Evidence map›Paper›PMID 35982483›Full record

Trial reportJournal of hematology & oncology2022

Olverembatinib (HQP1351), a well-tolerated and effective tyrosine kinase inhibitor for patients with T315I-mutated chronic myeloid leukemia: results of an open-label, multicenter phase 1/2 trial.

Qian Jiang, Zongru Li, Yazhen Qin, Weiming Li, Na Xu, Bingcheng Liu, Yanli Zhang, Li Meng, Huanling Zhu, Xin Du and 13 more

Erratum issued 2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of hematology & oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 83 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
83citing papers in PubMed, 4 pooled it
14.1field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03883087 phase2unknown statusnot on this map

A Phase II Multi-center, Open Label Study of HQP1351 in Chinese Patients of Chronic Myeloid Leukemia With T315I Mutation in Chronic Phase

TypeinterventionalSponsorAscentage Pharma Group Inc.Ran2019 to 2025Enrolled41ConditionsChronic Myeloid Leukemia, Chronic PhaseArmsHQP1351
NCT03883100 phase2unknown statusnot on this map

A Phase II Multi-center, Open Label Study of HQP1351 in Chinese Patients of Chronic Myeloid Leukemia With T315I Mutation in Accelerated Phase

TypeinterventionalSponsorAscentage Pharma Group Inc.Ran2019 to 2025Enrolled23ConditionsChronic Myeloid Leukemia - Accelerated PhaseArmsHQP1351
3 · Its place in the literature

Who cites it

83 citing papers in PubMed, 4 syntheses or guidelines pooled it, 93 citations in OpenAlex.

  1. [Guideline for the diagnosis and treatment of chronic myeloid leukemia in China (2025)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2025
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23 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 10 institutions in 1 country.

Qian JiangNational Clinical Research Center for Hematologic Disease, Peking University People's Hospital, Peking University Institute of Hematology, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, China.
Zongru LiNational Clinical Research Center for Hematologic Disease, Peking University People's Hospital, Peking University Institute of Hematology, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, China.
Yazhen QinNational Clinical Research Center for Hematologic Disease, Peking University People's Hospital, Peking University Institute of Hematology, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, China.
Weiming LiUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, Hubei, China.
Na XuDepartment of Hematology, Nanfang Hospital, Southern Medical University, 1838 Guangzhou N Ave, Baiyun, Guangzhou, 510515, Guangdong Province, China.
Bingcheng LiuState 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, 300020, China.
Yanli ZhangDepartment of Hematology, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, 450008, Henan, China.
Li MengDepartment of Hematology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, Hubei, China.
Huanling ZhuDepartment of Hematology, West China Hospital of Sichuan University, No. 37 Guoxue Alley, Wuhou District, Chengdu City, 610000, Sichuan Province, China.
Xin DuDivision of Hematology, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University, 3002 Sungang W Rd, Futian District, Shenzhen, 518000, Guangdong Province, China.
Suning ChenNational Clinical Research Center for Hematologic Diseases, The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology, Institute of Blood and Marrow Transplantation, Collaborative Innovation Center of Hematology, Soochow University, Suzhou, China.
Yang LiangState Key Laboratory of Oncology in South China, Department of Hematologic Oncology, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, Guangdong Province, China.
Yu HuUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, Hubei, China.
Xiaoli LiuDepartment of Hematology, Nanfang Hospital, Southern Medical University, 1838 Guangzhou N Ave, Baiyun, Guangzhou, 510515, Guangdong Province, China.
Yongping SongDepartment of Hematology, The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, 450008, Henan, China.
Lichuang MenGuangzhou Healthquest Pharma Co. Ltd., Room F314, GIBI, No. 3 Lanyue Road, Guangzhou, 510663, China.
Zi ChenGuangzhou Healthquest Pharma Co. Ltd., Room F314, GIBI, No. 3 Lanyue Road, Guangzhou, 510663, China.
Qian NiuGuangzhou Healthquest Pharma Co. Ltd., Room F314, GIBI, No. 3 Lanyue Road, Guangzhou, 510663, China.
Hengbang WangGuangzhou Healthquest Pharma Co. Ltd., Room F314, GIBI, No. 3 Lanyue Road, Guangzhou, 510663, China.
Ming LuAscentage Pharma Group Inc., 800 King Farm Blvd Suite 300, Rockville, MD, 20850, USA.
Dajun YangAscentage Pharma (Suzhou) Co., Ltd, 218 Xinghu St, Bldg B7, 7th Floor, Suzhou Industrial Park, Suzhou, 215000, Jiangsu, China.
Yifan ZhaiGuangzhou Healthquest Pharma Co. Ltd., Room F314, GIBI, No. 3 Lanyue Road, Guangzhou, 510663, China.
Xiaojun HuangNational Clinical Research Center for Hematologic Disease, Peking University People's Hospital, Peking University Institute of Hematology, No. 11 South Street of Xizhimen, Xicheng District, Beijing, 100044, China. huangxiaojun@bjmu.edu.cn.
Peking University People's Hospital · CNHenan Cancer Hospital · CNSouthern Medical University · CNSun Yat-sen University Cancer Center · CNWuhan Union Hospital · CNHuazhong University of Science and Technology · CNInstitute of Hematology & Blood Diseases Hospital · CNShenzhen Second People's Hospital · CNSoochow University · CNWest China Hospital of Sichuan University · CN

Funding

Foundation for Innovative Research Groups of the National Natural Science Foundation of China 81621001Key Program of the National Natural Science Foundation of China 81530046Key Program of the National Natural Science Foundation of China 81930004National Key Research and Development Program of China 2017YFA0104500National Nature Science Foundation of China 81770161National Nature Science Foundation of China 81970140National Science and Technology Major Project 2018ZX09301021-005
6 · The paper itself

Abstract

backgroundBCR-ABL1

methodsIn the phase 1 study, olverembatinib was orally administered once every other day in 28-day cycles at 11 dose cohorts ranging from 1 to 60 mg, and we evaluated the maximum tolerated dose, recommended phase 2 dose (RP2D), safety, efficacy, and pharmacokinetics of olverembatinib. In the phase 2 studies, olverembatinib was administered at the RP2D of 40 mg orally on alternate days for 28-day cycles. The primary outcome measure is major cytogenetic response (MCyR) and major hematologic response by the end of Cycle 12 in CML-CP and CML-AP, respectively. Fine and Gray's hazard models were used to identify covariates associated with responses.

resultsA total of 165 patients (> 80.0% of whom had received ≥ 2 TKIs) were enrolled in this study. Among 127 patients with CML-CP, the 3-year cumulative incidences of achieving MCyR, complete cytogenetic response (CCyR), major molecular response (MMR), MR

conclusionsOlverembatinib was well tolerated, with significant antileukemic activity in adults with TKI-resistant CML-CP and CML-AP, especially those with the T315I mutation.

trial registrationThe phase 1 trial is registered at CTR20220566, and the two single-arm, open-label phase 2 studies are registered at ClinicalTrials.gov: NCT03883087 (CML-CP) and NCT03883100 (CML-AP).

Indexed as

Fusion Proteins, bcr-ablLeukemia, Myelogenous, Chronic, BCR-ABL PositiveAdultAngiogenesis InhibitorsDrug Resistance, NeoplasmHumansMutationProtein Kinase InhibitorsAngiogenesis InhibitorsFusion Proteins, bcr-ablProtein Kinase InhibitorsAccelerated phaseChronic myeloid leukemiaChronic phaseT315I mutationTyrosine kinase inhibitor

Identifiers

PMID35982483
PMCPMC9389804
OpenAlexW4292210375

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.