ViraferonPeg (peginterferon-α-2b) / Merck (MSD) - LARVOL DELTA

Real-world Clinical Outcomes of Polycythemia Vera Patients Treated with Ropeginterferon a-2b: a multicenter, retrospective analysis (DGHO 2025) - "Among disease-modifying therapies, pegylated interferons—particularly Ropeginterferon alfa-2b (Besremi®) and Peginterferon alfa-2a (PEG-Intron®)—have shown the ability to induce both hematologic and molecular remissions, improve quality of life, and are increasingly used in clinical practice. This real-world multicenter study supports the clinical effectiveness and tolerability of pegylated interferons in the treatment of PV and ET. Observed hematologic and molecular responses, along with improvements in quality of life, reinforce the disease-modifying potential in routine clinical settings. Ongoing follow-up and prospective comparative studies are warranted to refine treatment strategies and optimize patient selection."

Clinical data • Real-world • Real-world evidence • Retrospective data • Cardiovascular • Essential Thrombocythemia • Fatigue • Hematological Disorders • Myeloproliferative Neoplasm • Polycythemia Vera • Thrombocytosis • CALR • JAK2

Allogeneic, Antigen-Presenting, GM-CSF-secreting, SV-BR-1-GM Whole Cell-Therapeutic Vaccine and Immunotherapy: A Phase I Pilot Safety and Feasibility Study for Solid Tumor Patients With CNS Metastases (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Medical College of Wisconsin

New P1 trial • Oncology • Solid Tumor

A Study to Compare Quality of Life and Compliance in Patients Receiving High-dose Interferon Versus Pegylated Interferon in Patients With Surgically Resected Melanoma (clinicaltrials.gov) - P=N/A | N=50 | Completed | Sponsor: St. Luke's Hospital and Health Network, Pennsylvania | Unknown status ➔ Completed

Compliance • HEOR • Trial completion • Melanoma • Oncology • Solid Tumor

PInNACLe: Pegylated Interferon Alfa-2b and Nilotinib for Augmentation of Complete Molecular Response in Chronic Myeloid Leukaemia (clinicaltrials.gov) - P2 | N=60 | Completed | Sponsor: Australasian Leukaemia and Lymphoma Group | Unknown status ➔ Completed | N=100 ➔ 60

Enrollment change • Trial completion • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • ABL1 • BCR

Phase II Study Incorporating Pegylated Interferon In the Treatment For Children With High-Risk Melanoma (clinicaltrials.gov) - P2 | N=29 | Active, not recruiting | Sponsor: St. Jude Children's Research Hospital | Trial completion date: May 2023 ➔ May 2026

Trial completion date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

Pilot Peg-Interferon-a2b in Decreasing Viral DNA in HIV (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: The Wistar Institute | Unknown status ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease • CD4

EURAMOS-1: Combination Chemotherapy, PEG-Interferon Alfa-2b, and Surgery in Treating Patients With Osteosarcoma (clinicaltrials.gov) - P3 | N=1334 | Completed | Sponsor: Children's Oncology Group | Unknown status ➔ Completed

Surgery • Trial completion • Oncology • Osteosarcoma • Sarcoma • Solid Tumor

MOLECULAR RESPONSE TO HYDROXYUREA AND ROPEGINTERFERON ALFA-2B IN THE PROUD-PV RANDOMIZED PHASE 3 TRIAL (EHA 2017) - P3; "In this phase 3 trial comparing Ropeginterferon alfa-2b versus HU, we found a different impact of both drugs on hematopoietic cells. Although both treatment induced a decrease of JAK2 mutant allele burden at 12 mos in peripheral blood, BM clonogenic assays suggest that AOP2014 is able to specifically target JAK2 mutant progenitors, an effect not seen in HU treated pts. Such targeted impact of AOP2014 may account for the strikingly different kinetics in allele burden reduction and suggests that sustained long-term molecular response may only be achieved with IFNa based treatment."

P3 data • Biosimilar • Myelodysplastic Syndrome

Recombinant Interferon-β in the Treatment of Polycythemia Vera and Related Neoplasms: Rationales and Perspectives. (PubMed, Cancers (Basel)) - "Later, pegylated IFN-α2a (Pegasys) and pegylated IFN-α2b (PegIntron) were introduced, which have since been reported to be better tolerated due to reduced toxicity...Within the hematological malignancies, rIFN-α2 has been used off-label for decades in patients with Philadelphia-negative chronic myeloproliferative neoplasms (MPNs)-i.e., essential thrombocythemia, polycythemia vera, and myelofibrosis-and in recent years rIFN-α2 has been revived with the marketing of ropeginterferon-α2b (Besremi) for the treatment of polycythemia vera patients...Another rIFN formulation-recombinant interferon-β (rIFN-β)-has been used for decades in the treatment of multiple sclerosis but has never been studied as a potential agent to be used in patients with MPNs, although several studies and reviews have repeatedly described rIFN-β as an effective anticancer agent as well. In this paper, we describe the rationales and perspectives for launching studies on the safety and efficacy of rIFN-β..."

Journal • Chronic Eosinophilic Leukemia • Chronic Myeloid Leukemia • CNS Disorders • Essential Thrombocythemia • Immune Modulation • Inflammation • Multiple Sclerosis • Myelofibrosis • Myeloproliferative Neoplasm • Polycythemia Vera • Thrombocytosis • IFNA1 • IFNB1

A phase III randomized study of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon alfa-2b for resected high-risk melanoma (U.S. Intergroup E1609): Preliminary safety and efficacy of the ipilimumab arms. (ASCO 2017) - P3; "Adjuvant therapy of pts with high-risk melanoma is associated with significantly more toxicity at ipi10 compared to ipi3. An unplanned RFS analysis of concurrently randomized pts on the 2 ipi arms showed no difference in RFS."

Clinical • Head-to-Head • P3 data • Biosimilar • Melanoma

Pembrolizumab (pembro) plus low-dose ipilimumab (ipi) for patients (pts) with advanced renal cell carcinoma (RCC): Phase 1 KEYNOTE-029 study. (ASCO-GU 2017) - P1/2; "...KEYNOTE-029 (NCT02089685) is a phase 1/2 study designed to assess the safety and efficacy of pembro + ipi or pegylated interferon alfa-2b (IFN-α) in pts with advanced melanoma or RCC... The combination of pembro + low-dose ipi for 4 doses, followed by pembro monotherapy, demonstrates a manageable toxicity profile and preliminary antitumor activity in pts with advanced RCC."

Checkpoint inhibition • Clinical • P1 data • Melanoma • Renal Cell Carcinoma

Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=8 | Completed | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Active, not recruiting ➔ Completed

Trial completion • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=8 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: May 2022 ➔ Dec 2022

Trial completion date • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

DALIAH: A Study of Low Dose Interferon Alpha Versus Hydroxyurea in Treatment of Chronic Myeloid Neoplasms (clinicaltrials.gov) - P3 | N=202 | Completed | Sponsor: Thomas Stauffer Larsen | Active, not recruiting ➔ Completed

Trial completion • Chronic Myeloid Leukemia • Hematological Disorders • Myelofibrosis • Myeloproliferative Neoplasm • Oncology • Polycythemia Vera • Thrombocytosis

Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) - P2; N=8; Active, not recruiting; Sponsor: H. Lee Moffitt Cancer Center and Research Institute; Trial completion date: Dec 2021 ➔ Apr 2022

Trial completion date • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • MRI

Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) - P2; N=8; Active, not recruiting; Sponsor: H. Lee Moffitt Cancer Center and Research Institute; Trial completion date: Aug 2021 ➔ Dec 2021

Trial completion date • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • MRI

Peg Interferon α-2b for Relapsed Hematological Malignancies After Allo-HSCT (clinicaltrials.gov) - P2/3; N=50; Recruiting; Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Oncology • Transplantation

Pegylated Interferon ALFA-2b in Children With Juvenile Pilocytic Astrocytomas and Optic Pathway Gliomas (clinicaltrials.gov) - P2; N=9; Completed; Sponsor: Emory University; Recruiting ➔ Completed; N=20 ➔ 9

Enrollment change • Trial completion • Astrocytoma • Brain Cancer • Glioma • Oncology • Solid Tumor • MRI

Intraperitoneal Infusion of Autologous Monocytes With Sylatron (Peginterferon Alfa-2b) and Actimmune (Interferon Gamma-1b) in Women With Recurrent or Refractory Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer (clinicaltrials.gov) - P1; N=18; Terminated; Sponsor: National Cancer Institute (NCI); Completed ➔ Terminated; Study was closed to accrual due to lack of drug supply.

Trial termination • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • CYP1A2 • IFNA1 • IFNG

Peg-Interferon Alpha 2b Combined With Two Intravenous Broadly HIV-1 Neutralizing Antibodies 3BNC117 and 10-1074 (BEAT-2) (clinicaltrials.gov) - P1; N=15; Active, not recruiting; Sponsor: Luis Montaner; Recruiting ➔ Active, not recruiting; Trial completion date: Jun 2022 ➔ Oct 2022

Clinical • Enrollment closed • Trial completion date • Human Immunodeficiency Virus • Infectious Disease • CD4 • IFNA1

Treatment of Advanced Melanoma With MK-3475 and Peginterferon (clinicaltrials.gov) - P1; N=43; Completed; Sponsor: Hassane M. Zarour, MD; Active, not recruiting ➔ Completed; Trial completion date: Dec 2023 ➔ Jul 2020

Trial completion • Trial completion date • Melanoma • Oncology • Solid Tumor

KEYNOTE 029: Safety and Tolerability of Pembrolizumab (MK-3475) + Pegylated Interferon Alfa-2b and Pembrolizumab+ Ipilimumab in Participants With Advanced Melanoma or Renal Cell Carcinoma (MK-3475-029/KEYNOTE-29) (clinicaltrials.gov) - P1/2; N=295; Completed; Sponsor: Merck Sharp & Dohme Corp.; Active, not recruiting ➔ Completed

Trial completion • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Melanoma • Oncology • Renal Cell Carcinoma • Solid Tumor

A monocentric phase I study of vemurafenib plus cobimetinib plus PEG-interferon (VEMUPLINT) in advanced melanoma patients harboring the V600BRAF mutation. (PubMed, J Transl Med) - P1/2 | "Our study supports the overall safety of the vemurafenib + PEG-IFN-α-2b + cobimetinib combination. IFNAR1 expression levels correlated with response to treatment, including survival. Vemurafenib + PEG-IFN-α-2b + cobimetinib would have difficulty finding a niche in the current treatment scenario for advanced melanoma, but we speculate that our findings may contribute to identify subjects particularly responsive to treatment."

Clinical • Journal • P1 data • Melanoma • Oncology • Solid Tumor • BRAF • GAS1 • IFNAR1

Fludarabine, Mitoxantrone, and Dexamethasone (FND) Plus Rituximab for Lymphoma Patients (clinicaltrials.gov) - P3; N=210; Active, not recruiting; Sponsor: M.D. Anderson Cancer Center; Trial primary completion date: Dec 2014 ->Dec 2015

Trial primary completion date • Biosimilar • Hematological Malignancies • Oncology

Intraperitoneal Infusion of Autologous Monocytes With Sylatron (Peginterferon Alfa-2b) and Actimmune (Interferon Gamma-1b) in Women With Recurrent or Refractory Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer (clinicaltrials.gov) - P1; N=18; Completed; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Completed; N=40 ➔ 18; Trial completion date: Jul 2023 ➔ Sep 2020; Trial primary completion date: Apr 2022 ➔ Sep 2020

Clinical • Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • CYP2D6 • IFNA1 • IFNG