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

Structure/Sequence

Sequence Code 9975842H

Source: *****

Sequence Code 10002449L

Source: *****

Clinical Trials associated with Mogamulizumab-KPKC

NCT07132567

/ RecruitingNot Applicable

Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance

The purpose of this surveillance is to assess the safety and efficacy of Poteligeo Inj. 20 mg (mogamulizumab) in routine clinical settings.

Start Date02 May 2025

Sponsor / Collaborator

Kyowa Kirin Co., Ltd.

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 or CHOEP 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) or CHOEP 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]

100 Clinical Results associated with Mogamulizumab-KPKC

100 Translational Medicine associated with Mogamulizumab-KPKC

100 Patents (Medical) associated with Mogamulizumab-KPKC

432

Literatures (Medical) associated with Mogamulizumab-KPKC

01 Jan 2026·CLINICAL IMMUNOLOGY

Prognostic value of lymphocyte-to-monocyte ratio in relapsed/refractory adult T-cell Leukemia/lymphoma patients receiving mogamulizumab

Article

Author: Yamashita, Kiyoshi ; Kawano, Noriaki ; Kitawaki, Toshio ; Toyama, Takanori ; Shimazu, Yutaka ; Takaori-Kondo, Akifumi ; Kamiunten, Ayako ; Kameda, Takuro ; Sekine, Masaaki ; Maeda, Kouichi ; Kawano, Hiroshi ; Takeuchi, Masanori ; Shimoda, Kazuya ; Ishizaki, Junzo ; Sato, Seiichi

BACKGROUND:

Mogamulizumab, an anti-CCR4 monoclonal antibody, is approved for relapsed/refractory (r/r) aggressive adult T-cell leukemia/lymphoma (ATL), although durable responses are limited.

OBJECTIVE:

To identify biomarkers associated with mogamulizumab efficacy, focusing on host immune status and known prognostic factors.

METHODS:

We retrospectively analyzed 315 patients with r/r aggressive ATL using real-world data from Japan. Clinical and prognostic variables were analyzed for association with overall survival (OS), stratified by mogamulizumab use.

RESULTS:

Among 315 patients, 97 received mogamulizumab (Moga [+]). One-year OS was higher in Moga (+) than Moga (-) patients (51.2 % vs. 34.0 %, p = 0.006). Multivariate analysis identified age < 70, PS 0-1, cCa < 11 mg/dL, albumin ≥3.5 g/dL, LDH < 265 IU/L, LMR ≥ 2.6, and Moga (+) use as independent predictors of OS. In Moga (+) patients, cCa and LMR remained independent prognostic factors.

CONCLUSION:

LMR is a novel prognostic factor in r/r ATL and may provide useful information when considering mogamulizumab-based treatment.

01 Jan 2026·Advanced Science

Repurposing of Chemokine Antagonists for Combined Phase‐Resolved Spinal Cord Injury Treatment

Article

Author: Rustam H. Ziganshin ; Yuri M. Poluektov ; Alexander N. Konovalov ; Alena S. Evpak ; Daniil A. Barsuk ; Maksim V. Rodionov ; Alexander G. Gabibov ; Daria A. Orlova ; Dmitri Yu Usachev ; Aldo Spallone ; Dmitry S. Asyutin ; Fedor A. Mesheryakov ; Nikolay A. Konovalov ; Anna A. Kudriaeva ; Alexey N. Minakov ; Aleksandr S. Chernov ; Igor N. Pronin ; Georgii B. Telegin ; Viktor A. Palikov ; Vitaly A. Kazakov ; Alexey A. Belogurov Jr.

Abstract:

Spinal cord injury (SCI) is a medical challenge that results in the formation of a glial scar preventing recovery of axonal conductivity. Cytokines and chemokines significantly affect the pathogenesis of SCI and represent important targets for therapeutic intervention. Here, dozens of cytokines and chemokines are dynamically monitored in plasma, cerebrospinal fluid, and injury site released in response to experimental SCI conducted in two rodent strains and patients undergoing surgical removal of intramedullary tumors. Dataset comprising 6,172 cytokine/chemokine values across 8 time points suggests that SCI in mammals is accompanied by a massive cytokine storm in cerebrospinal fluid, mainly driven by CXCL1, IL‐6, and CCL2‐5. Sub‐acute phase is mostly associated with IL‐2, IL‐7, CCL22 and CX3CL1, whereas TNFα and IL17α permanently persists in CNS for even weeks following SCI. The effects of mogamulizumab and chemical antagonists of C‐C/C‐X‐C chemokine receptors TAK‐799, SB225002, and MK‐7123 on SCI recovery in rodents are further estimated. Here blockade of CCR5 and CXCR1/2 chemokine receptors is shown beneficial for amelioration of acute SCI, whereas anti‐CCR4 antibody mogamulizumab readily prevents secondary inflammation in the injured area. Summarizing, the current report claims for a novel combined time‐resolved therapeutic modality in SCI treatment, which supports feasibility and motivates off‐label clinical evaluation in appropriate cohorts.

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.

News (Medical) associated with Mogamulizumab-KPKC

10 Nov 2025

·www.businesswire.com

Innate Pharma Announces FDA Clearance to Proceed With TELLOMAK 3, a Confirmatory Phase 3 Trial of Lacutamab in CTCL

MARSEILLE, France--(BUSINESS WIRE)--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the confirmatory Phase 3 protocol for lacutamab in cutaneous T-cell lymphomas (CTCL), with no further comments, clearing the trial to proceed. The planned confirmatory Phase 3 trial, TELLOMAK 3, is an open-label, randomized study designed to demonstrate the efficacy of lacutamab in patients with Sézary syndrome and Mycosis fungoides, who failed at least one prior line of systemic therapy. The trial will include two independent cohorts: one enrolling patients with Sézary syndrome post-mogamulizumab treatment randomized 1:1 to receive lacutamab or romidepsin, and one enrolling patients with Mycosis fungoides randomized 1:1 to receive lacutamab or mogamulizumab. The primary endpoint of the study for both cohorts is progression-free survival (PFS) evaluated by blinded central review. Data from the Phase 2 TELLOMAK trial in CTCL demonstrated durable activity, a favorable safety profile, and improvements in patients’ quality of life. With this feedback from FDA, the Company is progressing towards the initiation of the confirmatory Phase 3 TELLOMAK 3 trial in H1 2026. FDA provided encouraging initial feedback on Innate Pharma’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome, once the Phase 3 trial is underway. “This important regulatory milestone with the FDA marks a key step forward for the lacutamab program,” said Jonathan Dickinson, Chief Executive Officer of Innate Pharma. “Building on robust Phase 2 data from TELLOMAK, this milestone brings us one step closer to our next goal, submitting for accelerated approval in Sézary syndrome once the Phase 3 trial is underway. We remain deeply committed to advancing this differentiated therapy for patients with CTCL, while creating meaningful value for our shareholders.” “We are pleased to reach this important milestone for the lacutamab program as we prepare to initiate the confirmatory Phase 3 study, TELLOMAK 3,” said Sonia Quaratino, Chief Medical Officer of Innate Pharma. “The efficacy and safety data from the TELLOMAK Phase 2 trial suggest that lacutamab has the potential to be a game changer in the treatment of CTCL, an orphan disease with a high unmet medical need. Our expert clinical team looks forward to collaborating with CTCL investigators and regulators to start the Phase 3 trial in due time.” About lacutamab Lacutamab is a first-in-class anti-KIR3DL2 antibody, currently developed in cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). CTCL is a group of rare non-Hodgkin’s lymphomas that develop in the skin and severely affect patients’ quality of life. Sezary syndrome (SS) is a rare and aggressive leukemic form with poor survival, while mycosis fungoides (MF) is the most common subtype, with advanced stages associated with poor outcomes. Data from the Phase 2 TELLOMAK trial in CTCL demonstrated durable activity, a favorable safety profile, and improvements in patients’ quality of life. FDA provided encouraging initial feedback on Innate Pharma’s proposed regulatory pathway, which could potentially include Accelerated Approval for Sézary syndrome. The program has received Fast Track designation from the FDA, PRIME designation from the EMA for SS, and Orphan Drug designation in both the US and EU for CTCL. More recently it has received Breakthrough Therapy Designation for SS. A Phase 3 in CTCL is under preparation. About Innate Pharma: Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Leveraging its antibody-engineering expertise, the company has developed innovative therapeutic approaches, including Antibody Drug Conjugates (ADC), monoclonal antibodies (mAbs) and multi-specific NK Cell Engagers through its proprietary ANKET® (Antibody-based NK cell Engager Therapeutics) platform. Innate’s portfolio includes IPH4502, a differentiated Nectin-4 ADC in development in solid tumors, lacutamab, an anti-KIR3DL2 mAb developed in advanced forms of cutaneous T cell lymphomas and peripheral T cell lymphomas, and monalizumab, an anti-NKG2A antibody developed in collaboration with AstraZeneca in non-small cell lung cancer. Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as renowned research institutions, working together to accelerate innovation, research and development for the benefit of patients. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X. Information about Innate Pharma shares ISIN code FR0010331421 Ticker code Euronext: IPH Nasdaq: IPHA LEI 9695002Y8420ZB8HJE29 Disclaimer on forward-looking information and risk factors This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, including the goals of the confirmatory Phase 3 trial, TELLOMAK 3, the initiation date of the Phase 3 trial and potential acceleration thereof, and the potential of lacutamab. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “intend,” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

Phase 2Phase 3Fast TrackImmunotherapyOrphan Drug

30 Oct 2025

·pmlive.com

Kyowa Kirin and University Hospitals Birmingham announce new survival data in rare disease study

Kyowa Kirin, the European subsidiary of the Japan-based specialty pharmaceutical company, and University Hospitals Birmingham NHS Foundation Trust have announced new findings from the ongoing PROCLIPI study on the treatment of cutaneous T cell lymphoma (CTCL) using POTELIGEO (mogamulizumab). The PROCLIPI (PROgnostic Cutaneous Lymphoma International Prognostic Index) study is a prospective, observational, multicentre registry that now includes more than 2,000 patients across 19 countries – making it one of the largest CTCL data sets worldwide. Its primary objective is to collect robust clinical data to support the development of prognostic indices for CTCL. “The PROCLIPI Study demonstrates the power of global collaboration in rare diseases. By bringing together data from across the world, we can generate insights that simply wouldn’t be possible in isolation,” said Professor Julia Scarisbrick, Chief Investigator of the PROCLIPI Study and Honorary Professor of Dermatology, University Hospitals Birmingham NHS Foundation Trust. “We are working to build rigorous scientific evidence while giving patients and their families a better understanding of what long-term survival looks like.” The latest results, presented at the European Organisation for Research and Treatment of Cancer – Cutaneous Lymphoma Tumour Group (EORTC-CLTG) Annual Meeting in Athens, Greece, focused on overall survival (OS) outcomes. Findings showed that POTELIGEO was associated with statistically significant and clinically meaningful improvements in median OS among patients with mycosis fungoides (MF) and Sézary syndrome (SS) – two rare CTCL subtypes, which is itself a rare form of non-Hodgkin’s lymphoma that remains treatable but not curable. “These insights into improved overall survival for patients living with CTCL mark an important step forward, providing a stronger clinical evidence base and reinforcing the value of international networks in rare disease research,” says Dr Nick Kronfeld, Head of Medical Affairs, Kyowa Kirin International. “By working alongside scientific and patient communities in CTCL, we can gain a better understanding of real-world outcomes, enabling us to bring life-changing value to patients and families, not just today but over the long term.”

Clinical Study

22 Oct 2025

·www.businesswire.com

Global Registry Data Show Meaningful Overall Survival Benefit in Patients with Advanced Cutaneous T-cell Lymphoma (CTCL) treated with POTELIGEO (mogamulizumab)

GALASHIELS & MARLOW, & BIRMINGHAM, United Kingdom--(BUSINESS WIRE)--Kyowa Kirin International (KKI), a wholly owned subsidiary of Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin), a Japan-based global specialty pharmaceutical company, and the University Hospitals Birmingham NHS Foundation Trust, today announced new overall survival (OS) insights from the PROCLIPI (PROgnostic Cutaneous Lymphoma International Prognostic Index) Study aligning with previous findings that suggest mogamulizumab may offer meaningful OS benefit for patients living with mycosis fungoides (MF) and Sézary syndrome (SS), two rare conditions and subtypes of cutaneous T-cell lymphoma (CTCL).2 Key findings2: For patients with advanced-stage MF and SS (n=371), the median overall survival from the onset of treatment was higher for patients treated with mogamulizumab (n=72) at 64 months compared with those not receiving mogamulizumab (n=175) at 54 months (p<0.01). Patients treated with mogamulizumab showed a trend toward improved OS compared to those not receiving mogamulizumab across risk-stratified groups according to the new Cutaneous Lymphoma International Prognostic Index (CLIPI). For a subset of patients with SS (n=96), the median OS is around 6.5 years for patients treated with mogamulizumab (n=46) compared with around 3 years for systemic treatment but not mogamulizumab (n=50) (p<0.01). This research was presented as part of the Scientific Proceedings at this year’s European Organisation for Research and Treatment of Cancer Cutaneous Lymphoma Tumour Group (EORTC-CLTG) Annual Meeting in Athens, Greece.2 The data contributes to a growing body of evidence suggesting potential OS benefits with mogamulizumab, 4,5 highlighting the importance of collaboration across the CTCL community in advancing understanding of survival outcomes and helping to shape the future of patient care. “The PROCLIPI Study demonstrates the power of global collaboration in rare diseases. By bringing together data from across the world, we can generate insights that simply wouldn’t be possible in isolation,” says Professor Julia Scarisbrick, Chief Investigator of the PROCLIPI Study and Honorary Professor of Dermatology, University Hospitals Birmingham NHS Foundation Trust. “We are proud to coordinate this initiative as we’re working to build rigorous scientific evidence while giving patients and their families a better understanding of what long-term survival looks like.” The PROCLIPI Study, now in its tenth year, aims to develop prognostic indices for MF and SS. The study collects comprehensive data, including clinical, haematological, pathological, imaging, treatment with responses, quality of life and survival data.1 Recently, a new prognostic index (CLIPI) for advanced CTCL was published to enable precise patient risk stratification.6 “For those of us in the CTCL community, survival isn’t just about numbers on a chart - it’s about being able to spend more time with our families, plan for the future, and live life with dignity”, says Susan Thornton, CEO, Cutaneous Lymphoma Foundation. “That’s why initiatives like PROCLIPI are important, as the data collected reflects real lived experiences and can help inform future improvements in care for patients.” The independent international PROCLIPI Study aligns with Kyowa Kirin International’s commitment to generating real-world insights that advance the understanding of CTCL and turn these clinical insights into meaningful improvements in access, policy, and patient care. Cutaneous T-cell lymphoma is a rare disease7, and innovation in this environment can be challenging due to the rarity of this disease.8 Yet despite these challenges, mounting evidence continues to emerge4,5 to help strengthen our collective understanding of potential treatment benefits. “These insights into improved overall survival for patients living with CTCL mark an important step forward, providing a stronger clinical evidence base and reinforcing the value of international networks in rare disease research,” says Dr Nick Kronfeld, Head of Medical Affairs, Kyowa Kirin International. “By working alongside scientific and patient communities in CTCL, we can gain a better understanding of real-world outcomes, enabling us to bring life-changing value to patients and families, not just today but over the long term.” Note to editors The OS data from the PROCLIPI Study was presented as an oral presentation during the EORTC CTCL Annual Group Meeting 2025. 2 KKI did not sponsor the PROCLIPI study or OS analysis. The median OS for patients (n=72) receiving mogamulizumab compared to those not receiving mogamulizumab (n=175) was 64 months versus 54 months. 2 Median OS data amongst risk stratifications according to CLIPI: 2,6 Low-risk: 67 months vs. ‘not reached’ for mogamulizumab versus those who had not received mogamulizumab Medium-risk: 64 vs. 48 months for mogamulizumab versus those who had not received mogamulizumab High-risk: 26 vs. 13 months for mogamulizumab and for those who had not received mogamulizumab Low-risk: 67 months vs. ‘not reached’ for mogamulizumab versus those who had not received mogamulizumab Medium-risk: 64 vs. 48 months for mogamulizumab versus those who had not received mogamulizumab High-risk: 26 vs. 13 months for mogamulizumab and for those who had not received mogamulizumab 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 University Hospitals Birmingham NHS Foundation Trust University Hospitals Birmingham NHS Foundation Trust (UHB) is one of the largest teaching hospital trusts in England, serving a regional, national and international population. The Trust provides high-quality acute and specialist care across four main hospital sites, Queen Elizabeth Hospital Birmingham, Heartlands Hospital, Good Hope Hospital, and Solihull Hospital, as well as a range of community services. With over 25,000 staff and approximately 2,700 beds, UHB delivers care to more than 2.2 million patients annually. It is a regional centre for trauma, burns, neurosciences, cancer, and military medicine - proudly hosting the Royal Centre for Defence Medicine. UHB is also a leader in clinical research and innovation, home to the NIHR Birmingham Biomedical Research Centre and the Institute of Translational Medicine. Guided by its 2024-2029 strategy, Building Healthier Lives, UHB is committed to improving health and wellbeing, shaping an equitable and sustainable future, and creating excellent experiences for patients and staff. The Trust’s core values, Kind, Connected, and Bold, underpin its mission to deliver compassionate care, foster collaboration, and drive innovation across all services. For more information, visit www.uhb.nhs.uk. About PROCLIPI PROCLIPI is the PROgnostic Cutaneous Lymphoma International Prognostic Index Study with the main aim to produce a prognostic index in mycosis fungoides (MF) and Sezary syndrome (SS). The study prospectively collects clinical, haematological, pathological, imaging, treatment with responses, quality of life and survival data using careful predefined datasets. Patients are subject to a central review to confirm diagnosis. PROCLIPI opened in 2015 and recruitment has been strong with to date over 2,000 patients recruited from 52 Centres from 19 countries across 6 continents.1 This trial was registered at www.ClinicalTrials.gov NCT02848274.3 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.7 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.9 MF and SS are characterised by localisation of cancerous white blood cells called T lymphocytes (T cells), to the skin.10 These cancerous T cells consistently express a protein called CCR4, which enables them to move from the blood to the skin.11-13 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.14 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 CTCLs15 and is typically indolent, characterised by skin symptoms including patches or plaques, skin redness and tumours. SS is much rarer, accounting for around 5% of CTCLs,16 and is more aggressive,14 with high levels of blood involvement.16 It can cause severe itching, erythroderma, intense scaling of the skin and hair loss.14 CTCL can take, on average, between 2 and 7 years for individuals to receive a confirmed diagnosis.14 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. 11-13 Once mogamulizumab binds to CCR4, it increases attraction of immune cells from the immune system to destroy the cancerous cells.17 References 1 Scarisbrick, J. The PROCLIPI international registry, an important tool to evaluate the prognosis of cutaneous T cell lymphomas. Presse Med. 2022 Mar;51(1):104123. doi: 10.1016/j.lpm.2022.104123. 2 Peterknecht E, et al. Real-World Survival with Mogamulizumab versus Brentuximab in Advanced CTCL: Insights from PROCLIPI. Presented at EORTC 2025; Athens, Greece. Abstract #145. 3 ClinicalTrials.Gov. ID Of Prognostic Factors In Mycosis Fungoides/ Sezary Syndrome. #NCT02848274. Available at: https://clinicaltrials.gov/study/NCT02848274?term=%23NCT02848274&rank=1. Last accessed: October 2025. 4 Broccoli, A, et al. Quality and duration of responses with mogamulizumab in cutaneous T-cell lymphomas: Insights into long-lasting outcomes. Br J Haematol. 2025;00:1–5. doi: 10.1111/bjh.70161. 5 Bozonnat, A, et al. Real-life efficacy of immunotherapy for Sézary syndrome: a multicenter observational cohort study. EClinicalMedicine. 2024;79:102979. doi: 10.1016/j.eclinm.2024.102979. 6 Scarisbrick, J, et al. A new prognostic index (CLIPI) for advanced cutaneous lymphoma enables precise patient risk stratification. Blood. 2025;146 (14), 1687–1692. doi: 10.1182/blood.2025029628 7 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. 8 Targeted Oncology. Immunotherapy Advances and Challenges in T-Cell Lymphoma. Available at: https://www.targetedonc.com/view/immunotherapy-advances-and-challenges-in-t-cell-lymphoma. Last accessed: October 2025. 9 Williams et al (2020) – Health state utilities associated with caring for an individual with CTCL. Journal of Medical Economics. 2020; 23(10):1142-1150 10 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. 11 Ferenczi K, et al. Increased CCR4 expression in cutaneous T cell lymphoma. J Invest Dermatol. 2002;119:1405–10. 12 Yoshie O, et al. 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. 13 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. 14 Lymphoma Coalition. Cutaneous lymphoma – a patient’s guide. Available at: https://lymphomacoalition.org/wp-content/uploads/Cutaneous_lymphoma_-_patients_guide_-.pdf. Last accessed: October 2025. 15 Willemze R, et al. The 2018 update of the WHO-EORTC classification for primary cutaneous lymphomas. Blood. 2019;133(16):1703-1714. 16 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. 17 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

Clinical ResultPhase 3Immunotherapy

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 Kirin 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.	30 Mar 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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ASH2025	Not Applicable	Sezary Syndrome	10	Mogamulizumab	klktzfyxei(qqooewiden) = Patients who progressed showed lower IL-1β at baseline (4 vs 14.65 pg/mL, p = 0.0346) and 3 months (4 vs 19.2 pg/mL, p = 0.0210) fsnmbfyvli (lwaqukfzbw ) View more	Positive	06 Dec 2025
ASH2025	Not Applicable	Mycosis Fungoides \| Sezary Syndrome	110	Mogamulizumab as monotherapy (MT)	eyupiwoadv(nlqivjfxmi) = Infections included cellulitis (MT: 7 pts [8.6%], CT: 1 pt [3.4%]), pneumonia (MT: 4 pts [4.9%], CT: 0 pts), and sepsis (MT: 2 pts [2.6%], CT: 0 pts) jtvzwwdvib (izknhigdee ) View more	Positive	06 Dec 2025
				Mogamulizumab as combination therapy (CT)
ASH2025	Not Applicable	Cutaneous T-Cell Lymphoma	19	Mogamulizumab	oibvvsloap(eaedinphtr) = zeomxpwoqu vfpwjohcqc (ejehyptvbh, 6.8 - 32.3) View more	Positive	06 Dec 2025
NCT04745234 (MOGA-2MG-Q4W, ASH2025)	Phase 2	Mycosis Fungoides \| Sezary Syndrome	34	Mogamulizumab 2.0 mg/kg Q4W (patients with MF)	yeuestwafh(ferwbcjagg) = pvzwipnmjo wwilmtugso (dggahbynfr )	Positive	06 Dec 2025
				Mogamulizumab 2.0 mg/kg Q4W (patients with SS)	yeuestwafh(ferwbcjagg) = myaemyulbc wwilmtugso (dggahbynfr )
NCT04541017 (CTgov)	Phase 1/2	Mycosis Fungoides \| Sezary Syndrome \| T-cell lymphoma recurrent	8	Punch Biopsy+Magrolimab+Mogamulizumab (Arm I (Magrolimab, Mogamulizumab), Phase Ib and Phase II)	dslififuzt = zparmpqxto xoanxitith (lpqkzfkrqv, rrfoxbolla - oyrmxnkumd) View more	-	16 Oct 2025
				Punch Biopsy+Mogamulizumab (Arm II (Mogamulizumab), Phase II)	yqunggnaeu(juulpjumqh) = fimoeqzxnq kaklqxtrwx (iihwhflfiq, vrnpxzydzl - vfvswepcyr) View more
ASCO2025	Not Applicable	Adult T-Cell Leukemia-Lymphoma HTLV-1 infection	9	Mogamulizumab	sfbdpshald(rjniifshsa) = ixygbdcpha cfyumcchjs (gbbsqioahu ) View more	Positive	30 May 2025
				mogamulizumab (Historical Control Group)	jwvjmxomcr(fepkoazpww) = lyxdqoqxgm isvduyqrpj (ezgxmfqgbh )
EHA2025	Not Applicable	Cutaneous T-Cell Lymphoma TCR clonality	12	Mogamulizumab	wxirrymiun(irghgihnjn) = nibjjvhsbl cjrofdwyet (cbrnqgxksq ) View more	Positive	14 May 2025
MAVORIC (EHA2025)	Phase 3	Mycosis Fungoides \| Sezary Syndrome	25	Mogamulizumab	pefvixobse(zklxbayaru) = 3.8% of patients experienced anemia leading to treatment discontinuation opbcobrfmd (vctdkhwhnw ) View more	-	14 May 2025
NCT02946671 (Phase I study on neoadjuvant combination immunotherapy with mogamulizumab and nivolumab for solid tumors, Pubmed \| J Immunother Cancer)	Phase 1	Solid tumor Neoadjuvant FoxP3+	16	Nivolumab 3.0 mg/kg	qufoyleskc(nttqrtbtyv) = 25% bxoyufniaj (gyouzvvyzg ) View more	Positive	01 Apr 2025
ASH2024	Not Applicable	Mycosis Fungoides \| Sezary Syndrome	-	Mogamulizumab monotherapy	ziwkqhpqmx(ezugtkaxew) = ixctmlseon fxqmjhesaw (uhjuxpnmei, 10.9 - 32.3) View more	-	09 Dec 2024
				Mogamulizumab combination therapy	ziwkqhpqmx(ezugtkaxew) = zhztptjgxa fxqmjhesaw (uhjuxpnmei, 3.0 - 12.3) View more

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