Foundation Medicine and its Collaborators Present New Findings Supporting Tissue- and Blood-based Comprehensive Genomic Profiling (CGP) to Inform Targeted and Cancer Immunotherapy Treatment Strategies
--Data to be Presented at the 2018 Annual Meeting of the
The AACR Annual Meeting will be held
“Personalized oncology care is rapidly evolving, underscoring the need for the identification of new biomarkers that may help predict response to treatment and improve access to, and success of, targeted therapeutic trials in oncology,” said
In the area of immunotherapy, new data will be presented highlighting the use of Foundation Medicine’s bTMB assay, which is currently being utilized in a global clinical trial setting to investigate bTMB as a non-invasive biomarker of response to first-line atezolizumab in advanced non-small cell lung cancer (NSCLC) patients as part of
Additional findings to be presented may help further guide the use of checkpoint inhibitor cancer immunotherapy. For example, one study found that tumor mutational burden (TMB), which has been shown to predict response to immunotherapy in many cancer types, varied between patients of different ancestries, suggesting that the likelihood of benefit from immunotherapy may differ in these patients as well. Another study, performed on the largest sequenced cohort of Merkel cell carcinoma to date, identified TMB-high and TMB-low subsets linked to distinct disease etiologies, providing evidence that TMB and or presence of the etiologic virus may help guide therapy in these patients.
Data generated utilizing the FoundationACT liquid biopsy assay will be presented, which supports its potential utility in predicting clinical outcomes. An oral presentation will highlight a retrospective analysis utilizing FoundationACT, as well as a custom liquid biopsy assay, to measure circulating tumor DNA (ctDNA) from a Phase II study of metastatic triple-negative breast cancer (mTNBC), showing that on-treatment quantitative changes in genomic alterations were associated with clinical outcomes to a targeted therapy/chemotherapy treatment combination.
Clinical validation data for FoundationOne CDx will also be presented, demonstrating high concordance with multiple
Other studies include those that identify novel biomarkers of targeted therapy treatment response, such as novel PTEN alterations in metastatic triple negative breast cancer (mTNBC), or genomic loss of heterozygosity in non-BRCA positive ovarian cancer patients. Such findings could be used to broaden intent-to-treat populations in clinical trials and identify larger patient populations that may respond to approved treatments.
Following is a list of abstracts that will be presented at the meeting.
Presentation # | Title | Day/Time | Location | |||||||||
Immunotherapy/TMB | ||||||||||||
PO.EP01.04 | Somatic genome alterations in cancer as compared to inferred patient ancestry | April 16; | Poster Section 10 | |||||||||
CTPL03-CT077 (Oral Presentation) | Nivolumab (nivo) + ipilimumab (ipi) vs platinum-doublet chemotherapy (PT-DC) as first-line (1L) treatment (tx) for advanced non-small cell lung cancer (NSCLC): initial results from CheckMate 227 | April 16;
| N Hall B | |||||||||
CTPL03-CT078 (Oral Presentation) | Tumor mutational burden (TMB) as a biomarker for clinical benefit from dual immune checkpoint blockade with nivolumab (nivo) + ipilimumab (ipi) in first-line (1L) non-small cell lung cancer (NSCLC): identification of TMB cutoff from CheckMate 568 | April 16; 12:05pm- | N Hall B | |||||||||
PO.TB11.02 | Comprehensive genomic profiling of Merkel cell carcinoma samples reveals bimodal distribution of tumor mutational burden and two mutually exclusive candidate mechanisms of carcinogenesis | April 17; | Poster Section 1 | |||||||||
PO.IM02.04 | A Blood Based Next Generation Sequencing Assay to Determine Tumor Mutational Burden (bTMB) Is Associated with Benefit to an Anti-PD-L1 Inhibitor, Atezolizumab | April 18; | Poster Section 32 | |||||||||
Liquid Biopsy & Targeted Therapy | ||||||||||||
PO.ET04.05 | Identification of potential resistance mechanisms to EGFR treatment in the real world using a clinicogenomic database | April 16; | Poster Section 36 | |||||||||
MS.CL10.02 (Oral Presentation) | On-treatment changes in circulating tumor DNA (ctDNA) level as an early predictor of clinical outcome in the LOTUS randomized phase II trial of first-line ipatasertib (IPAT) plus paclitaxel (PAC) for metastatic triple-negative breast cancer (mTNBC) | April 16; | Room S406 | |||||||||
PO.CL10.02 | A novel PI3K/Akt-pathway activation biomarker using comprehensive genomic profiling (CGP) for clinical trial assay | April 16; | Poster Section 25 | |||||||||
PO.MCB09.03 | Novel CDH1 mutations in breast invasive lobular carcinoma | April 16; | Poster Section 16 | |||||||||
PO.CL10.06 | A validated diagnostic assay for identifying patients with ovarian cancer with high genomic loss of heterozygosity (LOH) without deleterious BRCA mutations | April 17; | Poster Section 24 | |||||||||
FoundationOne CDx | ||||||||||||
PO.MCB09.02 | Comparative analysis of clinically validated NGS-based assays reveals high concordance across short variants | April 15; | Poster Section 19 | |||||||||
PO.CL01.03 | An ERBB2 follow-on companion diagnostic for clinical care of patients with breast cancer | April 16; | Poster Section 27 | |||||||||
PO.SHP01.01 | A clinically-validated comprehensive companion diagnostic platform for care of patients with advanced cancer | April 17; | Poster Section 35 | |||||||||
About
Cautionary Note Regarding Forward-Looking Statements for
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 value and impact of CGP, including FoundationOne, FoundationACT and FoundationOne CDx, and molecular information from CGP, in cancer care, predicting response to treatment, and improving access to and success of targeted trials in oncology; and the ability of tissue and blood based TMB to predict responses to certain types of cancer, including NSCLC. 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 risk that the results presented are found to lack scientific, medical or clinical utility or that subsequent research renders the results presented less useful or not useful in clinical practice;
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Source:
Foundation Medicine, Inc.
Media Contact:
Lee-Ann Murphy, 617-245-3077
pr@foundationmedicine.com
or
Investor Contact:
Kimberly Brown, 617-418-2215
ir@foundationmedicine.com