ORYZON presents final data from Phase IIa ALICE trial in unfit AML patients with first-line treatment of iadademstat and azacitidine in oral presentation at ASH- 2022
Clinical efficacy signals were robust, with an objective response rate (ORR) of 81%; of these, 64% were complete remissions (14 CR/CRi) and 36% partial remissions (8 PR)
Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, today presents the final data from its Phase IIa ALICE trial, investigating iadademstat in combination with azacitidine in elderly or unfit patients with acute myeloid leukemia (AML), at the 64th American Society of Hematology (ASH) Annual Conference, in an oral presentation entitled “Iadademstat Combination with Azacitidine Is a Safe and Effective Treatment in First Line Acute Myeloid Leukemia. Final Results of the ALICE Trial”, by Dr. Olga Salamero, MD from the Vall d’Hebron Hospital in Spain.
Clinical efficacy signals were robust, with an objective response rate (ORR) of 81% (22 of 27 evaluable patients); of these, 64% were complete remissions (14 CR/CRi) and 36% partial remissions (8 PR). The historical ORR in elderly or unfit AML population treated with azacitidine alone is 28%. Responses were deep and durable: 71% of CR/CRi achieved transfusion independence and 82% of tested samples were MRD negative (100% of 7 CRs and 50% of 4 CRis), and rapid (by two months). The RP2D was established at 90 μg/m2/d iadademstat in combination with SoC azacitidine. At this dose, LSD1 target engagement consistently reached >90%, translating in higher quality of responses without compromising safety, and the median OS was > 1 year (with 50% and 42% of patients surviving after 12 and 18 months, respectively).
Of note, responses were seen in patients with a diverse array of AML mutations, suggesting a broad applicability for iadademstat in AML. All FLT3+ patients included in ALICE (100%; 3 out of 3) and a high proportion of TP53+ patients (75%; 6 out of 8) responded. Patients with monocytic AML subtypes (M4/M5) also showed high response levels (86%; 6 out of 7).
Dr. Carlos Buesa, Oryzon’s CEO, said: "These final results confirm a strong synergy between iadademstat and azacitidine in combination. These data open new options to explore iadademstat in a broad range of AML patients. We are thrilled to have been selected for an oral presentation at the conference. Thisreflects the interest for the therapeutical potential of LSD1 inhibitors like iadademstat in the field and the promise of the clinical efficacy signals presented.”
Dr. Douglas Faller, Oryzon’s Global CMO, stated: “Combinations of antileukemic agents with iadademstat have the potential to significantly improve patient outcomes and will increase therapeutic options for AML patients not only in first line, but also for patients with disease which is refractory or who are intolerant to BCL2 inhibitors. To further investigate iadademstat’s activity in AML in second line, Oryzon is launching FRIDA, a new clinical trial with iadademstat in combination with gilteritinib in FLT3-mutant relapsed/refractory AML.”
A copy of Oryzon’s oral presentation at ASH-2022 is available here.
For more information about ASH-2022, please visit ASH-2022’s website.