Abstracts highlighting the value of the Endocrine Activity Index were presented at ASCO 2024. The first abstract (538) highlighted the prognostic value for patients with Stage II-III breast cancer. The second abstract (565) highlighted the added prognostic value to the Recurrence Score.
Houston, TX, August 5, 2024 – Delphi Diagnostics, Inc. announces two abstracts highlighting the Endocrine Activity Index’s underlying technology presented at the American Society for Clinical Oncology (ASCO) 2024 Meeting. ASCO is a premier oncology event gathering 40,000+ oncology professionals, held in Chicago, from May 31st to June 4th, 2024. During the event, Delphi was also an exhibitor and held an advisory board dinner to discuss the data presented with leaders in the field. The data from both abstracts adds to the mounting clinical evidence supporting the Endocrine Activity Index and its value to both healthcare providers and breast cancer patients.
Abstract 538 entitled, “Analysis of the sensitivity to endocrine therapy (SET) assay in the PALLAS adjuvant trial of palbociclib in HR+/HER2- breast cancer,” presented by Otto Metzger MD, from the Dana-Farber Cancer Institute, concluded that EAI was strongly prognostic for patients with Stage II-III breast cancer, with excellent 5-year invasive disease-free survival (iDFS) for patients classified as EAI High. This abstract provides a fifth independent validation of the EAI assay’s prognostic ability in a retrospective analysis of a large prospective cohort of 3093 patients from the PALLAS trial, further solidifying the assay’s clinical value in Stage II-III HR+ breast cancer patients.
Abstract 565 entitled, “Combination of predicted sensitivity to endocrine therapy (EAI) and the Recurrence Score in node-positive breast cancer: Independent validation in the PACS-01 trial,” presented by Frederique Madeleine Penault-Llorca, concluded EAI added independent prognostic information to the Recurrence Score in this blinded validation study of the PACS-01 trial for node-positive breast cancer. This abstract presents the sixth independent validation of the EAI assay’s prognostic capacity for invasive disease-free survival in a retrospective analysis of a prospective cohort of 659 patients from the PACS-01 trial. Furthermore, the data support the independent prognostic value of EAI beyond the 21-gene recurrence score (Oncotype DX®), suggesting potential additive benefit for risk stratification in node-positive breast cancer.
“These findings presented at ASCO 2024 continue to build the clinical evidence backing the Endocrine Activity Index,” said Federico Monzon, MD, Chief Medical Officer at Delphi Diagnostics Inc. “Prior studies have shown and confirmed the prognostic value of EAI determining disease-free survival for Stage II-III breast cancer patients, and this additional data, especially the results from the large PALLAS trial patient cohort adds the strongest confirmatory evidence to date.” Dr. Monzon continued, “The data from the PACS-01 trial also confirms that EAI provides independent and additive prognostic information to the Recurrence Score. In addition, the PACS-01 study also compared patients with and without adjuvant endocrine therapy, and these results suggest another potential predictive utility for EAI.”
*EAI is known in scientific publications as the Sensitivity to Endocrine Therapy (SET) Test.
1. Otto Metzger et al., Analysis of the sensitivity to endocrine therapy (SET) assay in the PALLAS adjuvant trial of palbociclib in HR+/HER2- breast cancer (ABCSG-42/AFT-05/BIG-14-13).. JCO 42, 538-538(2024). DOI:10.1200/JCO.2024.42.16_suppl.538
2. Frederique Madeleine Penault-Llorca et al., Combination of predicted sensitivity to endocrine therapy (SET2,3 index) and the Recurrence Score in node-positive breast cancer: Independent validation in the PACS-01 trial.. JCO 42, 565-565(2024). DOI:10.1200/JCO.2024.42.16_suppl.565
About EAI
Delphi Diagnostics test, the Endocrine Activity Index™ (EAI) can provide actionable information for prognosis and prediction of chemotherapy benefits. The EAI measures endocrine activity in stage II-III, HR+HER2- breast cancer. The Index Score is adjusted for baseline prognosis using molecular subtype genes (RNA4) and clinical factors such as tumor size and regional lymph node involvement. The EAI test has been shown in various studies to be a consistent prognostic indicator for long-term outcomes in stage II-III breast cancer patients, be independent of other prognostic tests, as well as be predictive for response to dose-intense chemotherapy.
About Delphi Diagnostics
Delphi Diagnostics Inc. is a Texas-based company focused on advancing clinically valid tests for the prognosis and prediction of breast cancer treatment. Delphi Diagnostics, Inc. holds an exclusive license from The University of Texas MD Anderson Cancer Center in Houston, TX to commercialize the Endocrine Activity Index, a technology that was developed by the laboratory of Dr. W. Fraser Symmans**. The Endocrine Activity Index (EAI) test measures endocrine activity in stage II-III, HR+HER2- breast cancer. Delphi’s vision is to make the EAI test available to breast cancer patients and open new pathways for personalized breast cancer treatment. To learn more, visit www.delphi-diagnostics.com.
**Dr. Symmans has a personal financial relationship with Delphi that has been identified as a conflict of interest with this research and is managed by MD Anderson’s Conflict of Interest Committee.
Contact Delphi Diagnostics:
Emily Granger
Delphi Diagnostics Inc.
egranger@delphi-diagnostics.com
508.341.9331