter: Pedram Razavi, M.D., Ph.D.
Circulating tumor DNA (ctDNA) dynamics as a predictor of treatment response in metastatic breast cancer (mBC)

June 2, 3:00 PM CT | 504 | Breast
Presenter: Rita Mukhtar, M.D.
Predicting nodal burden after neoadjuvant chemotherapy (NAC) with circulating tumor (ct)DNA for surgical planning: Results from the I-SPY2 trial

Full list of poster presentations at ASCO (Free ASCO Whitepaper):

May 31, 9:00 AM CT | 11537 | Sarcoma
Presenter: Adie Victor, M.D., M.S.
Early on-treatment circulating tumor (ct)DNA dynamics in response to therapy in patients with sarcoma

May 31, 9:00 AM CT | 11531 | Sarcoma
Presenter: Maggie Zhou, M.D.
Early assessment of response to chemotherapy via ctDNA in soft tissue sarcoma

May 31, 9:00 AM CT | TPS3647 | Gastrointestinal
Presenter: Clara Montagut, M.D.
A precision medicine trial leveraging tissue and blood-based tumor genomics to optimize treatment in resected stage III and high-risk stage II colon cancer (CC) patients (pts): The SAGITTARIUS Trial.

May 31, 9:00 AM CT | 4067 | Gastrointestinal – FMI
Presenter: Michele Prisciandaro, M.D.
Tumor-informed liquid biopsy in predicting recurrence in patients with operable gastroesophageal adenocarcinoma: the LIQUID study

May 31, 9:00 AM CT | 4130 | Gastrointestinal
Presenter: Maen Abdelrahim, M.D.
Real-world analysis of ctDNA and other biomarkers in patients with curatively resected Stage I-III Biliary Tract Cancer

May 31, 9:00 AM CT | 3600 | Gastrointestinal
Presenter: Eiji Oki, Ph.D.
Impact of Perioperative Complications on ctDNA-based MRD Detection and Prognosis: Insights from the GALAXY Study

May 31, 9:00 AM CT | 3591 | Gastrointestinal
Presenter: Emerik Osterlund, M.D., Ph.D.
Biologic correlates of circulating tumor DNA (ctDNA) shedding in the INTERCEPT colorectal cancer (CRC) study

May 31, 9:00 AM CT | 3597 | Colorectal
Presenter: Midhun Malla, M.D., M.S.
ctDNA dynamics and targeted therapies associated with genetic mutations in patients with colorectal cancer

May 31, 9:00 AM CT | 4073 | Esophagogastric Gastric
Presenter: Reetu Mukherji, M.D.
Exome analysis of over 5000 esophagogastric cancers

June 1, 9:00 AM CT | 9574 | Merkel Cell Carcinoma
Presenter: Joshua Elbridge Chan
Comparison of surveillance circulating tumor DNA and merkel polyomavirus antibody titer for detection of merkel cell carcinoma recurrence

June 1, 9:00 AM CT | 9571 | Melanoma
Presenter: George Ansstas, M.D.
Longitudinal ctDNA monitoring for post-surgical molecular residual disease in patients with stage I-IIIb melanoma

June 1, 9:00 AM CT | 9523 | Melanoma
Presenter: Caroline Burkey
Circulating tumor DNA (ctDNA) dynamics during anti-PD-1 based therapy to predict clinical outcomes in advanced stage melanoma: A multicenter retrospective study.

June 1, 9:00 AM CT | 9584 | Melanoma
Presenter: Vincent The-Luc Ma
Sensitivity of circulating tumor DNA (ctDNA) for disease recurrence or relapse in melanoma patients

June 1, 9:00 AM CT | 5563 | Gynecological
Presenter: Jung-Yun Lee, M.D., Ph.D.
ctDNA monitoring in participants with ovarian cancer treated with neoadjuvant pembrolizumab (pembro) plus chemotherapy (chemo) with or without the anti–immunoglobulin-like transcript 4 (ILT4) monoclonal antibody MK-4830

June 2, 9:00 AM CT | 4565 | Genitourinary
Presenter: Adanma Ayanambakkam, M.D.
Association of Tumor-Informed ctDNA-based Molecular Residual Disease (MRD) with Clinical Outcomes for Upper Tract Urothelial Cancer (UTUC)

June 2, 9:00 AM CT | 4602 | Genitourinary
Presenter: Ilana Epstein
Correlation of circulating tumor DNA (ctDNA) dynamics with clinical response in muscle-invasive bladder cancer (MIBC) patients (pts) undergoing trimodality therapy (TMT)

June 2, 9:00 AM CT | 4560 | Genitourinary
Presenter: Kevin R. Reyes, BS
Circulating tumor DNA (ctDNA) monitoring in patients (pts) with advanced urothelial carcinoma (aUC) treated with Enfortumab Vedotin +/- Pembrolizumab (EVP)

June 2, 9:00 AM CT | TPS620 | Breast
Presenter: Michail Ignatiadis, M.D., Ph.D.
EORTC-2129-BCG: Elacestrant for treating ER+/HER2- breast cancer patients with ctDNA relapse (TREAT ctDNA)

June 2, 9:00 AM CT | 581 | Breast
Presenter: Julia Foldi, M.D., Ph.D.
Serial circulating tumor DNA (ctDNA) monitoring in early-stage, HR+/HER2-, invasive lobular carcinoma (ILC) of the breast and impact on clinical outcomes

June 2, 9:00 AM CT | 560 | Breast
Presenter: Marla Lipsyc-Sharf, M.D.
Cadence of circulating tumor DNA (ctDNA) testing for molecular surveillance in early-stage breast cancer (eBC)

June 2, 9:00 AM CT | 612 | Breast
Presenter: Mei Wei, M.D.
I-SPY2 endocrine optimization pilot (EOP): Neoadjuvant lasofoxifene (Laso) in molecularly selected patients with hormone receptor positive (HR+)/HER2 negative (HER2-) stage 2/3 breast cancer (BC)

June 2, 1:30 PM CT | 3142 | Pancancer
Presenter: Mridula George, M.D.
Clinical performance of Signatera Genome assay in a cohort of patients (pts) with solid tumors

June 2, 1:30 PM CT | 3048 | Gastrointestinal
Presenter: John Paul Y.C. Shen, M.D.
Development of a methylation-based, tissue-free test for the detection of molecular residual disease by circulating tumor DNA

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and has coverage by Medicare across a broad range of indications. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.

On May 22, 2025 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported the poster presentation of two abstracts at the 2025 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30-June 3 in Chicago (Press release, Bicycle Therapeutics, MAY 22, 2025, View Source [SID1234653296]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Poster Presentation Details:

Title: Phase 1/2 Duravelo-1 study: Preliminary results of Nectin-4-targeting zelenectide pevedotin (BT8009) plus pembrolizumab in previously untreated, cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer
Poster Session: Genitourinary Cancer—Kidney and Bladder
Date and Time: Monday, June 2, at 9 a.m.-12 p.m. CT
Abstract Number: 4567
Lead Author: Patrizia Giannatempo, M.D., Fondazione IRCCS – Istituto Nazionale dei Tumori, Milan, Italy

Title: A phase 2/3 study of Bicycle Drug Conjugate zelenectide pevedotin (BT8009) targeting Nectin-4 in patients with locally advanced or metastatic urothelial cancer (la/mUC; Duravelo-2)
Poster Session: Genitourinary Cancer—Kidney and Bladder
Date and Time: Monday, June 2, at 9 a.m.-12 p.m. CT
Abstract Number: TPS4619
Lead Author: Yohann Loriot, M.D., Ph.D., Gustave Roussy Institute, University Paris-Saclay, Villejuif, France

The posters will be made available in the Publications section of the Bicycle Therapeutics website at the beginning of the poster session.

On May 22, 2025 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported the presentation of new data from two clinical trials evaluating its cancer immunotherapy candidates — VB10.16 and VB10.NEO, both in combination with atezolizumab (Tecentriq), — at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois (Press release, Nykode Therapeutics, MAY 22, 2025, View Source [SID1234653312]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The two posters highlight the potential of Nykode’s targeted immunotherapy platform in inducing robust immune responses in heavily pre-treated patient populations across multiple tumor types, with encouraging safety profiles.

"These new data add to the growing body of clinical evidence supporting our vaccine candidates VB10.NEO and VB10.16," said Agnete Fredriksen, CSO and Co-founder of Nykode Therapeutics. "The quality of the immune responses seen in both trials and the increased understanding of the relation between the immune responses and patient characteristics—reinforce the potential of our APC-targeted technology and help define the best path forward for these promising assets."

Sunday, June 1, 2025 | 9:00 AM–12:00 PM

CT Abstract #: 5538

Title: Integrative analysis of VB10.16 and atezolizumab in advanced HPV16-positive cervical cancer: Linking biomarker insights to clinical outcomes.

Presenter: Kristina Lindemann, Department of Gynecological Oncology, Oslo University Hospital & Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway

Session Type and Title: Poster Session – Gynecologic Cancer

Poster Board Number: 436

• In patients with persistent, recurrent, or metastatic HPV16-positive cervical cancer, VB10.16 combined with atezolizumab induced durable clinical responses. • The VB C-02 trial demonstrated that stronger HPV16-specific T cell responses were associated with reduced systemic immunosuppression during treatment. • Tumor microenvironment (TME) characteristics are associated with higher response rates. • These findings support the importance of identifying the right patient population as well as elucidating the treatment effect on the systemic immunosuppression and highlights the promise of VB10.16 in combination with atezolizumab, warranting further exploration.

Monday, June 2, 2025 | 1:30 PM–4:30 PM CT

Abstract #: 2639

Title: Induction of neoantigen-specific immune responses by VB10.NEO in combination with atezolizumab in heavily pretreated patients with advanced solid tumors: Final analysis of the phase 1b VB N-02 trial.

Presenter: Sebastian Ochsenreither, Charité University of Medicine Berlin Comprehensive Cancer Center, Berlin, Germany Session Type and Title: Poster Session – Developmental Therapeutics – Immunotherapy

Poster Board Number: 286

• VB10.NEO, Nykode’s personalized cancer neoantigen vaccine, in combination with atezolizumab, induced neoantigen-specific immune responses. • Neoantigen-specific immune responses were observed in 100% of the patients and de novo immune responses were observed in 85% of patients, as measured by in vitro stimulated IFNγ ELISpot. • Expansion of durable T cell clones was seen in 82% of patients, suggesting persistence of the immune response. • The trial enrolled heavily pre-treated patients across more than 10 indications, a median of 5 prior therapy lines and predominantly low or negative PD-L1 expression resulting in a median PFS reached before 2 months, limiting the opportunity for thorough assessment of long-term immune responses and clinically meaningful responses. • VB10.NEO in combination with atezolizumab demonstrated a favorable safety profile. • These results support further development of VB10.NEO in additional solid tumor settings.

On May 22, 2025 GNTbm (stock code: 7427, Taiwan) reported the preclinical data on GNTbm-38, an novel epigenetic immune activator for cancer immunotherapy. GNTbm-38 was presented as posters at the 2025 American Association of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is held in Chicago, USA, from May 30 to Jun 04, 2025 (Press release, GNT Biotech & Medicals, MAY 22, 2025, View Source;medicals-corporation-gntbm-presented-preclinical-data-on-gntnm-38-an-novel-epigenetic-immune-activator-at-the-2025-asco-annual-meeting-302461449.html [SID1234653327]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Abstract: 2574

Title: Preclinical development of GNTbm-38, a novel class I histone deacetylase inhibitor, while combined with anti-VEGFR TKI or anti-PD-1 Ab: Assessment of immune activation and immune memory in cancer immunotherapy.

Session Date/Time: 6/2/2025, 1:30 PM-4:30 PM CT

Poster Board Number: 221

At present, there is no ICI-based drug combination for the treatment of advanced MSS colorectal cancer, which is a cold tumor. Studies have shown that epigenetic regulators such as class I HDAC inhibitors are an emerging and important drug component for combination therapy that can greatly increase the anti-cancer benefits of cancer immunotherapy. Therefore, rational drug combinations, containing class I HDACi, may provide opportunities in cancer immunotherapy.

GNTbm-38 is a new drug candidate independently developed by GNTbm. GNTbm-38 acts as a TME reprogramming regulator in immunotherapy. When combined with TKI, GNTbm-38 significantly improved tumor response rate and survival rate through synergistic effect by normalizing tumor vessels, increasing tumor antigen presentation, increasing activated CD8+ T cell infiltration into tumors, inducing memory T cell persistence, and inhibiting mobilization of immunosuppressive cells into tumors. On the other hand, treatment with GNTbm-38 plus anti-PD-1 antibody in the CT-26 model showed greatly improved tumor response rate and survival rate with a strong synergistic effect. Furthermore, in B-hPD-1/hPD-L1 mice (humanized model) subcutaneously injected with B-hPD-L1 CT-26 cells, treatment of pembrolizumab and GNTbm-38 resulted in a 46.5% inhibition on tumor growth. Therefore, our data provided a strong rationale to explore the combination of GNTbm-38 with anti-VEGF TKI with or without ICI. From these data GNTm-38 has been shown to display powerful induction of immune activation and immune memory in combination therapy with TKI/ICI against colon CT-26 cold tumor. Based on the in vitro, in vivo and preclinical studies, these data show that GNTbm-38 exhibits markedly superior pharmacokinetics, tolerability, and efficacy in animal models. It is expected to complete the US IND application by the end of 2025 and enter the clinical study.

About GNTbm-38

GNTbm-38 is a new chemical entity with potential as a pivotal drug component of a new generation of cancer immunotherapy independently developed by GNTbm. It is a drug candidate selected by an immuno-competent tumor-bearing animal testing platform, and has undergone many preclinical research studies to confirm that it has very outstanding anti-cancer activity in tumor microenvironment. GNTbm-38 is an oral drug with dual effects of epigenetic regulation of gene expression and immune activation, which is unique when compared to the mechanism of other epigenetic drugs. GNTbm-38 can remodel the tumor microenvironment (TME) through a unique epigenetic regulatory mechanism, including the cell composition and gene expression that affect the TME, so that "cold tumors" can be transformed into "hot tumors", which can attract CTL to infiltrate into the TME, and at the same time, it can also reduce the attraction of immunosuppressive cells (such as : TAM, Treg, and MDSCs) into the TME, so as to achieve the remodeling of the TME, which is more conducive to obtaining the therapeutic benefits of cancer immunotherapy. GNTbm-38 monotherapy can be used in the treatment of hematological tumors, and GNTbm-38 can also be combined with a unique multi-kinase inhibitor or immune checkpoint inhibitor for treatment of a variety of solid tumors, mainly through a unique anti-cancer immune-regulating mechanism to achieve anti-cancer treatment goals.

On May 22, 2025 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported the company and its research collaborators will present data from more than 19 studies, including a landmark plenary session on the Phase 3 SERENA-6 trial, demonstrating the critical role of Guardant liquid biopsy tests in cancer screening, therapy selection and recurrence monitoring at the 2025 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Press release, Guardant Health, MAY 22, 2025, View Source [SID1234653343]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Featured presentations demonstrate the use of Guardant’s portfolio of blood tests, real-world data and AI to identify genomic and epigenomic biomarkers that can inform treatment decisions across a variety of solid tumor types. Studies also highlight new capabilities of the Guardant360 Liquid test to identify molecular tumor type in carcinomas of unknown primary and confirm the absence of actionable biomarkers, both enabled by the Guardant Infinity smart liquid biopsy platform, Presentation highlights include:

Abstract LBA4 plenary session demonstrating the use of the Guardant360 CDx test in detecting emergent ESR1 mutations during first-line endocrine-based therapy and ahead of disease progression in patients with HR+/HER2- advanced breast cancer in the Phase 3 SERENA-6 trial
Abstract 3504 oral session evaluating tissue-free epigenomic-based molecular residual disease (MRD) detection using Guardant Reveal in stage III colon cancer patients after surgery and prior to adjuvant therapy. This study showed a robust prognostic utility of Reveal to identify patients with poorer disease-free and overall survival in a large clinical trial cohort of over 2,000 patients with a median follow-up of 6.1 years.
Abstract 3584 providing analytic and clinical validation of an algorithm to predict the absence of actionable mutations in ctDNA-negative colorectal and non-small cell lung cancer samples, utilizing genomic and epigenomic profiling with the Guardant360 Liquid test.
Abstract 3073 demonstrating application of an epigenomic-based classifier to identify tumor type on liquid biopsy in cancer of unknown primary origin. Study provides validation data for the new molecular tumor type feature of Guardant360 Liquid utilizing DNA methylation signatures across thousands of cancer-specific differentially methylated regions for 14 cancer types.
"The data we and our research colleagues are presenting at ASCO (Free ASCO Whitepaper) demonstrate the clear and growing contribution of liquid biopsy in transforming cancer care and helping to improve patient outcomes," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "The SERENA-6 study in particular highlights how we are pushing the boundaries of what can be done with liquid biopsy in characterizing disease and potential drug efficacy, providing insights that could potentially change clinical practice."

The full abstracts for Guardant Health and a list of all abstracts being presented at ASCO (Free ASCO Whitepaper) 2025 can be found on the ASCO (Free ASCO Whitepaper) website.

For information and updates from the conference, follow Guardant Health on LinkedIn, X (Twitter) and Facebook or visit ASCO (Free ASCO Whitepaper) booth #25077.

Guardant Health and collaborator presentations at ASCO (Free ASCO Whitepaper)

Abstract/Poster

Title (Hall A unless otherwise noted)

Product

Friday, May 30, 2:45 pm – 5:45 pm CT (Arie Crown Theater, Live Stream)

3504

Oral Abstract Session: Tissue-free circulating tumor DNA assay and patient outcome in a phase III trial of FOLFOX-based adjuvant chemotherapy (Alliance N0147)

Guardant Reveal

Saturday, May 31, 9:00 am – 12:00 pm CT

3584/253

Analytic and clinical validation of a negative prediction algorithm for actionable mutations utilizing genomic and epigenomic profiling in cfDNA

Guardant360 Liquid

4200/490

Circulating tumor DNA-based genomic profiling and real-world outcomes in cancer of unknown primary (CUP)

Guardant360 Liquid

GuardantINFORM

Saturday, May 31, 1:30 pm – 4:30 pm CT

8528/8

Genomic and circulating tumor DNA landscape in young-onset non-small cell lung cancer

Guardant360 Liquid

8642/122

Use of targeted therapy, healthcare costs, and survival with large panel testing, narrow testing, or no molecular testing in patients with metastatic non-small cell lung cancer (mNSCLC)

Guardant360 Liquid

Guardant360 CDx

10550/275

Validation of a plasma cell-free DNA methylation-based multi-cancer detection test

Shield MCD

Sunday, June 1, 2:41 pm – 2:53 pm CT (Plenary Session, Hall B1, Live Stream)

LBA4

Oral Clinical Science Symposium: Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent ESR1 mutations during first-line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): Phase 3, double-blind ctDNA-guided SERENA-6 trial

Guardant360 CDx

Sunday, June 1, 4:30 pm – 6:00 pm CT (Arie Crown Theater, Live Stream)

1012

Oral Clinical Science Symposium: Assessment of ctDNA somatic homologous recombination deficiency (HRD) in triple-negative breast cancer (TNBC) from SWOG S1416 trial

Guardant OMNI

Monday, June 2, 9:00 am – 12:00 pm CT

1052/31

Circulating tumor DNA (ctDNA)-based minimal residual disease (MRD) measured by Guardant Reveal in patients (pts) with HER2-positive (HER2+) metastatic breast cancer (mBC) with long-term disease control on first-line trastuzumab-pertuzumab

Guardant Reveal

1075/54

Use of baseline plasma circulating tumor DNA (ctDNA) to predict duration of endocrine therapy (ET) and CDK4/6 inhibitor (CDK4/6i) therapy (tx) and to analyze intrinsic vs acquired endocrine resistance

Guardant360 Liquid

5052/251

Evaluating the prognostic utility of cell-free (cf)DNA tumor fraction (TF) in metastatic castration-resistant prostate cancer (mCRPC)

Guardant360 Liquid

5053/252

Real world outcomes for patients with metastatic castration resistant prostate cancer (mCRPC) and AR T878A alterations treated with enzalutamide

GuardantINFORM

5077/276

Real-world prevalence of homologous recombination repair alterations (HRRa) and poly (ADP-ribose) polymerase inhibitor (PARPi) use/outcomes in patients (pts) with metastatic prostate cancer (mPC) by race and ethnicity

GuardantINFORM

5086/285

Association between epigenomic biomarkers and baseline clinical characteristics in patients with mCRPC treated with rucaparib in TRITON2

Guardant Infinity

Monday, June 2, 1:30 pm – 4:30 pm CT

3073/388

Application of an epigenomic-based classifier to identify cancer signal of origin on liquid biopsy in cancer of unknown primary cases

Guardant360 Liquid

3074/389

HRD status prediction in patients with advanced breast, prostate, ovarian and pancreatic cancers in a liquid biopsy assay

Guardant360 Liquid

Tuesday, June 3, 8:30 am CT

5512

Oral Abstract Session: Durvalumab plus carboplatin/paclitaxel followed by durvalumab with or without olaparib as first-line treatment for endometrial cancer: Longitudinal changes in circulating tumor DNA

Guardant Infinity

Online Abstracts

e20536

Accelerating treatment decisions with liquid biopsy NGS in non-small cell lung cancer

Guardant360 Liquid

e13084

Targeted agents for the treatment of hormone receptor–-positive, human epidermal growth factor receptor 2–negative metastatic breast cancer (HR+/HER2- MBC) with co-alterations in ESR1 and AKT pathway: A retrospective analysis

Guardant360 Liquid