On May 18, 2017 Foundation Medicine, Inc. (NASDAQ:FMI) reported that data from its suite of comprehensive genomic profiling (CGP) assays, including FoundationOne, FoundationACT liquid biopsy, FoundationOne Heme, and FoundationFocus CDxBRCA will be presented during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 2-6, 2017 in Chicago (Press release, Foundation Medicine, MAY 18, 2017, View Source [SID1234519213]).

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 company and its collaborators will present a total of 33 studies at the meeting, including two oral presentations, eight poster discussions and twenty-three posters, ranging across 15 different tumor types. Data demonstrate the impact of tissue- and blood-based CGP on guiding targeted therapy, immunotherapy, or clinical trial decisions in advanced cancers. In addition, the clinical value of CGP as evidenced through real world evidence and outcomes research (HEOR) studies, as well as data highlighting the ability of CGP to accelerate clinical trial enrollment will be presented.

"Together these studies highlight the importance of our CGP approach in advancing precision medicine in cancer care and build upon the growing body of evidence supporting its use in clinical practice," said Vincent Miller, M.D., chief medical officer at Foundation Medicine. "Previous findings from Foundation Medicine have shown that measuring tumor mutational burden (TMB) with FoundationOne can predict responses to FDA-approved anti-PD-1/anti-PD-L1 immunotherapies across multiple tumor types. New results will be presented at this year’s ASCO (Free ASCO Whitepaper) which help describe the landscape of TMB in triple-negative breast cancer, ovarian cancer, metastatic melanoma, biliary tract cancer and cancer of unknown primary, pointing to potentially new subsets of patients who may benefit from this therapeutic strategy. We believe these data will be critical to advancing the field of immunotherapy, and will be particularly insightful for clinicians, as well as biopharma companies seeking to advance immunotherapeutic agents. In addition, we’ll present exciting new data demonstrating the impact of our decision support tools on accelerating clinical trial enrollment – – helping to address an important need in cancer care."

New results include an oral presentation titled "Comprehensive genomic profiling with loss of heterozygosity to identify therapeutically relevant subsets of ovarian cancer," which shows that CGP can reveal molecular, rather than histologic, patient subsets who may benefit from poly (ADP-ribose) polymerase (PARP) inhibitor targeted therapy or immunotherapy. These results also provide support for insurance coverage and further integration of CGP into clinical trials in ovarian cancer.

Further supporting the integration of CGP at diagnosis, results from health economic and outcomes studies will be presented, demonstrating that early integration of CGP into a patient’s clinical and diagnostic work-up leads to improved patient outcomes associated with reasonable incremental costs to the payer that are largely driven by increased survival time on treatment. One poster titled "Estimated Cost of Anti-Cancer Therapy Directed by CGP in a Single-Center Study" discusses estimated anti-cancer drug costs and the associated cost impact of overall survival (OS) for matched vs. unmatched therapy in patients enrolled in a previously reported clinical trial using FoundationOne to guide therapeutic decisions.

In addition, important new studies will be presented on the ability of FoundationACT liquid biopsy assay to identify ESR1 and PIK3CA mutations in metastatic breast cancer, acquired resistance mutations in non-small cell lung cancer and BRCA1/2 reversion mutations in prostate cancer, all of which could help guide treatment decisions for these indications.

Other studies demonstrate the ability of CGP to accelerate clinical trial enrollment. Results from "Accelerating clinical trial enrollment with comprehensive genomic profiling (CGP) and ‘Just-in-Time’ clinical trial sites: An index case of a paradigm shift", reveal a new approach for matching patients to clinical trials that focus on rare genomic findings. Combined with a computational matching infrastructure, this approach could accelerate drug development and improve access to novel targeted therapies.

Following is a list of selected abstracts, including those referenced above.

Visit View Source for a complete list of abstracts and to stay connected with Foundation Medicine during the ASCO (Free ASCO Whitepaper) meeting.

Immunotherapy/TMB Data

Oral Presentation: Abstract 5512 – Comprehensive genomic profiling (CGP) with loss of heterozygosity (LOH) to identify therapeutically relevant subsets of ovarian cancer (OC), June 5, E450ab, 8:48am – 9:00am
Abstract 9536 – Landscape of genomic alterations (GA) and tumor mutational burden (TMB) in different metastatic melanoma (MM) subtypes, June 3, Hall A, 1:15pm – 4:45pm
Abstract 4086 – Tumor mutational burden (TMB) and co-existing actionable mutations in biliary tract cancers (BTC), June 3, Hall A, 8:00am – 11:30am
Abstract 3039 – Mutational burden of tumors with primary site unknown, June 5, Hall A, 8:00 am – 11:30am
Abstract 9072 – BRAF fusions in clinically advanced non-small cell lung cancer: An emerging target for anti-BRAF therapies, June 3, Hall A, 8:00am – 11:30am
Targeted Therapy Data

Oral Presentation: Abstract 11001 – Impact of next-generation sequencing (NGS) on diagnostic and therapeutic options in soft-tissue and bone sarcoma, June 2, S100bc, 3:12pm – 3:24pm
Abstract 3583 – Targeted therapy for HER2 driven colorectal cancer, June 3, Hall A, 8:00am – 11:30am
Health Economic Data

Abstract 6599 – Comprehensive genomic profiling (CGP) versus conventional molecular diagnostic testing of patients with advanced non-small cell lung cancer (NSCLC): Overall survival (OS) and cost in US health plan population, June 5, Hall A, 1:15pm – 4:45pm
Abstract 6605 – Estimated cost of anti-cancer therapy directed by comprehensive genomic profiling (CGP) in a single-center study, June 5, Hall A, 1:15pm – 4:45pm
Liquid Biopsy Data

Abstract 1016 – Genomic profiling of circulating tumor DNA (ctDNA) from patients (pts) with metastatic breast cancer (mBC), June 4, Hall B1, 4:45pm – 6:00pm
Abstract 9025 – Genomic profiling of circulating tumor DNA (ctDNA) from patients (pts) with advanced non-small cell lung cancer (NSCLC), June 3, Hall A, 8:00am – 11:30am
Abstract 5024 – BRCA1/2 reversion mutations in prostate cancer identified from clinical tissue and liquid biopsy samples, June 5, Hall A, 1:15pm – 4:45pm
Abstract 4128 – Genomic profiling of circulating tumor DNA (ctDNA) from patients (pts) with pancreatic ductal adenocarcinoma (PDA), June 3, Hall A, 8:00am – 11:30am
Clinical Trial and Partnerships Data

Abstract 6539 – Accelerating clinical trial enrollment with comprehensive genomic profiling (CGP) and just-in-time clinical trial sites: An index case of a paradigm shift, June 5, Hall A, 1:15pm – 4:45pm
Abstract 2512 – Personalized, molecularly matched combination therapies for treatment-naïve, lethal malignancies: The I-PREDICT study, June 5, Arie Crown Theater, 11:30am – 12:45pm