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A Phase 2, Randomized, Open-label, Multicenter Study to Evaluate Efficacy, Pharmacokinetics, Safety, and Tolerability of Treatment With JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog With or Without JNJ-56136379 in Treatment-naive Patients With HBeAg Positive Chronic Hepatitis B Virus Infection

The purpose of this study is to evaluate the efficacy of a treatment regimen of JNJ-73763989 + pegylated interferon alpha-2a (PegIFN-alpha-2a) + nucleos(t)ide analog (NA).

Start Date14 Sep 2020

Sponsor / Collaborator

Janssen Research & Development LLC

100 Clinical Results associated with Pegylated interferon alpha-2a(Janssen)

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100 Translational Medicine associated with Pegylated interferon alpha-2a(Janssen)

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100 Patents (Medical) associated with Pegylated interferon alpha-2a(Janssen)

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61

Literatures (Medical) associated with Pegylated interferon alpha-2a(Janssen)

01 Nov 2024·JDDG: Journal der Deutschen Dermatologischen Gesellschaft

Pegylated interferon‐α2a in cutaneous T‐cell lymphoma – a multicenter retrospective data analysis with 70 patients

Article

Author: Hansen‐Abeck, Inga ; Nicolay, Jan P. ; Tratzmiller, Sabine ; Booken, Nina ; Albrecht, Jana D. ; Mengoni, Miriam ; Assaf, Chalid ; Wobser, Marion ; Menzer, Christian ; Kött, Julian ; Dobos, Gabor ; Livingstone, Elisabeth ; Mitteldorf, Christina ; Cankaya, Rohat ; Braun, Andreas D. ; Schneider, Stefan W. ; Geidel, Glenn ; Klespe, Kai‐Christian ; Klemke, Claus‐Detlev ; Terheyden, Patrick ; Abeck, Finn

SummaryBackgroundInterferon‐alpha is an important therapeutic option for the treatment of the cutaneous T‐cell lymphomas (CTCL). Since the approved recombinant interferon‐α‐2a (IFN‐α2a) has no longer been produced since January 2020, pegylated interferon‐α2a (pegIFN‐α2a) can be used as an alternative treatment, even though it is not approved for the treatment of CTCL. The aim of this multicentre study was to generate comprehensive data on the efficacy and tolerability of pegIFN‐α2a in the treatment of CTCL.Patients and MethodsA multicenter retrospective study was conducted with 70 patients with CTCL from twelve German skin centers.ResultsIn total, 70 patients were included in the study, with 57.2% male and a mean age of 58.8 ± 14.9 years. Mycosis fungoides was present in 71.4% of cases and Sézary Syndrome in 28.6%. An overall response rate of 55.2% was observed with pegIFNα‐2a therapy. In 50% of cases, therapy was discontinued after 63.6 ± 33.5 weeks. The most common reason for discontinuation was adverse events, which occurred in 68.6% of cases and which were classified as severe in 29.2%. Blood count changes, fatigue and liver toxicity occurred most frequently.ConclusionsOur analysis provides comprehensive data on the efficacy and tolerability of pegIFNα‐2a therapy in patients with CTCL. In terms of response rates and side effect profile, pegIFNα‐2a appears to be comparable to IFN‐α2a therapy.

01 Jan 2023·British Journal of Haematology

Dasatinib plus Peg‐Interferon alpha 2b combination in newly diagnosed chronic phase chronic myeloid leukaemia: Results of a multicenter phase 2 study (DASA‐PegIFN study)

Article

Author: Mahon, Francois‐Xavier ; Guilhot, François ; Dubruille, Viviane ; Guilhot, Joëlle ; Ame, Shanti ; Roy, Lydia ; Giraudier, Stéphane ; Rea, Delphine ; Johnson‐Ansah, Hyacinthe ; Nicolini, Franck E. ; Lenain, Pascal ; Cayssials, Emilie ; Charbonnier, Aude ; Hermet, Eric ; Rousselot, Philippe ; Guerci‐Bresler, Agnès ; Cony‐Makhoul, Pascale ; Chomel, Jean‐Claude ; Huguet, Françoise ; Bouchet, Stéphane ; Courby, Stéphane ; Ianotto, Jean‐Christophe ; Machet, Antoine ; Coiteux, Valérie ; Etienne, Gabriel ; Escoffre‐Barbe, Martine ; Legros, Laurence

SummarySuperior rates of deep molecular response (DMR) have been reported with the combination of tyrosine kinase inhibitors and pegylated‐interferon‐alpha (Peg‐IFN) in patients with newly diagnosed chronic phase‐chronic myeloid leukaemia (CP‐CML). In this setting, this study investigated the efficacy and safety of dasatinib combined to Peg‐IFN‐α2b (Dasa‐PegIFN, NCT01872442). A total of 79 patients (age ≤65 years) started dasatinib; 61 were eligible for Peg‐IFNα‐2b add‐on therapy at month 3 for a maximum 21‐months duration. Dasatinib was continued thereafter. The primary endpoint was the cumulative rate of molecular response 4.5 log (MR4.5) by 12 months. The results are reported for the 5‐year duration of the study. Grade 3 neutropenia was frequent with the combination but did not induce severe infection (one of grade 3). Other adverse events were generally low grade (4% of grade 3–4) and expected. Seventy‐nine per cent and 61% of patients continued the Peg‐IFN until months 12 and 24, respectively. Overall, at these time points, MR4.5 rates were 25% and 38%, respectively. Thereafter, 32% and 46% of patients achieved a sustained (≥2 years) MR4.5 or MR4, respectively. This work established the feasibility and high rates of achievement of early and sustained DMR (a prerequisite for treatment‐free‐remission) with dasatinib and Peg‐IFNα‐2b combination as initial therapy.

01 Aug 2021·LeukemiaQ1 · MEDICINE

Long-term outcome of imatinib 400 mg compared to imatinib 600 mg or imatinib 400 mg daily in combination with cytarabine or pegylated interferon alpha 2a for chronic myeloid leukaemia: results from the French SPIRIT phase III randomised trial

Q1 · MEDICINE

Article

Author: Johnson-Ansah, Hyacinthe ; Maisonneuve, Herve ; Maloisel, Frédéric ; Santagostino, Alberto ; Fouillard, Loïc ; Rigal-Huguet, Françoise ; Nicolini, Franck-Emmanuel ; Dorvaux, Véronique ; Vekhoff, Anne ; Chomel, Jean-Claude ; Bulabois, Claude-Eric ; Glaisner, Sylvie ; Alexis, Magda ; Cayuela, Jean-Michel ; Arkam, Yazid ; Zerazhi, Hacene ; Delmer, Alain ; Rea, Delphine ; Ghomari, Kamel ; Plantier, Isabelle ; Preudhomme, Claude ; Miclea, Jean-Michel ; Joly, Bertrand ; Deconinck, Eric ; Rousselot, Philippe ; Jourdan, Eric ; Gyan, Emmanuel ; Mercier, Melanie ; Gardembas, Martine ; Kiladjian, Jean-Jacques ; Coiteux, Valérie ; Etienne, Gabriel ; Guilhot, Joëlle ; Cony-Makhoul, Pascale ; Dubruille, Viviane ; Berthou, Christian ; Roy, Lydia ; Lebon, Delphine ; Cambier, Nathalie ; Legros, Laurence ; Chapiro, Jacques ; Delord, Marc ; Muller, Marc ; Caillot, Denis ; Mahon, François-Xavier ; Lenain, Pascal ; Escoffre Barbe, Martine ; Vaida, Iona ; Pollet, Bertrand ; Penot, Amélie ; Berger, Marc ; Guilhot, Francois ; Guerci-Bresler, Agnès-Paule ; Lhermitte, Ludovic ; Charbonnier, Aude

The STI571 prospective randomised trial (SPIRIT) French trial is a four-arm study comparing imatinib (IM) 400 mg versus IM 600 mg, IM 400 mg + cytarabine (AraC), and IM 400 mg + pegylated interferon alpha2a (PegIFN-α2a) for the front-line treatment of chronic-phase chronic myeloid leukaemia (CML). Long-term analyses included overall and progression-free survival, molecular responses to treatment, and severe adverse events. Starting in 2003, the trial included 787 evaluable patients. The median overall follow-up of the patients was 13.5 years (range 3 months to 16.7 years). Based on intention-to-treat analyses, at 15 years, overall and progression-free survival were similar across arms: 85%, 83%, 80%, and 82% and 84%, 87%, 79%, and 79% for the IM 400 mg (N = 223), IM 600 mg (N = 171), IM 400 mg + AraC (N = 172), and IM 400 mg + PegIFN-α2a (N = 221) arms, respectively. The rate of major molecular response at 12 months and deep molecular response (MR4) over time were significantly higher with the combination IM 400 mg + PegIFN-α2a than with IM 400 mg: p = 0.0001 and p = 0.0035, respectively. Progression to advanced phases and secondary malignancies were the most frequent causes of death. Toxicity was the main reason for stopping AraC or PegIFN-α2a treatment.

100 Deals associated with Pegylated interferon alpha-2a(Janssen)

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic hepatitis C genotype 1	Phase 3	AT	Janssen Infectious Diseases-Diagnostics BV	01 Dec 2010
Chronic hepatitis C genotype 1	Phase 3	IE	Janssen Infectious Diseases-Diagnostics BV	01 Dec 2010
Chronic hepatitis C genotype 1	Phase 3	SE	Janssen Infectious Diseases-Diagnostics BV	01 Dec 2010
Chronic hepatitis C genotype 1	Phase 3	ES	Janssen Infectious Diseases-Diagnostics BV	01 Dec 2010
Chronic hepatitis C genotype 1	Phase 3	DE	Janssen Infectious Diseases-Diagnostics BV	01 Dec 2010
Chronic hepatitis C genotype 1	Phase 3	FR	Janssen Infectious Diseases-Diagnostics BV	01 Dec 2010
Chronic hepatitis C genotype 1	Phase 3	PL	Janssen Infectious Diseases-Diagnostics BV	01 Dec 2010
Chronic hepatitis C genotype 1	Phase 3	BE	Janssen Infectious Diseases-Diagnostics BV	01 Dec 2010
Chronic hepatitis C genotype 1	Phase 3	AU	Janssen Infectious Diseases-Diagnostics BV	01 Dec 2010
Chronic hepatitis C genotype 1	Phase 2	GB	Janssen Infectious Diseases-Diagnostics BV	01 Dec 2010

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04667104 (PENGUIN, CTgov)	Phase 2	Hepatitis B, Chronic	48	JNJ-3989+PegIFN-alpha2a+JNJ-6379 (TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA)	segusabqjf(jjausypxdg) = ixusesioxa tjsmhfootw (ltjqtctbrq, aeyolxdxgr - bcyqfgjmbo) View more	-	03 Jul 2024
				JNJ-73763989+JNJ-56136379 (TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA)	hcedexsagw(mghbrmccry) = fqrttgbzxv pljhloyldg (kcxgxezefc, tbmilqrrbf - siypkgjqrz) View more
IAS2015	Not Applicable	HIV Infections \| Hepatitis C	-	pegIFN-a 2a 180 mg/week	tqyunszvdd(nhgwhlyjbg) = eykpomdpla ntsdnmjwee (auafvypvbq ) View more	-	01 Jan 2015
				pegIFN-a 2a 360 mg/week	tqyunszvdd(nhgwhlyjbg) = aklimjgtvf ntsdnmjwee (auafvypvbq ) View more
NCT00535847 (CTgov)	Phase 2	Hepatitis C	117	Pegylated interferon alfa 2a+Telaprevir+Ribavirin (Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week)	eucedzjcpd(qjzkkgxdkx) = simlstndwu lcybuknqyz (vrxweuoncr, hoeyseyeez - vufukvdfnd) View more	-	25 Jul 2011
				Pegylated interferon alfa 2a+Telaprevir+Ribavirin (Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week)	eucedzjcpd(qjzkkgxdkx) = itmmjqvpmj lcybuknqyz (vrxweuoncr, bhbkmxuoou - lyiycakchx) View more
NCT00627926 (CTgov)	Phase 3	Chronic hepatitis C genotype 1	1,095	Placebo+Pegylated Interferon Alfa 2a+Ribavirin (PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week)	oezopnrzkv(weicumnihq) = gpuaawrchh ujiwnjudhz (ueoituxkqa, bobdkptqxf - hozqspirde) View more	-	21 Jul 2011
				Placebo+Pegylated Interferon Alfa 2a+Telaprevir+Ribavirin (Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week)	oezopnrzkv(weicumnihq) = ivtvckplww ujiwnjudhz (ueoituxkqa, rwouhixarj - ahkhwgwavd) View more