- Data from the I-SPY 2 trial showed the first long-term survival results for patients pre-selected as MammaPrint high-risk, with 94% of the patients who achieved pathological complete response event-free at three years
- MammaPrint assessment is cost effective in clinical high risk patients compared to clinical risk assessment alone
- Additional data from MINDACT trial confirmed comparable outcome across all three age-groups including young patients
Irvine, CA, USA and Amsterdam, the Netherlands , December 12, 2017 / B3C newswire / -- Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, announces findings of three studies presented at the 2017 San Antonio Breast Cancer Symposium (SABCS) last week.
These studies demonstrate the important role that the MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test is playing in the pre-selection of patients for the I-SPY 2 trial, in achieving significant international cost savings and in adding to the limited evidence available for younger patients with breast cancer.
Pathological complete response predicts event-free and distant disease-free survival in the I-SPY2 TRIAL (Oral session GS3-08) (1)
The first long-term survival results from the I-SPY 2 trial for patients pre-selected by MammaPrint were presented. I-SPY 2 is a phase II neoadjuvant clinical trial designed to decrease the amount of time required to collect drug efficacy data. The results support the use of pathological complete response (pCR) as a primary endpoint for accelerated approval of new drugs.
Achieving pCR was a strong surrogate endpoint for improved Event Free Survival (EFS) and Distant Disease-Free Survival (DDFS) across all 11 treatment arms, regardless of molecular subtype. Patients who achieved pCR had an impressive three-year EFS and DDFS of 94% and 95% respectively. Based on these findings, the I-SPY2 TRIAL will now test whether therapy can be deescalated or escalated for individual patients with the goal of achieving pCR for all.
MammaPrint is cost-effective compared to clinical risk assessment in early stage breast cancer (Poster P4-12-01) (2)
A study evaluating prospective survival data from the MINDACT trial and US insurance claim data demonstrated that adding MammaPrint to clinical risk assessment is highly cost-effective compared to clinical risk assessment alone. When the cost of chemotherapy (and consequences) exceeded $30,000 MammaPrint was found to be cost-effective for the total early-stage breast cancer population. When the costs were below $30,000 MammaPrint is cost effective for patients with high clinical risk.
In the US, with approximately 250,000 new breast cancer patients per year and a cost saving of $3,342 per patient, annual budget savings were expected to be $836M. The MINDACT trial provided level 1A evidence to support the clinical utility of MammaPrint but cost-effectiveness data like these are important to inform reimbursement.
Young age and the risk of disease recurrence as assessed by the 70-gene signature – an analysis from the EORTC10041/BIG 03-04 MINDACT trial (Poster P1-07-08) (3)
Additional data from the MINDACT trial showed that not all young women with breast cancer are at high risk of disease recurrence. MammaPrint classified 48% of the 1,100 patients as genomic High Risk, compared to 61% using clinical risk assessment alone. The outcome for women with a MammaPrint Low Risk result within the three age categories of up to 45, 45-55 and 55 or over, was a five-year Distant Metastasis-Free Survival (DMFS) of 95-98%. These clinically-relevant results add important additional data to limited available evidence on genomic expression in young early-stage breast cancer patients.
Dr. William Audeh, Chief Medical Officer at Agendia, said: “These impressive data represent the highlights of eleven posters and discussions showcasing new MammaPrint and BluePrint data presented during SABCS this year, truly demonstrating the versatility and value of these tests. We are seeing the utility of using MammaPrint to pre-select patients for the I-SPY 2 trial in the shape of the impressive first long-term survival outcomes, plus encouraging cost-effectiveness data to support the level 1A evidence already proving the clinical benefits of the test.
“The continuing value of the unique, and independent MINDACT trial has also been demonstrated in additional data that will enable physicians to better support younger patients with breast cancer and tailor treatment based on genomic risk-of-recurrence, a group for whom further evidence was certainly needed.”
MammaPrint is an in vitro diagnostic medical device, performed in a central laboratory, using the gene expression profile of breast cancer tissue samples to assess a patients’ risk for distant metastasis. MammaPrint is cleared by the US FDA. The device is CE marked, enabling use in the European Union. MammaPrint is indicated for use by physicians as a prognostic marker only, along with other clinical-pathological factors. It is not intended to determine the outcome of disease, nor to suggest or infer an individual patient’s response to therapy.
Agendia is a privately held, leading molecular diagnostics company that develops and markets genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer tests were developed using an unbiased gene selection by analyzing the complete human genome. Our offerings include the MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test, and the BluePrint® Molecular Subtyping Test that provide deeper insight leading to more clinically actionable breast cancer biology.
In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology.
For more information on Agendia or the MammaPrint and BluePrint tests, you can visit Agendia’s patient site at www.KnowYourBreastCancer.com or the corporate site at www.agendia.com.
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Instinctif Partners (Agendia)
Ashley Tapp / Lynne Trowbridge / Samantha Cheung
+44 (0) 20 7866 7923
1. Pathological complete response predicts event-free and distant disease-free survival in the I-SPY2 TRIAL. Oral presentation at SABCS. December 2017; San Antonio, Texas.
2. MammaPrint is cost-effective compared to clinical risk assessment in early stage breast cancer. Poster presented at SABCS. December 2017; San Antonio, Texas.
3. Young age and the risk of disease recurrence as assessed by the 70-gene signature – an analysis from the EORTC10041/BIG 03-04 MINDACT trial. Poster presented at SABCS. December 2017; San Antonio, Texas.