Novel interferon appears safer than HU in PV

There was a significantly higher incidence (P<0.01) of the following AEs in the HU arm than the ropeginterferon alfa-2b arm: anemia (24.4% vs 6.3%), leukopenia (21.3% vs 8.7%), thrombocytopenia (28.3% vs 15.0%), and nausea (11.8% vs 2.4%).

There was no significant difference in the incidence of fatigue—13.4% in the HU arm and 12.6% in the ropeginterferon alfa-2b arm.

Patients in the ropeginterferon alfa-2b arm had a significantly higher incidence of gamma-glutamyl transferase increase—14.2% vs 0.8% in the HU arm (P<0.01).

Patients in the ropeginterferon alfa-2b arm also had a higher—but non-significant—incidence of endocrine disorders (3.1% vs 0.8%), psychiatric disorders (1.6% vs 0%), cardiac/vascular disorders (3.1% vs 1.6%), and tissue disorders (1.6% vs 0%).

None of the patients in the ropeginterferon alfa-2b arm developed secondary related malignancies. In the HU arm, however, there were 2 cases of acute leukemia, 2 cases of basal cell carcinoma, and 1 case of malignant melanoma. (This includes data from the ongoing follow-up trial CONTINUATION-PV.)

Drug development

AOP Orphan Pharmaceuticals AG said that, in the coming months, it will submit data from PROUD-PV and the ongoing follow-up trial, CONTINUATION-PV, to obtain European marketing authorization for ropeginterferon alfa-2b.

PharmaEssentia plans to submit the same data to the US Food and Drug Administration.

PharmaEssentia discovered ropeginterferon alfa-2b and has licensed the rights for development and commercialization of the drug in myeloproliferative neoplasms to AOP Orphan Pharmaceuticals AG in Europe, the Commonwealth of Independent States, and Middle Eastern markets.

*Information presented at the meeting differs from the abstract.