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Ropeginterferon Alfa-2b Shows Promise in early Myelofibrosis Treatment
Chicago, Il – Exciting new data presented at the 2025 American Society Of Clinical Oncology (ASCO) Annual Meeting reveals that Ropeginterferon Alfa-2b (Besremi) is showing significant promise in the treatment of early-stage Myelofibrosis (MF). The Phase 2 study highlights the drug’s ability to induce favorable clinical, hematologic, and molecular responses in patients with pre-primary Myelofibrosis (PMF) and low/intermediate-1-risk MF.
Myelofibrosis is a rare bone marrow cancer that disrupts the body’s normal production of blood cells. This news offers a beacon of hope for those affected by this challenging condition.
Clinical Trial Highlights
The multicenter,open-label phase 2 trial investigated Ropeg-IFN-α2b in patients with pre-fibrotic or low-intermediate-1 risk MF. Researchers focused on hemoglobin, white blood cell, and platelet responses at 24 and 52 weeks. Secondary endpoints encompassed safety, reductions in variant allele frequencies, spleen size, symptom scores, and bone marrow fibrosis.
Key Findings at a Glance
- Hemoglobin Response: 73.9% at week 24, 76.2% at week 52.
- White Blood Cell Response: 82.6% at week 24, 79.4% at week 52.
- Platelet Response: 100% at both week 24 and week 52.
- JAK2V617F VAF Reduction: 34% of patients by week 52.
Ropeginterferon alfa-2b: A New Generation Interferon
First introduced in 1957 to combat viral infections like hepatitis, interferons have as proven effective in treating MF. Ropeg-IFN-α2b represents a next-generation, monopegylated interferon alfa-2b, specifically designed for myeloproliferative neoplasms (MPN). Approved in 2021 for polycythemia vera, its manufacturer is seeking approval for essential thrombocytopenia based on the SURPASS-ET trial data as of January 2025.
Detailed Trial Results
The trial involved 71 patients (40 men, 31 women) with a median age of 60. They received Ropeg-IFN-α2b starting at 250 mcg, escalating to 500 mcg every two weeks from week 4.
After a median follow-up of 119 weeks, significant improvements were observed across key indicators:
| Response | Week 24 | week 52 |
|---|---|---|
| Hemoglobin | 73.9% | 76.2% |
| White Blood Cell | 82.6% | 79.4% |
| Platelet | 100% | 100% |
| JAK2V617F VAF Reduction | 34% (by Week 52) | |
| CALR VAF Reduction | 53% (10/19 patients) | 43% (6/14 patients) |
| spleen Size Reduction | 47% (9/19 patients) | 53% (9/17 patients) |
| MPNSAF-TSS Reduction (≥50%) | 42.9% (27/63 patients) | 42.1% (23/57 patients) |
The most common nonhematologic adverse events were transaminitis (49.2%), malaise (40.8%), and hair loss (33.8%). Hematologic adverse events included anemia (21.1%), neutropenia (21.1%), and thrombocytopenia (11.2%).
Implications and Future Directions
These findings suggest Ropeg-IFN-α2b’s potential in treating pre-fibrotic MF. Continued research is essential to fully understand these results and optimize treatment strategies. This coudl mark a significant advancement in Myelofibrosis care.
