Perspectives for effective cancer drug development: The EORTC SPECTA Initiative

Bookmark and Share
Published: 26 Jun 2014
Views: 3039
Rating:
Save
Dr Denis Lacombe - EORTC, Brussels, Belgium

Dr Lacombe, director of the European Organisation for Research and Treatment of Cancer, talks to ecancertv about the SPECTA (Screening Patients for Efficient Clinical Trial Access) initiative at WIN 2014.

What brings me to the WIN symposium is really the possibility to exchange so many great ideas and new ideas, emerging ideas and see actually how we can collaborate and increase the capacity of what we are doing because today things are not possible any longer in silo and knowledge and capacities have to be exchanged, certainly.

What is the EORTC SPECTA initiative and why is it needed?

The EORTC SPECTA Initiative, actually SPECTA stands for screening patients for efficient clinical trial access. Basically we created it because there is no initiative currently in Europe, so pan-European and across tumour types, that would gather patients for profiling for their genotype and offer access to clinical trials. So we really built this initiative to maximise patient access, again, across tumour types and at a pan-European level, in order to address efficiently in a timely manner clinical trials in subsets of patients.

Could you briefly summarise what the EORTC SPECTA is currently doing and the status?

The initiative we started with five tumour types so we have five platforms. The first one addresses colorectal cancer and it’s up and running. We currently have about 250 patients that have already consented with a very good tissue submission, biological material submission rate over 80%. So it demonstrates that it can work internationally, despite the fragmented environment of Europe. We have four other platforms that follow very rapidly in melanoma, in neuro-oncology and in lung cancer and the last one will be in prostate.

Why have you chosen those particular tumour types?

We have chosen these tumour types because it was a matter of compromises and interest in terms of feasibility: where there is a need, where our network is ready to take such complex approaches, think differently. So I believe these tumours were a good compromise at a European level for the organisation to get started. It doesn’t mean that this is an end; if we are successful we will certainly continue beyond these tumour types.

Can you explain what one of these screening platforms actually involves?

What happens is once patients have consented, so their tumour, but it can be extended, of course, to also blood. It’s centralised in a central biobank where quality control of the biological material is performed. We proceed according to very specific and consistent, so high quality assurance, protocol to the extraction of nucleic acid. From there potentially we test biomarkers of interest for potential entry into clinical trial but what we offer is an opportunity for all the patients to benefit from next generation sequencing and try from there to push a little bit better our knowledge and see what we can offer with these new technologies. So it’s at the same time a platform for immediate clinical trial entry based on known biomarkers or emerging biomarkers but also a platform of research for the next generation sequencing possibilities.

What have been some of the challenges in setting up these platforms?

The challenges have been certainly things are much more difficult internationally because of the regulatory environment. So we know how to organise a prospective therapeutic clinical trial and the systems to challenging are made specifically for activating this type of trial. The regulatory environment is not made for activating, for conducting, platforms that do not have a priori therapeutic intent because we cannot guarantee necessarily access to clinical trials. So it’s changing the paradigm. I would say our ethics committees, are not necessarily primed, don’t have the full understanding of what it is today so that has been a challenge, I would say probably the greatest challenge. The second one is to convince the scientific community that, for instance, biological material has to be centralised, quality assurance, so that all of us have to leave a little bit our comfort zone and go more to mutualisation of efforts. This is something that needs to evolve and possibly, and that’s what we hope, is that an initiative like SPECTA will help actually the community to improve and to move more towards mutualisation of efforts.

What do you hope the EORTC SPECTA initiative will achieve?

The initiative is made for clinical trial access so we have given some room of observation. We have our metrics that we are targeting in terms of number of patients to reach, proportional to the prevalence of alterations we could be targeting. Of course, one of the major metrics will be the downstream access to clinical trials and how many patients will benefit from access to new drugs. So this is, of course, a work in progress and this is something we will have to monitor to ensure the success of this initiative. I think the initiative, what I would like to mention certainly, is that it also demonstrates and I hope it will serve the capacity to develop a new type of interaction, new types of partnerships across the stakeholders. We are very happy to have the active contribution of the European regulators, the European Medicine Agency, that really advise us in building this programme. So we are looking also at SPECTA as an infrastructure that will help build new forms of partnerships across the stakeholders.