US plans to speed personalized breast cancer drugs to market

Breast cancer cells. Image: Wellcome Library, London

Proponents of the I-Spy 2 mega-trial announced this week say it could shave 10 years and millions of dollars off drug development. Participants predict it will become the standard way of developing and testing new drugs in the future.

“Currently, it takes over $1 billion, 12 to 15 years, and thousands of patient volunteers to get a single drug to market,” according to the National Institutes of Health (NIH) Foundation. A consortium of agencies and companies – one of the largest ever -- aims to streamline that process during the course of a major new five-year breast cancer treatment trial. The I-SPY 2 trials will allow drugs to be assessed and approved faster and less expensively and with fewer patients, according to the NIH Foundation.

Three pharmaceutical companies, the Food and Drug Administration (FDA) and the NIH are collaborating on the $26 million experiment aimed at testing and bringing new breast cancer drugs to market. The trial will recruit women who are newly diagnosed with advanced breast cancer to test whether adding investigational drugs to standard chemotherapy is better than standard chemotherapy alone before having surgery.

Formed under the aegis of the Biomarkers Consortium, the study will use genetic testing to match drugs to individual patients. Five new experimental drugs will be tested at once and up to 12 drugs may be tested in all. The trials will proceed under an expedited FDA process which allows drugs to be dropped or added during the trial without having to start from scratch.

The companies will share information on using genes to predict how well a patient will respond. After giving tissue samples, patients at 17 cancer centers across the country will be matched to one of five experimental drugs based on the biological makeup of their tumors. The drugs will be given prior to any surgery to evaluate their effectiveness in preventing tumor growth.

“The I-SPY 2 trial explores a whole new way to rapidly screen new cancer treatments and match the therapy to specific markers,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “Developing individualized medicines needs a solution bigger than any one group can generate. The Biomarkers Consortium is a public-private collaboration of scores of organizations working together to achieve this critical mission.”

The new drugs to be tested include:

Abbott Laboratories’ ABT-888 (veliparib), a PARP inhibitor, which blocks a cell repair enzyme used by cancer cells.

Amgen’s AMG 655 (conatumumab), an APO/TRAIL inhibitor that causes cancer cells to self-destruct, and AMG 386, an angiogenesis inhibitor that prevents tumors from growing blood vessels which nourish cancer cells.

Pfizer’s CP-751,871 (figitumumab) which targets the insulin growth factor receptor or IGFR and HKI-272 (neratinib), a Pan ErbB inhibitor, which targets several receptors used by cancer cells.

Other big pharmaceutical companies are also supporting the trials. Safeway Inc., Johnson & Johnson, Genentech (a subsidiary of Roche AG) and Eli Lilly and Co. are contributing funding to the study.

The I-SPY 2 trial is recruiting women  with newly diagnosed invasive breast cancer to participate in the randomized trial. Women will be eligible for screening if their tumor is 2.5 cm or larger in size. Once accepted into the study, participants may or may not receive one of the new drugs.