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    DRUG:

    Pegasys (pegylated interferon α -2a)

    i
    Other names: RG 44, RG 964, RO253036, RO258310, RO25-8310, R-442, R-964, RG-44, RG-964, RO-253036, RO-258310, RO-25-8310, PEG IFN-alpha-2a, R442, R964, RG44, RG964, RO 253036, RO 25-8310, RO 258310, R 442, R 964
    Company:
    Ascletis, Roche
    Drug class:
    IFNα stimulant
    Related drugs:
    23d
    A Study to Evaluate the Safety, Tolerability, Drug Levels, Food, Formulation, and pH Effects on Relative Absorption of BMS-986465 and Its Active Derivative BMS-986464 in Healthy Participants (clinicaltrials.gov)
    P1, N=132, Active, not recruiting, Bristol-Myers Squibb | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Pegasys (pegylated interferon α -2a)
    4ms
    Piranga: A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B (clinicaltrials.gov)
    P2, N=281, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed | Trial completion date: Jul 2025 --> Jul 2024 | Trial primary completion date: Oct 2024 --> Jul 2024
    Trial completion • Trial completion date • Trial primary completion date • Combination therapy
    |
    Pegasys (pegylated interferon α -2a)
    5ms
    A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients (clinicaltrials.gov)
    P2, N=8, Completed, Shanghai HEP Pharmaceutical Co., Ltd. | Recruiting --> Completed | N=30 --> 8
    Trial completion • Enrollment change
    |
    Pegasys (pegylated interferon α -2a)
    6ms
    Piranga: A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B (clinicaltrials.gov)
    P2, N=280, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Jan 2025 --> Jul 2025
    Trial completion date • Combination therapy
    |
    Pegasys (pegylated interferon α -2a)
    8ms
    A Study to Evaluate the Safety, Tolerability, Drug Levels, Food, Formulation, and pH Effects on Relative Absorption of BMS-986465 and Its Active Derivative BMS-986464 in Healthy Participants (clinicaltrials.gov)
    P1, N=132, Recruiting, Bristol-Myers Squibb | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Pegasys (pegylated interferon α -2a)
    10ms
    ACTIVATE: Reducing the Residual Reservoir of HIV-1 Infected Cells in Patients Receiving Antiretroviral Therapy (clinicaltrials.gov)
    P1/2, N=17, Completed, Massachusetts General Hospital | Active, not recruiting --> Completed | N=34 --> 17
    Trial completion • Enrollment change
    |
    CD4 (CD4 Molecule)
    |
    Farydak (panobinostat) • Pegasys (pegylated interferon α -2a)
    11ms
    MoST-TAP: Tiragolumab and Atezolizumab in Advanced Pan-cancer Patients (clinicaltrials.gov)
    P2, N=96, Recruiting, Omico | Not yet recruiting --> Recruiting
    Enrollment open • Pan tumor • Metastases
    |
    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    PD-L1 expression • PD-L1 amplification
    |
    Tecentriq (atezolizumab) • Pegasys (pegylated interferon α -2a) • tiragolumab (RG6058)
    1year
    A Phase II Study of Hepalatide in Subjects With Chronic Hepatitis B (clinicaltrials.gov)
    P2, N=96, Completed, Shanghai HEP Pharmaceutical Co., Ltd. | Recruiting --> Completed
    Trial completion
    |
    Pegasys (pegylated interferon α -2a)
    1year
    Real-World Experience of Ropeginterferon-Alfa Treatment of PV and ET - Two Centers Experience (ASH 2023)
    Prior to ropeginterferon-alfa, the participants were managed with therapeutic phlebotomies, or cytoreduced with either hydroxyurea, pegylated interferon-alpha 2a ( Pegasys), JAK2 inhibitors, or were newly diagnosed and previously untreated. Ropeginterferon-alfa is effective in PV and ET, however, the dose that achieves CHR is highly individualized, necessitating an incremental titration approach. The patients already in CHR from prior therapy needed relatively lower doses of ropeginterferon-alfa to maintain CHR. Clinical trials are ongoing with an alternate accelerated dosing scheme and results are awaited.
    Clinical • Real-world evidence • Real-world
    |
    DNMT3A (DNA methyltransferase 1) • TET2 (Tet Methylcytosine Dioxygenase 2) • CALR (Calreticulin)
    |
    DNMT3A mutation • TET2 mutation • CBL mutation • JAK2 V617F • JAK2 mutation • CALR mutation
    |
    Pegasys (pegylated interferon α -2a) • hydroxyurea
    1year
    Pilot Study of Betaine + Combination Antiviral Therapy for Chronic Hepatitis C Genotype 1 Non-responder/Relapsers (clinicaltrials.gov)
    P1, N=2, Terminated, University of Nebraska | N=30 --> 2
    Enrollment change
    |
    Pegasys (pegylated interferon α -2a)
    1year
    A Study to Evaluate the Safety, Tolerability, Drug Levels, Food, Formulation, and pH Effects on Relative Absorption of BMS-986465 and Its Active Derivative BMS-986464 in Healthy Participants (clinicaltrials.gov)
    P1, N=132, Not yet recruiting, Bristol-Myers Squibb
    New P1 trial
    |
    Pegasys (pegylated interferon α -2a)
    1year
    EFFICACY AND SAFETY OF XALNESIRAN COMBINATION THERAPIES WITH AND WITHOUT AN IMMUNOMODULATOR IN VIROLOGICALLYSUPPRESSED PARTICIPANTS WITH CHRONIC HEPATITIS B: PRIMARY ENDPOINT RESULTS FROM THE PHASE 2, RANDOMIZED, CONTROLLED, ADAPTIVE, OPEN-LABEL PLATFORM STUDY (PIRANGA) (AASLD 2023)
    Here, we report the primary endpoint results of xalnesiran, a small interfering ribonucleic acid (siRNA) targeting the HBsAg coding region of the HBV genome (RO7445482, RG6346) in combination with nucleos(t)ide analogues (NUC), with or without an immunomodulator: pegylated interferon alfa-2a (Peg-IFN-α, Pegasys®), or ruzotolimod (toll-like receptor 7 agonist, RO7020531, RG7854). Xalnesiran combination therapies of 48 wks treatment duration were generally safe and well tolerated. Higher HBsAg loss rates were observed when xalnesiran was combined with an immunomodulator (PegIFN-α or ruzotolimod).
    Clinical • P2 data • Late-breaking abstract • Combination therapy • Immunomodulating
    |
    IFNA1 (Interferon Alpha 1)
    |
    Pegasys (pegylated interferon α -2a)
    1year
    FAIM: Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression (clinicaltrials.gov)
    P2, N=324, Recruiting, Royal Marsden NHS Foundation Trust | Trial completion date: Aug 2024 --> Sep 2026 | Trial primary completion date: Aug 2023 --> Sep 2026
    Trial completion date • Trial primary completion date • Circulating tumor DNA • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
    |
    HER-2 positive • ER positive • HER-2 negative • PIK3CA mutation • HER-2 mutation • ER positive + HER-2 negative • CDK4 mutation
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • ipatasertib (RG7440) • Pegasys (pegylated interferon α -2a)
    over1year
    Phase II trial of Pegasys in Glivec responsive chronic phase chronic myeloid leukaemia (ACTRN12605000041651)
    P2, N=60, Completed, Australasian Leukaemia and Lymphoma Group | Recruiting --> Completed
    Trial completion
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase)
    |
    imatinib • Pegasys (pegylated interferon α -2a)
    over1year
    MoST-TAP: Tiragolumab and Atezolizumab in Advanced Pan-cancer Patients (clinicaltrials.gov)
    P2, N=96, Not yet recruiting, Omico
    New P2 trial • Pan tumor • Metastases
    |
    PD-L1 (Programmed death ligand 1) • TMB (Tumor Mutational Burden) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    PD-L1 expression • PD-L1 amplification
    |
    Tecentriq (atezolizumab) • Pegasys (pegylated interferon α -2a) • tiragolumab (RG6058)
    over1year
    IPOS: Effect of Low-dose Interferon-alfa2a on Peri-operative Immune Suppression (clinicaltrials.gov)
    P2, N=68, Recruiting, Zealand University Hospital | Not yet recruiting --> Recruiting | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Oct 2023 --> Aug 2025
    Enrollment open • Trial completion date • Trial primary completion date
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    Pegasys (pegylated interferon α -2a)
    over1year
    Pegasys® in Patients With Myeloproliferative Diseases (clinicaltrials.gov)
    P2, N=84, Completed, M.D. Anderson Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jun 2024 --> May 2023 | Trial primary completion date: Jun 2024 --> May 2023
    Trial completion • Trial completion date • Trial primary completion date
    |
    Pegasys (pegylated interferon α -2a)
    over1year
    FAIM: Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression (clinicaltrials.gov)
    P2, N=324, Recruiting, Royal Marsden NHS Foundation Trust | Not yet recruiting --> Recruiting
    Enrollment open • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
    |
    HER-2 positive • ER positive • HER-2 negative • PIK3CA mutation • HER-2 mutation • ER positive + HER-2 negative • CDK4 mutation
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • ipatasertib (RG7440) • Pegasys (pegylated interferon α -2a)
    almost2years
    Successful CAR-T Cell Treatment of JAK1/2 Inhibitor Treatment Induced DLBCL (EHA-EBMT-CART 2023)
    Ruxolitinib was discontinued and the patient received two cycles of RR-EPOCH, four cycles of R-COMP and lenalidomide. While this treatment resulted in complete metabolic response, the patient was deemed eligible for CAR-T cell treatment by the lymphoma-board, because of the high-risk features of this lymphoma (immunosuppression associated, high IPI score and double expressor score of 2).After bridging with polatuzumab-vedotin-bendamustin, the patient received axicabtagene ciloleucel on 22.11.2021... Therapy of JAK1/2 inhibitor associated aggressive B-Cell lymphoma is feasible and results in durable remissions with acceptable toxicity.Figure 1DateJAK2 V617F Allelic burden(Sample site: peripheral blood)17.07.20192,108%27.08.20192,038%29.10.20191,37816.10.20200,889%04.03.20210,814%23.08.20210,275%15.09.20210,528%12.01.20221,101%23.02.20220,645%Table 1
    CAR T-Cell Therapy
    |
    CD19 (CD19 Molecule)
    |
    JAK2 V617F
    |
    lenalidomide • Jakafi (ruxolitinib) • Yescarta (axicabtagene ciloleucel) • bendamustine • Pegasys (pegylated interferon α -2a) • Polivy (polatuzumab vedotin-piiq)
    2years
    Challenging the Concept of Triple-Negative Thrombocytosis: Real-World Evidence from a Single Institution Experience (ASH 2022)
    Cytoreductive therapy was given to 14 TNT patients (Hydroxycarbamide, n=12; Pegasys, n=1,; Anagrelide, n=1) dictated by physician choice.In evaluable patients with TNT (n=69), NDM was found in only 9 patients (13.2%) and associated with older age (median age 69.3 yr)...We hence favour the term idiopathic thrombocytosis in selected for patients with TNT patients. Further studies are warranted to examine the role of cytoreduction and anti-platelet therapy in TNT in selected patient groups, e.g. previous thrombosis , cardiovascular risk factors, older age and extreme thrombocytosis.
    Clinical • HEOR • Real-world evidence
    |
    ABL1 (ABL proto-oncogene 1) • BCR (BCR Activator Of RhoGEF And GTPase) • DNMT3A (DNA methyltransferase 1) • JAK2 (Janus kinase 2) • SF3B1 (Splicing Factor 3b Subunit 1) • ASXL1 (ASXL Transcriptional Regulator 1) • TET2 (Tet Methylcytosine Dioxygenase 2) • CALR (Calreticulin)
    |
    TET2 mutation • BCR-ABL1 mutation
    |
    Pegasys (pegylated interferon α -2a) • hydroxyurea
    2years
    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 in patients with MPNs.
    Journal
    |
    IFNA1 (Interferon Alpha 1) • IFNB1 (Interferon Beta 1)
    |
    Pegasys (pegylated interferon α -2a) • Besremi (ropeginterferon alfa-2b-njft) • ViraferonPeg (peginterferon-α-2b)
    2years
    A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (clinicaltrials.gov)
    P1/2, N=510, Recruiting, Hoffmann-La Roche | Trial completion date: Apr 2027 --> Oct 2026 | Trial primary completion date: Oct 2026 --> Apr 2026
    Trial completion date • Trial primary completion date
    |
    ER (Estrogen receptor) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 positive • ER positive
    |
    Herceptin (trastuzumab) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • Kisqali (ribociclib) • ipatasertib (RG7440) • Itovebi (inavolisib) • giredestrant (GDC-9545) • Pegasys (pegylated interferon α -2a) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • samuraciclib (CT7001)
    almost3years
    PENGUIN: A Study of JNJ-73763989, JNJ-56136379, Nucleos(t)Ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection (clinicaltrials.gov)
    P2; N=48; Active, not recruiting; Sponsor: Janssen Research & Development, LLC; Recruiting --> Active, not recruiting
    Enrollment closed • Clinical
    |
    Pegasys (pegylated interferon α -2a)
    3years
    A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (clinicaltrials.gov)
    P1/2, N=415, Recruiting, Hoffmann-La Roche | N=255 --> 415
    Enrollment change
    |
    ER (Estrogen receptor) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 positive • ER positive
    |
    Herceptin (trastuzumab) • Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • Kisqali (ribociclib) • ipatasertib (RG7440) • Itovebi (inavolisib) • giredestrant (GDC-9545) • Pegasys (pegylated interferon α -2a) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • samuraciclib (CT7001)
    3years
    The use of pegulated interferon a2a in a cohort of Greek patients with Mycosis Fungoides. (PubMed, J Eur Acad Dermatol Venereol)
    (1) However, recombinant IFN a-2a or IFN a-2b interferon regimens are no longer available and therefore, the pegylated analogue (pegylated IFN a-2a, Pegasys; Hoffmann-La Roche) has been currently used. Nevertheless, treatment outcomes have only been reported in case reports and in a few clinical trials.(2)(3)(4) The current study aimed to evaluate the efficacy and safety profile of peg IFN in the treatment of mycosis fungoides (MF).
    Clinical • Journal
    |
    IFNA1 (Interferon Alpha 1)
    |
    Pegasys (pegylated interferon α -2a)
    over3years
    IPOS: Effect of Low-dose Interferon-alfa2a on Peri-operative Immune Suppression (clinicaltrials.gov)
    P2, N=68, Not yet recruiting, Zealand University Hospital | Trial completion date: May 2023 --> Dec 2023 | Initiation date: Apr 2021 --> Oct 2021 | Trial primary completion date: Apr 2023 --> Oct 2023
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    Pegasys (pegylated interferon α -2a)
    over3years
    FAIM: Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression (clinicaltrials.gov)
    P2, N=324, Not yet recruiting, Royal Marsden NHS Foundation Trust
    Clinical • New P2 trial • Circulating tumor DNA
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PTEN (Phosphatase and tensin homolog) • AKT1 (V-akt murine thymoma viral oncogene homolog 1)
    |
    HER-2 positive • ER positive • HER-2 negative • PIK3CA mutation • HER-2 mutation • ER positive + HER-2 negative • CDK4 mutation
    |
    Ibrance (palbociclib) • Verzenio (abemaciclib) • Kisqali (ribociclib) • fulvestrant • ipatasertib (RG7440) • Pegasys (pegylated interferon α -2a)
    almost4years
    A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (clinicaltrials.gov)
    P1/2, N=255, Recruiting, Hoffmann-La Roche
    Clinical • New P1/2 trial
    |
    ER (Estrogen receptor) • CDK4 (Cyclin-dependent kinase 4)
    |
    ER positive
    |
    everolimus • Verzenio (abemaciclib) • Kisqali (ribociclib) • ipatasertib (RG7440) • Itovebi (inavolisib) • giredestrant (GDC-9545) • Pegasys (pegylated interferon α -2a)
    almost4years
    IPOS: Effect of Low-dose Interferon-alfa2a on Peri-operative Immune Suppression (clinicaltrials.gov)
    P2, N=68, Not yet recruiting, Zealand University Hospital
    New P2 trial
    |
    CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
    |
    Pegasys (pegylated interferon α -2a)
    almost5years
    The spectrum of BRCA1 and BRCA2 Pathogenic Sequence Variants (PSVs) in Middle Eastern, North African, and South European countries. (PubMed, Hum Mutat)
    Notably, some mutations [e.g., p.Asn257Lysfs (c.771_775del)] were observed in unrelated populations. Thus, seemingly genotyping recurring BRCA PSVs in specific populations may provide first pass BRCA genotyping platform.
    Journal • BRCA Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
    |
    BRCA2 mutation • BRCA1 mutation
    |
    Pegasys (pegylated interferon α -2a)
    almost5years
    A Study to Assess the Safety and Tolerability of Atezolizumab in Combination With Other Immune-Modulating Therapies in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=158, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed
    Clinical • Trial completion • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • PD-1 (Programmed cell death 1)
    |
    EGFR mutation • BRAF mutation • BRAF V600 • ALK rearrangement
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • Gazyva (obinutuzumab) • Pegasys (pegylated interferon α -2a) • Roferon A (recombinant interferon alfa-2a)
    5years
    A Study to Assess the Safety and Tolerability of Atezolizumab in Combination With Other Immune-Modulating Therapies in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=158, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Aug 2019 --> Nov 2019 | Trial primary completion date: Aug 2019 --> Nov 2019
    Clinical • Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • PD-1 (Programmed cell death 1)
    |
    EGFR mutation • BRAF mutation • BRAF V600 • ALK rearrangement
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • Gazyva (obinutuzumab) • Pegasys (pegylated interferon α -2a) • Roferon A (recombinant interferon alfa-2a)
    over5years
    A Study to Assess the Safety and Tolerability of Atezolizumab in Combination With Other Immune-Modulating Therapies in Participants With Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1; N=158; Active, not recruiting; Sponsor: Hoffmann-La Roche; Trial completion date: Feb 2019 --> Aug 2019; Trial primary completion date: Feb 2019 --> Aug 2019
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • PD-1 (Programmed cell death 1)
    |
    EGFR mutation • BRAF mutation • BRAF V600 • ALK rearrangement
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • Gazyva (obinutuzumab) • Pegasys (pegylated interferon α -2a) • Roferon A (recombinant interferon alfa-2a)