The promise that personalized cancer treatment holds is that patients can be treated as individuals, not merely as members of a “population”. Current believe is that future cancer treatments will be truly based on the actual biology of the disease. But what is personalized cancer treatment? And how does that translate into best practices for clinical development?
Certainly molecular medicine has boosted research and development in oncology. Many new cancer targets and pathways have been discovered. These new targets and pathways drive the discovery and development of new anticancer drugs.
Unfortunately, many anticancer drugs still fail to make it to the market. First of all, reality teaches us that many drugs with promising anticancer activity in mice, fail in men. In a recent article in Nature, Glenn Begley and Lee Ellis have confirmed the low number of pre-clinical studies that have been converted into clinical success, and the authors conclude that a major factor is the overall poor quality of published preclinical data. A warning sign, they say, should be the “shocking” number of research papers in the field for which the main findings could not be reproduced. Thus there is a high need for better predictive and reproducible preclinical models. But at the same time we need to move forward and test new anticancer drugs in men.
Ideally, trials based on personalized cancer treatment should include patients that are most likely to respond and exclude patients that are pre-disposed to toxicity. However, discussions about optimal trial designs for trials with new agents are ongoing. On another note, do we need to study new targeted (personalized) drugs in patients or in healthy volunteers in the early stages of development? As discussed in an article by Iwamoto and others, development of noncytotoxic oncology therapeutics has opened the opportunity for clinical investigation beyond cancer patients. Utilization of the healthy volunteer population has provided valuable safety, pharmacokinetic, drug interaction, and pharmacodynamic data that have greatly aided oncology clinical drug investigation. However, healthy volunteer studies and application of these data have not yet been optimally employed.
I will be presenting a talk on the above topics at the 4th edition of the European Cancer Cluster Partnering (ECCP) meeting, November 11th 2012 in Hamburg. The ECCP meeting precedes Europe´s largest partnering event BIO-Europe 2012 also in Hamburg. If you are in Hamburg next month, visiting ECCP meeting or BIO-Europe do not hesitate to drop me an e-mail so that we can set up a meeting at the event.
C. Glenn Begley, Lee M. Ellis (2012). Drug development: Raise standards for preclinical cancer research. Nature 483, 531–533.
M. Iwamoto, R. Iannone and J.A. Wagner (2012). Use of Healthy Volunteers Drives Clinical Oncology Drug Development Decision Making. Clinical Pharmacology & Therapeutics 92, 571-574.