FoundationOne can help to guide clinicians in determining the most effective therapy for their patients
FoundationOne has been used to profile over 150,000 patients,1 with many patients being shown to have had at least 1 clinically relevant alteration (~90% of patients).2–4 Numerous studies have shown that the use of biomarker-directed therapies, following the identification of such alterations, is associated with significantly improved clinical outcomes in patients compared with a non-targeted approach.5–7
There is increasing recognition that broader profiling is an effective strategy to help to identify both common and rare mutations in a patient’s cancer, so that targeted, biomarker-directed therapy options may be identified.8–10 Broad molecular profiling, such as with FoundationOne, can identify alterations in all driver genes listed, and recommended for testing, by the National Comprehensive Cancer Network (NCCN).8 For example, 71% of genomic alterations identified in non-small cell lung cancer (NSCLC) samples profiled using FoundationOne were found to have an alteration in at least 1 of these drivers.11
These alterations may otherwise go undetected and, as a result, broad molecular profiling is now strongly recommended by NCCN guidelines in the diagnosis and treatment of NSCLC.8
“The NCCN Panel strongly advises broader molecular profiling (also known as precision medicine) to identify rare driver mutations to ensure patients receive the most appropriate treatment”8
Biomarker-directed treatment strategies have been associated with improved clinical outcomesAcross multiple meta-analyses, biomarker-directed therapies have demonstrated significantly improved response rates (RR), progression-free survival (PFS) and overall survival (OS) when compared to a non-biomarker-directed approach.5–7 Use of a personalised, biomarker-directed anticancer treatment strategy has also been identified as an independent predictor of improved outcomes and fewer toxic deaths compared with a routine, non-personalised approach.5
FoundationOne can detect clinically relevant alterations in the majority of patients, in a broad range of cancers
Genomic profiling with FoundationOne can open up treatment possibilities for patients through the identification of clinically relevant alterations within their tumour. Utilising hybrid capture-based next-generation (NGS) technology, FoundationOne profiling analyses entire exomes (the coding regions of the DNA) of 315 cancer-related genes, meaning that even rare alterations may be identified.9,12
FoundationOne genomic profiling was proven to facilitate a more comprehensive and efficient strategy in a study of 31 lung adenocarcinoma patients, when compared to non-NGS testing methods. The study found that actionable genomic alterations could be detected in 65% of patients who were previously deemed to be without targetable genomic alterations by earlier non-NGS testing.10
This improved detection was also confirmed in a study of 5,605 advanced and metastatic breast cancers that were analysed using FoundationOne to assess the frequency of alterations in the breast cancer-related gene ERBB2. It was found that 12.5% of patients (698/5,605) featured ERBB2 alterations, with 1.8% of patients harbouring a type of alteration that would be undetectable by standard of care methods.13
Profiling with FoundationOne can impact clinical decision making
Genomic profiling with FoundationOne has been shown by several studies to facilitate clinical decisions and specific patient disease management.15–17
In a prospective clinical study of 100 patients with diverse, rare or poor prognosis, 92 underwent genomic profiling using FoundationOne.
95% of these patients (87/92) were recommended a clinical action or investigational trial.17
Clinical trial evidence supporting genomic profiling using FoundationOne
Work is ongoing to clinically evaluate the impact that genomic profiling techniques can have on patients’ lives. Genomic profiling, such as that offered by FoundationOne, has been proven to improve outcomes through the actioning of identified clinically relevant alterations compared with non-personalised approaches and non-targeted therapies.5,15–17
- Genomeweb. Foundation Medicine Q3 revenues up 45 percent. Available at: https://www.genomeweb.com/molecular-diagnostics/foundation-medicine-q3-revenues-45-percent [accessed November 2017].
- Blumenthal DT et al. J Neurooncol 2016; 1:211–219.
- Rodriguez-Rodriguez L et al. Gynecol Oncol 2016; 141:2–9.
- Schwaederle M et al. Mol Cancer Ther 2015; 14:1488–1494.
- Schwaederle M et al. J Clin Oncol 2015; 33:3817–3825.
- Schwaederle M et al. JAMA Oncol 2016; 2:1452–1459.
- Jardim DL et al. J Natl Cancer Inst 2015; 107:e253.
- National Comprehensive Cancer Network (NCCN) NSCLC guidelines, Version 9, 2017.
- Frampton, GM et al. Nat Biotechnol 2013; 31:1023–1031
- Drilon A et al. Clin Cancer Res 2015; 16:3631–3639.
- Suh JH et al. Oncologist 2016; 21:684–691.
- FoundationOne technical information.
- Ross JS et al. Cancer 2016; 17:2654–2562.
- Ross JS et al. JAMA Oncol 2015; 1:40–49.
- Reinbolt RE et al. J Clin Oncol 2016; 34 (and supplementary material).
- Rozenblum AB et al. J Thorac Oncol 2017; 2:258–268 (and supplementary material).
- Hirshfield KM et al. Oncologist 2016; 21:1315–1325.
- Wheler JJ et al. Cancer Res 2016; 76:3690–3701.
- Schwaederle M et al. Mol Cancer Ther 2016; 15:743–752.
- Yuan Y et al. Oncotarget 2017; 8:26414–26423.
- Dhir M et al. Cancer Med 2017; 1:195–206.