Lancet Haematol: Jin Jie / Zhu Honghu team used Veneclax + DA regimen to treat AML, the first CR was as high as 91%

Acute myelogenous leukemia (AML) is the most common acute leukemia in adults (accounting for more than 80%), and its treatment is still dominated by chemotherapy, DA regimen consisting of daunorubicin and cytarabine ( Also known as the "3+7" regimen) is the standard induction regimen for adult AML, and the one-course remission rate of this regimen is about 60%-65% in young AML patients (<60 years old) and 60%-65% in older AML patients (≥60 years old).

leukemia

The HAA program designed by the team of Professor Jin Jie from the Department of Hematology of the First Affiliated Hospital of Zhejiang University in early 2000 (in domestic multi-center clinical studies, the remission rate was increased by 12 percentage points compared with the international standard program, reaching a CR rate of 73% (Lancet Oncology 2013)

NEJM: venetoclax combined with azacitidine in the treatment of elderly patients with acute myeloid leukemia Clin Cancer Res: venetoclax + azacitidine can significantly improve the prognosis of IDH1/2 mutant AML patients

This is an investigator-initiated, multicenter, two-phase, phase 2 clinical trial

^{2 2} Guide

The primary endpoint is composite response rate after the first cycle (CRc: CR+CRi), and secondary endpoints include minimal residual disease (MRD), event-free survival (EFS), and overall survival (OS) detected by flow cytometry and adverse events

From December 25, 2020, to July 7, 2021, a total of 36 adult patients with new-onset AML in three hospitals were recruited, and 33 patients were finally evaluated

Fifteen (45%) patients were male and 18 (55%) were female, all Asian

In the entire cohort, the composite complete response rate after one cycle of the DAV regimen was 91% (95% CI 76-98; 30 of 33 patients)

Outcomes of patients with different molecular subtypes were further analyzed

stem cell

At a median follow-up of 11 months (IQR 9-12) , 4 of the 30 patients in remission relapsed (2 after completing all required treatment regimens and 2 after allo-HSCT)

Median Follow-up 11 months (IQR 9-12) Median Follow-up 11 months (IQR 9-12)

The safety analysis showed that adverse events (AEs) during the first cycle of induction therapy with DAV are shown in Table 3

This study shows that a new DAV regimen consisting of veneclax added to the standard DA regimen can achieve a CR rate of up to 91% after one course of induction therapy

diagnosis

At the same time, the encouraging results of this phase 2 study will be further validated by the same group's ongoing randomized controlled trial comparing DAV and DA regimens in newly diagnosed adult AML patients (ChiCTR2100045780)

Huafeng Wang, Liping Mao, Min Yang, Pengxu Qian, Huan Lu,Hongyan Tong, Wanzhuo Xie, De Zhou, Xin Huang, Yungui Wang, Gaixiang Xu, Ying Lu, Juying Wei, Wenyuan Mai, Xiujin Ye, Haitao Meng, Yaojia Shen , Jian Huang, Wenjuan Yu, Jie Sun, Jianpeng Sheng, Xiaoyan Yan, Jie Jin†, Hong-Hu Zhu.

Jin J , Wang JX, Chen FF, Wu DP, Hu J, Zhou JF, Hu JD, Wang JM, Li JY, Huang XJ, Ma J, Ji CY, Xu XP, Yu K, Ren HY, Zhou YH, Tong Y , Lou YJ, Ni WM, Tong HY, Wang HF, Mi YC, Du X, Chen BA, Shen Y, Chen Z, Chen SJ.

Jin J , Wang JX, Chen FF, Wu DP, Hu J, Zhou JF, Hu JD, Wang JM, Li JY, Huang XJ, Ma J, Ji CY, Xu XP, Yu K, Ren HY, Zhou YH, Tong Y , Lou YJ, Ni WM, Tong HY, Wang HF, Mi YC, Du X, Chen BA, Shen Y, Chen Z, Chen SJ.
Jin J Homoharringtonine-based induction regimens for patients with de-novo acute myeloid leukaemia: a multicentre , open-label, randomised, controlled phase 3 trial.
Lancet Oncol .
2013 Jun;14(7):599-608 Lancet Oncol commented

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