In addition, we have a lot of trials showing that single-agent FLT3 inhibitors tend to have very good efficacy in patients with relapsed AML, especially in elderly patients who are not candidates for more chemotherapy. We have several trials showing that these drugs can put patients into remission; however, this remission, unfortunately, does not last long. This tells us that we need better drugs—and maybe more drugs—to keep putting these patients into remission again and again.
If some of these newer regimens and agents are positive in phase III trials, how could their potential approvals shake up the AML paradigm?
These are important drugs. They seem to be showing clear evidence of superiority, improving outcomes, and making patients live longer. Once they are approved, we can look for better drugs to even build up on that success. We do know that the response is higher in the pracinostat/azacitidine combination trial.
This means that patients are getting a better response, it is lasting longer, the quality is not that terrible, and the toxicity doesn’t seem to be increased that much. Once we achieve that, I am sure that the next step will be to build up on that success by having better drugs or better combinations for more responses and longer duration of response.
There is a lot of work going on in the field currently. What are the biggest challenges you hope we can tackle soon?
In acute leukemia, relapse is the big problem. We are getting so much better in terms of getting better remission, but the problem is that we are not able to keep that remission, whether it is in adult or elderly patients. Instead of a remission that lasts 12 months, how can we make remissions last 5 years?
That is the area where we need to have a lot of improvements. Unfortunately, the steps have to be sequential. First, we have to improve the response. Once that becomes the standard, then we can add more drugs to make that response last longer. There are a lot of new drugs and new classes of medication; however, for development purposes, they have to be approved first before we start combining some of these new drugs.
Garcia-Manero G, Atallah E, Khaled SK, et al. Final results from a phase 2 study of pracinostat in combination with azacitidine in elderly patients with acute myeloid leukemia (AML). Presented at: 57th American Society of Hematology Annual Meeting; Orlando, Florida; December 5-8, 2015. Abstract 453.