On May 29, 2020 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that new data from ongoing clinical research on MammaPrint and BluePrint was debuted at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program (ASCO) (Free ASCO Whitepaper) (Press release, Agendia, MAY 29, 2020, View Source [SID1234558767]). A total of five posters were presented on Agendia’s genomic profiling assays.
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The highlighted data below further illustrate the efficacy of Agendia’s MammaPrint and BluePrint genomic testing to consistently stratify breast cancers, allowing for a highly personalized regimen throughout a patient’s treatment journey. The latest findings from Agendia deliver immediate, actionable information for doctors and patients early in the diagnosis and treatment planning process and build on research that will impact breast cancer treatment and outcomes in the future.
One scientific presentation, entitled "Adding precision to 2018 ASCO (Free ASCO Whitepaper)/CAP HER2 testing guidelines in breast cancer with genomic profiling," evaluated the concordance between human epidermal growth factor receptor 2 (HER2) status as put forth by the 2018 ASCO (Free ASCO Whitepaper)/CAP guidelines and Agendia’s BluePrint genomic testing. In this real-world diagnostic data set, the 2018 guideline recommendations led to fewer HER2 equivocal tumors overall, confirming the positive impact of the revisions. Of note, BluePrint reclassified 69 percent of HER2-positive tumors and all HER2 equivocal tumors to non-HER2 molecular subtypes, indicating that these tumors may have suboptimal responses to HER2-directed therapy. This study found that molecular classification by BluePrint adds further precision in stratifying HER2-positive patients, offering the potential to predict responsiveness to HER2-targeted therapies.
"In this study, nearly 70 percent of HER2-positive diagnoses were reclassified to non-HER2, based on molecular subtyping. This is interesting and may have the potential at some point to affect treatment decisions and patient outcomes," said Adam Brufsky, MD, PhD, and Professor of Medicine at the University of Pittsburgh School of Medicine. "Data continue to show the value of MammaPrint and BluePrint as diagnostic tools that allow physicians to make more informed decisions to address their patients’ disease."
Also at ASCO (Free ASCO Whitepaper), Agendia shared updates on the ongoing FLEX trial, the massive real-world clinical data set designed to drive the medical community forward in its approach to precision medicine. In addition to a designated FLEX study poster – "The FLEX Real World Data Platform Explores New Gene Expression Profiles and Investigator-Initiated Protocols in Early Stage Breast Cancer" – that gave general updates on the registry, Agendia also highlighted FLEX and forward-looking studies, one of which has immediate implications for how a patient’s treatment may change based on comprehensive information uncovered by BluePrint.
The FLEX scientific presentation, entitled, "TNBC subtype and clinical estrogen receptor status of genomically basal breast tumors in Caucasian, African American, and Latin American patients," evaluated the distribution of triple-negative breast cancer (TNBC) subtypes in genomically Basal-Type cancers from self-reported patient ethnicities (Caucasian, African American, and Latin American). The data show that Basal-Type tumors are heterogeneous and include all defined TNBC subtypes, independent of ethnicity.
In addition, the study evaluated the association of IHC-determined estrogen receptor status and Basal-Type tumors of each ethnicity. Analyses demonstrated that BluePrint reclassified a subset of estrogen receptor positive (ER+) tumors to molecular Basal-Type and that ER status was not significantly associated with a specific TNBC subtype or ethnicity. This highlights the clinical need to trace basal biology in ER+ patients to refine treatment for basal-like tumors.
"The reclassification of a subset of ER+ tumors identifies an urgent and actionable situation," said Cathy Graham, MD, Assistant Professor of Surgery in the Division of Surgical Oncology at Emory University School of Medicine and Director, Breast Surgery at Emory St. Joseph’s Hospital. "From a clinical perspective, when these patients are first diagnosed, they appear to have luminal breast cancer. But, when you are able to look at the underlying mechanism with comprehensive genomic testing, a large subset of these breast cancers is reclassified to Basal-Type, which is high risk. This knowledge allows us to execute a more personalized and precise treatment approach immediately."
Two other forward-looking studies reinforce the future utility of better stratifying patients, and Agendia’s ability to provide a more sophisticated platform for discovery in gene signature research.
In the first, entitled, "High Risk breast cancer genes at 8q22-24 and their role in over 5,000 patients evaluated with the MammaPrint risk of recurrence assay," FLEX researchers looked at the 8q22-24 chromosomal region, known to be associated with breast cancer. The study results provided further evidence that aberrations in this region are associated with higher-risk disease. Within the MammaPrint signature, the genes CCNE2, MTDH, and TSPYL5 have similar expression patterns and when overexpressed, represent a unique subgroup of high-risk tumors. These findings and further research on the 8q22-24 region may help to better stratify high-risk patients through ongoing clinical trials evaluating response and resistance to targeted therapies.
The second, entitled, "12-chemokine gene expression score in breast cancer patients treated with neoadjuvant chemotherapy," builds on existing research related to gene expression as a predictive biomarker for immune responses in breast cancer patients. The study found that chemokine gene expression, which indicates the presence of immune cells, was associated with pathologic complete response (pCR), MammaPrint High Risk index, and BluePrint subtypes. This research suggests that chemokine score may be further stratified by using MammaPrint and BluePrint in order to identify patients who may be more likely to benefit from neoadjuvant chemotherapy. This work also suggests that future studies may evaluate the potential utility for chemokine score and MammaPrint in predicting responses to immunotherapy in breast cancer patients.
"The research we are showcasing at this year’s ASCO (Free ASCO Whitepaper) Annual Meeting underscores our commitment to patients and physicians," said William Audeh, MD, Chief Medical Officer at Agendia. "With our growing arsenal of data collected through prospective clinical trials such as FLEX, I-SPY2 and MINDACT, we are able to help patients now while information-gathering for future breast cancer treatment strategy."
Agendia is proud to present these findings at the ASCO (Free ASCO Whitepaper) 2020 Annual Meeting, which underscore the company’s commitment to innovation and discovery through extraordinary, patient-focused research.