Cancer Conference Update: A Multimedia Review of Key Presentations from the 2016 American Society of Hematology Annual MeetingAbstract 674: Intergroupe Francophone Du Myélome (IFM) Phase II study of the oral ixazomib/lenalidomide/dexamethasone (IRd) regimen before and after autologous stem cell transplantation (ASCT) followed by ixazomib maintenance in patients with newly diagnosed MM (NDMM)
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TRANSCRIPTION:
DR MIKHAEL: We’re very interested in providing more and more options for our patients, ones that are more convenient and ones that are still effective. Ixazomib/lenalidomide/dex has proven itself as a relapse therapy, of course FDA approved for patients with 1 to 3 prior lines of therapy. And this French study was looking at the feasibility of giving ixazomib/len/dex prior to and after an autologous stem cell transplant in eligible patients. And, no surprise, it’s a very well-tolerated combination that has an excellent response rate. It’s an all-oral combination, which makes it even more convenient for patients. The standard of care currently, more often than not, is bortezomib/len/dex. And in some of those patients, of course, they can have a neuropathy. And we hesitate in using it in patients with preexisting neuropathy and sometimes turn to carfilzomib/lenalidomide/dex. But with studies like this, I think it’ll be ultimately feasible for us to use ixazomib/len/dex not only in the older, frail patient who for many reasons may not go to transplant, but even in the transplant-eligible population. DR LOVE: I think a lot of people, as soon as they heard about — at least, I did — of ixazomib, I immediately started thinking about maintenance, because the longer-term therapy, oral versus IV really makes a difference. But are there Phase III trials looking at IRd? I mean, do you see this getting pushed into front-line therapy? DR MIKHAEL: I think we will see more and more of it in front-line therapy. Yes, there are various Phase III trials that are planned and one that’s ongoing in ixazomib up front based on this Phase II trial that the French did. I agree with you. It’s a very attractive partner for maintenance, which is why I think this study was designed to use ixazomib not only later on but right through the course, induction, in consolidation and, indeed, in maintenance therapy. And we’re seeing that phenomenon since ixazomib was approved here in the US, that, basically, in situations where people would have used bortezomib, be it up front or in maintenance, that they’re switching out for ixazomib. DR LOVE: One thing I’m always curious about in terms of your own clinical experiences, what have you seen in terms of tolerability issues with ixazomib? Early on, we heard about some GI problems that maybe were dose related. What are you seeing? DR MIKHAEL: I treat a lot of patients with ixazomib. And my general explanation to them is that the GI toxicity that comes with ixazomib is most pronounced in those first 3 pills. It’s weekly, 3 weeks out of 4. So we’re very aggressive in those first 3 weeks to ensure the patient’s well hydrated in advance just with oral hydration. We provide them antinauseants. We even provide them with antidiarrheals if they develop diarrhea. And I tell all of my patients, in fact, that if they can get through those first 3 doses, it’s remarkable how the body seems to adjust. And the subsequent months are much easier. And I would say 9 out of 10 patients have that experience. Now, there are some patients that continue to have GI challenges with it, but more often than not we’ve found that we can overcome those by month 2 or 3. And the majority of patients in the long run really barely know that they’re taking anything. |