IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--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
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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
