IRVINE, Calif. & AMSTERDAM, Netherlands (October 31, 2023) – Agendia, Inc., a global leader in innovative genomic technology and diagnostic tests, is collaborating with National Cancer Institute (NCI), part of the National institutes of Health and SWOG Cancer Research Network, funded by NCI, for a new clinical trial that will test the effectiveness of neoadjuvant immunotherapy for high-risk HR+ breast cancer patients.
SWOG Trial S2206 (NCT06058377) is a prospective, randomized, Phase III trial focused on the application of immunotherapy in patients with MammaPrint High 2 Hormone Receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Stage II-III Breast Cancer. This trial is sponsored by NCI and led by SWOG with participation of the National Clinical Trials Network (NCTN). Agendia’s MammaPrint gene expression profiling test analyzes 70 genes associated with breast cancer recurrence and classifies patients with early-stage breast cancer as having a low or high risk of distant metastasis within four categories: UltraLow, Low, High 1, and High 2.
Dr. Erin Cobain, MD, University of Michigan, will be the Principal Investigator of S2206. Also collaborating on the study is Dr. Lajos Pusztai, MD, PhD, Yale University Cancer Center, who serves as the SWOG Breast Cancer Committee Chair.
“We have known for many years that gene expression profiling tests such as MammaPrint can be used in the clinic to determine if chemotherapy treatment will improve the likelihood of cure for patients with estrogen receptor positive breast cancer,” said Dr. Cobain. “We now have emerging evidence to suggest that gene expression profiling may also help identify which estrogen receptor positive breast cancers benefit from immunotherapy treatment. The goal of this study is to further increase the likelihood of cure by delivering immunotherapy to the patients most likely to benefit based on the unique features of their tumor.”
The I-SPY2 trial observed that patients with Stage II/III ER+/HER2- Breast Cancer with a MammaPrint High 2 (MP2) result had a significantly increased rate of pathologic complete response (pCR) when treated with neoadjuvant chemotherapy combined with an immune checkpoint inhibitor. 1,2
“A subset of estrogen receptor positive breast cancers share many molecular and clinical similarities with triple negative cancers and has high rates of recurrence, despite best current therapies,” added Dr. Pusztai. “We are excited to launch a randomized clinical trial for these MammaPrint High 2 risk cancers aiming to further improve cure rates by adding immunotherapy to preoperative chemotherapy.”
In this trial, patients with MP High 2 results will be randomized to two study arms to test if adding durvalumab (NSC 778709) to neoadjuvant chemotherapy can increase pCR rates, shift residual cancer burden to lower values and improve invasive breast cancer free survival in HR positive MP High 2 breast cancers.
“The application of immunotherapy to women with HR positive breast cancer in S2206, using MammaPrint as the biomarker to identify those most likely to benefit, is a major step in our efforts to improve the care of women with high-risk HR positive breast cancer. The insights we gain from this landmark trial may well provide new and much-needed therapeutic options for these women,” noted Dr. Audeh. “We at Agendia are thrilled and honored to be partnering with SWOG and the SWOG investigators in such an important endeavor, seeking new data to support our collective goals of optimizing treatment and improving outcomes for women with breast cancer.”
The study aims to enroll 960 patients with MP High 2 results at SWOG member sites and other sites within the National Cancer Institute’s National Clinical Trial Network throughout the United States.
To learn more about the trial and enrollment criteria, visit www.swog.org. For more information about Agendia, visit www.agendia.com and follow Agendia on Facebook, Twitter, YouTube, and LinkedIn.
Agendia is a leading provider of innovative solutions in the field of precision oncology. With a focus on early-stage breast cancer, Agendia offers reliable biological insights that inform personalized treatment decisions for patients and their care teams. Their advanced genomic assays, MammaPrint® + BluePrint®, enable clinicians to quickly identify the most effective treatment plan, minimizing the risk of both under- and over-treatment.
Founded in 2003 in Amsterdam, Agendia is headquartered in Irvine, California with a state-of-the-art laboratory facility. Led by world-renowned scientists and oncologists, Agendia is committed to advancing genomic insights through ongoing research. This includes the notable FLEX Study– the world’s largest whole transcriptome Real-World Evidence-based Breast Cancer database which aims to revolutionize precision in breast cancer management. With cutting-edge technology, research and innovation, Agendia strives to shape the future of precision oncology and make a significant impact in the fight against breast cancer.
About SWOG Cancer Research Network
SWOG Cancer Research Network is part of the National Cancer Institute’s National Clinical Trials Network and the NCI Community Oncology Research Program and is part of the oldest and largest publicly funded cancer research network in the nation. SWOG has more than 18,000 members in 45 states and nine foreign countries who design and conduct clinical trials to improve the lives of people with cancer. SWOG trials have led to the approval of 14 cancer drugs, changed more than 100 standards of cancer care, and saved more than 3 million years of human life. Learn more at swog.org and follow us on Twitter at @SWOG.
- Nanda R, Liu MC, Yau C, Shatsky R, Pusztai L, Wallace A, Chien AJ, Forero-Torres A, Ellis E, Han H, Clark A. Effect of pembrolizumab plus neoadjuvant chemotherapy on pathologic complete response in women with early-stage breast cancer: an analysis of the ongoing phase 2 adaptively randomized I-SPY2 trial. JAMA oncology. 2020 May 1;6(5):676-84.
- Pusztai L, Yau C, Wolf DM, Han HS, Du L, et al. Durvalumab with olaparib and paclitaxel for high-risk HER2-negative stage II/III breast cancer: Results from the adaptively randomized I- SPY2 trial. Cancer Cell 39:1–10, 2021