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Peg-IFN plus ruxolitinib in newly diagnosed patients with PV: Results from the COMBI II trial
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The phase II COMBI II trial assessed the safety and efficacy of Peg-IFN (45 μg/week) and ruxolitinib (10 mg twice daily) in 25 adult patients with newly diagnosed PV.1 Results from this trial with a 2-year follow-up were published in Blood Advances by Soerensen et al.1 |
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The combination of Peg-IFN and ruxolitinib was well tolerated. Grade 1 and 2 anemia occurred in 68% and 20% of patients, respectively, which was managed with dose adjustments. In total, 12% and 16% of patients discontinued Peg-IFN and ruxolitinib, respectively. Sensory neuropathy was reported in 68% of patients. |
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Significant reduction in TSS from baseline was observed at 14 days and 21 months. TTS items that reduced at more than half of the time points included abdominal discomfort (p < 0.001), night sweats (p < 0.001), itching (p < 0.05), and bone pain (p < 0.001). No TTS items increased during the trial. |
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After 24 months, the PBCR, ORR, CR, and PR rates were 92%, 56%, 12%, and 44%, respectively. The overall molecular response rate at 24 months was 68% and the median JAK2V617F VAF after 2 years was 7% vs 47% at baseline. |
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Results demonstrate that Peg-IFN and ruxolitinib were well tolerated, with high response rates and a reduction in JAK2V617F VAF, suggesting that this combination therapy with disease-modifying potential, has a beneficial impact on long-term disease control and quality of life in patients with newly diagnosed PV. |
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Abbreviations: CR, complete remission; ORR, overall response rate; PBCR, peripheral blood cell count remission; Peg-IFN, pegylated interferon-alpha-2a; PR, partial remission; PV, polycythemia vera; TTS, Myeloproliferative Neoplasm Symptom Total Symptom Score; VAF, variant allele frequency. |
- Soerensen AL, Skov V, Kjær L, et al. Combination therapy with ruxolitinib and pegylated interferon-alpha2a in newly diagnosed patients with polycythemia vera. Blood Adv. 2024. Online ahead of print. DOI: 1182/bloodadvances.2024013170
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