The TAPUR trial family: a global data sharing platform

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Published: 9 Jul 2018
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Dr Richard Schilsky - American Society Of Clinical Oncology, USA

Dr Schilsky speaks with ecancer at the 2018 WIN symposium about the TAPUR trial which is an ASCO trial of which there may be an inspired WIN version.

The goal of the TAPUR trial is to learn about signals of activity for marketed drugs used off label, in tumour types which have a specific genomic alteration.

The potential of universal trials similar to the TAPUR trial could lead to a lot of useful data sharing.
 

The TAPUR trial, of course, is not a WIN trial, it’s an ASCO trial that we launched 2½ years ago, the goal of which is really to learn about signals of activity for marketed drugs used off label in tumour types that have a specific genomic alteration that is a drug target. It’s a large prospective multi-basket phase II trial. It’s running just in the US but it has inspired now versions of the study that are now running in other countries around the world. So in the US the trial has enrolled over 950 patients at 113 different locations and we’re beginning to generate some data from the study. But there is now a version of the study that launched about six months after the ASCO TAPUR trial called the DRUP study that’s running in the Netherlands that is also generating some very interesting data.

There’s a third study that launched at the end of 2017 in Canada called the CAPTUR study, which is also based off the TAPUR protocol, which is just now beginning to enrol patients. We are working on developing a WIN version of the TAPUR study that would then run in the WIN member institutions which are located on four continents around the world. So if we’re successful in doing that we really will have a global family of studies all based on a common protocol that has common objectives, common endpoints and very similar statistical designs. We are already developing a plan for how we’re going to share data among all the active studies so that we can learn more quickly and more reliably about the effectiveness of different drugs used in different tumour types with different genomic alterations.

But the nature of the trial is also in line with the missions of WIN

Absolutely. WIN, of course, was conceived as a global translational research consortium, that’s exactly what the TAPUR trials are trying to accomplish. The fact that the study that we began in the US sponsored by ASCO has inspired similar studies around the world just speaks to the interest in learning from genomic profiling of cancers and how that translates into potentially effective therapies for patients. Of course, one of the real values that the WIN Consortium brings into this whole discussion is access to populations all around the world because we know that the prevalence of different tumour molecular subtypes may differ in different ethnic populations, that the effectiveness of therapies may differ in different populations around the world. So the only way we’re going to really understand how best to use even the drugs that are already available to us but in broader populations is through a global collaboration.

Which discussions caught your attention from the WIN meeting this year?

There’s always a lot of interesting discussion at these meetings and I was particularly pleased with how engaged the audience is this year with lots of good questions. What we’re all struggling with in some ways is how to move the field beyond just single agent therapy that’s matched to some genomic marker. It’s clear that although those approaches can be effective, they’re of limited effectiveness for limited duration. What we need to do is move to combinations .We heard a wonderful talk just this morning from Yosef Yarden about tumour networks and the approach that may need to be taken with three or more drugs to really collapse the network that keeps the tumour going.

That’s exactly where WIN is going now as well with our SPRING trial in non-small cell lung cancer where we’re beginning to put together three targeted drugs in a rational combination in order to get the maximum potential benefit for patients and, in so doing, not only evaluate the effectiveness of the therapy but the effectiveness of a predictive algorithm developed by the WIN Consortium known as the SIMS algorithm which is really designed to navigate patients to the therapy or the drug combination that’s most likely to work in their particular case based on the unique molecular features of each person’s tumour.

The other thing that we heard expressed very eloquently yesterday by Laura Esserman in the panel discussion is that we need to think differently. That we can’t be mired in dogma, we can’t stick to outdated principles, we have to follow the science and we have to be a little bit disruptive in the way in which we conduct research because we still have too many unanswered questions.

We have more tools than ever before, we also have more drugs than ever before and an almost infinite number of drug combinations that could be studied. So we need to be more efficient, smarter and we need better preclinical models so that we can only advance into the clinic the things that are the most promising. Then we need to get the clinical trials completed as efficiently as possible in order to be able to bring these new therapeutic approaches to patients.

Do you have any final thoughts?

I would only say that, first, I’m deeply honoured to have been selected to take on the Chairmanship of the WIN Consortium. I think it’s a very exciting time for the consortium. There’s growing interest amongst the members in the studies that are being launched and enthusiasm for the future and I’m optimistic that WIN will, in many ways, be paving the way for how clinical trials of the future should be done.