Over the last 25 years, there has been an explosion of new and vitally important, anticancer drugs.
The development of these promising new therapeutic agents is generally based on preclinical and clinical research. In many cases, this research has, become prohibitively expensive. And only a relatively few investigational drugs have reached the market and successfully improved clinical outcomes in the treatment of patients with cancer and hematological malignancies. In the development of new therapies, the traditional clinical trial process of determining which drugs will ultimately benefit patients is long and expensive.
Over the last few decades scientists have tried to change – and improve - the way clinical trials are conducted. Their purpose… Improving the process and improving the way novel pharmaceutical drugs are being developed. But it still takes many years and huge investments to successfully bring a new drug to market.
But despite the huge efforts there is still a huge unmet medical need.
While there are many novel drugs being developed to help improve the outcome and improve survival, resources are limited. Optimal use of resources requires better understanding of cancer biology, the identification of novel therapeutic targets, and the ability to address inefficiencies in the cancer clinical trials system. This may especially be so in how we treat women with metastatic, high risk, breast cancer.
Based on the current limitations in how we conduct clinical trials, scientists of The Biomarkers Consortium, at the Foundation for the National Institutes of Health, are changing the way new anticancer drugs are being developed.
The Foundation’s unique and groundbreaking, re-engineered approach to clinical trials is the I-SPY Clinical Trial. This trial represents an unprecedented and streamlined method in developing new anticancer drugs. Using breast cancer treatment as a model - the I-SPY TRIALs are designed to significantly reduce the overall cost, time, and number of patients required to bring innovative anticancer agents to the right patient at the right time – and do this faster.
The I-SPY Trial Program integrates and links Phase I, Phase II and eventually Phase III clinical oncology trials to build a pipeline of novel anticancer agents. As a result, the new trial program accelerates the process of identifying a subset of high risk breast cancer patients that will directly benefit from these novel agents.
Among the targeted drugs being investigated in the I-SPY 2 trail are antibody-drug conjugates or ADCs. Antibody-drug Conjugates are part of a new wave of targeted antibody-based products. They are novel, innovative agents at the cutting edge of oncology and hematology.
During the Annual Meeting of the American Association of Cancer Research, held - April 16 – 20, 2016, in New Orleans, we sat down with Doctor Angela DeMichele, Professor of Medicine and Epi-demi-ology at the Perelman School of Medicine at the University of Pennsylvania.
We asked Doctor DeMichele a number of questions about a specific part of the I-SPY-2 trial in which researchers investigated a particular antibody-drug conjugate and how a combination of drugs, including antibody-drug conjugates, can bring a substantially greater proportion of patients to the primary endpoint of pathological complete response or PCR, an outcome in which, following neoadjuvant therapy, residual invasive cancer is detected in the breast tissue and lymph nodes during surgery.
And we asked her about the benefit of targeted therapy and how novel drugs like antibody-drug conjugates play a role.