RegulationOrphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Orphan Drug (South Korea), Orphan Drug (Australia), Breakthrough Therapy (United States), Orphan Drug (Japan)

Structure/Sequence

Sequence Code 9975842H

Source: *****

Sequence Code 10002449L

Source: *****

Clinical Trials associated with Mogamulizumab-KPKC

NCT06698003

/ RecruitingPhase 2IIT

A Phase 2 Study for Screening and Prevention of Adult T-cell Leukemia/Lymphoma With Mogamulizumab in High-Risk Carriers of HTLV-1

The purpose of this study is to find out whether the study drug mogamulizumab is effective in preventing the development of adult T-cell leukemia/lymphoma (ATL) in people who are at higher risk for this type of cancer because they are infected with the HTLV-1 virus and because of changes seen in some of their immune system cells called T-cells.

Start Date15 Nov 2024

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

NCT05996185

/ RecruitingPhase 2IIT

Phase II Study of Mogamulizumab With DA-EPOCH in Patients With Aggressive T Cell Lymphoma

Single- arm Phase II study evaluating the combination of mogamulizumab (MOGA) added on top of standard of care dose adjusted EPOCH (DA-EPOCH) in patients with newly diagnosed or relapsed/refractory (for CTCL only) aggressive T cell lymphoma including patients with Adult T-cell leukemia/lymphoma (ATLL).

Start Date09 Oct 2024

Sponsor / Collaborator

Yale University

[+1]

JPRN-UMIN000053792

/ SuspendedNot Applicable

Integrated analysis of the past mogamulizumab clinical trials for patients with ATL, PTCL and CTCL - Integrated analysis of the past mogamulizumab clinical trials for patients with ATL, PTCL and CTCL

Start Date01 Apr 2024

Sponsor / Collaborator

Kyowa Kirin Co., Ltd.

100 Clinical Results associated with Mogamulizumab-KPKC

100 Translational Medicine associated with Mogamulizumab-KPKC

100 Patents (Medical) associated with Mogamulizumab-KPKC

409

Literatures (Medical) associated with Mogamulizumab-KPKC

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

Insights into treatment of patients with mycosis fungoides or Sézary syndrome using mogamulizumab

Article

Author: Kim, Youn H. ; Akilov, Oleg ; Bagot, Martine ; Scarisbrick, Julia ; Ristuccia, Robert ; Wu, Wende ; Dwyer, Karen ; Foss, Francine

PURPOSE:

Mogamulizumab demonstrated improved outcomes vs. vorinostat across a range of disease and patient characteristics in patients with mycosis fungoides or Sézary syndrome in the MAVORIC trial.

MATERIALS AND METHODS:

This post-hoc analysis further examined MAVORIC data to assess factors associated with long-term response (ORR >12 months), time to next treatment (TTNT), and impact of concomitant steroid use, lymphopenia, and mogamulizumab-associated rash (MAR) on patient response.

RESULTS:

A higher proportion of patients achieved ORR lasting ≥4, 6, 8, or 12 months in the mogamulizumab vs. vorinostat arm. Long-term response was also observed in mogamulizumab-treated patients with more advanced disease (stage IVA1 [17/20], B2 blood involvement [18/20], and SS [14/20]). PFS was significantly longer (9.4 vs. 3.1 months; p < 0.0001) in mogamulizumab vs. vorinostat-treated patients taking concomitant steroids. Mogamulizumab-treated patients experienced longer TTNT vs. vorinostat. Lymphopenia and MAR were associated with response to mogamulizumab.

CONCLUSIONS:

MAVORIC demonstrated greater efficacy with mogamulizumab vs. vorinostat in relapsed/refractory patients with CTCL, including those with more advanced disease. Concomitant steroid use improved ORR and PFS but did not impact vorinostat outcomes. Overall responses occurred more frequently in mogamulizumab-treated patients that developed lymphopenia than those that did not. A higher percentage of patients with MAR had an overall response than those without MAR.

01 Mar 2025·JOURNAL DER DEUTSCHEN DERMATOLOGISCHEN GESELLSCHAFT

Practical recommendations for therapy and monitoring of mogamulizumab patients in Germany

Review

Author: Stadler, Rudolf ; Assaf, Chalid ; Klemke, Claus‐Detlev ; Eich, Hans‐Theodor ; Dobos, Gabor ; Mitteldorf, Christina ; Booken, Nina ; Dippel, Edgar ; Wobser, Marion ; Theurich, Sebastian ; Nicolay, Jan P.

Summary:

Mycosis fungoides (MF) and Sézary syndrome (SS) are the most common subtypes of the heterogeneous group of cutaneous T‐cell lymphomas (CTCL). With the expansion of the biologic treatment landscape, new treatment options have become available in recent years, most notably the C‐C chemokine receptor 4 (CCR4)‐directed monoclonal antibody mogamulizumab. Based on the phase III pivotal trial, mogamulizumab is recommended by the German S2k guidelines for the second‐line treatment of stage IB and above SS and MF, after at least one prior systemic therapy. Since then, new insights on safety and efficacy of mogamulizumab were generated by post hoc analyses and real‐world evidence. A panel of CTCL‐experts discussed available literature and own experiences and developed relevant recommendations on the use of mogamulizumab in clinical practice in Germany. The recommendations cover patient criteria, prior therapies, use of mogamulizumab as monotherapy or combination therapy, management of side effects, duration of therapy, and monitoring schedules. The aim of these clinical recommendations is to support healthcare professionals in their decision‐making and use of mogamulizumab in daily practice.

01 Feb 2025·INTERNATIONAL JOURNAL OF HEMATOLOGY

Clinical significance of NOTCH1 and FBXW7 alterations in adult T-cell leukemia/lymphoma

Article

Author: Tokunaga, Masahito ; Ishida, Takashi ; Ueda, Ryuzo ; Utsunomiya, Atae ; Muto, Reiji ; Suehiro, Youko ; Yonekura, Kentaro ; Nakano, Nobuaki ; Masaki, Ayako ; Sakamoto, Yuma ; Murase, Takayuki ; Iida, Shinsuke ; Tashiro, Yukie ; Takeshita, Morishige ; Kusumoto, Shigeru ; Choi, Ilseung ; Ito, Asahi ; Inagaki, Hiroshi ; Ohtsuka, Eiichi ; Iwasaki, Hiromi

Here, we investigated the clinical significance of NOTCH1 and FBXW7 alterations for adult T-cell leukemia/lymphoma (ATLL) treatment outcomes. NOTCH1 alterations were identified in 37 (14.4%) of 257 patients, of which 33 were single nucleotide variants/insertion-deletions in the PEST domain, and 7 were in the heterodimerization or LIN-12/Notch repeats domains. FBXW7 alterations were observed in nine ATLL patients (3.5%). For patients without allogeneic hematopoietic stem cell transplantation (HSCT), NOTCH1, but not FBXW7, alterations were significantly and independently associated with worse overall survival (median OS 0.5 years, 95% confidence interval [CI] 0.4-0.5 years for 27 patients with NOTCH1 alterations vs 1.8 years, 95% CI 1.3-2.2 years for 170 patients without). Also, for patients receiving mogamulizumab, but not allogeneic-HSCT, NOTCH1, but not FBXW7, alterations were significantly associated with worse survival (median survival from the first dose of mogamulizumab 0.4 years, 95% CI 0.3-0.5 years for 12 patients with NOTCH1 alterations vs 1.4 years, 95% CI 0.9-2.0 years for 87 without). In contrast, NOTCH1 alterations had no significant impact on survival of patients who did receive allogeneic-HSCT. Thus, mogamulizumab-containing treatment was unable to overcome treatment refractoriness of ATLL with NOTCH1 alterations. Therefore, patients with NOTCH1 alterations are recommended for allogeneic-HSCT.

News (Medical) associated with Mogamulizumab-KPKC

17 Feb 2025

·www.drugs.com

Innate Pharma Announces U.S. FDA Granted Breakthrough Therapy Designation to Lacutamab for Relapsed or Refractory Sézary Syndrome

February 17, 2025 -- Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to lacutamab, an anti-KIR3DL2 cytotoxicity-inducing antibody, for the treatment of adult patients with relapsed or refractory (r/r) Sézary syndrome (SS) after at least 2 prior systemic therapies including mogamulizumab. The BTD is granted based on Phase 1 study results as well as results from the Phase 2 TELLOMAK study, where lacutamab demonstrated encouraging efficacy and a favorable safety profile in heavily pretreated, post-mogamulizumab patients with advanced Sézary syndrome. “There is a high unmet medical need for patients with Sézary syndrome. In this aggressive and rare form of cutaneous T-cell lymphoma, patients in advanced disease often experience very poor quality of life and are in strong need of new, targeted treatment options,” commented Sonia Quaratino, MD, Chief Medical Officer of Innate Pharma. “The Breakthrough Therapy Designation underscores lacutamab’s potential to transform the patient’s care by achieving clinically meaningful efficacy and favorable safety profile compared to available therapies. This is an important step in Innate’s strategy for lacutamab. We are excited to work with the U.S. FDA to accelerate the development of this therapy.” A Breakthrough Therapy Designation by the FDA is intended to accelerate the development and regulatory review in the U.S. of drugs that are intended to treat a serious condition and that have shown encouraging early clinical results, which may demonstrate substantial improvement on a clinically significant endpoint over available medicines. Lacutamab previously received a Fast Track designation by the FDA in 2019 for the treatment of adult patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies as well as a PRIME designation by European Medicines Agency in 2020. Innate continues to align with the regulatory agencies around the confirmatory Phase 3 trial in CTCL and is actively seeking for a partner Cutaneous T-Cell Lymphoma (CTCL) is a heterogeneous group of non-Hodgkin’s lymphomas which arise primarily in the skin and are characterized by the presence of malignant clonal mature T-cells. CTCL accounts for approximately 4% of all non-Hodgkin’s lymphomas and has a median age at diagnosis of 55-65 years. Mycosis fungoides, and Sézary syndrome, its leukemic variant, are the most common CTCL subtypes. The overall 5-year survival rate, which depends in part on disease subtype, is approximately 10% for Sézary syndrome. There are approximately 6,000 new CTCL cases in Europe and the United States per year. Sézary syndrome is the leukemic variant of CTCL. Patients often experience very poor quality of life with severe and debilitating pruritus (chronic itchy skin). Despite recent advancements, Sézary syndrome is associated with a high relapse rate with currently available therapies. Lacutamab is a first-in-class anti-KIR3DL2 humanized cytotoxicity-inducing antibody that is currently in clinical trials for treatment of cutaneous T-cell lymphoma (CTCL), an orphan disease, and peripheral T cell lymphoma (PTCL). Rare cutaneous lymphomas of T lymphocytes have a poor prognosis with few efficacious and safe therapeutic options at advanced stages. KIR3DL2 is an inhibitory receptor of the KIR family, expressed by approximately 65% of patients across all CTCL subtypes and expressed by up 90% of patients with certain aggressive CTCL subtypes, in particular Sézary syndrome. It is expressed by up to 50% of patients with mycosis fungoides and peripheral T-cell lymphoma (PTCL). It has a restricted expression on normal tissues. Lacutamab is granted European Medicines Agency (EMA) PRIME designation and US Food and Drug Administration (FDA) granted Fast Track designation and Breakthrough Therapy Designation for the treatment of patients with relapsed or refractory Sézary syndrome who have received at least two prior systemic therapies. Lacutamab is granted orphan drug status in the European Union and in the United States for the treatment of CTCL. TELLOMAK (NCT03902184) is a global, open-label, multi-cohort Phase 2 clinical trial in patients with Sézary syndrome and mycosis fungoides (MF) in the United States and Europe. Specifically: The trial is fully enrolled. The primary endpoint of the trial is objective global response rate. Key secondary endpoints are progression-free survival, duration of response, overall survival, quality of life, pharmacokinetics and immunogenicity and adverse events. Source: Innate Pharma SA Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Phase 2Clinical ResultFast TrackOrphan DrugBreakthrough Therapy

17 Feb 2025

·www.pharmaceutical-technology.com

Innate’s lacutamab gains FDA breakthrough therapy designation

Innate has secured FDA’s fast track designation and PRIME designation from the European Medicines Agency for lacutamab. Credit: Stock-Asso/Shutterstock. Innate Pharma has secured US Food and Drug Administration (FDA) breakthrough therapy designation for lacutamab to treat adults with relapsed or refractory Sézary syndrome. Lacutamab is a first-in-class antibody designed to target killer cell immunoglobulin-like receptor 3DL2 (KIR3DL2) and induce cytotoxicity. It is being tested in clinical trials for cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma. The FDA’s designation follows positive results from the Phase I study and the Phase II TELLOMAK trial, which showed lacutamab’s efficacy and safety in patients who had previously undergone at least two systemic therapies, including mogamulizumab. TELLOMAK is a global Phase II clinical trial for patients with Sézary syndrome and mycosis fungoides in the US and Europe. It is an open-label, multi-cohort study. The trial’s primary endpoint is an objective global response rate, with key secondary endpoints including progression-free survival, overall survival, duration of response and quality of life. Innate Pharma previously received fast track designation from the FDA in 2019 and PRIME designation from the European Medicines Agency in 2020 for lacutamab. The company is currently aligning with regulatory agencies for a confirmatory Phase III trial in CTCL and is seeking a partner. Lacutamab also holds orphan drug status in both the European Union (EU) and the US for the treatment of CTCL. Innate Pharma chief medical officer Sonia Quaratino stated: “There is a high unmet medical need for patients with Sézary syndrome. “In this aggressive and rare form of cutaneous T-cell lymphoma, patients in advanced disease often experience very poor quality of life and are in strong need of new, targeted treatment options.” In March 2024, Innate dropped plans to assess lacutamab as a monotherapy in KIR3DL2-expressing refractory/relapsing peripheral T-cell lymphoma following disappointing data from a Phase Ib trial.

Phase 2Fast TrackOrphan DrugClinical ResultBreakthrough Therapy

30 Jan 2025

·www.businesswire.com

Kyowa Kirin and Swixx BioPharma announce expansion of access to POTELIGEO® (mogamulizumab) for adults living with mycosis fungoides or Sézary syndrome in Central and Eastern Europe

GALASHIELS & MARLOW, England & BAAR, Switzerland--( BUSINESS WIRE )--Kyowa Kirin International (KKI), a wholly owned subsidiary of Kyowa Kirin Co. Ltd., and Swixx BioPharma AG today announced that the Croatian National Health Insurance Fund (NHIF) and the Bulgarian Ministry of Health have both approved the reimbursement of POTELIGEO ® (mogamulizumab) for adult patients with mycosis fungoides (MF), and Sézary syndrome (SS). MF and SS are two subtypes of cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin’s lymphoma that presents and persists in the skin and can cause debilitating physical, emotional and social challenges. 1 MF—the most common CTCL subtype—accounts for approximately 60% of all CTCLs. 2 With an average time to diagnosis of 3-4 years, MF is typically characterised by skin symptoms including patches or plaques, skin redness and tumours. 3,4 SS is much rarer, accounting for around 5% of CTCLs, 5 and is more aggressive, causing severe itching, erythroderma, intense scaling of the skin and frequent hair loss. 6 Jeremy Morgan, President of Kyowa Kirin International, commented: “ I am delighted that the Croatian and Bulgarian authorities have agreed to reimburse POTELIGEO for MF and SS patients. Both decisions are important milestones for people impacted by these rare and challenging forms of CTCL, and with mogamulizumab now reimbursed in more than 20 countries across the EMEA region we remain as committed as ever to delivering life changing value for people impacted by under-diagnosed and under-served diseases, and making more people smile.” Poteligeo is distributed in Central and Eastern Europe by Swixx, on behalf of KKI. The two companies signed a Promotion and Distribution Agreement in October 2022. Under the terms of the agreement, Swixx will exclusively market, promote and distribute mogamulizumab in both Croatia and Bulgaria, among other countries. “ At Swixx, our mission is to unlock access to innovative medicines, and the recent reimbursement approvals in Croatia and Bulgaria mark significant progress in improving therapeutic options for patients with MF and SS in those markets,” said Dezso Martha, Chief Operating Officer of Swixx. “ We will continue working closely with health authorities, the scientific community, and Kyowa Kirin to expand access to this important medicine, ensuring better outcomes for patients across our Central and Eastern European countries.” With Croatian reimbursement effective as of 15 th November 2024, and Bulgaria’s Ministry of Health confirming reimbursement as of 2 nd January 2025, both decisions build on the inclusion of POTELIGEO ® (mogamulizumab) in the Polish Ministry of Health’s Drug Programme announced in July 2024 and the ongoing expansion of access to patients across Central and Eastern Europe (CEE). About Poteligeo (mogamulizumab) Mogamulizumab is a first-in-class humanised monoclonal antibody directed against CC-chemokine receptor 4 (CCR4), a protein consistently expressed on cancerous cells seen in both MF and SS. 7-9 Once mogamulizumab binds to CCR4, it increases attraction of immune cells from the immune system to destroy the cancerous cells. 10 About MF and SS MF and SS are two subtypes of CTCL, which is itself a rare form of non-Hodgkin’s lymphoma that presents and persists in the skin. 1 CTCL is treatable, but is not generally considered to be curable, and there has been a clear unmet need for novel treatment options. As well as the obvious impact of symptoms upon patients, there can be significant erosions to quality of life for those caring for an individual living with CTCL. 11 MF and SS are characterised by localisation of cancerous white blood cells called T lymphocytes (T cells), to the skin. 12 These cancerous T cells consistently express a protein called CCR4, which enables them to move from the blood to the skin. 7-9 When these cancerous T cells move to the skin, this results in the visible early skin symptoms of red patches or plaques which can resemble psoriasis or eczema in the early stages of the disease. 6 Later, for some patients, skin involvement may evolve to include tumours or reddening of the majority of the skin’s surface (erythroderma). MF—the most common CTCL subtype—accounts for approximately 60% of all CTCLs 2 and is typically indolent, characterised by skin symptoms including patches or plaques, skin redness and tumours. 3,4 SS is much rarer, accounting for around 5% of CTCLs, 5 and is more aggressive, 6 with high levels of blood involvement. 5 It can cause severe itching, erythroderma, intense scaling of the skin and frequent hair loss. 6 CTCL can take, on average, between 2 and 7 years for individuals to receive a confirmed diagnosis. 6 About Kyowa Kirin Kyowa Kirin aims to discover novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company, we have invested in drug discovery and biotechnology innovation for more than 70 years and are currently working to engineer the next generation of antibodies and cell and gene therapies with the potential to help patients affected by severe and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across our four regions – Japan, Asia Pacific, North America, and EMEA/International. You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com About Swixx BioPharma AG Swixx BioPharma is one of the fastest-growing, largest, intercontinental commercial platforms for the biopharmaceutical industry. Swixx operates subsidiaries across Central and Eastern Europe, Greece, Russia, several Eurasian countries, the Middle East, and via Biopas, a Swixx BioPharma company, in almost 20 Latin American countries. Swixx BioPharma Group has over 1,600 employees and sales likely to exceed a billion Euros in 2024. The company has gathered outstanding rare disease, oncology-hematology, specialty, vaccines and self-medication talent under one roof. For more information about Swixx BioPharma, please visit: www.swixxbiopharma.com References 1 Kim YH, Bagot M, Pinter-Brown L, et al. Mogamulizumab versus vorinostat in previously treated cutaneous T-cell lymphoma (MAVORIC): an international, open-label, randomised, controlled phase 3 trial. Lancet Oncol. 2018;19(9):1192-1204. 2 Willemze R, et al. The 2018 update of the WHO-EORTC classification for primary cutaneous lymphomas. Blood. 2019;133(16):1703-1714. 3 Scarisbrick, J, et al. The PROCLIPI international registry of early-stage mycosis fungoides identifies substantial diagnostic delay in most patients. Br J Dermatol. 2019;181(20):350–357. 4 Demierre M-F, et al. Significant impact of cutaneous T-cell lymphoma on patients’ quality of life. Cancer. 2006;107(10):2504-2511. 5 Trautinger F, et al. European Organisation for Research and Treatment of Cancer consensus recommendations for the treatment of mycosis fungoides/Sézary syndrome - Update 2017. European Journal of Cancer. 2017;77:57–74. 6 Lymphoma Coalition. Cutaneous lymphoma – a patient’s guide. Available at: https://lymphomacoalition.org/wpcontent/uploads/Cutaneous_lymphoma_-_patients_guide_-.pdf . Last accessed: January 2025. 7 Ferenczi K, et al. Increased CCR4 expression in cutaneous T cell lymphoma. J Invest Dermatol. 2002;119:1405–10. 8 Yoshie O, et al. Frequent Expression of CCR4 in Adult T-Cell Leukemia and Human T-cell Leukemia Virus Type 1-transformed T cells. Blood. 2002;99(5):1505–11. 9 Ishida T, et al. Clinical Significance of CCR4 Expression in Adult T-cell Leukemia/Lymphoma: Its Close Association With Skin Involvement and Unfavorable Outcome. Clin Cancer Res. 2003;9:3625–34. 10 Duvic M, et al. Mogamulizumab for the treatment of cutaneous T-cell lymphoma: recent advances and clinical potential. Ther Adv Hematol. 2016;7(3):171–174. 11 Williams et al (2020) – Health state utilities associated with caring for an individual with CTCL. Journal of Medical Economics. 2020; 23(10):1142-1150. 12 Scarisbrick JJ, Prince M, Vermeer MH, et al. Cutaneous Lymphoma International Consortium Study of Outcome in Advanced Stages of Mycosis Fungoides and Sézary Syndrome: Effect of Specific Prognostic Markers on Survival and Development of a Prognostic Model. J Clin Oncol. 2015;33(32):3766-3773.

Phase 3Drug ApprovalLicense out/in

100 Deals associated with Mogamulizumab-KPKC

External Link

KEGG	Wiki	ATC	Drug Bank
-	Mogamulizumab-KPKC	L01XC25	DB12498

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Mycosis Fungoides	United States	Kyowa Kirin Co., Ltd.	08 Aug 2018
Sezary Syndrome	United States	Kyowa Kirin Co., Ltd.	08 Aug 2018
Cutaneous T-Cell Lymphoma	Japan	Kyowa Hakko Kogyo Co., Ltd.	17 Mar 2014
Peripheral T-Cell Lymphoma	Japan	Kyowa Hakko Kogyo Co., Ltd.	17 Mar 2014
Adult T-Cell Leukemia-Lymphoma	Japan	Kyowa Kirin Co., Ltd.	24 May 2012
T-Cell Lymphoma	Japan	Kyowa Kirin Co., Ltd.	30 Mar 2012

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Paraparesis, Tropical Spastic	Phase 3	Japan	Kyowa Kirin Co., Ltd.	22 May 2017
Anaplastic Large-Cell Lymphoma	Phase 2	United States	Kyowa Kirin, Inc.	09 Oct 2024
Enteropathy-Associated T-Cell Lymphoma	Phase 2	United States	Kyowa Kirin, Inc.	09 Oct 2024
hepatosplenic T-cell lymphoma	Phase 2	United States	Kyowa Kirin, Inc.	09 Oct 2024
Immunoblastic Lymphadenopathy	Phase 2	United States	Kyowa Kirin, Inc.	09 Oct 2024
Subcutaneous Panniculitis-Like T-Cell Lymphoma	Phase 2	United States	Kyowa Kirin, Inc.	09 Oct 2024
Cutaneous T-cell lymphoma refractory	Phase 2	United States	Kyowa Kirin, Inc.	16 Aug 2021
Cutaneous T-cell lymphoma refractory	Phase 2	France	Kyowa Kirin, Inc.	16 Aug 2021
Cutaneous T-cell lymphoma refractory	Phase 2	Italy	Kyowa Kirin, Inc.	16 Aug 2021
Cutaneous T-cell lymphoma refractory	Phase 2	Spain	Kyowa Kirin, Inc.	16 Aug 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2024	Not Applicable	Mycosis Fungoides \| Sezary Syndrome	-	Mogamulizumab monotherapy	yiomfyoruw(aprwhmpseg) = yhpskzyeco opabsuonuh (wderjvjznn, 10.9 - 32.3) View more	-	09 Dec 2024
ASH2024	Not Applicable	Mycosis Fungoides \| Sezary Syndrome	-	Mogamulizumab combination therapy	yiomfyoruw(aprwhmpseg) = zfygrivpgx opabsuonuh (wderjvjznn, 3.0 - 12.3) View more	-	09 Dec 2024
ASH2024	Not Applicable	Sezary Syndrome	-	Mogamulizumab 2 mg/kg Q4W	bnalyrcgbj(ugjeohwijy) = Of the 32 ADA evaluable pts, the ADA status of 4 (12.5%) was positive, 27 (84.4%) negative, and 1 (3.1%) unknown. No pts were positive for anti-moga neutralizing antibodies. sstgirbfhc (mofatmsjca ) View more	-	08 Dec 2024
NCT04745234 (MAVORIC, EORTC_CLTG2024)	Phase 2	Cutaneous T-Cell Lymphoma CD7 \| CD26	34	Mogamulizumab 2mg/kg Q4W	rlmvgwbzjg(jlabfjtrcx) = not estimable at data cut olyusxgmwi (uavrmsafsi ) View more	Positive	09 Oct 2024
MINT study (EORTC_CLTG2024)	Not Applicable	Mycosis Fungoides \| Sezary Syndrome	76	Mogamulizumab	wsbkumfsoo(xlnrdbjjwe) = veelyzqkkg pbbmrsgfpa (ndxpgwtmph, 11.0–34.8) View more	-	09 Oct 2024
MIBERIC study (EORTC_CLTG2024)	Not Applicable	CC chemokine receptor 4 (CCR4)	73	Mogamulizumab	bgizrqdqgt(mxthcwobbu) = iamkvteuvt ebplvlmnvo (hglgzgotup ) View more	Positive	09 Oct 2024
NCT05455931 (PROSPER, PRNewswire) Manual	Not Applicable	Mycosis Fungoides \| Sezary Syndrome	20	mogamulizumab	rcgnowuqws(ibipnclbom) = symptom severity had decreased considerably with the greatest improvement seen in skin redness (-2.9) closely followed by skin itch (-2.7), flaking skin (-2.5) and skin pain (-2.2). the proportion of patients reporting sleep problems or difficulties regulating body temperature either "frequently" or "always" decreased to less than 20%. vjkjywfgxk (cnfwtfolwj )	Positive	15 Apr 2024
MINT study (EORTC_CLTG2023)	Not Applicable	Mycosis Fungoides \| Sezary Syndrome CCR4	40	Mogamulizumab	fwhkjwtzdi(imzlvvvxur) = iscicfkoar mijqrwifyq (igcysesmly ) View more	Positive	21 Sep 2023
MINT study (EORTC_CLTG2023)	Not Applicable	Mycosis Fungoides \| Sezary Syndrome CCR4	40	Placebo	fwhkjwtzdi(imzlvvvxur) = lxsnqtdjtr mijqrwifyq (igcysesmly ) View more	Positive	21 Sep 2023
ICML2023	Not Applicable	Cutaneous T-Cell Lymphoma CCR4	9	Mogamulizumab	rmhbanfqyo(jwrembthot) = eczpmapwvm lsyaflftnx (jtirqkrygv ) View more	Positive	09 Jun 2023
NCT04745234 \| NCT01728805 (MAVORIC, ICML2023)	Not Applicable	Cutaneous T-Cell Lymphoma TCR clonality	65	Mogamulizumab	uyrnhrnmlm(rhmdrzyyok) = vtgdubjbgg hljpnsamjg (zsmnjoypmv ) View more	Positive	09 Jun 2023
NCT04745234 \| NCT01728805 (MAVORIC, ICML2023)	Not Applicable	Cutaneous T-Cell Lymphoma TCR clonality	65	Combination therapies with Mogamulizumab	nikhdfldby(udkxjghmyq) = rrsascjdaq bsustaykry (aucempxqna ) View more	Positive	09 Jun 2023
JPRN-jRCTs041180130 (ASCO 12023 \| ASCO 22023) Manual	Phase 2	Adult T-Cell Leukemia-Lymphoma First line	50	mogamulizumab+CHOP	wayzjhtzvs(nvrtmvvjuw) = inyzzwjxfp whvzcvklet (wzocfpchon, 24.9 - 47.6) View more	Positive	26 May 2023

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