Huge excitement has greeted the launch of an innovative clinical trial model which will test several investigational breast cancer drugs at the same time from a number of different pharmaceutical companies.
The Biomarkers Consortium, a public-private partnership whose 50 members includes the US Food and Drug Administration, the National Institutes of Health and major drugmakers, has launched a trial that uses biomarkers from individual patients’ tumours to screen promising new treatments. The I-SPY 2 study will see all patients (about 800) receive the current standard of care and most will also get receive one investigational drug.
The most striking feature of the trial is that it will screen “multiple drugs from multiple companies”, up to 12 different ones over the course of the trial. The Consortium notes that the FDA will allows the I-SPY 2 team to “graduate, drop and add drugs seamlessly” without having to stop the trial to write a whole new protocol. “This will dramatically reduce the time it takes to move from one drug to another in the trial,” it claims, and therefore increase its safety.
Five candidates currently in development have already been selected and will be donated by the companies “with each agent representing a different drug class or type of chemical mechanism”. They are Abbott Laboratories’ ABT-888 (veliparib), a PARP inhibitor, two Amgen drugs – AMG 655 (conatumumab), an APO/TRAIL inhibitor and AMG 386, an angiogenesis inhibitor – and two from Pfizer; CP-751,871 (figitumumab), an IGFR inhibitor and HKI-272 (neratinib), a Pan ErbB inhibitor.
The Consortium added that a goal of I-SPY 2 “is to shave several years and hundreds of millions of dollars off the current process”, which takes over $1 billion, 12 to 15 years, and thousands of patients to get a single drug to market.
I-SPY 2 is expected to cost approximately $26 million over five years and the cash will come from a variety of sources. The supermarket giant Safeway “has stepped up as a significant seed funder”, the Consortium notes, and “major foundational investment” has also been secured from Johnson & Johnson. The project is being developed in part with funds from Roche’s Genentech and Eli Lilly.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said that “developing individualised medicines needs a solution bigger than any one group can generate”. She added that the Consortium is “a model for the future”.
