Peg-IFN plus ruxolitinib in newly diagnosed patients with PV: Results from the COMBI II trial

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. 

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. 

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 JAK2^V617F VAF after 2 years was 7% vs 47% at baseline.

Results demonstrate that Peg-IFN and ruxolitinib were well tolerated, with high response rates and a reduction in JAK2^V617F 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.