Foundation Medicine and Collaborators to Present New Clinical Data on FoundationOne® and FoundationOne Heme at the 2014 ASCO Annual Meeting

Data Describe Clinical Application of FoundationOne Across Multiple Tumor Types

Business Wire

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Foundation Medicine, Inc. (FMI) today announced that 17 abstracts highlighting new clinical data on FoundationOne® and FoundationOne Heme will be presented at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3, 2014 in Chicago.

The company’s clinical assays, FoundationOne for solid tumors and FoundationOne Heme for hematologic malignancies, sarcomas and pediatric cancers, provide a fully informative genomic profile to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies and clinical trials. The data to be presented at ASCO provide further evidence of the utility of Foundation Medicine’s assays to help inform the treatment of patients today and aid in the development of targeted therapies.

“We are pleased to be reporting initial data at ASCO from our long-term FoundationOne decision impact study conducted in collaboration with US Oncology,” said Vincent Miller, M.D., chief medical officer, Foundation Medicine. “In addition, we will be presenting new clinical data on the use of FoundationOne for genomic profiling in several common and rare tumor types, as well as the adolescent and young adult and pediatric cancer populations, which are historically underappreciated. We believe our clinical tests and growing knowledge base may accelerate the understanding and targeted treatment of these diseases.”

The schedule for oral presentations by Foundation Medicine and/or its collaborators is as follows:

Date & Time: Monday, June 2, 2014 from 2:03 p.m. to 2:15 p.m. CT
Title: Whole-exome and targeted sequencing of angiosarcomas: Target identification and treatment implications
Abstract: 10512
Session: Clinical Science Symposium
Location: S406
Presenter: Vinod Ravi, M.D.
Collaborator: The University of Texas MD Anderson Cancer Center

Date & Time: Monday, June 2, 2014 from 5:24 p.m. to 5:36 p.m. CT
Title: Comprehensive genomic profiling of solid tumors from 677 adolescents and young adults for revealing a distinct spectrum of targetable genomic alterations
Abstract: 11008
Session: Oral Abstract Session
Location: S100bc
Presenter: Brandon Hayes-Lattin, M.D.

The schedule for poster highlight presentations by Foundation Medicine and/or its collaborators is as follows:

Date & Time: Monday, June 2, 2014 from 8:00 a.m. to 11:45 a.m. CT
Title: Clinical application of comprehensive next-generation sequencing-based genomic profiling for identification of actionable genomic alterations in pediatric solid tumors and hematolymphoid malignancies: The Foundation Medicine pediatric experience
Abstract: 10035
Session: Poster Highlights Session
Poster Board: #336
Location: S Hall A2
Presenter: Matthew J. Hawryluk, Ph.D.

Date & Time: Monday, June 2, 2014 from 8:00 a.m. to 11:00 a.m. CT
Title: Next-generation sequencing (NGS)-based profiling of pancreatic acinar cell carcinoma for identification of a recurrent SND1-BRAF fusion
Abstract: 11029
Session: Poster Highlights Session
Poster Board: #18
Location: S405
Presenter: Juliann Chmielecki, Ph.D.

Date & Time: Monday, June 2, 2014 from 8:00 a.m. to 11:00 a.m. CT
Title: Analysis of candidate homologous repair deficiency genes in a clinical trial of olaparib in patients (pts) with platinum-sensitive, relapsed serous ovarian cancer (PSR SOC)
Abstract: 5536
Session: Poster Highlights Session
Poster Board: #26
Location: E354b
Presenter: Jonathan Ledermann, M.D.
Collaborator: AstraZeneca

Date & Time: Monday, June 2, 2014 from 1:15 p.m. to 4:15 p.m. CT
Title: Next-generation sequencing (NGS) in relapsed/refractory triple-negative breast cancer (TNBC) in Israel
Abstract: 1028
Poster Board: #21
Session: Poster Highlights Session
Location: E354b
Presenter: Noa Ben-Baruch, M.D.
Collaborator: Teva Pharmaceuticals

Date & Time: Tuesday, June 3, 2014 from 8:00 a.m. to 11:00 a.m. CT
Title: Rictor amplification to define a novel and unique subset of lung cancer patients
Abstract: 8027
Session: Poster Highlights Session
Poster Board: #42
Location: E354b
Presenter: Haiying Cheng, M.D., Ph.D.
Collaborator: Columbia University Medical Center

Date & Time: Tuesday, June 3, 2014 from 8:00 a.m. to 11:00 a.m. CT
Title: Next-generation sequencing (NGS) to identify actionable genomic alterations (GA) in “pan-negative” lung adenocarcinomas (ADC) from patients with no smoking or a light smoking (NS/LS) history
Abstract: 8029
Session: Poster Highlights Session
Poster Board: #44
Location: E354b
Presenter: Alexander E. Drilon, M.D.
Collaborator: Memorial Sloan-Kettering Cancer Center

The schedule for poster presentations by Foundation Medicine and/or its collaborators is as follows:

Date & Time: Saturday, May 31, 2014 from 8:00 a.m. to 11:45 a.m. CT
Title: Comprehensive genomic profiling of gallbladder adenocarcinoma and frequent genomic-derived targets of therapy
Abstract: 4142
Session: General Poster Session
Poster Board: #229
Location: S Hall A2
Presenter: Juliann Chmielecki, Ph.D.

Date & Time: Saturday, May 31, 2014 from 1:15 p.m. to 5:00 p.m. CT
Title: BATTLE-2: KRAS mutation and outcome in a biomarker-integrated study in previously treated patients (pts) with advanced non-small cell lung cancer (NSCLC)
Abstract: 8042
Session: General Poster Session
Poster Board: #223
Location: S Hall A2
Presenter: Vassiliki Papadimitrakopoulou, M.D.
Collaborator: The University of Texas MD Anderson Cancer Center

Date & Time: Saturday, May 31, 2014 from 1:15 pm. to 5:00 p.m. CT
Title: Identifying ALK rearrangements that are not detected by FISH with targeted next-generation sequencing of lung carcinoma
Abstract: 8049
Session: General Poster Session
Poster Board: #230
Location: S Hall A2
Presenter: Siraj M. Ali, M.D., Ph.D.

Date & Time: Saturday, May 31, 2014 from 1:15 p.m. to 5:00 p.m. CT
Title: Effect of clinical NGS-based cancer genomic profiling on physician treatment decisions in advanced solid tumors
Abstract: 11109
Session: General Poster Session
Poster Board: #391
Location: S Hall A2
Presenter: Fadi S. Braiteh, M.D.
Collaborator: Comprehensive Cancer Centers of Nevada

Date & Time: Saturday, May 31, 2014 from 1:15 p.m. to 5:00 p.m. CT
Title: Targeted next-generation sequencing (NGS) of carcinoma of unknown primary site (CUP): Actionable genomic alterations (GA) and new routes to targeted therapies
Abstract: 11048
Session Type: General Poster Session
Poster Board: #330
Location: S Hall A2
Presenter: Jeffrey S. Ross, M.D.

Date & Time: Sunday, June 1, 2014 from 8:00 a.m. to 11:45 a.m. CT
Title: PI3K/AKT/mTOR genomic alterations in 94 patients with metastatic breast cancer in the Phase I clinic at MD Anderson: Prevalence and association with response
Abstract: 2606
Session: General Poster Session
Poster Board: #69
Location: S Hall A2
Presenter: Jennifer J. Wheler, M.D.
Collaborator: The University of Texas MD Anderson Cancer Center

Date & Time: Monday, June 2, 2014 from 8:00 a.m. to 11:45 a.m. CT
Title: Evidence of PIK3CA and TP53 co-mutation in breast cancer identification on next-generation sequencing (NGS) of ERBB2 (HER2)-amplified residual disease following preoperative anti-HER2 therapy
Abstract: 625
Session: General Poster Session
Poster Board: #89
Location: S Hall A2
Presenter: Frankie Ann Holmes, M.D.
Collaborator: Texas Oncology

Date & Time: Monday, June 2, 2014 from 8:00 a.m. to 11:45 a.m. CT
Title: Estrogen receptor-positive (ER+) metastatic breast cancer (MBC) patients (pts) with extreme responses (ERs) to capecitabine having tumors with genomic alterations in DNA repair and chromatin remodeling genes
Abstract: 555
Session: General Poster Session
Poster Board: #19
Location: S Hall A2
Presenter: Joyce O’Shaughnessy, M.D.
Collaborator: Texas Oncology-Baylor Charles A. Sammons Cancer Center

Date & Time: Monday, June 2, 2014 from 1:15 p.m. to 5:00 p.m. CT
Title: Next-generation sequencing to identify molecular alterations in DNA repair and chromatin maintenance genes associated with pathologic complete response (pT0) to neoadjuvant accelerated methotrexate, vinblastine, doxorubicin, and cisplatin (AMVAC) in muscle-invasive bladder cancer (MIBC)
Abstract: 4538
Session: General Poster Session
Poster Board: #106
Location: S Hall A2
Presenter: Elizabeth R. Plimack, M.D., M.S.
Collaborator: Fox Chase Cancer Center

About FoundationOne®

FoundationOne, the company’s first clinical product, is a fully informative genomic profile for solid tumors used by oncologists to identify the molecular alterations in a patient's tumor and match those alterations with relevant targeted therapies and clinical trials. Using next-generation sequencing in routine cancer specimens, FoundationOne interrogates all genes somatically altered in human cancers that are validated targets for therapy or unambiguous drivers of oncogenesis based on current knowledge. It reveals all classes of genomic alterations including base substitutions, insertions, deletions, copy number alterations and select rearrangements. FoundationOne fits easily into the clinical workflow of the ordering physician, and test results are provided in an easy-to-interpret report supported by a comprehensive review of published literature. FoundationOne is a laboratory-developed test performed at Foundation Medicine's CLIA-certified lab. Please visit www.FoundationOne.com for more information.

About FoundationOne® Heme

FoundationOne Heme is a fully informative genomic profile for hematologic cancers (leukemia, lymphoma and myeloma), sarcomas and pediatric cancers, designed to provide physicians with clinically actionable information to guide treatment options for patients based on the genomic profile of their cancer. It is Foundation Medicine’s second clinical product and was developed in collaboration with Memorial Sloan-Kettering Cancer Center. Using next-generation sequencing in routine cancer specimens, FoundationOne Heme interrogates all genes somatically altered in these cancers that are validated targets for therapy or unambiguous drivers of oncogenesis based on current knowledge. The test employs RNA sequencing in addition to DNA sequencing to simultaneously detect all classes of genomic alterations, including base pair substitutions, insertions and deletions, copy number alterations and rearrangements, and gene fusions (a type of alteration that is a common driver of hematologic malignancies, sarcomas and pediatric cancers). FoundationOne Heme fits easily into the clinical workflow of the ordering physician, and test results are provided in an easy-to-interpret report supported by a comprehensive review of published literature. FoundationOne Heme is a laboratory-developed test performed at Foundation Medicine's CLIA-certified lab. Please visit www.FoundationOne.com for more information.

About Foundation Medicine

Foundation Medicine (FMI) is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company's clinical assays, FoundationOne for solid tumors and FoundationOne Heme for hematologic malignancies, sarcomas and pediatric cancers, provide a fully informative genomic profile to identify the molecular alterations in a patient's cancer and match them with relevant targeted therapies and clinical trials. Foundation Medicine's molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit www.FoundationMedicine.com or follow Foundation Medicine on Twitter (@FoundationATCG).

Foundation Medicine® and FoundationOne® are registered trademarks of Foundation Medicine, Inc.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the benefits to patients of next-generation sequencing of their tumors and blood based cancers, the utility of Foundation Medicine’s products in informing patient treatment, clinical data related to Foundation Medicine’s products, and Foundation Medicine’s participation in the ASCO annual meeting. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include the risks that Foundation Medicine’s products will not be able to identify genomic alterations in the same manner as prior clinical studies; and the risks described under the caption “Risk Factors” in Foundation Medicine’s Annual Report on Form 10-K for the year ended December 31, 2013, which is on file with the Securities and Exchange Commission, as well as other risks detailed in Foundation Medicine’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Foundation Medicine undertakes no duty to update this information unless required by law.

Contact:
Media Contact:
Pure Communications, Inc.
Dan Budwick, 973-271-6085
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or
Investor Contact:
Foundation Medicine
Khaled Habayeb, 617-418-2283
ir@foundationmedicine.com
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