Dr Elizabeth Griffiths Outlines Recent Approvals in AML

Elizabeth Griffiths, MD, associate professor of oncology, department of medicine, Roswell Park Comprehensive Cancer Center, discusses recent approvals for acute myeloid leukemia (AML).

Transcript

The past year has brought several new approvals for acute myeloid leukemia (AML). What treatments were approved and how are they bringing hope to this patient population?

There have been several approvals in the past 2 years, among them the drugs targeted IDH1 and IDH2. Those 2 drugs were approved a little bit earlier, and we’ve already started to see evidence to suggest that there’s substantial clinical utility. In the relapsed/refractory patients, they’ve been established, they’re not approved. At this meeting, Eytan Stein, MD, hematologic oncologist, Memorial Sloan Kettering Cancer Center, is going to present some data really showing very intriguing and very exciting combinatorial activity in combination with 7+3. So, I think those agents are likely to come a little bit more up front in our AML therapeutics, which really pushes us to get mutational profiles back quickly.

Other agents that have now been approved are targeted agents targeting FLT3. Very recently, we have approval of gilteritinib in context of relapsed/refractory disease. That data’s actually not even been presented, other than in abstract form, so we don’t have the final publication. But, that is very exciting.

The other agents that have newly been approved include these nontargeted drugs. Things like the combination of azacitidine or decitabine or loto cytarabine with the BCL2 inhibitor venetoclax. Again, not a combination that is really molecularly targeted. In fact, it seems to have activity in a variety of different AML subgroups, including FLT3 mutant patients, IDH mutant patients, where it seems to be particularly active. Also, in those patients with poor risk features, such as p53. So, I think that this novel therapy, which seems to have really remarkable activity in patients with what has been historically deemed unfit disease, that approval is extraordinarily exciting.

The drug glasdegib was also approved recently in combination with loto cytarabine. The responses to that combination were a little bit less impressive, but nonetheless, it seems real and durable. So, those approvals are all very, very exciting, and I think in the AML field, we’re really privileged to have so many new drugs.

Also, we have the nontargeted therapies of Vyxeos, again also a repackaging, if you will, of 7+3, which seems to have substantial activity, particularly in those patients with poor risk cytogenetics or secondary-type disease who are then going to go on to allogeneic transplant, where we tend to use that kind of combination as an alternative to intensive induction regimens.