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

Clinical research at Sarah Cannon UK

Dr Tobias Arkenau – The Sarah Cannon Research Institute, London, UK

So Sarah Cannon opened the phase I Drug Development Unit in 93 Harley Street last year and this is a twelve bed phase I unit with state of the art pharmacodynamics and pharmacokinetic research facilities and really focussing on opening clinical trials, early clinical trials, to give patients access to the latest and new compounds currently in research.

Welcomed or not? Resented or not? How has the reception been from this American model parachuting in to Harley Street?

It’s a process of scepticism in the first instance, but seeing that this model works, being now one year in practice, and seeing that we can recruit patients with quicker set-up, we are very professional and have a great team, people who were sceptical before are excited and want to collaborate now. So definitely we’ve done this one year good journey and could convince people that this is a model.

How many phase I trials have you got running at the moment and how many patients have you put into trials this year?

We have four phase I trials open at the moment and another ten in our pipeline. For a one-year period it’s quite impressive times. These are not all the first and then the latest compounds but we have to show that we’re doing things properly at the beginning. We put several patients on clinical trials; just for one example we had a trial open for two months where we recruited eleven patients for screening and put five patients on clinical trials.

And you’re linked with University College, London, tell us about that?

Yes, to do really early drug development and really meaningful drug development and give patients a chance to have their tumours assessed for biomarker development you have to really have, today, a link with academic centres. And our partners, Chris Boshoff’s, team, Hilary Calvert at University College of London, are great supporters and collaborators.

How do you handle this issue of tissue, access to tissue and informed consent and ethical committee approval and so on? How do you physically do that?

We’re in the area of targeted therapies and you want to make sure you hit the target and you want to really make sure that patients benefit from these new compounds. I’ll give you one example - in melanoma, for example, we have certain mutations, 50% of patients have a certain mutation called BRAF and a drug developed, or two drugs currently in development, really working only in drugs with these gene mutations, you really have to test these in patients before and this is going into the direction of personalised medicine.

But how does the SCRI, which is not an academic institute with a pathology lab, presumably, how do you handle the…? Because this is sometimes where this falls down; you need to give an informed consent form to the patient, you have to tell them what’s going to happen with their tissue.

Absolutely.

And who is going to get it, so how do you do that?

As part of the clinical trials, often you have support by a lab, so it’s part of the clinical trials. In parallel, and it’s very important you asked this question, is Sarah Cannon and UCL are currently building a molecular profiling lab next to the Cancer Research Institute. This will be a lab on 10,000 square feet and to really test patients before they actually go on trial to give them a print-out of the most common mutations or loss of tumour suppressor genes, and really making sure patients have a list and we can then decide to put them on the right clinical trial. We have shown here at ASCO that, for example, MD Anderson showed this, that patients who are selected, who have a target and selected for the right drug do much better than just put on a phase I trial.

Jonathan Ledermann was saying that the facility is available to the National Health Service patients as well, how does that function?

Our unit is a stand-alone phase I, phase II, early clinical trials unit and we are set up, accredited by the Quality Care Commission. And private patients, but also NHS, can come to us because we are doing clinical trials, they are not paying to come to 93 Harley Street, they are covered by clinical trials insurance, by the Hospital Corporation, America Insurance and obviously the private insurance of the investigators. So patients can come from the NHS.

So how do they get to know about you?

We have a website which is sarahcannonresearch.co.uk, so they can actually see our trial portfolio, trial menu. Patients can only be seen at our site if they’re referred from a specialist, so they can’t self-refer, which is very important to make sure that you have a process in place that not everyone comes from various places. So they have to be referred. So this is really on our website where physicians can download these referrals and pass on. We send, on a weekly basis really, our trials portfolio to our collaborating physicians; it’s a group of nearly two hundred oncologists, haematologists, clinical oncologists, who are informed what kind of trials are coming up. So it’s really the patient can, and this is really if you have new therapies available like the BRAF or MEK inhibitors for melanoma, patients today search Google and find us in this way.

So patients can come to you via Google?

They would find us on Google but obviously they need to liaise with their physician and get referred.

I think it’s a really, really interesting experiment and I think it’s still clearly in its adolescent period and I very much hope that it works out because we need to have variation in the system in the UK. And I think if it works out in the UK, which will have to be the most difficult test bed for you as Sarah Cannon Research Institute United States of America, then perhaps across the Channel there are opportunities awaiting.

Absolutely, and it’s an attractive model. Just our track record could already show that the process to set up a clinical trial, it’s not the Research Ethics Committee, they really have their acts together, the MHRA, they are fantastic, they have six to eight weeks, their time length where they really approve clinical trials. It’s a big problem in the National Health Service is the R&D; the R&D is not meant to do clinical trials, to set up clinical trials. I actually foresee even more concern with the financial restrictions the NHS is facing, that these R&D offers actually will take much longer to get clinical trials open. It can’t be that you have clinical trials open in three to four, and five, six months, that’s impossible for sponsors, you make yourself very unattractive as the UK market. So it is important to have processes in place and we’re very lucky that our whole set-up, R&D set-up, sits at our headquarters in Nashville, Tennessee with three or four hundred people doing nothing else than setting up these clinical trials in a time of three to four weeks’ time. So we really could show this now that you get trials open in eight weeks’ time. And it’s not about the UK being a slow market or it’s the Research and Ethics Committees and MHRA.

I wish you well, Toby, and maybe in ASCO 2012 you’ll come back and tell us how you’re getting on?

Great, thank you so much.