WIN 2011, 6-8 July, 2011, Paris

Designing clinical trials, sharing information and combination therapy

Dr John Mendelsohn – University of Texas MD Anderson Cancer Center, Houston, Texas

This is an exciting meeting for me because it is a new format: we have invited researchers from industry to appear on the same panels and take turns giving talks with the researchers from academia and I’m finding that we share a great deal in common. The people from industry at this meeting are opening up and showing the rationale for what they are doing, talking about different drug doses, talking about pre-clinical models, talking about how to more rapidly detect markers that would be useful in deciding which targets might be good for developing a new drug and it’s a very open discussion. What’s encouraging to me is this is an idea we had, the planning committee had, which will move things forward faster. We’re all after the same goal, really, and we all have learned how difficult it is to achieve what we want to achieve, so sharing information between academia and industry is very exciting.

Do you feel that combination therapy will play a prominent role in the future treatment of cancer patients?

We’ve learned in the past few years that if you are targeting the right target, and you don’t always know it’s the right one, that even in phase I, giving the drug for the first time to patients with this particular genetic abnormality, aberrancy, we can get response rates of 50% or even higher that are durable for many months; no cures, but certainly very nice responses. The fact that the patients escape eventually suggests what we knew already from all of our model systems and our previous experience: it’s going to take combinations of two, three or maybe even four drugs for most types of cancer to get durable prolongation of life and hopefully cures. The challenge is to decide on the right combinations and then to work through the regulatory requirements and the natural desire of industry to protect its own intellectual property and get these trials going. And this morning we heard of three examples where two different companies got together and agreed to take new unapproved drugs and work with them together, based on pre-clinical information that suggested this should be a rational combination. That’s a huge step forward, I’m very excited about that.

Is there a risk in using multiple drugs for treatment?

We’re always balancing risks and industry is beginning to feel that the risk of reaching out and doing combination therapy early is less than the risk of just losing out on a drug because it only works in a very small percentage of patients if given alone. We’re always balancing risks and benefits in treating cancer and in developing new treatments.

How has the WIN symposium made an impact thus far?

WIN is a group of academic medical centres that carry out cancer research and industrial sponsors and technology sponsors and some patient advocacy groups who are getting together with a major purpose of designing clinical trials that allow us to study new drugs on a very diverse population, probably five different continents; we have now membership on four and I think it will be five soon. The reason for this is that while we can test a patient’s tumour in great detail and determine the genetic aberrations that we’d like to target with a new therapy, there are issues with the patient who has the tumour, their genetic make-up, how they handle the drug, what their inflammatory response is to the tumour; the microenvironment around the tumour may vary from one type of patient from another type of patient and we don’t know how to query that in a genetic sense yet. So we can at least say it would be intelligent to check people from China and India and the Middle East and Europe and North America and South America and Australia because that allows a diversity of genetic make-up in the patient who has the tumour and we will not lose a chance of finding a drug that might be effective in one diverse population but not another. So that’s why WIN was actually set up along with the second goal of holding a conference like this every year where we bring together all of the stakeholders and peer through different lenses and try to speed up this process.