My talk was based on a description of the current clinical trials landscape in Asia-Pacific. Actually during the talk I wanted to highlight the problems of the huge variation in clinical practice and drug accessibility in the region and how we develop a clinical trial network based in Asia. The countries involved are Singapore, Thailand, Taiwan, Hong Kong, Japan, Korea and China. We wanted to create a trial network based around these countries initially because these are the countries with a well-established clinical trial activity in the treatment of myeloma as well as a well-established clinical database or national registry. This effort was put together with a lot of assistance from the International Myeloma Foundation who also shared the same concern that drug access, especially in light of all these new drugs that have been approved in the last ten years, was an issue in Asia because despite the great improvement with all the new drugs in Asia we are actually getting access to these drugs either late, because approval is late, or in fact even when approval is there it was not easy to obtain because of the high cost of these drugs.
So we formed this network and we spent actually a couple of years establishing the contractual framework to actually allow us to do clinical trials together. We executed our first trial, started enrolling our first patients in our first trial, in December 2014. That was a trial using pomalidomide and dexamethasone in Asian countries. In two years we recruited 136 patients so that, first of all, showed that we can execute the trial, we can recruit patients in a fairly rapid manner and this is conducted in a multi-centre, multi-country setting which is something that hasn’t quite been achieved before in Asia. The results actually were presented in the American Society of Haematology meeting last year showing great response of about 50%. It’s very equivalent in Asia compared to the West but, more importantly, is that the median overall survival of these patients was more than a year. Essentially these are patients coming in the trial where they would essentially have no more treatment options in the Asian setting.
So this is great because it achieved one of our main aims which is to get early access to these new drugs and, more importantly, for free while they’re on the clinical trials they actually end up benefitting a significant number of patients. So, moving forward, having established the ability of us to do this, we have now actually lined up another three to four studies that will be opened in the course of this year, 2017, with another two in discussion that may come on in 2018. So this is really going great and these new trials will involve drugs like daratumumab, which is a new monoclonal antibody, will include carfilzomib, which is a very potent new proteasome inhibitor, and will also involve again pomalidomide in a randomised fashion. So, again, we’re venturing beyond just a single arm study as well; we’ll be conducting our first randomised study this year and also towards the end of this year or early next year one of the new trials will actually be looking at newly diagnosed patients as well. So we are really expanding the scope of the kind of trials that we are doing. The idea is really eventually we hope to have a trial that is suitable for patients in every single indication – newly diagnosed, young versus old, relapsed setting – so that we can actually, first of all, bring these drugs to Asia early on and allow our patients to have early access for free essentially. Also by doing this it allows us to generate the kind of data that is very often missing in global clinical trials where only a very small amount of Asian patients are involved. Certainly in these studies we have identified some unique side effects that may be much more common in Asian patients. So again this will inform subsequent practice in Asia and precautions, or the way to handle patients and drugs.
So this effort, we’re just at its infancy, we’re very hopeful that it will be something that will be sustainable in the long term and will establish Asia as a hub for pharma companies to engage with, to do clinical trials that hopefully will benefit our patients as well as importantly produce useful data that will inform clinical practice in the future as well.