Can Vyxeos cure AML? What research is being done?

Can Vyxeos cure AML?

Well, that's a hard question to answer. We think in most cases, the patients that are treated with Vyxeos that have secondary AML are not dealing with a subtype of AML that is considered curable without a bone marrow transplant. Now, there may be some cases where Vyxeos does cure patients, but that's clearly not the majority of patients. And the path to cure for most cases of AML, especially secondary or higher risk, AML subtypes is clearly through a bone marrow transplant. Vyxeos is effective at getting patients into remission and paving the way for a future bone marrow transplant that can be curative. And that's, I think its main role is to get excellent disease control and bridge a patient to a potentially curative transplant.

What research is being done with Vyxeos to make this therapy more effective?

So there's a lot of different clinical research studies being done right now to better understand how Vyxeos might be used in combination with other, newer and targeted drugs. Right now there are several trials going on that are combining Vyxeos with drugs such as Venetoclax, drugs such as Gilteritinib which is a FLT3 inhibitor, drugs such as Gemtuzumab, which is a CD33 antibody drug conjugate. So there's quite a bit of excitement that Vyxeos can be a platform with which to combine other targeted therapies to further improve the outcomes. But we definitely need to see more in the way of mature studies to really understand the impact of these combinations. So there has been a lot of progress made in the therapy for AML over the past 5 to 7 years, including not just Vyxeos but several other novel therapies in combination. I think the most notable one that has really become mainstream in the clinic is the combination of Azacitidine and Venetoclax, and that regimen was developed primarily for older, less fit and more frail patients and determined to have a really impressively high response rate and survival rate in that group of patients. It kind of led to the question, well, if it works very well in this less fit group of patients, wouldn't it work just as well, or maybe even better in younger, more fit patients? And that may be true. And then the next question would be, well, how does it compare to more traditional therapy, more intensive therapy such as Vyxeos? And unfortunately, we don't have an answer to that question because the two regimens, Vyxeos on one hand and Azacitidine and Venetoclax on the other hand, have never been compared head to head. So without a randomized trial, it's very difficult to make assumptions as to which treatment may be better, or are they the same, and what are the implications for toxicity, hospitalizations, future transplant. We just don't know the answer to those questions. What we can say is that Vyxeos is better than 7+3 in the secondary AML setting and should be the preferred regimen over 7+3. I think when it comes to deciding on Vyxeos versus Azacitidine plus Venetoclax, that's a very in-depth, personalized discussion between the healthcare team and the patient, because there may be reasons for doing one versus the other that are not necessarily related to the disease, but may be related to other factors such as the physical status of the patient, their ability to travel back and forth to the clinic on a regular frequent basis for transfusions as an outpatient, if they're not dealing with a good support system at home. So there are many factors that go into that decision, and hopefully we'll have models that are developed over the next few years that help us make that decision more rationally and based upon evidence rather than just the physician or the physician's team objectively or subjectively deciding what might be best for the patient.