Summary of clinical trials of IFNα products in patients with MPN.
Clinical trial | Phase | Characteristics | Patient population | IFN | Comparator | Clinical response (ORR/CHR) | Molecular response (ORR/CMR) | Grade III/IV AE/discontinuation rate | |||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
IFN | Comparator | IFN | Comparator | IFN | Comparator | ||||||||
LOW-PV [41] (abstract) | 2 | Low-risk PV (diagnosed less than 3 yr prior) | PV(N=100) | Ropeg-IFNα-2b | Phlebotomy | 84%/NR | 66%/NR | NR | NR | 6%/NR | 8%/NR | ||
Proud-PV/continuation-PV [40] | 3 | Early stage PV (less than 3 years of previous hydroxyurea treatment) | PV (N=257) | Ropeg-IFNα-2b | Hydroxyurea | NR/43% | NR/46% | 34%/NR | 42%/NR (1 yr f/u) | 43%/8% | 34%/4% | ||
NR/71% | NR/51% | 66%/NR | 27%/NR (3 yr f/u) | ||||||||||
MPD-RC 112 [39] (abstract) | 3 | High risk (Treatment-naïv, hydroxyurea <3 mo) | ET (N=81) | Peg-IFNα-2a | Hydroxyurea | 78.0%/35.4% | 69.8%/37.2% (1 y f/u) | NR | NR | 46.3%/NR | 27.5%/NR | ||
PV (N=87) | 59.6%/28.8% | 40.7%/20.4% (2 y f/u) | |||||||||||
MPD-RC 111 [38] | 2 | High risk (hydroxyurea intolerant or resistant) | ET (N=65) | Peg-IFNα-2a | None | 69.2%/43.1% (ET) | CR patients ( |
30.7%/13.9% | |||||
PV(N=50) | 60%/22% (PV) | ||||||||||||
COMBI [46] | 2 | IFN+JAK inhibitor | PV (N=32) | Peg-IFNα-2a+ruxo-litinib | 31%/9% (PV) | 41%/2% | NR/31% (PV) | ||||||
MF (N=18) | 44%/28% (MF) | NR/39% (MF) |
Abbreviations: AE, adverse event; CHR, complete hematologic response; CMR, complete molecular response; ET, essential thrombocythemia; f/u, follow-up; IFNα, interferon alpha; MF, myelofibrosis; MPN, myeloproliferative neoplasm; NR, not reported; ORR, overall response rate; Peg-IFNα-2a, pegylated interferon alpha-2a; PV, polycythemia vera; Ropeg-IFNα-2b, ropeginterferon alpha-2b.