At the recent American Society of Hematology (ASH) Annual Meeting in New Orleans, Jorge Cortes, Director of the Georgia Cancer Center in Augusta, Georgia, sat down with Oncology Data Advisor to discuss his presentation regarding the results of a pivotal phase 2 study in which olutasidenib was studied in patients with relapsed/refractory isocitrate dehydrogenase 1 (IDH1)–mutant acute myeloid leukemia.

This podcast episode was recorded live by Oncology Data Advisor and ConveyMED at the 2022 ASH Annual Meeting in New Orleans.

Oncology Data Advisor: Welcome to Oncology Data Advisor. Today, we're here at the ASH Annual Meeting, and I'm here with Dr. Jorge Cortes from the Georgia Cancer Center. Thanks so much for joining today.

Jorge Cortes, MD: Thank you for having me.

Oncology Data Advisor: Would you like to tell us a little bit about yourself and about what you do?

Dr. Cortes: My name is Jorge Cortes. I'm the Director of the Georgia Cancer Center at Augusta University. My career has been about doing clinical research in hematologic malignancies, specifically in acute and chronic leukemias, and that's still what I'm doing now.

Oncology Data Advisor: Great. So, I know you presented results this week about olutasidenib for relapsed/refractory IDH-mutant acute myeloid leukemia. Would you like to tell us about the study and about the results?

Dr. Cortes: Certainly. The drug olutasidenib is an orally available IDH1 inhibitor, and what I presented today were the results of the pivotal study that is part of a large umbrella study that has multiple cohorts. The one in question was patients with refractory/relapsed acute myeloid leukemia with the IDH1 mutation. These patients were treated with single-agent olutasidenib. I think it's important to mention that this drug was just very recently, about a week ago, approved by the FDA, and that was based on the results of this study that was presented here at the ASH Meeting. So, these patients, again, were treated with single-agent olutasidenib, and it's a continuous administration. The patient population was older patients, in general; the median age was 70. About a third were refractory to prior therapy and the others were relapsed. Most of the relapse had occurred within the first 12 months, which is a harder patient population to be treated.

I should mention that in this study, patients could not have received another IDH1 inhibitor. There's a separate cohort that's looking into that, but that's not included in these results. What we saw were very favorable responses to this drug. The response rate, complete remission (CR) plus CR with partial hematologic recovery (CRh), which was the primary end point, was 35%, but particularly attractive was the fact that 32% were CRs. So, there's only a handful of CRh. Most of these were CRs. Also very attractive was the fact that the remission duration was very long. The median remission duration was 28 months. That is very impressive in the context of other options that we have for this entity. If we include other responses— complete remission with incomplete count recovery (CRi) and morphologic leukemia-free and all that—the response rate goes to nearly 50%, so also very good. And as you can imagine, the survival was very good with this approach.

Of course, it's particularly good for patients who achieved a CR or CRh where the median survival has not been achieved, but even patients with other responses had a favorable survival. Also, very attractive is the fact that these patients became transfusion-independent. Nearly everybody who had a CR or CRh became platelet transfusion– and red cell transfusion–independent if they were dependent before.

But we also saw transfusion independence in patients with other responses. That's also valuable.

Then finally, I'll just mention the safety. It's a very well-tolerated drug, very minimal toxicity—mostly grade 1 and grade 2 nausea and some gastrointestinal (GI) toxicity, but very minimal. Nothing exceeded 40% grade 1 or grade 2. There is differentiation syndrome, as we know, with these drugs, but it was only about 15%. It was very manageable in most patients with interruptions and dose adjustments and things like that. We didn't see QTc prolongation hardly at all; there was about 8%. Only one patient had grade 3 or 4, so it doesn't have QTc signal. There is some elevation of liver function tests in about 20% to 24% of the patients. They're mostly manageable with interruptions and dose adjustments and things like that. So, there was only a patient or two who had to discontinue the treatment because of the liver function test abnormality.

I think that it's a very valuable new addition to the armamentarium. Of course, we have another IDH1 inhibitor, but because of the high CR rate and the very prolonged remission duration and the very good safety profile, it is a very welcome addition to this field.

Oncology Data Advisor: Fantastic. Anything else you'd like to share about either this study or other results you've seen presented here?

Dr. Cortes: Well, I think that the good thing about this drug, because we have many other cohorts in combination and in other settings—maintenance and so on—is this drug will very likely be able to be expanded in other fields as these results become available and used in other settings. Of course, the approval right now is as a single agent in the refractory/relapsed setting, but I think it has a lot of life ahead of it. It's very valuable.

Oncology Data Advisor: Great, it's very exciting. Thanks so much for sharing all this.

Dr. Cortes: My pleasure. Thank you.

Thank you for listening to this podcast, recorded live at the 2022 ASH Annual Meeting by Oncology Data Advisor and ConveyMED. For more expert perspectives on the latest in cancer research and treatment, be sure to subscribe to the podcast at ConveyMED.io and OncData.com. Don't forget to follow us on social media for news, exclusive interviews, and more.

About Dr. Cortes

Jorge Cortes, MD, is the Director of the Georgia Cancer Center in Augusta, Georgia. In addition, he is a Clinical Investigator for acute and chronic myeloid leukemia, in which he has helped develop and research new treatment options. Dr. Cortes previously worked as the Deputy Department Chair and the Chair of the Acute and Chronic Myeloid Leukemia Sections at MD Anderson Cancer Center and has authored and coauthored many publications investigating new research and treatments for leukemia.

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Transcript edited for clarity. Any views expressed above are the speaker's own and do not necessarily reflect those of Oncology Data Advisor.