National Comprehensive Cancer Network (NCCN) Oncology Clinical Practice Guidelines Revised Name Ropegin Interferon Alfa-2b-njft As Preferred Treatment Option for High-Risk and Low-Risk Polycythemia Vera (PV) Patients, Regardless of Treatment (Bethlemi) is now included. history.1 The revised version, released May 19, 2023, also granted the agent Category 2A status, indicating NCCN’s uniform consensus that treatment is appropriate.
“Importantly, the NCCN guideline update includes moving ropegin interferon alfa-2b to recommended status, and ropegin interferon alfa-2b, due to its broad utility, is expected to be used in the aggressive treatment of PV. It reinforces what is recommended for treating physicians and patients,” said John Mascarenhas, M.D., Ph.D. The Department of Hematology and Medical Oncology at the Icahn School of Medicine in Mount Sinai, New York, said in a press release.
In November 2021, FDA Approves Ropegin Interfeon Alfa-2b for Treatment of PV Patients Based on PEGINVERA and PROUD/CONTINUATION-PV study data.2 Regarding efficacy, 61% of patients experienced a complete hematologic response with this agent after 7.5 years of treatment. Furthermore, most patients (80%) achieved a hematologic response.
In the overall safety population of patients treated with ropegin interferon alfa-2b, the most frequent adverse reactions (AEs) included influenza-like illness, arthralgia, fatigue, pruritus, nasopharyngitis, musculoskeletal included pain. Serious adverse events include urinary tract infections, transient ischemic attacks, and depression.
Additional Long-Term Data from the Phase 3 PROUD-PV (NCT01949805) and CONTINUATION-PV (NCT02218047) Trials Presented at the 2022 EHA Conferenceshowed that treatment with ropegin interferon alfa-2b reduced the symptom burden and the need for phlebotomy compared with the best available treatment in PV patients.3
Specifically, symptoms such as fatigue, early satiety, abdominal discomfort, inactivity, pruritus, and fever as defined by the Myeloproliferative Neoplasia Symptom Assessment Form (MPN-SAF) were significantly higher than at 1 year of treatment. It was low after the 4th week of the 6th year of treatment. Overall, 15.7% of his patients receiving ropegin interferon alfa-2b reported disease-related symptoms at year 6 of treatment compared with 20.7% of him in the control group.
Furthermore, at 6 years of treatment, 81.4% of patients in the experimental group did not require phlebotomy compared to 60% of patients in the control group (P. = .005).
“The recent update of NCCN’s treatment guidelines represents community recognition of the value of Ropegin interferon alfa-2b as a treatment option for all adults with PV, regardless of prior treatment.” said Raymond Urbanski, M.D., head of US clinical development. said Medical Affairs. “Given the profound and lasting control of the disease beyond symptoms, we continue to investigate Ropegin interferon alfa-2b in PV, as well as other myeloproliferative neoplasms and hematologic malignancies. ”
Ropeginterferon Interferon alfa-2b is ongoing in PV patients in the Phase 3b ECLIPSE PV trial (NCT05481151). Eligible patients will be randomly assigned to an accelerated dosing schedule compared to the currently labeled dose of ropegin interferon alfa-2b.Four The primary endpoint of the study was the proportion of patients who achieved a complete hematologic response 24 weeks after initiation of therapy, i.e., a hematocrit <45% and a platelet count of 400 x 10 for at least 3 months after the last phlebotomy. defined as not exceeding9/L, white blood cells 10 × 109/L or less.
References
- The NCCN Oncology Clinical Practice Guidelines have been updated to recommend Besremi® (rope diinterferon alfa-2b-njft) as the preferred intervention for polycythemia vera. news release. PharmaEssentia USA Corporation. May 23, 2023. Accessed May 24, 2023. https://us.pharmaessentia.com/wp-content/uploads/2023/05/NCCN_Guidelines_Update_Press_Release_May-23-2023.pdf
- The US FDA has approved Bethlemi (lopeginterferon alfa-2b-njft) as the only interferon for adults with polycythemia vera. news release. Pharma Essentia, Inc. November 12, 2021. Accessed May 24, 2023. https://us.pharmaessentia.com/wp-content/uploads/2021/11/BESREMi-FDA-Approval-April-12-2021.pdf
- Gisslinger H, Klade C, Georgiev P, et al. Ropeginterferon alfa-2b Meets Patient-Specific Treatment Goals in Polycythemia Vera: Final Results of the PROUD-PV/CONTINUATION-PV Study. Presented at: 2022 EHA Congress; June 9-12, 2022. Vienna, Austria. Summary S196.
- PharmaEssentia initiates a Phase 3b trial of Ropegin interferon alfa-2b-njft investigating a new dosing regimen for polycythemia vera (PV) patients. news release. May 3, 2023. Accessed May 24, 2023. https://us.pharmaessentia.com/wp-content/uploads/2023/05/ECLIPSE-PV_Initiation_Press_Release_May-3-2023-1.pdf