Key clinical point: The maximum tolerated dose (MTD) of combined romidepsin and azacitidine (ROM/AZA) therapy was well tolerated and clinically active in patients with newly diagnosed, relapsed or refractory (R/R) acute myeloid leukemia (AML) and unfit for intensive chemotherapy.
Major finding: Overall, 23.7% of patients treated with the MTD had a complete remission (CR)/incomplete CR or partial response by cycle 6. The combination therapy was well tolerated with 5 grade 3 or higher nonhematologic treatment-related adverse events affecting at least 10% of patients. Only 4 patients discontinued treatment because of toxicity.
Study details: Findings are from the phase 1/2 ROMAZA trial including 48 patients with newly diagnosed, R/R AML ineligible for intensive chemotherapy. The MTD of ROM/AZA therapy was established as 12 mg/m 2 romidepcin on days 8 and 15 with 75 mg/m 2 azacitidine on days 1-9.
Disclosures: This study was funded by Bloodwise and Celgene. The lead author reported ties with Novartis, Daichi-Sankyo, Pfizer, Janssen, and Amgen. Some investigators reported ties with various pharmaceutical companies, including Celgene.
Source: Loke J et al. Br J Haematol. 2021 Sep 6. doi: 10.1111/bjh.17823 .