Startseite Kongressberichte & Archiv 59th ASH Annual Meeting and Exposition AML Oral Sessions Acute Myeloid Leukemia: Clinical Studies: Novel Therapies for AML and APL

613. Acute Myeloid Leukemia: Clinical Studies: Novel Therapies for AML and APL

Geoffrey L. Uy, MD1, John Godwin, MD2, Michael P Rettig, PhD3, Norbert Vey4, et al.

The authors of the study conclude that:

Flotetuzumab in R/R AML and MDS demonstrated evidence of anti-leukemic activity (ORR 43%) with a manageable safety profile. This program advances an immune-activating agent in treating AML and continues to enroll patients in cohort expansion (24 AML and 24 MDS patients at the MTDS) in the US and Europe. NCT02152956.

Daniel A. Pollyea, MD1,2, Martin S. Tallman, MD3,4, Stephane De Botton5,6*, Courtney D. DiNardo, MD, MSc7, et al.

The authors of the study conclude that:

Enasidenib induced hematologic responses in these older patients with previously untreated mIDH2 AML who were not candidates for standard treatment. Approximately 1 in 5 of these patients attained CR and 1 in 3 patients had a response with enasidenib monotherapy. Responses were durable: at a median of 7.9 months of follow-up, median CR duration was not reached and median duration of any response was > 1 year. Median OS and EFS were also promising (10.4 months and 11.3 months, respectively). Rates of treatment-related TEAEs were low and only 1 patient discontinued treatment due to a TEAE. These results suggest enasidenib may benefit older adults with mIDH2 AML who are not fit to receive cytotoxic chemotherapy. These encouraging findings have prompted follow-up studies of enasidenib in older patients with previously untreated mIDH2 AML, such as the Beat AML Master Trial (NCT03013998).

Courtney D. DiNardo, MD, MSc1, Anthony S. Stein, MD2, Amir T. Fathi, MD, MD, BS3,4, Pau Montesinos, MD, PhD5*, et al.

The authors of the study conclude that:

Enasidenib or ivosidenib + AZA combination regimens were generally well tolerated in pts with ND-AML, with 10 of the initial 13 pts remaining on-study at data cutoff, and only 2 discontinuations due to PD. The most common TEAEs with all regimens were grade 1 and 2 GI events and indirect bilirubin increases (likely due to off-target inhibition of UGT1A1 enzyme). Preliminary efficacy results with these combination regimens are encouraging, with 5 CRs and 1 PR on-study. Based on clinical activity and tolerability, the 100 mg enasidenib dose and 500 mg ivosidenib dose will move forward for further study in combination regimens. Evaluation of mIDH inhibitors + AZA continues in 2 currently enrolling randomized studies, including the expansion phase of the current study and the phase 3 AGILE study of ivosidenib + AZA (NCT03173248), to further assess the safety and clinical efficacy of these regimens.

Amer M. Zeidan, MD1, Rachel J. Cook, MD2, Rodolfo Bordoni, MD3*, Ekaterine Asatiani, MD4,et al.

The authors of the study conclude that:

Preliminary findings from this phase 1/2 trial indicate that INCB052793 has encouraging clinical activity, especially in combination with AZA, in patients with advanced myeloid malignancies, including those who previously failed HMAs. These data indicate that INCB052793 might (re)-sensitize HMA-refractory or relapsed patients to the effects of HMAs. Preliminary safety and efficacy data support further evaluation of INCB052793 in this setting. Enrolment is ongoing in phase 2 and expanded data, including PK/PD, will be presented.

Honghu Zhu1*, Depei Wu, MD 2, Xi Zhang, MD, PhD3*, Lin LIU4*, et al.

The authors of the study conclude that:

RIF plus ATRA is not inferior to ATO plus ATRA in the treatment of patients with non high-risk APL (Chinese Clinical Trial Registry number, ChiCTR-TRC-13004054).

Akihiro Takeshita, MD, PhD1, Norio Asou, MD2, Masamitsu Yanada, MD, PhD3*, Toru Sakura, PhD, MD4*, et al.

The authors of the study conclude that:

Maintenance therapy with tamibarotene was effective at decreasing the relapse rate in APL patients by comparison to ATRA at the 7-year observation point. In particular, tamibarotene was significantly more effective than ATRA for high risk patients with leukocytes ≧10,000/μl. These results could lead to a new strategy for the treatment of high risk patients, which is one of the recent priority issues in the treatment of APL.