NCCN Adds Ropeginterferon alfa-2b the Clinical Practice Guidelines for MPNs

Ruben Mesa, MD, FACP

The National Comprehensive Cancer Network (NCCN)1 Clinical Practice Guidelines in Oncology have been updated to include ropeginterferon alfa-2b-njft (Besremi) as a treatment option for adults who have polycythemia vera (PV), announced by PharmaEssentia USA Corporation in a press release.²

These updates take into account ropeginterferon alfa-2b’s FDA approval for the treatment of adult patients with polcythemia vera in November 2021, considering the agent a useful drug in treating both high- and low-risk adult patients with PV, no matter the treatment history.

Results from the phase 3 PROUD-PV and CONTINUATION-PV (NCT01949805; NCT02218047) with primary endpoints of complete hematological response with normal spleen size and hematological response with improved disease burden, respectively, supported the FDA approval for ropeginterferon alfa-2b.³ In PROUD-PV, 21% patients in the ropeginterferon alfa-2b group and 28% patients in the standard therapy group met the primary endpoint of complete hematological response with improved disease burden and normal spleen size. In CONTINUATION-PV, complete hematological response met in 53% of patients in the ropeginterferon alfa-2b group versus 38% of patients in the standard therapy group (P = .044).

Safety in these trials proved tolerable as the most frequent grade 3 and grade 4 treatment-related adverse events were increased γ-glutamyltransferase (6%) and increased alanine aminotransferase (3%) in the ropeginterferon alfa-2b group, and leucopenia (5%) and thrombocytopenia (4%) in the standard therapy group.

Further safety findings for the agent were reported from the PEGINVERA’s study (NCT01193699). In more than 40% of patients, cases of influenza-like illness, arthralgia, fatigue, pruritis, nasopharyngitis, and musculoskeletal pain were observed. The study had a pooled safety population (n = 178) where the most common adverse events were liver enzyme elevations (20%), leukopenia (20%), thrombocytopenia (19%), arthralgia (13%), fatigue (12%), myalgia (11%), and influenza-like illness (11%).

“Importantly, the NCCN Guidelines update includes mention of Besremi in multiple settings, and in particular, as the only systemic option for low-risk patients with PV, which signals a shift toward more proactive treatment earlier in the disease journey,” said Ruben Mesa, MD, FACP, executive director of the UT Health San Antonio MD Anderson Cancer Center. “Now, treating physicians can leverage these expert guidelines to gain greater familiarity with Besremi in the real world setting and understand its broad utility for patient care in a variety of treatment settings.”

“Our goal with Besremi has been to offer a compelling therapeutic alternative to conventional treatment options that can enable physicians to gain durable control over the disease beyond the symptoms and help more patients reach their long-term health goals,” said Raymond Urbanski, MD, PhD, United States head of Clinical Development and Medical Affairs. “The NCCN Guidelines update just three months following our approval illustrates the community’s recognition of the strong potential of Besremi in PV care.”

_Reference

_{1. Mesa R, Jamieson C, Bhatia R, et al. Myeloproliferative Neoplasms, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2016;14(12):1572-1611. doi:10.6004/jnccn.2016.0169}

_{2. NCCN clinical practice guidelines in oncology update recommends besremi® (ropeginterferon alfa-2b-njft) for the treatment of polycythemia vera. Press release. BioSpace; March 2, 2022. Accessed March 4, 2022. https://bit.ly/35JhQ5X}

_{3. Gisslinger H, Klade C, Georgiev P, et al. Ropeginterferon alfa-2b versus standard therapy for polycythaemia vera (PROUD-PV and CONTINUATION-PV): a randomised, non-inferiority, phase 3 trial and its extension study [published correction appears in Lancet Haematol. 2020 Feb 25;:]. Lancet Haematol. 2020;7(3):e196-e208. doi:10.1016/S2352-3026(19)30236-4}