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Ruxolitinib Exhibits Safety, Efficacy Among Elderly Patients With Therapy-Naïve Myelofibrosis
Interim Results from the JAKoMo Trial
Interim Results from the JAKoMo Trial
According to interim results with a median of 1.5 years of follow-up from JAKoMo, a prospective, non‑interventional, phase 4 study among elderly patients with therapy-naïve myelofibrosis (MF), ruxolitinib treatment demonstrated safety and efficacy in the real-world setting.
A total of 928 Janus kinase 1/2 inhibitor (JAKi)-naïve and -pretreated patients enrolled from 122 German centers in this trial. Ruxolitinib was administered according to the Summary of Product Characteristics. Compared to data from the COMFORT-I, -II, and JUMP trials, patients in the JAKoMo study were older, had poorer Eastern Cooperative Oncology Group (ECOG) performance statuses (16.5% had ECOG ≥ 2), and were more transfusion-dependent. Risk scores were noted to be used in less than half of the patients to initiate the ruxolitinib treatment.
Following ruxolitinib treatment, 82.5% of patients experienced rapid (≤ 1 month), significant decreases in palpable spleen size, which remained durable for 24 months among 60% of patients. It was noted that symptom assessment scores improved significantly in month 1 (median –5.2) up to month 12 (–6.2).
The most common adverse events were anemia and thrombocytopenia. At cutoff, 54.3% of patients had terminated the study due to death, adverse events, or deterioration of health. No new safety signals were observed.
Study authors concluded that, “Interim analysis of the JAKoMo study confirms [ruxolitinib] safety and efficacy in a representative cohort of real-world, elderly, JAKi-naïve patients with MF.”
Source:
Koschmiede S, Isfort S, Schulte C, et al. Real-world analysis of ruxolitinib in myelofibrosis: interim results focusing on patients who were naïve to JAK inhibitor therapy treated within the JAKoMo non-interventional, phase IV trial. Published online October 4, 2023. doi:10.1007/s00277-023-05458-1
