About the Phase 1/2 Study 2102-HEM-101 of Olutasidenib in IDH1-Mutated AML

Jorge E. Cortes, MD, director at the Georgia Cancer Center at Augusta University, provides an overview of the background and findings of the phase 1/2 Study 2102-HEM-101 (NCT02719574) which evaluated treatment with olutasidenib (Rezlidhia) in patients with relapsed/refractory acute myeloid leukemia (AML) who harbor IDH1 mutations.

According to Cortes and findings presented at the 2022 American Society of Hematology Annual Meeting, treatment with olutasidenib alone resulted in high complete response (CR) rates as well as a manageable toxicity profile in this patient population.

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0:08 | The study that [I presented] at ASH was the study on olutasidenib in patients with IDH1-mutated acute myeloid leukemia, refractory or relapsed disease. This is an important study because it's the basis for the recent approval of this drug. This drug is an oral agent, it's an IDH1 inhibitor, and it was administered orally to patients twice daily. This is based on the phase 1 study that was recently published and showed the recommended phase 2 dose.

0:48 | In this study, we included patients that had received prior therapy, everybody had received induction chemotherapy, many of them had received venetoclax [Venclexta]. This is a relatively older patient population, the median age is over 70, and about a third of the patients were refractory to prior therapy. Of those who had relapsed, the great majority had relapsed within 12 months. It's really a high-risk patient population and most of them had intermediate cytogenetics, which is typical for the IDH1-mutated patients.

1:24 | What we saw is a high level of response. The response rate, the CR plus [complete remission with partial hematologic recovery], was 35%. But very importantly, the CRs were 32%, so the great majority of the responses were actually true CRs. The other thing that is very exciting in my opinion about this study, is the fact that these remissions are durable. The remission duration was 28 months, more than 2 years of remission duration. We have some remissions that are still ongoing and are very long term. It is exciting to see that high level of response with durable responses. That of course reflected in good overall survival and progression-free survival.