Long-term treatment continuation of gecacitinib in myelofibrosis patients after ruxolitinib failure

Abstract Introduction To evaluate treatment continuation of gecacitinib in myelofibrosis (MF) patients after ruxolitinib failure, we conducted a post-hoc analysis of pooled data from two phase 2 single-arm studies: ZGJAK006 (ruxolitinib-intolerant MF) and ZGJAK017 (ruxolitinib-refractory/relapsed MF). Methods Study designs were previously published. This analysis included 84 patients (ZGJAK006: n=50; ZGJAK017: n=34) with long-term follow-up for treatment continuation. Results Among the 84 patients, the median age was 60 years (range 25–75), with 50 males (59.5%). Disease subtypes included primary MF (n=70), post-polycythemia vera MF (n=7), and post-essential thrombocythemia MF (n=7). Molecular profiling showed JAK2V617F mutations (n=56), CALR mutations (n=20; Type 1: n=10, Type 2: n=7, uncommon: n=3), MPL mutations (n=6), and triple-negative (n=3). Baseline hematologic parameters included a median hemoglobin level of 87 g/L (range 44–149) and median platelet count of 136×10⁹/L (range 48–951). The median time from initial diagnosis was 24.2 months (range 2.7–352.1), with a median prior ruxolitinib treatment duration of 14.1 months (range 1.5–90.5). Seventy-eight patients started gecacitinib at 100 mg BID, 4 at 150 mg QD, and 1 each at 200 mg QD and 100 mg QD. Thirty-nine patients (46.4%) entered a compassionate use program after study completion. As of June 25, 2025, with a median follow-up of 3.8 years, 31 patients (36.9%) remained on gecacitinib. The median treatment duration was 22.4 months (range 0.1–60.3) for the entire cohort; 23.0 months (range 0.1–53.0) for patients starting at 100 mg BID; 23.0 months (range 0.1–60.3) for ruxolitinib-intolerant patients; and 18.3 months (range 3.2-47.0) for ruxolitinib-refractory/relapsed patients. Additionally, regression analysis demonstrated that treatment duration was significantly positively correlated with the percentage reduction in spleen volume from baseline at week 24. ConclusionsGecacitinib demonstrates durable treatment continuation (median >18 months across subgroups) in MF patients after ruxolitinib failure. These long-term data support its viability as a therapeutic option for ruxolitinib-intolerant or refractory/relapsed MF patients.

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Journal
Blood
Published
2025-11-03
DOI
https://doi.org/10.1182/blood-2025-5584
Primary Topic
Myeloproliferative Neoplasms: Diagnosis and Treatment
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article
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article

Long-term treatment continuation of gecacitinib in myelofibrosis patients after ruxolitinib failure

Qingchi Liu, Guangsheng He, Liangming Ma, Minghui Duan et al.
Blood
Myeloproliferative Neoplasms: Diagnosis and Treatment
article

Long-term treatment continuation of gecacitinib in myelofibrosis patients after ruxolitinib failure

Qingchi Liu, Guangsheng He, Liangming Ma, Minghui Duan, Junmin Li, Qike Zhang, Mei Hong, Chunkang Chang, Zhijian Xiao, Hongmei Jing, Huanling Zhu, Shanshan Suo, Yi Zhang, Yuqing Chen, Peng Zhao, Xin Li, Hu Zhou, Jie Jin, Jishi Wang, Sujun Gao, Xin Du, Huibing Dang, Na Xu, Haiping Yang, Wei J. Wang
article en

Abstract

Abstract Introduction To evaluate treatment continuation of gecacitinib in myelofibrosis (MF) patients after ruxolitinib failure, we conducted a post-hoc analysis of pooled data from two phase 2 single-arm studies: ZGJAK006 (ruxolitinib-intolerant MF) and ZGJAK017 (ruxolitinib-refractory/relapsed MF). Methods Study designs were previously published. This analysis included 84 patients (ZGJAK006: n=50; ZGJAK017: n=34) with long-term follow-up for treatment continuation. Results Among the 84 patients, the median age was 60 years (range 25–75), with 50 males (59.5%). Disease subtypes included primary MF (n=70), post-polycythemia vera MF (n=7), and post-essential thrombocythemia MF (n=7). Molecular profiling showed JAK2V617F mutations (n=56), CALR mutations (n=20; Type 1: n=10, Type 2: n=7, uncommon: n=3), MPL mutations (n=6), and triple-negative (n=3). Baseline hematologic parameters included a median hemoglobin level of 87 g/L (range 44–149) and median platelet count of 136×10⁹/L (range 48–951). The median time from initial diagnosis was 24.2 months (range 2.7–352.1), with a median prior ruxolitinib treatment duration of 14.1 months (range 1.5–90.5). Seventy-eight patients started gecacitinib at 100 mg BID, 4 at 150 mg QD, and 1 each at 200 mg QD and 100 mg QD. Thirty-nine patients (46.4%) entered a compassionate use program after study completion. As of June 25, 2025, with a median follow-up of 3.8 years, 31 patients (36.9%) remained on gecacitinib. The median treatment duration was 22.4 months (range 0.1–60.3) for the entire cohort; 23.0 months (range 0.1–53.0) for patients starting at 100 mg BID; 23.0 months (range 0.1–60.3) for ruxolitinib-intolerant patients; and 18.3 months (range 3.2-47.0) for ruxolitinib-refractory/relapsed patients. Additionally, regression analysis demonstrated that treatment duration was significantly positively correlated with the percentage reduction in spleen volume from baseline at week 24. ConclusionsGecacitinib demonstrates durable treatment continuation (median >18 months across subgroups) in MF patients after ruxolitinib failure. These long-term data support its viability as a therapeutic option for ruxolitinib-intolerant or refractory/relapsed MF patients.

BloodVol. 146(Supplement 1)
Qingdao University (CN), Hebei Medical University (CN), Central South University (CN), Guiyang Medical University (CN), Shanghai Jiao Tong University (CN), Jilin University (CN), Chinese Academy of Medical Sciences & Peking Union Medical College (CN), Peking University (CN), Sichuan University (CN), Peking Union Medical College Hospital (CN), West China Hospital of Sichuan University (CN), Tongren Hospital (CN), Affiliated Hospital of Guizhou Medical University (CN), Gansu Provincial Hospital (CN), Affiliated Hospital of Qingdao University (CN), First Hospital of Jilin University (CN), Henan Provincial People's Hospital (CN), First Affiliated Hospital of Henan University of Science and Technology (CN), Nanyang Medical College (CN), Peking University Third Hospital (CN), Henan Cancer Hospital (CN), Shanghai Sixth People's Hospital (CN), Institute of Hematology & Blood Diseases Hospital (CN), Guangdong Provincial People's Hospital (CN), Third Xiangya Hospital (CN), First Affiliated Hospital of Hebei Medical University (CN), Shanxi Academy of Medical Sciences (CN), First Affiliated Hospital Zhejiang University (CN), Huazhong University of Science and Technology (CN), Southern Medical University (CN), Nanjing Medical University (CN)
Openalex Percentile: Top 41%
Myeloproliferative Neoplasms: Diagnosis and Treatment
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