US Implements I-Spy2, A New Breast Cancer Treatment Study

A new treatment study has been initiated by the US government, and pharmaceutical companies and researchers that aims to treat aggressive breast cancer. The study named ‘I-Spy2’ involves using patients’ own tumours to reveal a course of treatments that are best suited from their own genetic markers.

Researchers will use the results of this study to develop phase III trial drugs might be more useful for patients later in the trial, and eliminate ineffective treatments more quickly.

The Biomarkers Consortium, a unique public-private partnership that includes the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH), and major pharmaceutical companies, led by the Foundation for the National Institutes of Health (FNIH), is spearheading this large-scale trial.

“I-SPY 2 promises to leverage convergence of progress on a number of research fronts to speed the evaluation of promising new breast cancer drugs using molecular cancer biomarkers to identify those agents that are effective in specific subpopulations of breast cancer patients,” said Anna D. Barker Ph.D., Deputy Director, National Cancer Institute, and Co-Chair of The Biomarkers Consortium Cancer Steering Committee. “This will allow us to finally design advanced, smaller and less expensive Phase III trials that test the right drugs in the right patients.”

Currently, the timelines to bring a single drug from the laboratory into a pharmacy is about 12-15 years and requires over $1 billion of investment and thousands of patient volunteers. The innovative trial design for I-SPY2 promises to significantly shave off millions of dollars of investment, reduce the number of patients involved and also reduce the number of years involved in drug development.

The I-SPY 2 trial will focus on treatments in which patients receive chemotherapy to reduce tumour size before surgery. Five new experimental anti-cancer treatments which are being developed by three major pharmaceutical companies will be tested as part of the study, which is expected to cost 26 million dollars over five years.

Written by Snigdha Taduri