Results from APHINITY Trial using BluePrint ® as a Biomarker Assay Presented at SABCS in Poster Spotlight Discussion

Agendia, Inc., a world leader in precision oncology for breast cancer, today announced data from the APHINITY trial in a poster spotlight discussion at the 2020 San Antonio Breast Cancer Symposium (SABCS 2020).

The poster, titled Prediction of benefit from adjuvant pertuzumab by BluePrint RNA sequencing in the APHINITY trial, outlines data from an exploratory analysis of the Phase 3 study that randomized 4,805 patients with histologically centrally confirmed HER2+ early breast cancer into two arms, one which received standard adjuvant chemotherapy and trastuzumab plus pertuzumab, and one which received standard adjuvant chemotherapy and trastuzumab plus placebo, for one year. The analysis was conducted in collaboration with Roche Pharmaceuticals.

At median follow up of 45 months, the primary analysis of the study showed a significant invasive disease-free survival benefit for patients treated with pertuzumab. In this analysis, BluePrint, Agendia’s 80-gene molecular subtyping test, was used to evaluate a subset of tumor samples to identify which patients in the APHINITY trial population would benefit from the addition of pertuzumab based on gene expression profiling of their tumors. The poster presented at SABCS showed that BluePrint may identify subgroups of patients within the study population with differing degrees of benefit from the addition of pertuzumab based on gene expression.

“What is exciting about these data is that we are going back to look deeper at the genomic makeup of tumors in the APHINITY cohort to better understand how these cancers respond to therapy,” said Ian Krop, M.D., Ph.D., Associate Chief, Division of Breast Oncology at the Dana-Farber Cancer Institute, Associate Professor of Medicine at Harvard Medical School, and first author on the poster. “It reveals interesting trends that need to be studied further but could ultimately provide information to make more precise treatment decisions right at diagnosis.”

With further research, this trend could offer HER2+ breast cancer patients and their doctors early information at the beginning of their journeys that could help them define the path ahead.

“The findings from the APHINITY trial are encouraging and warrant further investigation to see if offering genomic profiling to clinically HER2+ patients routinely could have a meaningful impact on their outcomes,” said Adam Brufsky, M.D., Ph.D., Medical Director of the Magee-Womens Cancer Program, part of the UPMC Hillman Cancer Center, and Professor of Medicine at the University of Pittsburgh School of Medicine.

These data are part of a large suite of 13 posters, spotlight sessions and an oral presentation on MammaPrint and BluePrint that were accepted to SABCS 2020, and underscore Agendia’s mission to help guide the diagnosis and personalized treatment of breast cancer for all patients throughout their treatment journey.

About Agendia

Agendia is a precision oncology company headquartered in Irvine, California, committed to bringing early stage breast cancer patients and their physicians the information they need to make the best decisions for the full treatment journey. The company currently offers two commercially-available genomic profiling tests, supported by the highest levels of clinical and real world evidence, that provide comprehensive genomic information that can be used to identify the most effective breast cancer treatment possible for each patient.

MammaPrint^®, the 70-gene breast cancer recurrence assay, is the only FDA-cleared risk of recurrence test backed by peer-reviewed, prospective outcome data and inclusion in both national and international treatment guidelines. BluePrint^®, the 80-gene molecular subtyping assay, is the only commercially-available test that evaluates the underlying biology of a tumor to determine what is driving its growth. Together, MammaPrint^® and BluePrint^® provide a comprehensive genomic profile to help physicians make more informed decisions in the pre- and post-operative treatment settings.

Agendia develops evidence-based novel genomic tests and forges partnerships with groundbreaking companies to develop next-generation digital treatment tools. The ongoing research builds an arsenal of data that improve patient outcomes and support the evolving clinical needs of breast cancer patients and their physicians every step of the way, from initial diagnosis to cancer-free.

Agendia’s assays can be ordered on core biopsies or surgical specimens to inform pre- and post-operative treatment decisions. For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com.

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Contact information

Terri Clevenger
Westwicke/ICR Healthcare PR
Tel: 203.856.4326
Terri.Clevenger@icrinc.com