US-based biopharmaceutical services company Quintiles has made a US$2.6 million contribution in support of I-SPY 2, the adaptive clinical trial with multiple cancer therapies that was launched last year in the US and Canada by the Biomarkers Consortium and QuantumLeap Healthcare Collaborative.

Quintiles will donate the funds over four years through QuantumLeap Healthcare Collaborative, a non-profit foundation and co-project manager of I-SPY-2, as well as joining the management consortium for the project.

“Multi-party collaboration, adaptive trial design, biomarker use and point-of-care data access are major steps in the right direction,” said chairman and chief executive officer Dennis Gillings. “Quintiles is proud to be part of this revolutionary effort.”

I-SPY 2 (Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging and Molecular Analysis) involves 800 patients with advanced breast cancer and 20 cancer research centres and institutional review boards across the United States and Canada. Its aim is to develop breast cancer therapies twice as quickly as, and at one-fifth the cost of, current methods. 

As things stand, development costs typically exceed US$1 billion and it takes 12 to 15 years to bring a single drug to market, Quintiles noted. I-SPY 2 employs an innovative adaptive trial design, as well as genetic and biological markers from individual patients’ tumours, to screen multiple investigational therapies in parallel, so that investigators can quickly get a measure of their effectiveness.

Adaptive design

Whereas in a conventional clinical trial, investigators will not see the results until the study has ended, the adaptive design in I-SPY 2 uses outcomes information from each patient as she progresses through the study to help shape the treatment plan for the next patient, without the need to halt the trial and write a new protocol.

It also allows for personalised treatment within predefined subsets of the disease, based on the patient’s tumour profile, Quintiles explained. Patients can therefore be assigned therapies shown to have an effect within their subset. 

Up to 12 different drugs will be tested over the course of the trial, including Abbott Laboratories’ PARP inhibitor ABT-888 (veliparib); two Amgen drugs – the APO/TRAIL inhibitor AMG 655 (conatumumab) 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 I-SPY 2 project is expected to cost around US$27 million in total over five years. Other than Quintiles, funding sources include non-profits such as the Safeway Foundation; for-profit companies such as Johnson & Johnson, Genentech and Eli Lilly; and private donors and foundations.

Collaborative input

The trial’s sponsor is the Foundation for the National Institutes of Health (FNIH), with collaborative input from the US Food and Drug Administration (FDA), the National Cancer Institute and 20 leading academic cancer centres.  

The Biomarkers Consortium is a public/private partnership between the FNIH, the US National Institutes of Health, the FDA and leading biopharmaceutical companies. Its co-project manager QuantumLeap Healthcare was established in 2005 as a collaboration between medical researchers at the University of California at San Francisco and Silicon Valley entrepreneurs. 

QuantumLeap Healthcare’s efforts are directed at accelerating the transfer of high-impact research in clinical processes and technology into widespread adoption, so that patients can benefit from the research as soon as is practicable.

Anna Barker, former deputy director of the NCI, an original designer of I-SPY 2 and a board member of QuantumLeap, welcomed Quintiles’ participation in the project, commenting: “As the leading biopharmaceutical services organisation, Quintiles brings the best in clinical trial management practices to this effort to dramatically reduce the time and cost of bringing new therapies to market”.

As the company “works with hundreds of biopharmaceutical companies and healthcare organisations around the world, it can help disseminate I-SPY 2 innovations”, added co-principal investigator Dr Laura Esserman of the University of California, San Francisco.