On May 20, 2021 Foundation Medicine, Inc. reported that the company and its collaborators will present a total of 29 studies, including two clinical science symposia presentations and two poster discussions, at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program (ASCO21) from June 4-8 (Press release, Foundation Medicine, MAY 20, 2021, View Source [SID1234580387]). Among the presentations are data reinforcing the role of comprehensive genomic profiling (CGP) in increasing equitable patient access to precision medicine tools, as well as studies highlighting the clinical utility of CGP and the power of real-world data to inform treatment decisions and better understand disparities in care.
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Highlights of these presentations include:
new data emphasizing how the lack of early CGP testing and clinical trial enrollment in patients of African ancestry may help explain disparities in prostate cancer;
clinical data reinforcing the value of tissue- and liquid-based CGP as tools for oncologists to identify predictive biomarkers and enable precision medicine; and
additional evidence of the power of real-world data from Foundation Medicine and Flatiron Health’s joint clinico-genomic database (CGDB) to inform treatment decisions.
"At our core, Foundation Medicine is focused on using the highest quality insights to transform cancer care for everyone, and the breadth of data we’re presenting at ASCO (Free ASCO Whitepaper) in collaboration with our research and industry partners reflects that commitment," said Brian Alexander, M.D., M.P.H., CEO at Foundation Medicine. "The data we’ll share with the oncology community will help us continue moving the needle on changing clinical care by showing the clinical value of CGP across the spectrum of cancers, as well as highlighting the need to consistently and equitably improve access to genomic testing so that every person facing a cancer diagnosis has the insights needed to inform the best possible care."
Understanding Genomic Ancestry and CGP Utilization in Men with Prostate Cancer
In a study conducted in collaboration with Sylvester Comprehensive Cancer Center at the University of Miami, researchers investigated the genomic landscape and therapeutic implications of CGP in prostate cancer across men of European and African ancestry. Researchers believe this is the largest known cohort of its kind that describes CGP utilization, the genomic landscape from CGP, and treatment patterns in prostate cancer across ancestry groups. The analysis revealed men of African ancestry were less likely to receive CGP earlier in their treatment course and less likely to be treated in clinical trials. The findings potentially advance the field’s understanding of ancestry-based disparities in prostate cancer.
[Ancestral characterization of the genomic landscape, comprehensive genomic profiling utilization, and treatment patterns may inform disparities in advanced prostate cancer: A large-scale analysis. Abstract #5003.]
Clinical Utility of Comprehensive Genomic Profiling
In a study exploring the genomic and immunologic profile of intrahepatic cholangiocarcinoma (IHCC) with IDH1/2 genetic alterations in partnership with The University of Texas MD Anderson Cancer Center and others, researchers found significant differences in alterations between IDH1+/IDH2+ IHCC and IDH wild-type IHCC. The data suggest these alterations are IHCC driver oncogenes and support investigation of IDH inhibitors in these patients.
[IDH1 and IDH2 driven intrahepatic cholangiocarcinoma (IHCC): A comprehensive genomic and immune profiling study. Abstract #4009]
In a real-world clinical outcomes study of alpelisib in patients with PIK3CA-mutated breast cancer conducted in partnership with UCSF Helen Diller Family Comprehensive Cancer Center, researchers validated the effectiveness of alpelisib in a diverse, real-world population. Results showed these patients had longer progression-free survival with alpelisib plus fulvestrant than with fulvestrant alone. The study also showed liquid biopsy CGP detected PIK3CA mutations at a similar rate to tissue biopsy, reinforcing the clinical utility of both testing types depending on the patient’s unique situation.
[Real world (rw) clinical outcomes on alpelisib (ALP) in patients (pts) with breast cancer (BC) and PIK3CA mutations (PIK3CAm). Abstract #1068]
As the cancer community works to expand access to precision medicine trials to more patients, the need for decentralized trials has become increasingly apparent. In the Alpha-T study, a clinical trial sponsored by Roche using Foundation Medicine’s precision enrollment services, researchers at multiple institutions, including UCSD Moores Cancer Center and Vanderbilt University Medical Center, are investigating patients with ALK-positive solid tumors, identified through either liquid or tissue biopsy, being treated with alectinib. Through remote support, patients are participating in the trial from their local care setting, demonstrating the potential of decentralized trials to increase broader and more diverse enrollment in clinical trials.
[Alpha-T: An innovative decentralized (home-based) phase 2 trial of alectinib in ALK-positive (ALK+) solid tumors in a histology-agnostic setting. Abstract #TPS3155]
Power of Real-World Data to Advance Personalized Medicine
Using the CGDB, researchers assessed outcomes for metastatic breast cancer patients with somatic BRCA or other homologous recombination (HR)-pathway mutations treated with a PARP inhibitor. Results suggested these patients had similar benefit from PARP inhibitor treatment compared to patients with germline BRCA mutations, supporting future studies of this targeted treatment approach for these patients.
[Analysis of real-world (RW) data for metastatic breast cancer (mBC) patients (pts) with somatic BRCA1/2 (sBRCA) or other homologous recombination (HR)-pathway gene mutations (muts) treated with PARP inhibitors (PARPi). Abstract #10512]
Leveraging routine CGP testing of metastatic castrate resistant prostate (mCRPC) cancer tissue samples, researchers discovered that patients with biomarkers routinely assessed by CGP, including AR amplification, may help predict which patients are likely to benefit from taxane chemotherapy instead of novel hormonal therapy.
[Using real-world outcomes to evaluate the predictive power of tissue-assessed genomic biomarkers for taxane versus novel hormonal therapy (NHT) outcomes in metastatic castration-resistant prostate cancer (mCRPC). Abstract #5054]
The following is a list of select abstracts that will be presented at the meeting. To access all abstracts being presented by Foundation Medicine and its collaborators, please visit: meetinglibrary.asco.org.
Abstract #
Title
Collaborator
Clinical Science Symposia
5003
Ancestral characterization of the genomic landscape, comprehensive genomic profiling utilization, and treatment patterns may inform disparities in advanced prostate cancer: A large-scale analysis.
University of Michigan Cancer Center, Sylvester Comprehensive Cancer Center, Harvard Medical School
4009
IDH1 and IDH2 Driven Intrahepatic Cholangiocarcinoma (IHCC): A comprehensive genomic and immune profiling study.
MD Anderson
Poster Discussions
10512
Analysis of real-world (RW) data for metastatic breast cancer (mBC) patients (pts) with somatic BRCA1/2 (sBRCA) or other homologous recombination (HR)-pathway gene mutations (muts) treated with PARP inhibitors (PARPi).
Beth Israel Deaconess Medical Center; Dana Farber Cancer Institute, Flatiron
3009
Prevalence of inferred clonal hematopoiesis (CH) detected on comprehensive genomic profiling (CGP) of solid tumor tissue or circulating tumor DNA (ctDNA).
Poster Presentations
5054
Using real-world outcomes to evaluate the predictive power of tissue-assessed genomic biomarkers for taxane versus novel hormonal therapy (NHT) outcomes in metastatic castration-resistant prostate cancer (mCRPC).
MD Anderson
5567
Assessment of predictive biomarker prevalence in molecularly defined adult-type ovarian granulosa cell tumors.
MD Anderson
TPS3143
TCF-001 TRACK (Target Rare Cancer Knowledge): A national patient-centric precision oncology trial for rare cancers.
University of California San Diego, TargetCancer Foundation
TPS3155
Alpha-T: An innovative decentralized (home-based) phase 2 trial of alectinib in ALK-positive (ALK+) solid tumors in a histology-agnostic setting.
Roche, UCSD Moores Cancer Center, Vanderbilt University Medical Center
2599
Real-world pan-cancer landscape of frameshift mutations (FSM) and their role in predicting responses to immune checkpoint inhibitors (ICI) in patients (pts) with tumors with low tumor mutational burden (TMB).
Huntsman Cancer Institute
1068
Real-world (rw) clinical outcomes on alpelisib (ALP) in patients (pts) with breast cancer (BC) and PIK3CA mutations (PIK3CAm).
University of California, San Francisco
2541
Genomic immunotherapy (IO) biomarkers detected on comprehensive genomic profiling (CGP) of tissue and circulating tumor DNA (ctDNA).
National Cancer Center Hospital East; Kashiwa, Japan
1036
Concordance of HER2+ status by IHC/ISH and ERBB2 status by NGS in a real-world clinicogenomic database and analysis of outcomes in patients (pts) with metastatic breast cancer (mBC).
Flatiron
539
Comprehensive genomic profiling (CGP) of 275 male breast cancer (BC) tissue (TBx) and liquid (LBx) biopsies: Comparative analysis to a female cohort (FBC) and therapeutic considerations.
Dana Farber Cancer Institute
9101
Identification of potential germline (GL) variants by routine clinical comprehensive genomic profiling (CGP) and confirmatory GL testing in 24 tumor types.
Dana Farber Cancer Institute