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Jaktinib for patients with MF: Final results from the phase III ZGJAK016 trial
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Ruxolitinib is the only JAKi approved for the treatment of patients with MF in China. However, the efficacy of ruxolitinib in Chinese populations is slightly lower when compared to other regions.1 While hydroxyurea (HU) is commonly used to treat patients with MF in China, the duration of response is typically 1 year, and 50% of patients experience worsening anemia or cytopenia.1 Jaktinib (also known as gecacitinib) is a novel inhibitor of JAK and ACVR1.1 The multicenter, 2:1 randomized, phase III ZGJAK016 trial (NCT04617028) assessed the efficacy and safety of jaktinib (n = 71) vs HU (n = 34) in 105 adult patients with intermediate-2 or high-risk MF across 38 centers in China.1 The MPN Hub previously reported results from the interim analysis of this trial. Final results were published in Blood Cancer Journal by Zhang, et al.1 |
| Key learnings |
| The primary endpoint was met; at Week 24, the SVR35 response rates were 64.8% in the jaktinib group vs 26.5% in the HU group (p = 0.0002). |
| Patients receiving jaktinib showed greater anemia improvements, with 31% of non-transfusion-dependent patients achieving a ≥20 g/L hemoglobin increase vs 15% in the HU group, suggesting potential benefits in managing MF-associated anemia. |
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Jaktinib had a more favorable safety profile, with lower rates of Grade ≥3 TEAEs such as anemia (26.8% vs 44.1%), thrombocytopenia (15.5% vs 32.4%), leukopenia (2.8% vs 20.6%), and neutropenia (1.4% vs 20.6%) vs HU. |
| These findings support jaktinib as a promising first-line treatment option for patients with MF, particularly in patients with anemia, offering a more effective and well-tolerated alternative to HU. |
Abbreviations: ACVR1, activin receptor type I; HU, hydroxyurea; JAK, Janus kinase; JAKi, JAK inhibitor; MF, myelofibrosis; SVR35, ≥35% reduction in spleen volume; TEAE, treatment-emergent adverse event.
- Zhang Y, Zhou H, Suo S, et al. Evaluation of gecacitinib vs hydroxyurea in patients with intermediate-2 or high-risk myelofibrosis: final analysis results from a randomized phase 3 study. Blood Cancer J. 2024;14(1):216. DOI: 10.1038/s41408-024-01202-8
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