ASCO 2011 Annual Meeting, 3—7 June 2011, Chicago

Research from the Sarah Cannon Research Institute

Dr Howard (Skip) Burris – The Sarah Cannon Research Institute, Nashville, USA

Skip, thanks very much indeed for coming on ecancer.tv for, I think, the second time.

It is.

You’re here in strength and in force, I have to say, because in the year since we met you’ve done God knows how many trials, fifty or something like that, and you’ve got 53 presentations here.

We do, it’s been a great meeting.

Covering what sorts of things? From phase I through to phase III?

The trials are covering the gamut, we go from… we had more than a dozen phase I presentations and then we had a number of phase IIs and a few phase IIIs. The tumour types went from all comer populations in phase I to trials that were in breast, kidney cancer, melanoma, lung cancer, both non-small cell and small cell, brain tumours; so really a variety of different malignancies that we reported on.

You’re bottom up driven, are you?

We are.

You’re at the top, so how does that feel, not having control?

In terms of what drugs come into the process? I think it’s interesting, nowadays the drug development process has become more complex; hopefully that will work out to be better for the patients as we’re looking for the specific patient, that mantra of the right therapy for the right patient at the right time seems to be coming to a realisation. And then certainly encouraging former biotech to do the trials that are necessary to advance the science.

A bit of resistance still?

From former biotech? I think the investment, both the investment in time, energy and risk as well as the financial investment is considerable. I think the length of time that it takes to get a drug approved has gotten difficult to do the right studies and it comes back to the patent position. I think one thing I will say about the European authorities is that no matter how long it took you to get the drug developed, in Europe you’re guaranteed at least ten years of exclusivity. In the United States it’s five years; I don’t know what the right number is but five years is an awfully short period of time to be exclusive. So that creates some pressure around developing drugs.

And I can assure you companies are just as risk adverse in Europe as they are in the United States, that’s a global issue. People are preaching the personalised medicine story and finding the target and doing the genetics and then getting the drug out of the cupboard, I still see a lot of trials that don’t do that. Is that your experience too in the SCRI trials?

It is. I think we probably have four out of five studies, 80% still are for unscreened patient populations. And some are done retrospectively, which is certainly not the right way to go about it. So it remains an issue. I think getting tissue from the patients, it needs to be organised from the beginning. Hopefully we’ll get to a place when a cancer patient is diagnosed we’ll think about it from day one and get that patient profiled.

Is this an education issue? Doctor education or patient education?

I think a little bit of both. I think the patient needs to know the right questions and to push the story. I think when you get diagnosed with cancer your first thought is to get rid of it and not to think about the long-term complications and issues. For the doctors an awareness that it can make a difference. Right now, many of these therapies are available only through clinical trials but the drug development process is such that I think now, during this next year, we’re going to have one or two new therapies for melanoma approved and it’s going to make a difference what type of melanoma you have.

Yes, absolutely. Do you have problems with informed consent and from the ethics side of things?

I think informed consent has become… it’s interesting, the idea was to simplify and inform the patient; the things that are required to be put in the informed consent actually make it quite a complex endeavour sometimes. So I think we want the patient to know everything and at the same time medical school is a long process and a lot of training and to try and impart all that knowledge to a patient to sign a consent form can be difficult. So it would be nice to see some standardisation and simplification. I think the patient just wants to know that we’re thinking about their safety and that what we’re doing is ethical.

Interesting, one of my last PhD students was looking at the ethics of phase 0 trials and, alongside that, phase I and phase II and her conclusion as an ethicist was that phase I trials are unethical, phase 0 trials are completely ethical. Because in phase I trials the doctor can’t stop himself, whether by body language or by anything else, saying there might be a little bit of hope for you in this trial and that’s unethical because there shouldn’t be. So it’s interesting.

Well it’s an interesting point. You know, there was an abstract here presented by MD Anderson that looked at 1,000 patients and their phase I experience and looked at those that had received some sort of profiling to see what trial they should go on. And it was very, very interesting, if you were selected for a trial based on something about your tumour, your odds of surviving longer, responding and having a better outcome were substantially better. So I think that’s going to be the happy ground for the ethicists on the phase I trial, is doing as much as you can to know the patient is getting on the right study.

I don’t think there’s any doubt that if you take more interest in the patient and the patient’s tumour, they’re more likely to be compliant.

Exactly.

But, as you’ve just pointed out, 80% of the trials are not doing this sort of technology there, for whatever reason, and I think we’ve still got to sort that, especially if we’re going to accelerate the timescale of getting drugs to the market. And we all need that, patients more than anybody. Now, tell me just for a minute or two about your venture into the United Kingdom – that looks, to me from sitting in Chicago, to be pretty hostile territory. But there you are, you’re going into the private sector in London and you’re putting up the flag and saying, OK, come here and get your phase I trials done. Well done you. Is it working, is it going to work, or is it too early?

No, I don’t think that it’s too early and I think it is going to work. I think that there are a number of new drugs that are worthy of exploration; I think that, incorrectly, former biotech has been a little concerned about the United Kingdom because NICE maybe hasn’t been so nice in terms of speaking about the economic considerations. The physicians there are outstanding, I think one thing that we’ve learned in the United Kingdom is even those physicians that are participating in private practice all have academic careers. In the United States that isn’t true, some doctors are university based, some are private based and very few have both. So we have been impressed with the quality of the physician, it’s a very well-educated and informed patient population and we think it’s actually an ideal setting. The Sarah Cannon infrastructure, our relationships with pharma biotech, have helped to streamline the process so there are engaged and interested physicians, there’s a good patient population and I’m very optimistic. We’ve got a number of friends from cross-Atlantic collaborations and I think we’re optimistic for it to be more of a partnership than a battle.

Too early to get any abstracts for ASCO, but 2012?

2012 definitely, we will have abstracts that will be presented from the site on Harley Street, there in central London, likely involving several of the new drugs. So that will be a very exciting time for us.

Good, I’ll interview you then, if you agree?

I’ll be happy to.

Thanks very much indeed.