Agendia Achieves Historic Milestone of Enrolling 10,000 Patients in FLEX, the Largest-Ever Prospective, Real-World-Evidence Trial for Patients With Early Stage Breast Cancer

Company to present multiple recent Registry sub-studies driving cancer care innovation at ASCO 2022

Agendia, Inc., a commercial-stage company focused on improving outcomes for breast cancer patients worldwide by providing physicians and patients with next-generation diagnostic and information solutions to inform optimized treatment decision-making, today announced 10,000 patients have been successfully enrolled in the FLEX Registry. Agendia’s unique FLEX Registry is a real-world, large-scale, prospective, observational breast cancer study (NCT03053193) intended to enable the discovery of novel genomic profiles to improve precision in the management of breast cancer.

The FLEX Registry’s groundbreaking approach to cancer research is accelerating impactful data generation with its patient-centric design and national network of participating sites, allowing its investigator-initiated sub-studies to produce critical results that drive science forward. Six posters based on data from FLEX will be presented at ASCO 2022, one of which will be a poster discussion session.

“When we developed the idea for FLEX, we knew it was essential for breast cancer care but did not immediately expect this high level of engagement of the medical community in this real-world data trial,” said Bastiaan van der Baan, Chief Clinical and Business Development Officer at Agendia. “Because we blazed this trail, we are ahead in data collection and already producing actionable insights. We are so proud of the FLEX Registry, which allows not only for the gathering of whole transcriptomic data from valuable tumor samples, but also expands the power of genomic insights to physicians practicing in their communities. We look forward to further partnering with physicians to continue this valuable work, and believe FLEX will advance cancer care for the better.”

Since its launch in April 2017, FLEX has enrolled patients at greater than 90 global study sites, including ten National Cancer Institute-designated comprehensive cancer centers. Participating sites also include community hospitals to ensure inclusion of diverse populations, especially those which are often underrepresented in traditional clinical trials. Additionally, the FLEX collaborative platform allows participating investigators the opportunity to author their own sub-study protocols, as approved by the FLEX Scientific Review Committee. To date, 38 investigator-initiated sub-studies have been approved, resulting in 30 published abstracts at major oncology conferences, including those to be shared at ASCO 2022.

“The massive dataset provided by the FLEX Registry has the potential to be one of the most impactful and representative prospective breast cancer studies in recent history,” said Cynthia X Ma, MD, PhD, oncologist and FLEX national principal investigator at Washington University School of Medicine in St. Louis. “Not only will the data from FLEX be valuable to clinicians like myself, but to the millions of women with breast cancer seeking clarity, guidance, and evidence-based research throughout their journey. The broad and inclusive nature of FLEX translates into findings beyond data collection, allowing for several ongoing sub-studies to be conducted to uncover new, meaningful insights to inform personalized, precise breast cancer treatment plans.”

The FLEX Registry has yielded potentially practice-changing data across a wide variety of questions researchers seek to answer about breast cancer. These include:

• Insights from multiple sub-studies which showed clinical and molecular differences between tumors of African American and Caucasian patients with HR+ breast cancer;
• An age-related sub-study of ER+ breast cancers from women over 50 compared to those 50 and younger showed there is no substantial difference in gene expression, suggesting any observed differences in response to therapy are determined more by genomic features than by age; and
• A molecular subtype sub-study showed the gene expression patterns of high-risk ER+, BluePrint^® Basal breast cancers are much more like IHC triple negative breast cancers than other ER+ cancers.

“It is truly remarkable how rapidly the FLEX Registry was able to enroll 10,000 breast cancer patients especially in light of the COVID-19 pandemic, signifying the uptick in clinical momentum to better understand the real-world impact of genomic differences among women with breast cancer,” said Joyce O’Shaughnessy, MD, Director, Breast Cancer Research, Baylor University Medical Center, Texas Oncology and the US Oncology Research Network in Dallas, TX. “Under a shared vision to improve patient outcomes via personalized treatment planning, Agendia, in partnership with clinicians and researchers, is leading the charge to capture robust and valuable data that has the potential to change the breast cancer treatment paradigm for women of all backgrounds and genomic subtypes.”

Open to both women and men diagnosed with stage I, II, or III cancer, including all clinical subtypes, the dataset aims to be a true representation of the entire patient population. By capturing data from patients of all ethnicities, ages, genders, and health statuses, the FLEX database provides valuable opportunities to accelerate real-world breast cancer research and has the ability to enroll less prevalent patient populations on a larger scale. This enrollment strategy enables further investigation and the potential to provide targets for treatment optimization for those patients. FLEX is currently recruiting patients for sub-studies, including one prospective study that aims to assess treatment response differences of ER+ Basal-Type tumors, in comparison to Luminal tumors, to DNA-damaging neoadjuvant chemotherapy regimens.

“We’re extremely proud of this landmark achievement that brings us closer to meeting our 30,000-patient goal for total enrollment in the FLEX Registry,” said William Audeh, MD, Chief Medical Officer at Agendia. “At Agendia, our main goal with FLEX is to utilize the extensive genomic information present within each breast cancer to better understand the differences between breast cancer subgroups, in both clinically-defined subtypes and diverse patient populations. The genome-level insights we obtain are connected to clinical data and help us understand differences in response to therapy and outcomes. In designing FLEX’s wide inclusion criteria, we’re enabling researchers to access critical genomic data in a pooled database from many centers — data that otherwise would have been challenging to gather via recruitment in standard clinical trials. This approach furthers our collective understanding of tumor biology, providing more specific insights to support treatment planning decisions for women with breast cancer.”

After more than five years of collecting data, the FLEX Registry approaches a critical new phase of research in which Agendia will be able to generate outcomes-based analyses, develop interventional sub-studies, and extend the potential utility of liquid biopsy testing. With its centralized database, the FLEX Registry could be positioned to yield full transcriptome data to determine gene expression characteristics of tumors on a large scale, translating and qualifying these observations into clinically meaningful takeaways to help advise women with breast cancer throughout treatment planning.

About Agendia

Agendia is a mission-driven, commercial stage company focused on enabling optimized decision-making by providing physicians with next-generation diagnostic and information solutions that can be used to help improve outcomes for breast cancer patients worldwide. The company currently offers two commercially-available genomic profiling tests that help surgeons, oncologists and pathologists to personalize treatment for women at critical intervention points throughout their patient journey.

MammaPrint^® is a 70-gene prognostic test that, along with other clinicopathologic factors, determines a specific patient’s breast cancer recurrence risk. BluePrint^® is an 80-gene molecular subtyping test that identifies the underlying biology of an individual breast cancer to provide information about its behavior, long-term prognosis and potential response to systemic therapy. Together, MammaPrint^® and BluePrint^® provide a holistic view of an individual patient’s breast cancer, enabling physicians to objectively select the best treatment plan.

For more information on Agendia’s assays and ongoing trials, please visit www.agendia.com.

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