TEST:

GuardantINFINITY™

The ADC ABBV-400 comprises the c-Met–targeting antibody telisotuzumab conjugated to a potent topoisomerase 1 inhibitor payload. ABBV-400 showed promising preliminary efficacy, with molecular and radiographic responses in pts with advanced solid tumors with heterogeneous genomic profiles, including pts with high TMB and KRAS mutations.

T‑DXd outperformed T‑DM1 regardless of HRD+/- or BRCA1/2 alt status, although HRD+ status and BRCA1/2 alt were poor prognosticators for PFS in both arms. Mutational analysis at DP will be presented.

"Guardant Health, Inc...announced the company and its research collaborators will present data from several studies utilizing Guardant technology to advance precision oncology at the European Society for Medical Oncology Congress (ESMO) in Barcelona, Spain, Sept. 13-17, 2024."

"Guardant Health...will present data from 16 studies highlighting the role of Guardant blood tests and real-world data in advancing precision oncology and cancer screening at the 2024 American Society for Clinical Oncology (ASCO) Annual Meeting, May 31-June 4 in Chicago...Featured presentations will share data supporting the utility of therapy response monitoring with circulating tumor DNA (ctDNA) using Guardant Infinity and the use of the GuardantINFORM clinical-genomic database to characterize drivers and resistance mechanisms and their association with real-world outcomes in a variety of solid tumor types. Additional studies will present data supporting the application of genomic and epigenomic biomarkers in areas such as minimal residual disease detection and cohort characterization."

"Guardant Health, Inc...announced it will present data from nine studies highlighting advances in methylation-based epigenomic analysis for precision oncology at the 2024 American Association for Cancer Research (AACR) Annual Meeting, April 5-10 in San Diego. Multiple poster sessions will report on the utility of using the Guardant Infinity platform across the continuum of cancer care, ranging from predictive histologic subtyping of tumors to cardiac adverse event prediction. Data will also be presented demonstrating strong performance of Guardant Reveal for minimal residual disease (MRD) detection in breast cancer, allowing quantification of ctDNA even in early-stage disease without the need for a tissue specimen."

CDK4/6i received included 42/57 (73%) palbociclib, 14/57 (25%) ribociclib and 1/57 (2%) abemaciclib; 40/57 (70%) were in combination with an aromatase inhibitor and 17/57 (30%) with fulvestrant. Baseline methylation TF and ctDNA clearance as measured by GuardantINFINITY were prognostic in this cohort. Longitudinal sampling permitted genomic characterization and detection of alterations conferring acquired-resistance prior to clinical progression. Clinical correlates of ctDNA detection, clearance, and further serial genomic analyses will be presented.

No abstracts available

The antibody-drug conjugate ABBV-400 comprises the c-Met–targeting antibody telisotuzumab conjugated to a potent topoisomerase 1 inhibitor payload. A molecular response was observed in 48% (14/29) of all evaluated pts and 47% (8/17) of pts with CRC; median change from baseline tumor size was -22.5% and -20.3%, respectively. Table: 163P Pts with molecular response and correlation between baseline biomarker status and radiographic response Conclusions ABBV-400 showed promising preliminary efficacy, with molecular and radiographic responses in pts with advanced solid tumors with heterogeneous genomic profiles, including in pts with high TMB and KRAS mutations.

"Guardant Health, Inc...announced today that the company and its research collaborators will present data from 17 studies that highlight the contribution of Guardant blood tests and real-world data to advances in precision oncology and cancer screening at the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting, June 2-6 in Chicago....Guardant Health will present a session highlighting the performance of the Guardant Infinity platform in the detection of homologous recombination deficiency (HRD) status in patients with breast cancer....Guardant Health collaborators will present a session on the ESR1 mutational landscape and the impact of co-existing resistance variants on clinical outcomes in patients with metastatic breast cancer."

In this analysis, we demonstrate that a probabilistic model of genomic and methylation predictors can detect HRD status in patients with breast cancer from cfDNA using GuardantINFINITY. Additional analytical and clinical studies to further evaluate this model are ongoing. With HRD prediction, GuardantINFINITY provides a comprehensive minimally-invasive solution for PARPi and DNA damage treatment selection, longitudinal monitoring, and an exploratory platform for investigating epigenetic signals that may underpin resistance.

"Guardant Health, Inc...and the Parker Institute for Cancer Immunotherapy...announced a research collaboration agreement to study the correlation between molecular cancer biomarkers and patient response to immunotherapy treatment across more than 14 different types of cancer. Under the agreement, Guardant Health will analyze patient blood samples from PICI’s RADIOHEAD (Resistance Drivers for Immuno-Oncology Patients Interrogated by Harmonized Molecular Datasets) prospective study of 1,200 individuals on standard-of-care immune checkpoint inhibitor (ICI) treatment regimens in community hospitals....Guardant Health and PICI intend to begin publishing data generated by the study later in 2023."

"Guardant Health, Inc...announced today that it will present data from 14 studies highlighting advances in precision oncology and cancer screening at the 2023 American Association for Cancer Research (AACR) Annual Meeting, April 14-19 in Orlando, Florida....In particular, studies show that: Methylome sequencing with a liquid-only approach using the GuardantINFINITY platform can quantify circulating tumor DNA level and change with greater sensitivity and precision than genomic sequencing, making longitudinal ctDNA monitoring accessible to a broader range of patients....The analytical validation of the GuardantINFINITY genomic and epigenomic liquid biopsy platform showed its potential for ultra-sensitive ctDNA detection for minimal residual disease and recurrence surveillance, tumor fraction quantitation for therapy monitoring, oncogenic virus detection, immunogenotyping, epigenotyping, and tumor phenotype characterization, representing a new standard in biomarker discovery."

GuardantINFINITY is a patient-care-ready liquid biopsy capable of integrated genomic and epigenomic analysis of all solid tumors at single-molecule sensitivity. In addition to traditional genotyping compatible with Guardant360 for more content, the technology’s demonstrated LoD showed the potential for ultra-sensitive ctDNA detection for MRD and recurrence surveillance, tumor fraction quantitation for therapy monitoring, oncogenic virus detection, immunogenotyping, epigenotyping, and tumor phenotype characterization, representing a new standard in biomarker discovery.

GuardantINFINITY, a plasma-based diagnostic assay, detected both BRCA1 PM and genomic alterations in this unspecified advanced breast cancer cohort. The BRCA1 PMdetection rates of 4.0-8.9% are consistent with values previously reported in the literature. As BRCA1 PM has important prognostic and therapeutic implications for the management of breast (as well as ovarian) cancers, additional studies are warranted to further describe the PM patterns across breast cancer subtypes and how these patterns both influence and are influenced by disease evolution and therapeutic response.

The integration of Kmerizer into GuardantINFINITY enables accurate HLA germline and somatic detection along with neoantigen prediction, offering an enhanced and comprehensive biomarker profiling for ICI outcome prediction.

Methylome sequencing using GuardantINFINITY enables accurate and precise quantification of ctDNA level and change with a liquid-only approach, offering longitudinal ctDNA monitoring for more patients than previous methods.

"Guardant Health, Inc...announced...the introduction of GuardantINFINITY™, a next-generation liquid biopsy that provides new, multi-dimensional insights into the complexities of tumor molecular profiles and immune response to advance cancer research and therapy development."