On May 22, 2025 MiraDx, a molecular diagnostics company advancing germline-based personalization of cancer treatment, reported two studies will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 30 to June 3 in Chicago, IL (Press release, UCLA Technology Development Group, MAY 22, 2025, View Source [SID1234653347]). The studies, run in partnership with UCLA, highlight MiraDx’s platform as a predictive tool for treatment toxicity and response to modern cancer immunotherapies.

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"Toxicity from cancer therapies remains one of the most difficult challenges patients face, disrupting treatment, diminishing quality of life, and creating uncertainty at every step," said Joanne Weidhaas, MD, PhD, professor of radiation oncology and vice chair of molecular and cellular oncology at the David Geffen School of Medicine at UCLA and co-founder of MiraDx. "As cancer therapies become more targeted and complex, we need predictive tools based on personal patient genetics that identify who is at increased risk for treatment-related adverse events and toxicities. This same class of genetics can also indicate how they will respond to therapy. Research to be presented at ASCO (Free ASCO Whitepaper) 2025 in radiation treatment for soft tissue sarcoma and anti-PD1 therapies further demonstrate the robust accuracy of mirSNPs to give patient specific information that could guide treatment decisions that balance efficacy with long-term quality of life."

Poster Presentation #21 (Abstract #11538): Personalized Radiation Strategies in Soft Tissue Sarcoma

Title: MicroRNA-based Biomarkers of Outcome in Soft Tissue Sarcoma Treated with Hypofractionated Preoperative Radiation Therapy
Poster Session: Sarcoma
Date/Time: May 31, 9:00 AM CDT
Location: Hall A—Posters and Exhibits

Overview: Response to radiation in soft tissue sarcoma (STS) is highly variable, complicating treatment optimization. Building on prior research, this study analyzes a larger cohort treated with preoperative hypofractionated radiation therapy (SBRT) to assess the predictive value of germline mirSNPs (microRNA SNPs) for certain treatment-related outcomes. Preliminary genetic signatures were found to predict major wound toxicity, late toxicity, distant metastases, and pathological response, which points to the potential for mirSNPs to guide more personalized treatment strategies and decision-making regarding treatment regimens.

Poster Presentation #308 (Abstract #2661): Predicting Immune-Related Toxicity from Anti-PD1 Therapy

Title: MicroRNA-based Signatures of Early and Late Immune-Related Adverse Events to anti-PD1 Treatment
Poster Session: Developmental Therapeutics—Immunology
Date/Time: June 2, 1:30 PM CDT
Location: Hall A—Posters and Exhibits

Overview: As immune checkpoint inhibitors (ICIs) continue to reshape cancer treatment, predicting immune-related adverse events (irAEs) presents ongoing challenges. This study builds on earlier work by analyzing an expanded cohort, uncovering key genetic differences associated with cycle-specific toxicities in patients treated with anti-PD1 as well as treatment response. Enhanced models for early and late irAEs demonstrate strong predictive risk, confirming the potential of microRNA-based signatures to be applied to improve the safety of ICIs.

Meet the Investigator

Dr. Joanne Weidhaas, co-founder of MiraDx and professor at the David Geffen School of Medicine and head of translational research in the Department of Radiation Oncology at UCLA, will present both posters and discuss implications for personalized cancer therapy.

On May 22, 2025 Daiichi Sankyo (TSE: 4568) reported it will present new clinical research across its oncology portfolio with more than 20 abstracts in multiple cancers at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Scientific Program (#ASCO25) (Press release, Daiichi Sankyo, MAY 22, 2025, https://www.businesswire.com/news/home/20250522174780/en/Daiichi-Sankyo-Continues-to-Transform-Treatment-Landscape-for-Patients-with-Cancer-with-Practice-Changing-Data-at-ASCO [SID1234653346]).

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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

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Data at ASCO (Free ASCO Whitepaper) showcasing the company’s progress towards creating new standards of care for patients with cancer will include two late-breaking oral presentations. The first will feature results of the DESTINY-Breast09 phase 3 trial (LBA #1008) where ENHERTU (trastuzumab deruxtecan) in combination with pertuzumab demonstrated superior progression-free survival compared to taxane, trastuzumab and pertuzumab (THP) as a first-line treatment in patients with HER2 positive metastatic breast cancer. The second will highlight results of the DESTINY-Gastric04 phase 3 trial (LBA #4002) where ENHERTU demonstrated superior overall survival compared to ramucirumab and paclitaxel as a second-line treatment in patients with HER2 positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Data from DESTINY-Breast09 and DESTINY-Gastric04 will be featured in ASCO (Free ASCO Whitepaper) press briefings.

"This year’s ASCO (Free ASCO Whitepaper) marks the fourth in a row where potential practice-changing ENHERTU data will be showcased," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "With the results of DESTINY-Breast09 and DESTINY-Gastric04, we now have six breast and two gastric cancer randomized trials that have demonstrated significant survival improvements with ENHERTU. These data, along with other updates across our industry-leading oncology portfolio, underscore our commitment to pushing the boundaries of science to create new medicines or combination strategies that improve outcomes for patients with cancer."

Other ENHERTU data at ASCO (Free ASCO Whitepaper) will include an oral presentation featuring an exploratory circulating tumor DNA analysis of the DESTINY-Breast06 phase 3 trial (#1013) evaluating ENHERTU compared to physician’s choice of chemotherapy in hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) metastatic breast cancer. Updated results from the PRO-DUCE study (#1545) examining vital sign monitoring compared to usual care in patients with metastatic breast cancer receiving ENHERTU also will be highlighted as a poster presentation.

A trials-in-progress poster presentation will feature the DESTINY-Gastric05 phase 3 trial (TPS4207) evaluating ENHERTU in combination with a fluoropyrimidine-based chemotherapy and pembrolizumab compared to trastuzumab in combination with platinum-based chemotherapy and pembrolizumab in previously untreated patients with unresectable, locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or GEJ cancer.

Progress in Lung Cancer Across Daiichi Sankyo’s DXd ADC Portfolio
Updated DATROWAY (datopotamab deruxtecan) combination data across three early-phase trials will be highlighted in patients with early or advanced non-small cell lung cancer (NSCLC).

Updated results from the TROPION-Lung02 phase 1b trial (#8501) evaluating DATROWAY plus pembrolizumab with or without platinum-based chemotherapy in patients with previously untreated advanced NSCLC without actionable genomic alterations will be featured as an oral presentation. This will include results from an exploratory analysis using quantitative continuous scoring (QCS), AstraZeneca’s proprietary computational pathology platform.

Poster sessions will highlight the first presentation of data of DATROWAY and rilvegostomig, AstraZeneca’s PD-1/TIGIT bispecific antibody, from the TROPION-Lung04 phase 1b trial (#8521) cohort evaluating the combination in patients without actionable genomic alterations who have advanced or metastatic NSCLC, and the final pathologic complete response and major pathologic response data from the NeoCOAST-2 phase 2 trial (#8046) evaluating DATROWAY with durvalumab, AstraZeneca’s anti-PD-L1 therapy, and chemotherapy as neoadjuvant treatment followed by adjuvant treatment with durvalumab in patients with resectable early-stage (IIA to IIIB) NSCLC.

Additional lung cancer data at ASCO (Free ASCO Whitepaper) will include an oral presentation of the HERTHENA-Lung02 phase 3 trial (#8506) of patritumab deruxtecan (HER3-DXd) versus platinum doublet chemotherapy in patients with locally advanced or metastatic EGFR-mutated NSCLC with disease progression following the use of an EGFR tyrosine kinase inhibitor (TKI).

Trials-in-progress poster presentations in lung cancer across the DXd ADC portfolio will include the TROPION-Lung14 phase 3 trial (TPS8647) evaluating DATROWAY combined with osimertinib, AstraZeneca’s EGFR TKI, compared to osimertinib alone in the first-line setting of patients with locally advanced or metastatic EGFR-mutated NSCLC and a substudy of KEYMAKER-U01, a phase 1/2 trial (TPS8652), evaluating pembrolizumab plus ifinatamab deruxtecan (I-DXd) or patritumab deruxtecan with or without chemotherapy in patients with untreated advanced NSCLC.

Additional Data and Trials-in-Progress Across Daiichi Sankyo’s Oncology Portfolio at ASCO (Free ASCO Whitepaper)
Oral presentations also will highlight initial results from the TUXEDO-3 phase 2 trial (#2005) evaluating patritumab deruxtecan in patients with metastatic breast cancer or advanced NSCLC and active brain metastases and in patients with leptomeningeal carcinomatosis/disease from advanced solid tumors, as well as results from a phase 1 trial (#10003) evaluating valemetostat, a dual EZH1 and EZH2 inhibitor, in pediatric patients with malignant solid tumors.

Additional DXd ADC trials-in-progress poster presentations include the REJOICE-PanTumor01 phase 2 trial (TPS3158) evaluating raludotatug deruxtecan (R-DXd) in patients with locally advanced or metastatic gynecologic or genitourinary cancers, IDeate-PanTumor02 phase 1b/2 trial (TPS3157) evaluating ifinatamab deruxtecan in patients with recurrent or metastatic solid tumors and a substudy of KEYMAKER-U06, a phase 1/2 trial (TPS4209) evaluating ifinatamab deruxtecan in combination with pembrolizumab with or without chemotherapy in patients with advanced esophageal squamous cell carcinoma. Other trials-in-progress posters include the QuANTUM-Wild phase 3 trial (TPS6580) evaluating VANFLYTA (quizartinib) in combination with chemotherapy in patients with FLT3-ITD negative acute myeloid leukemia and a first-in-human phase 1 trial of DS-2243 (TPS2668), a potential first-in-class bispecific T-cell engager targeting HLA-A*02/NY-ESO in patients with advanced solid tumors.

Daiichi Sankyo will hold a virtual conference call for investors on Monday, June 2, 2025 from 6:00 to 7:15 pm CDT / Tuesday, June 3, 2025 from 8:00 to 9:15 am JST. Executives from Daiichi Sankyo will provide an overview of the ASCO (Free ASCO Whitepaper) research data and address questions.

Details of the two late-breaking ENHERTU oral presentations at ASCO (Free ASCO Whitepaper) 2025 include:

Presentation Title

Author

Abstract

Presentation (CDT)

LBAs

Trastuzumab deruxtecan (T-DXd) + pertuzumab vs taxane + trastuzumab + pertuzumab (THP) for first-line treatment of patients with human epidermal growth factor receptor 2 positive (HER2+) advanced/metastatic breast cancer: interim results from DESTINY-Breast09

S. Tolaney

LBA1008

Special LBA Session

Oral Presentation

Monday, June 2

7:30 – 8:00 am

Trastuzumab deruxtecan (T-DXd) vs ramucirumab plus paclitaxel in second-line treatment of patients with human epidermal growth factor receptor 2 positive (HER2+) unresectable/metastatic gastric cancer or gastroesophageal junction adenocarcinoma: primary analysis of the randomized, phase 3 DESTINY-Gastric04 study

K. Shitara

LBA4002

Oral Presentation

Saturday, May 31

3:00 – 6:00 pm

Highlights of additional clinical data and trials-in-progress from Daiichi Sankyo’s oncology pipeline include:

Presentation Title

Author

Abstract

Presentation (CDT)

Breast

Exploratory biomarker analysis of trastuzumab deruxtecan (T-DXd) vs physician’s choice of chemotherapy in HER2 low/ultralow, hormone receptor-positive (HR+) metastatic breast cancer in DESTINY-Breast06

R. Dent

1013

Oral Presentation​

Saturday, May 31​

1:15 – 4:15 pm

HERTHENA-Breast03: a phase 2, randomized, open-label study evaluating neoadjuvant patritumab deruxtecan + pembrolizumab before or after pembrolizumab + chemotherapy for early-stage TNBC or HR-low+/HER2- breast cancer

J.

O’Shaughnessy

TPS629

Poster Session

Monday, June 2

9:00 am – 12:00 pm

Electronic patient-reported outcomes with vital sign monitoring versus usual care during trastuzumab deruxtecan treatment for metastatic breast cancer: updated results from the PRO-DUCE study

Y. Kikawa

1545

Poster Session

Sunday, June 1

9:00 am – 12:00 pm

Lung

TROPION-Lung02: datopotamab deruxtecan (Dato-DXd) plus pembrolizumab with or without platinum chemotherapy as first-line therapy for advanced non-small cell lung cancer

B. Levy

8501

Oral Presentation

Sunday, June 1

8:00 – 11:00 am

Patritumab deruxtecan (HER3-DXd) in resistant EGFR-mutated advanced non-small cell lung cancer after a third-generation EGFR TKI: the phase 3 HERTHENA-Lung02 study

T. Mok

8506

Oral Presentation

Sunday, June 1

8:00 – 11:00 am

First-line datopotamab deruxtecan (Dato-DXd) + rilvegostomig in advanced or metastatic non-small cell lung cancer: results from TROPION-Lung04 (cohort 5)

S. Waqar

8521

Poster Session

Saturday, May 31

1:30 – 4:30 pm

TROPION-Lung14: a phase 3 study of osimertinib ± datopotamab deruxtecan (Dato-DXd) as first-line treatment for patients with EGFR-mutated locally advanced or metastatic non-small cell lung cancer

S. Lu

TPS8647

Poster Session

Saturday, May 31

1:30 – 4:30 pm

Neoadjuvant durvalumab + chemotherapy + novel anticancer agents and adjuvant durvalumab ± novel agents in resectable non-small cell lung cancer: updated outcomes from NeoCOAST-2

T. Cascone

8046

Poster Session

Saturday, May 31

1:30 – 4:30 pm

KEYMAKER-U01 substudy 01A: phase 1/2 study of pembrolizumab plus ifinatamab deruxtecan (I-DXd) or patritumab deruxtecan (HER3-DXd) with or without chemotherapy in untreated stage IV non-small cell lung cancer

C. Aggarwal

TPS8652

Poster Session

Saturday, May 31 1:30 – 4:30 pm

Gastric

An open-label, randomized, multicenter, phase 3 study of trastuzumab deruxtecan (T-DXd) + chemotherapy ± pembrolizumab versus chemo + trastuzumab ± pembro in first-line metastatic HER2+ gastric or gastroesophageal junction cancer: DESTINY-Gastric05

K. Shitara

TPS4207

Poster Session

Saturday, May 31

9:00 am – 12:00 pm

Esophageal

KEYMAKER-U06 substudy 06E: phase 1/2 open-label, umbrella platform study of ifinatamab deruxtecan in combination with pembrolizumab with or without chemotherapy for first-line treatment of advanced esophageal squamous cell carcinoma

K. Kato

TPS4209

Poster Session

Saturday, May 31

9:00 am – 12:00 pm

AML

QuANTUM-Wild: a phase 3, randomized, double-blind, placebo-controlled trial of quizartinib in combination with chemotherapy and as single-agent maintenance in FLT3-ITD negative acute myeloid leukemia

P. Montesinos

TPS6580

Poster Session

Sunday, June 1

9:00 am – 12:00 pm

Pan-Tumor

Patritumab deruxtecan (HER3-DXd) in active brain metastases from metastatic breast and non-small cell lung cancers, and leptomeningeal disease from advanced solid tumors: results from the TUXEDO-3 phase 2 trial

M. Preusser

2005

Oral Presentation

Friday, May 30

2:45 – 5:45 pm

IDeate-PanTumor02: a phase 1b/2 study to evaluate the efficacy and safety of ifinatamab deruxtecan (I-DXd) in patients with recurrent or metastatic solid tumors

T. Kogawa

TPS3157

Poster Session

Monday, June 2

1:30 – 4:30 pm

REJOICE- PanTumor01: a phase 2 signal-seeking study of raludotatug deruxtecan (R-DXd) in patients with advanced or metastatic gynecologic or genitourinary tumors

L. Albiges

TPS3158

Poster Session

Monday, June 2

1:30 – 4:30 pm

A phase 1, first-in-human study of DS-2243, an HLA-A*02/NY-ESO directed bispecific T‑cell engager, in patients with advanced solid tumors

S. D’Angelo

TPS2668

Poster Session

Monday, June 2

1:30 – 4:30 pm

Pediatric

Safety and efficacy of the EZH1/2 inhibitor valemetostat tosylate (DS-3201b) in pediatric patients with malignant solid tumors (NCCH1904): a multicenter phase 1 trial

A. Arakawa

10003

Oral Presentation

Saturday, May 31

3:00 – 6:00 pm

On May 22, 2025 Foundation Medicine, Inc., a genomic company committed to transforming cancer care, reported that the company and its collaborators will present more than 15 abstracts demonstrating the value of high-quality biomarker tests to inform cancer care at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 30 to June 3 in Chicago (Press release, Foundation Medicine, MAY 22, 2025, View Source [SID1234653345]).

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!

Foundation Medicine’s research presented at the meeting will include new insights across breast cancer, lung cancer and prostate cancer, including an oral presentation highlighting the findings from the COMRADE phase 2 clinical trial in castration resistant prostate cancer, which leveraged the research use version of FoundationOneMonitor, the company’s tissue-free treatment response monitoring assay, for serial ctDNA analysis. (Abstract 5007, Tuesday, June 3, at 11:57 am – 12:09 pm CT, Hall D1)

"In partnership with over 30 clinical collaborators, Foundation Medicine’s new research at the ASCO (Free ASCO Whitepaper) Annual Meeting further reinforces the important role high-quality biomarker testing plays in delivering personalized cancer care," said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. "From exploring the role of innovative and complex biomarkers to expanding the clinical utility of genomic profiling, we are excited to demonstrate how our testing portfolio, including our new treatment response monitoring assay, can help providers make more informed treatment decisions for their patients."

To access the abstracts being presented at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, please visit ASCO (Free ASCO Whitepaper).org/abstracts.

Follow Foundation Medicine on LinkedIn, X and Instagram for more updates from #ASCO25 and visit us in person at booth #27021.

Complete list of Foundation Medicine’s abstracts at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting

Abstract Number

Title

Product

Saturday, May 31

3570

Comparison of MET genomic alterations (GA) identified in colorectal cancer (CRC) vs gastric cancer (GCA)

FoundationOneCDx

4153

Pancreatic adenosquamous carcinoma (PASC): A comparative genomic landscape study

FoundationOneCDx

4183

BRCA1/2 and PALB2 short variants (SVs) contributed by clonal hematopoiesis (CH) in liquid biopsies (LBx) from patients with advanced pancreatic cancer (PC)

FoundationOneCDx / FoundationOneLiquid CDx

8036

Tumor type prediction via tissue- and liquid-based comprehensive genomic profiling: High-specificity tobacco signature detection to support lung cancer diagnosis

FoundationOneCDx / FoundationOneLiquid CDx

8039

Clinical utility of pathologist-directed comprehensive comparative molecular profiling for the classification of separate primary lung cancers vs. intrapulmonary metastasis

FoundationOneCDx

8628

Association of circulating tumor DNA (ctDNA) variant allelic frequency (VAF) with outcomes on matched targeted therapies (TT) in advanced non-small cell lung cancer (aNSCLC)

FoundationOneLiquid CDx

11161

Real-world analysis of factors influencing turnaround time (TAT) for tissue comprehensive genomic profiling (CGP) in non-small cell lung cancer (NSCLC)

FoundationOneCDx

Sunday, June 1

5592

Distinguishing tumor vs. clonal hematopoiesis (CH)–derived TP53 and BRCA1/2 alterations in ovarian cancer liquid biopsies with a predictive algorithm to inform clinical decision-making

FoundationOneCDx / FoundationOneLiquid CDx

6528

Nucleophosmin (NPM1) genomic alterations (GA) in acute myeloid leukemia (AML): A genomic landscape study

FoundationOneHeme

9520

Homologous recombination deficiency signature (HRDsig) in advanced cutaneous melanoma (ACM): A genomic landscape study

FoundationOneCDx

Monday, June 2

1043

TP53 genomic alterations including targetable TP53 Y220C mutation in clinically advanced breast cancer

FoundationOneCDx

1048

Genomic alterations (GAs) associated with durability of benefit from trastuzumab deruxtecan (T-DXd), trastuzumab emtansine (T-DM1) and sacituzumab govitecan (SG) in metastatic breast cancer (MBC)

FoundationOneCDx / FoundationOneLiquid CDx

1065

Quantifying the clinical impact of tissue reflex testing for liquid biopsy ESR1 mutation-negative cases with low ctDNA tumor fraction (TF) in HR(+)HER2(-) breast cancer

FoundationOneCDx / FoundationOneLiquid CDx

3081

Genomic landscape of 5’methylthioadenosine phosphorylase (MTAP) deleted (MTAP loss) non-squamous carcinoma of unknown primary site (nsCUP)

FoundationOneCDx

5064

Additive clinical utility of tissue biomarkers of microsatellite instability (MSI) status and tumor mutational burden (TMB) to predict immune checkpoint inhibitor (ICI) effectiveness for real-world patients with metastatic castration-resistant prostate cancer (mCRPC)

FoundationOneCDx

4564

Fibroblast growth factor receptor 3 (FGFR3) alteration status and outcomes with immune checkpoint inhibitors (ICPI) in patients with metastatic urothelial carcinoma

FoundationOneCDx

Tuesday, June 3

5007

A multicenter, randomized, phase 2, investigator-initiated ETCTN trial of olaparib + radium-223 vs. radium-223 in men with castration-resistant prostate cancer (CRPC) with bone metastases (BM) (COMRADE): Initial efficacy and biomarker analysis

Research use version of FoundationOneMonitor*

On May 22, 2025 Hologic, Inc. (Nasdaq: HOLX) and its subsidiary, Biotheranostics, Inc., reported new data demonstrating the significant clinical impact of the Breast Cancer Index (BCI) test, which will be presented at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 2, 2025 (Press release, Hologic, MAY 22, 2025, View Source [SID1234653344]).

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!

"These data highlight the critical role the Breast Cancer Index test plays in guiding extended endocrine therapy decisions for women with early-stage, hormone receptor-positive (HR+) breast cancer," said Jennifer Schneiders, PhD, President of Diagnostic Solutions at Hologic. "As the only genomic test recognized by clinical practice guidelines to inform such decisions, the BCI test is a powerful tool in personalized care. These findings reinforce our commitment to delivering clinically validated diagnostics that support treatment decisions based on each patient’s unique tumor biology."

During the meeting, Hologic will share the latest analysis of the prospective, multi-center BCI Registry Study, which evaluated how the BCI test influences clinical decision-making for extended endocrine therapy in patients with early-stage, HR+ breast cancer. Building on initial published data, this assessment reflects an even more comprehensive analysis of more than 2,800 patients. The latest data showed BCI testing led to a change in treatment recommendations for about 4 in 10 cases. Importantly, physician confidence in treatment recommendations also increased and patients reported feeling more comfortable with their treatment decisions, citing fewer concerns about cost, drug safety and preference related to extended endocrine therapy benefit.1

"Incorporating the Breast Cancer Index test into the conversation about extended endocrine therapy helps doctors and patients make decisions with more confidence and comfort," said Tara Sanft, MD, Associate Professor of Medicine at Yale School of Medicine and primary investigator of the new study. "As oncologists, we often look at clinical and pathologic factors to assess our patients’ risk of recurrence, but these factors are not enough to tell us whether longer treatment is likely to reduce that risk and may lead to misguided recommendations. Genomic testing with the BCI test allows us to determine which women are likely to derive benefit from extended endocrine therapy to make more informed, shared decisions with our patients."

The data presentations at ASCO (Free ASCO Whitepaper) 2025 focusing on the BCI test include:

Prospective Decision Impact Study of the Breast Cancer Index: Results from the BCI
Registry Study (Abstract #531/Poster Board #124)
Monday, June 2, 9 a.m.-12 p.m. CT; Breast Cancer — Local/Regional/Adjuvant Poster Session, Hall A
The expanded assessment of the BCI Registry Study found that incorporating the BCI test into clinical practice significantly influenced extended endocrine therapy decisions for early-stage, HR+ breast cancer patients.1
Assessment of Ovarian Function Suppression (OFS)-Containing Adjuvant
Endocrine Therapy in Premenopausal Women by Breast Cancer Index (Abstract #557/Poster Board #150)
Monday, June 2, 9 a.m.-12 p.m. CT; Breast Cancer — Local/Regional/Adjuvant Poster Session, Hall A
These translational data from the landmark Tamoxifen and Exemestane Trial (TEXT) trial further validate the ability of the BCI test to assess risk of overall and late distant recurrence in premenopausal women with early-stage, HR+ breast cancer.2*
About the Breast Cancer Index Test

The Breast Cancer Index test is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer. This breakthrough test helps oncology care teams and patients navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment. The Breast Cancer Index test has guideline designation from the American Joint Committee on Cancer for cancer staging based on molecular profile. The ASCO (Free ASCO Whitepaper) Clinical Practice Guideline and the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) acknowledge the Breast Cancer Index test as a biomarker to help inform extended endocrine treatment decisions.3,4 It is the only test recognized by guidelines to predict the likelihood of benefit from extended endocrine therapy.3,4

The Breast Cancer Index test is intended for routine clinical use, and physician treatment decisions based on results are the responsibility of the physician. It is a laboratory-developed test (LDT) performed in a single CLIA-certified and CAP-accredited diagnostic laboratory. For more information, visit www.breastcancerindex.com.

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