PMID- 38343062 OWN - NLM STAT- MEDLINE DCOM- 20240319 LR - 20240319 IS - 1096-8652 (Electronic) IS - 0361-8609 (Linking) VI - 99 IP - 4 DP - 2024 Apr TI - Efficacy, safety, and survival findings after long-term follow-up of ZGJAK002: A phase 2 study comparing jaktinib at 100 mg twice daily (BID) and 200 mg once daily (QD) in patients with myelofibrosis. PG - 774-779 LID - 10.1002/ajh.27245 [doi] AB - Jaktinib, a novel JAK and ACVR1 inhibitor, has exhibited promising results in treating patients with myelofibrosis (MF). ZGJAK002 is a Phase 2 trial aimed to assess the efficacy and safety of jaktinib 100 mg BID (N = 66) and 200 mg QD (N = 52) in JAK inhibitor-naive patients with intermediate- or high-risk MF. We herein present the long-term data with a median follow-up of 30.7 months. At data cutoff, 30.3% of patients in 100 mg BID and 28.8% in 200 mg QD were still continuing their treatment. The 100 mg BID group displayed a numerically higher best spleen response compared with the 200 mg QD group (69.7% vs. 46.2%), with 50.4% from the BID and 51.2% from the QD group maintaining spleen responses over 120 weeks. The 36-month survival rates were 78.2% in BID and 73.6% in QD group. The tolerability of jaktinib remained well, and common grade >/=3 adverse drug reactions included anemia (15.2% vs. 21.2%), thrombocytopenia (15.2% vs. 11.5%), and infectious pneumonia (10.6% vs. 1.9%) in BID and QD groups, respectively. By comparing the two groups, the incidence of adverse events (AEs) were similar, except for drug-related serious AEs (24.2% vs. 9.6%) and AEs leading to treatment discontinuation (15.2% vs. 7.7%), which were higher in BID group. The percentages of AEs resulting in death were comparable, with 6.1% in BID and 5.8% in QD group. These analyses further support the long-term durable efficacy and acceptable safety of jaktinib at 100 mg BID and 200 mg QD doses for treating MF. CI - (c) 2024 Wiley Periodicals LLC. FAU - Zhang, Yi AU - Zhang Y AUID- ORCID: 0000-0003-3625-2288 AD - Department of Hematology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China. AD - Zhejiang Provincial Key Laboratory of Hematopoietic Malignancy, Zhejiang University, Hangzhou, People's Republic of China. AD - Zhejiang Provincial Clinical Research Center for Hematological Disorders, Hangzhou, People's Republic of China. AD - Zhejiang University Cancer Center, Hangzhou, People's Republic of China. FAU - Zhou, Hu AU - Zhou H AD - Department of Hematology, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, People's Republic of China. FAU - Jiang, Zhongxing AU - Jiang Z AD - Department of Hematology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, People's Republic of China. FAU - Wu, Dengshu AU - Wu D AD - Department of Hematology, Xiangya Hospital, Central South University, Changsha, People's Republic of China. FAU - Zhuang, Junling AU - Zhuang J AUID- ORCID: 0000-0002-1228-0551 AD - Department of Hematology, Peking Union Medical College Hospital (Dongdan Campus), Beijing, People's Republic of China. FAU - Li, Wei AU - Li W AD - Department of Hematology, Cancer Center, The First Hospital of Jilin University, Changchun, People's Republic of China. FAU - Jiang, Qian AU - Jiang Q AUID- ORCID: 0000-0001-7131-0522 AD - National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell, Peking University Institute of Hematology, Beijing, People's Republic of China. FAU - Wang, Xiuli AU - Wang X AD - Department of Oncology Hematology, The Second Hospital of Jilin University, Changchun, People's Republic of China. FAU - Huang, Jinwen AU - Huang J AD - Department of Hematology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China. FAU - Zhu, Huanling AU - Zhu H AUID- ORCID: 0000-0002-5226-3828 AD - Department of Hematology, West China Hospital, Sichuan University, Chengdu, People's Republic of China. FAU - Yang, Linhua AU - Yang L AD - Department of Hematology, The Second Hospital of Shanxi Medical University, Taiyuan, People's Republic of China. FAU - Du, Xin AU - Du X AD - Department of Hematology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, People's Republic of China. FAU - Li, Fei AU - Li F AD - Department of Hematology, The First Affiliated Hospital of Nanchang University, Nanchang, People's Republic of China. FAU - Xia, Ruixiang AU - Xia R AD - Department of Hematology, The First Affiliated Hospital of Anhui Medical University, Hefei, People's Republic of China. FAU - Zhang, Feng AU - Zhang F AD - Department of Hematology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, People's Republic of China. FAU - Hu, Jianda AU - Hu J AUID- ORCID: 0000-0002-4438-2544 AD - Fujian Institute of Hematology, Fujian Medical University Union Hospital, Fuzhou, People's Republic of China. FAU - Li, Yan AU - Li Y AD - Department of Hematopathology, The First Hospital of China Medical University, Shenyang, People's Republic of China. FAU - Hu, Yu AU - Hu Y AUID- ORCID: 0000-0002-2815-4568 AD - Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, People's Republic of China. FAU - Liu, Jing AU - Liu J AD - Department of Hematology, Third Xiangya Hospital of Central South University, Changsha, People's Republic of China. FAU - Jin, Chenghao AU - Jin C AD - Department of Hematology, Jiangxi Provincial People's Hospital, Nanchang, People's Republic of China. FAU - Sun, Kai AU - Sun K AD - Department of Hematology, Henan Provincial People's Hospital, Zhengzhou, People's Republic of China. FAU - Zhou, Zeping AU - Zhou Z AD - Department of Hematology, The Second Affiliated Hospital of Kunming Medical University, Kunming, People's Republic of China. FAU - Wu, Liqing AU - Wu L AD - Suzhou Zelgen Biopharmaceuticals Co., Ltd, Suzhou, People's Republic of China. FAU - Yin, Hewen AU - Yin H AD - Suzhou Zelgen Biopharmaceuticals Co., Ltd, Suzhou, People's Republic of China. FAU - Suo, Shanshan AU - Suo S AD - Department of Hematology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China. AD - Zhejiang Provincial Key Laboratory of Hematopoietic Malignancy, Zhejiang University, Hangzhou, People's Republic of China. AD - Zhejiang Provincial Clinical Research Center for Hematological Disorders, Hangzhou, People's Republic of China. AD - Zhejiang University Cancer Center, Hangzhou, People's Republic of China. FAU - Yu, Wenjuan AU - Yu W AD - Department of Hematology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China. AD - Zhejiang Provincial Key Laboratory of Hematopoietic Malignancy, Zhejiang University, Hangzhou, People's Republic of China. AD - Zhejiang Provincial Clinical Research Center for Hematological Disorders, Hangzhou, People's Republic of China. AD - Zhejiang University Cancer Center, Hangzhou, People's Republic of China. FAU - Jin, Jie AU - Jin J AUID- ORCID: 0000-0002-8166-9915 AD - Department of Hematology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, People's Republic of China. AD - Zhejiang Provincial Key Laboratory of Hematopoietic Malignancy, Zhejiang University, Hangzhou, People's Republic of China. AD - Zhejiang Provincial Clinical Research Center for Hematological Disorders, Hangzhou, People's Republic of China. AD - Zhejiang University Cancer Center, Hangzhou, People's Republic of China. LA - eng GR - Suzhou Zelgen Biopharmaceuticals Co., Ltd/ GR - 2021C03123/Key Research and Development Program of Zhejiang Province/ GR - 82 100 159/The National Natural Science Foundation of China/ PT - Clinical Trial, Phase II PT - Letter DEP - 20240211 PL - United States TA - Am J Hematol JT - American journal of hematology JID - 7610369 SB - IM MH - Humans MH - Follow-Up Studies MH - *Primary Myelofibrosis/drug therapy MH - Treatment Outcome EDAT- 2024/02/12 15:43 MHDA- 2024/03/19 06:44 CRDT- 2024/02/12 00:44 PHST- 2024/01/17 00:00 [revised] PHST- 2023/12/21 00:00 [received] PHST- 2024/01/19 00:00 [accepted] PHST- 2024/03/19 06:44 [medline] PHST- 2024/02/12 15:43 [pubmed] PHST- 2024/02/12 00:44 [entrez] AID - 10.1002/ajh.27245 [doi] PST - ppublish SO - Am J Hematol. 2024 Apr;99(4):774-779. doi: 10.1002/ajh.27245. Epub 2024 Feb 11.