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969 Venetoclax Combined with Daunorubicin and Cytarabine (2 + 6) in Acute Myeloid Leukemia: Updated Results of a Phase II Trial

Program: Oral and Poster Abstracts
Type: Oral
Session: 615. Acute Myeloid Leukemias: Commercially Available Therapies, Excluding Transplantation and Cellular Immunotherapies: Improving Intensive Chemotherapy Regimens for Treatment of AML
Hematology Disease Topics & Pathways:
Combination therapy, Therapies
Monday, December 11, 2023: 5:00 PM

Xiaohui Suo1*, Dongmei Wang2*, Fang Zheng3*, Suping Zhang4*, Congcong Zhang1*, Yinling Li1*, Rui Shi2*, Yan Wu2*, Sisi Yang3*, Liyun Zhao5*, Zongjiu Jiao5*, Jie Liu, MBBS, MPH6, Ling Zhang6*, Ling Li7*, Zhihua Zhang, MD8*, Xinxiao Lu9*, Linyu Yuan9*, Sifeng Gao10*, Jilei Zhang10*, Xingli Zhao11*, Guanchen Bai10*, Yingchang Mi, MD12,13 and Kaiqi Liu13,14*

1Department of Hematology, Handan Central Hospital, Handan, Hebei, China, 056000,, Handan, China
2Department of Hematology, Harrison International peace Hospital, Hengshui, Hebei, China, 053000., Hengshui, China
3Department of Hematology, Baiyun Hospital affiliated to Guizhou Medical University, Guiyang, Guizhou, China, 550000., Guiyang, China
4Department of Hematology, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
5Department of Hematology, People Hospital of XingTai, Xing Tai, Hebei, China, 054001, Xingtai, China
6Department of Hematology, Sinopharm Tongmei General Hospital, Datong, Shanxi, China, 037003, Datong, China
7Department of Hematology, Inner Mongolia People's Hospital, Huhehaote, Neimenggu, China, 010000, Huhehaote, China
8Affiliated Hospital of Chengde Medical University, Chengde, China
9Department of Hematology, Oncology Center, Tianjin People's Hospital, No. 190 jieyuan Road, Hongqiao District, Tianjin 300121, P R China., Tianjin, China
10Department of Hematology, The Affiliated Tai'an City Central Hospital of Qingdao University, Taian, Shandong, China, 271000., Taian, China
11Tianjin People's Hospital, Tianjin, China
12State Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences &Peking Union Medical College, Tianjin, China
13Tianjin Institutes of Health Science, Tianjin, China
14National Clinical Research Center for Blood Diseases, State Key Laboratory of Experimental Hematology, Haihe Laboratory of Cell Ecosystem, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences &Peking Union Medical College, Tianjin, China

INTRODUCTION

Venetoclax (Ven) combined with intensive chemotherapy had been proven effectively in the management of newly diagnosed acute myeloid leukemia (AML). Our previous study showed that Ven combined with DA (2 + 6) is a highly effective and safe induction therapy for adults with newly diagnosed AML. To further validate the efficacy and safety of this induction regimen, the study continued to enroll young patients with newly diagnosed AML. Now, we have updated the results of this phase 2, multicenter, single-arm trial.

METHODS

Details of the Study design, participants, inclusion and exclusion criteria, procedures, efficacy and safety evaluation were provided in our previous article “Venetoclax combined with daunorubicin and cytarabine (2 + 6) as induction treatment in adults with newly diagnosed acute myeloid leukemia: a phase 2, multicenter, single‑arm trial” which published in the Journal of “Experimental Hematology & Oncology”.

RESULTS

Until June 30, 2023, seventy patients were enrolled and treated with Ven combined with DA (2 + 6) as induction therapy. The median age was 44 (range, 16–60) years, and 37 (52.9%) patients were male. According to the European Leukemia Network prognostic group (2022), 32 (45.7%), 9 (12.9%), and 29 (41.4%) patients were considered to belong to the favorable, intermediate, and adverse groups, respectively.

The ORR after one cycle of induction was 92.9% (65/70) with a composite complete response rate (CR + CRi) of 90.0% (CR 61/70, CRi 2/70). Moreover, 89.5% (51/57) of the patients reached CR with undetectable MRD. Grade 3 or worse adverse effects included neutropenia (100%), thrombocytopenia (100%), febrile neutropenia, and one mortality. The median neutrophil and platelet recovery times were 13 (5–36) and 13 (8–48) days, respectively. (Table 1)

Until Jan 30, 2023, with with a median follow-up of 9 (1-18) months, 6 patients proceed Allo-HSCT, the estimated 12-month OS, EFS, and DFS rates were 84.9%、81.0%、81.6%, respectively. (Figure 1)

Conclusion: Ven with DA (2 + 6) is a highly effective and safe induction therapy for adults with newly diagnosed AML.

【Keywords】Venetoclax, DA(2+6), induction treatment, acute myeloid leukemia

Disclosures: No relevant conflicts of interest to declare.

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