New Data with FoundationOne® Supports Clinical Utility and Improved Outcomes from Molecularly Matching Non-Small Cell Lung Cancer Patients to Targeted Therapy
Data Published in Peer-Reviewed Journals Provide Further Evidence of the Ability of Comprehensive Genomic Profiling to Find Clinically Relevant Alterations Often Missed by Hotspot Assays
Findings from the two studies were published in Oncotarget and
"Targeted therapies have revolutionized the treatment of lung cancer;
however, for such therapies to be optimally matched to the right
patients, there is an inherent mandate for comprehensive, highly
accurate and sensitive clinical testing that can detect all actionable
genomic alterations," said
Lung cancer is the leading cancer killer in both men and women in
"These studies demonstrate the clinical utility and the opportunity for
improved clinical outcomes achieved by integrating comprehensive genomic
profiling into clinical care for advanced non-small cell lung cancer,"
Key Findings Published in Oncotarget
The article, entitled "Genomic Profiling of Lung Adenocarcinoma Patients Reveals Therapeutic Targets and Confers Clinical Benefit When Standard Molecular Testing is Negative," was published online in the journal Oncotarget and demonstrates that maximally identifying actionable genomic alterations in advanced lung cancer patients is an important factor in improving clinical outcomes. Comprehensive genomic profiling using FoundationOne was performed on tumor specimens from 51 patients with advanced lung adenocarcinomas, which previously tested negative for the known driver oncogenes EGFR, KRAS and ALK. Key study findings include:
- 31 percent of patients harbored clinically relevant genomic alterations that were not previously discovered by the prior clinical testing.
- A genomic alteration with a corresponding targeted therapeutic based on the National Comprehensive Cancer Network (NCCN) guidelines was identified in 39 percent of patients. This data supports a previous finding by Drilon et al4 showing 26 percent of previously negative NSCLC patients harbored a genomic alteration with a corresponding targeted therapy in NCCN guidelines.
- Genomic alterations for which clinical trials of targeted therapies could be considered were discovered in an additional 27 percent of patients. Similarly, in the study referenced above, Drilon et al demonstrated that 39 percent of NSCLC patients enrolled in that study harbored genomic alterations that could be linked to a clinical trial at the principal investigator's cancer center.
- Seven patients with ROS1 rearrangements were enrolled in an ongoing trial assessing ceritinib, an inhibitor of activated ROS1. All but one of the patients who received ceritinib experienced objective responses.
Key Findings Published in
The article, entitled "Comprehensive Genomic Profiling Identifies
Frequent Drug Sensitive EGFR Exon 19 Deletions in NSCLC Not
Identified by Prior Molecular Testing," was published online in
- Pathology reports for 250 NSCLC cases harboring classic EGFR ∆ex19 deletions identified by comprehensive genomic profiling were systematically reviewed. Of these, previous EGFR test results were available for 71 cases, and 17 percent had previously tested negative for EGFR mutation.
- In a subset of these patients with available clinical outcome information, treatment benefit with EGFR inhibitors was observed with EGFR TKI therapy.
- Of 14 NSCLC cases with an EGFR ∆ex19 C-helical deletion, previous non-hybrid capture based EGFR sequencing results were available for six cases, and of these cases, five (83 percent) had negative prior testing.
"These studies show the discordant results between narrow sequencing and
comprehensive genomic profiling with FoundationOne, implying that
potentially clinically actionable targets may only be reliably detected
when comprehensive genomic profiling is incorporated into clinical
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 ability of
comprehensive genomic profiling, including FoundationOne, to identify
genomic alterations and improve patient outcomes; and the clinical
relevance of comprehensive genomic profiling in cancer treatment. 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
3 U.S. National Institutes of Health. National Cancer Institute: SEER Cancer Statistics Review, 1973-2006.
Drilon et al., Broad, Hybrid Capture-Based Next Generation Sequencing
Identifies Actionable Genomic Alterations in Lung Adenocarcinomas
Otherwise Negative for Such Alterations by Other Genomic Testing
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