Besremi (ropeginterferon alfa-2b-njft)

NLR half reduction significantly predicted hematologic response (week 24 OR 6.42, p = 0.001) and molecular response consistently across all time points (week 24 OR 27.94, p < 0.001). NLR half reduction is a simple, cost-effective biomarker that may reflect molecular response and treatment efficacy in PV.

The patient maintained CHR and MR for 2 years following treatment discontinuation. We also discuss the potential benefit of ropeg-IFN in low-risk PV patients who were not previously considered candidates for aggressive cytoreductive therapy.

The standard treatment is low-dose aspirin and phlebotomy, with cytoreductive therapy added for high-risk PV. All 3 patients achieved and maintained complete hematologic response with reduced JAK2 V617F allele burden. Ropeg-IFN is an effective and safe therapy for elderly patients with PV that also improves quality of life.

Clinical trials have demonstrated that ropeg-IFN reduces the JAK2 V617F allele burden, which is recognized as an independent risk factor for disease progression and thrombosis, apart from traditional factors such as age and prior cardiovascular events. To improve the prognosis of PV, it is essential to accumulate clinical evidence on trends in JAK2 V617F allele burden and the conditions required to maintain hematologic control after discontinuation of ropeg-IFN therapy in real-world settings.

Ongoing treatment with hydroxyurea was substituted with ropeg (week 0: 250 mcg; week 2: 350 mcg; week 4 onwards: 500 mcg every 2 weeks). In conclusion, ropeg was safe and induced CHCR associated with significant molecular responses in patients with early MF. ClinicalTrials.gov Identifier: NCT04988815.

P2, N=35, Not yet recruiting, Jonsson Comprehensive Cancer Center

This is the first study to provide pharmacokinetic evidence of RopegIFN exposure during pregnancy and lactation. These findings support the safety of RopegIFN use in pregnant ET and PV patients and highlight the need for a collaborative registry to collect real-world data and guide management for this high-risk population.

P=N/A, N=319, Active, not recruiting, FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS | Recruiting --> Active, not recruiting

P=N/A, N=150, Not yet recruiting, Federico II University

P2, N=40, Not yet recruiting, M.D. Anderson Cancer Center

Its favorable efficacy-toxicity balance and convenient dosing support long-term use, particularly in younger or treatment-naïve patients. Future research should refine patient selection, explore predictive biomarkers, and define its role among disease-modifying agents capable of transforming PV into a chronic, potentially controllable disorder.

The most common adverse events were elevated liver enzymes (AST: 0.28; ALT: 0.32), influenza-like illness (0.11), and anemia (0.09), with unresolved heterogeneity in all outcomes.Ropeginterferon alfa-2b shows promising efficacy in achieving hematological and molecular responses in patients with PV. However, notable heterogeneity and safety concerns, particularly liver-related adverse effects, warrant further investigation in large-scale trials.