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 Date01 Jun 2024

Sponsor / Collaborator

Yale University

[+1]

NCT05956041 / RecruitingPhase 2

A Phase II Study of Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas

This is an open-label, single-arm, multicenter, phase II study combining pembrolizumab and mogamulizumab in patients with advanced-stage, relapsed or refractory CTCL Each cycle will equal 6 weeks. Pembrolizumab will be administered on Day 1 of each cycle. Mogamulizumab will be administered on Day 1, 8, 15, and 22 of Cycle 1. For Cycle 2 and subsequent cycles, mogamulizumab will be administered on Day 1, 15 and 29 of each cycle. Subjects will undergo a response assessment prior to Cycle 3 and every 2 cycles thereafter.
Subjects will continue study treatment until documented progression, unacceptable toxicity, or any other condition for discontinuation is met in protocol. A maximum of 2 years of study treatment may be administered. If a subject achieves a complete response (CR) per mSWAT criteria after 3 months of study treatment (2 cycles), they will continue study therapy for an additional 6 months (4 cycles). If a confirmed and persistent CR is met, they may discontinue study treatment and enter an observation period in protocol. Repeat disease evaluation is required prior to study therapy discontinuation. Subjects who progress during the observation period may be eligible for up to an additional 9 cycles (1 year) of pembrolizumab and mogamulizumab.

Start Date06 Dec 2023

Sponsor / Collaborator

Rogel Cancer Center: University of Michigan

[+2]

NCT06285370 / RecruitingPhase 4

An Open-Label, Multicenter, Single Arm Study to Evaluate the Efficacy and Safety of Anti-CCR4 Monoclonal Antibody Mogamulizumab (KW-0761) in Chinese Subjects With Mycosis Fungoides or Sézary Syndrome Previously Treated With Systemic Therapy

The purpose of the study is to evaluate the efficacy and safety of mogamulizumab (KW-0761) in chinese subjects with mycosis fungoides or sézary syndrome previously treated with systemic therapy

Start Date29 May 2023

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

369

Literatures (Medical) associated with Mogamulizumab-KPKC

01 Feb 2024·Clinical lymphoma, myeloma & leukemia

Real-World Treatment Patterns and Clinical Outcomes With Brentuximab Vedotin or Other Standard Therapies in Patients With Previously Treated Cutaneous T-Cell Lymphoma in the United States

Article

Author: Liu, Nicholas ; Barta, Stefan K ; Surinach, Andy ; Duh, Mei Sheng ; Ye, Mingchen ; DerSarkissian, Maral ; Fanale, Michelle ; Yu, Kristina S ; Chang, Rose

INTRODUCTION/BACKGROUND:

Primary cutaneous anaplastic large-cell lymphomas (pcALCLs) are a type of cutaneous T-cell lymphoma (CTCL) in which CD30 is uniformly expressed. In mycosis fungoides (MF), another CTCL, CD30 is heterogeneously expressed. In ALCANZA, patients with pcALCLs or CD30-positive MF randomized to brentuximab vedotin (BV) vs. physician's choice of methotrexate or bexarotene had significantly improved outcomes, including higher objective response rates (ORR) lasting ≥4 months (ORR4), as well as longer median progression-free survival (PFS) and time to next treatment (TTNT). In this study, we sought to assess the real-world impact of treatment with BV in second or later lines of therapy for CTCL.

MATERIALS AND METHODS:

This retrospective chart review describes patient characteristics, treatment patterns, clinical outcomes, and healthcare resource use (HRU) in patients with pcALCLs or MF previously treated with ≥1 systemic therapy and subsequently treated with BV (n = 139) or other standard therapy (OST; n = 164).

RESULTS:

Most patients in the BV cohort (96.4%) received BV as second-line (2L) systemic therapy. The most common OSTs were methotrexate (11.6%), mogamulizumab (9.1%), and bendamustine (9.1%) monotherapies. For 2L BV and OST, median duration of therapy was 8.4 and 5.2 months, real-world ORR was 82.1% and 66.5%, and real-world ORR4 was 42.5% and 25.0%. Real-world 1- and 2-year PFS, TTNT, and OS were significantly longer (all P < .01) and HRU was lower for BV vs. OST.

CONCLUSION:

These real-world outcomes are consistent with ALCANZA results, demonstrating favorable outcomes with BV vs. OST in patients with CTCL previously treated with ≥1 systemic therapy.

01 Feb 2024·Clinical lymphoma, myeloma & leukemia

SOHO State-of-the-Art Updates and Next Questions: Treatment for Newly Diagnosed Peripheral T-Cell Lymphomas

Review

Author: Foley, Nicole C ; Mehta-Shah, Neha ; Burton, Jackson S

Although a rare subset of non-Hodgkin lymphomas, peripheral T-cell lymphomas (PTCL) account for a disproportionate proportion of patient mortality. Conventional therapies are derived from experience treating aggressive B-cell lymphomas and center around CHOP-based chemotherapy. However, due to the unique biology and diverse subtypes of PTCL, most patients fail to durably respond to this approach and 5-year survival is only 20% to 30%. There have been multiple attempts to improve outcomes for patients with PTCL. Among the more successful strategies are the use of consolidative autologous stem cell transplant, the augmentation of CHOP with etoposide (CHOEP), and the use of brentuximab vedotin in CD30-positive PTCL. Advances in the understanding of histology-specific biology has cultivated enthusiasm to evaluate hypomethylating agents, histone deacetylate inhibitors, and phosphoinositol-3-kinase inhibitors in the frontline setting. Improvements in monitoring disease response and prognostication including the use of cell-free DNA, mutational profiling, and interim PET/CT imaging are also on the horizon. For patients with acute T-cell leukemia/lymphoma, the use of mogamulizumab-based therapy in the frontline setting may lead to advances in care. The true impact of these new-era therapies will only be elucidated as clinical practices incorporate the rapidly changing evidence.

31 Jan 2024·Biological & pharmaceutical bulletin

Quantitative Analysis of Therapeutic Antibody Interactions with Fcγ Receptors Using High-Speed Atomic Force Microscopy

Article

Author: Yogo, Rina ; Kongsema, Mesayamas ; Kato, Koichi ; Yagi, Hirokazu ; Kondo, Sachiko ; Uchihashi, Takayuki ; Yanaka, Saeko ; Watanabe, Hiroki

This study employed high-speed atomic force microscopy to quantitatively analyze the interactions between therapeutic antibodies and Fcγ receptors (FcγRs). Antibodies are essential components of the immune system and are integral to biopharmaceuticals. The focus of this study was on immunoglobulin G molecules, which are crucial for antigen binding via the Fab segments and cytotoxic functions through their Fc portions. We conducted real-time, label-free observations of the interactions of rituximab and mogamulizumab with the recombinant FcγRIIIa and FcγRIIa. The dwell times of FcγR binding were measured at the single-molecule level, which revealed an extended interaction duration of mogamulizumab with FcγRIIIa compared with that of rituximab. This is linked to enhanced antibody-dependent cellular cytotoxicity that is attributed to the absence of the core fucosylation of Fc-linked N-glycan. This study also emphasizes the crucial role of the Fab segments in the interaction with FcγRIIa as well as that with FcγRIIIa. This approach provided quantitative insight into therapeutic antibody interactions and exemplified kinetic proofreading, where cellular discrimination relies on ligand residence times. Observing the dwell times of antibodies on the effector molecules has emerged as a robust indicator of therapeutic antibody efficacy. Ultimately, these findings pave the way for the development of refined therapeutic antibodies with tailored interactions with specific FcγRs. This research contributes to the advancement of biopharmaceutical antibody design and optimizing antibody-based treatments for enhanced efficacy and precision.

News (Medical) associated with Mogamulizumab-KPKC

04 Jun 2024

·www.biospace.com

Innate Pharma Presents Positive Results From TELLOMAK Phase 2 Study With Lacutamab in Mycosis Fungoides

In heavily pretreated patients with mycosis fungoides, treatment with lacutamab results in meaningful anti-tumor activity regardless of baseline KIR3DL2 expression level. Lacutamab was well-tolerated with a safety pro with prior studies. Innate will host a virtual KOL event on Tuesday, June 11, 2024 at 4:00PM CEST (10:00AM EDT). MARSEILLE, France--(BUSINESS WIRE)-- Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) announced favorable results from the Phase 2 TELLOMAK study with lacutamab in mycosis fungoides (MF). The results were presented at the ASCO 2024 Annual Meeting, in Chicago, Illinois. As of October 13, 2023, data cutoff, MF patients (n=107) received a median of 4 prior systemic therapies and had a median follow-up of 11.8 months. The data demonstrate that treatment with lacutamab resulted in meaningful antitumor activity, regardless of the KIR3DL2 baseline expression, and an overall favorable safety profile. The global objective response rate (ORR) was 16.8% (Olsen 2011) and 22.4% (Olsen 2022), including 2 complete responses (CR) and 16 partial responses (PR). In patients expressing a baseline KIR3DL2 ≥ 1%, the ORR was 20.8% (Olsen 2011) and 29.2% (Olsen 2022). Median progression-free survival was 10.2 months (95% CI 6.5, 16.8) for all MF patients and 12.0 months (95% CI 5.6, 20.0) in the KIR3DL2 ≥ 1% group. Time to response was 1.0 month (95% CI 1, 5). “The anti-tumor activity observed in the Phase 2 TELLOMAK trial confirms that treatment with lacutamab achieves clinically meaningful outcomes for heavily pretreated patients with mycosis fungoides regardless of baseline KIR3DL2 expression level,” commented Dr. Sonia Quaratino, Chief Medical Officer of Innate Pharma. “These results are very promising, considering the number of prior systemic therapies that the patients had received before, and the lack of available drugs. These data support further development of lacutamab to bring improved treatments to patients with cutaneous T cell lymphomas.” Prof. Pierluigi Porcu, Director, Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation, Sidney Kimmel Cancer Center, Jefferson Health, Philadelphia, and Principal Investigator in the TELLOMAK study, added: “Mycosis fungoides patients have few efficacious and safe therapeutic options at advanced stages. It is promising to see lacutamab achieving remarkable efficacy along with excellent tolerability in this heavily pre-treated population. We express our gratitude to the investigators, clinical research coordinators, patients and caregivers involved in the TELLOMAK program.” Efficacy in MF patients and according to KIR3DL2 subgroup ITT set All MF N=107 KIR3DL2 ≥ 1% N=48 KIR3DL2 <1% N=59 Olsen 2011 Global ORR % (95%CI) 16.8% (10.9, 25.0) 20.8% (11.7, 34.3) 13.6% (7.0, 24.5) Olsen 2022 Global ORR % (95%CI) 22.4% (15.6, 31.2) 29.2% (18.2, 43.2) 16.9% (9.5, 28.5) CR n (%) 2 (1.9) 2 (4.2) 0 (0.0) PR n (%) 16 (15.0) 8 (16.7) 8 (13.6) SD1 n (%) 74 (69.2) 30 (62.5) 44 (74.6) PD n (%) 13 (12.1) 6 (12.5) 7 (11.9) NE n (%) 2 (1.9) 2 (4.2) 0 (0.0) Time to global response (mo) median (range) 1.0 (1-5) 1.0 (1-5) 1.9 (1-4) Skin response (n=107) % (95%CI) 29.0% (21.2;38.2) 33.3% (21.7;47.5) 25.4% (16.1;37.8) PFS (months) median (95%CI) 10.2 (6.5, 16.8) 12.0 (5.6, 20.0) 8.5 (6.5, 17.5) Virtual KOL Event Details Tuesday, June 11, 2024 at 4:00PM CEST (9:00AM EDT) The live webcast will be available at the following link: Participants may also join via telephone using the following registration link: This information can also be found on the Investors section of the Innate Pharma website, . A replay of the webcast will be available on the Company website for 90 days following the event. About Lacutamab 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 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. About TELLOMAK 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: Cohort 1: lacutamab being evaluated as a single agent in approximately 60 patients with Sézary syndrome who have received at least two prior systemic therapies, including mogamulizumab. The Sézary syndrome cohort of the study could enable the registration of lacutamab in this indication. Cohort 2: lacutamab being evaluated as a single agent in patients with MF that express KIR3DL2, as determined at baseline with a Simon 2-stage design. Cohort 3: lacutamab being evaluated as a single agent in patients with MF that do not express KIR3DL2, as determined at baseline, with a Simon-2 stage design. All comers: lacutamab being evaluated as a single agent in patients with both KIR3DL2 expressing and non-expressing MF to explore the correlation between the level of KIR3DL2 expression and treatment outcomes utilizing a formalin-fixed paraffin embedded (FFPE) assay under development as a companion diagnostic. 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. About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through therapeutic antibodies and its ANKET® (Antibody-based NK cell Engager Therapeutics) proprietary platform. Innate’s portfolio includes lead proprietary program lacutamab, developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, monalizumab developed with AstraZeneca in non-small cell lung cancer, as well as ANKET® multi-specific NK cell engagers to address multiple tumor types. Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, 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 and follow us on LinkedIn and X. Information about Innate Pharma shares ISIN code Ticker code LEI FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29 Disclaimer on forward-looking information and risk factors This press release contains certain forward-looking statements, including those within the meaning of the Private Securities Litigation Reform Act of 1995. The use of certain words, including “believe,” “potential,” “expect” and “will” 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 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 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, 2023, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public, by the Company. 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. 1 SD includes 2 pts uPR confirmed after DCO & 1 new uPR after DCO. View source version on businesswire.com: Contacts For additional information, please contact: Investors Innate Pharma Henry Wheeler Tel.: +33 (0)4 84 90 32 88 Henry.wheeler@innate-pharma.fr Media Relations NewCap Arthur Rouillé Tel.: +33 (0)1 44 71 00 15 innate@newcap.eu Source: Innate Pharma SA View this news release online at:

Phase 2Clinical ResultOrphan DrugFast TrackImmunotherapy

14 May 2024

·www.biospace.com

CTCL Global Care Collaborative Pioneers Consensus for Improving Diagnosis and Care in Cutaneous T-Cell Lymphoma (CTCL)

Kyowa Kirin partners with patient advocacy groups to form global collaborative to address unmet needs in CTCL Consensus statement highlights 12 recommendations for healthcare authorities, policymakers, hospitals, and clinicians to drive positive change for the global CTCL patient community PRINCETON, N.J., May 14, 2024 /PRNewswire/ -- Kyowa Kirin, Inc. a wholly owned subsidiary of Kyowa Kirin Co. Ltd, today announced the publication of a patient-focused global consensus statement – 'Time to Act: A Global Patient-Focused Consensus for Improving the Care of Cutaneous T-Cell Lymphoma (CTCL)'. The statement calls on healthcare authorities, policymakers, hospitals, and clinicians worldwide to undertake 12 specific actions to enhance awareness, diagnosis, care, and support for people impacted by CTCL, which encompasses several types of rare blood cancer that primarily manifest in the skin.1,2 The consensus statement is the inaugural output of the CTCL Global Care Collaborative, a newly established group united by a shared mission to reduce the time to an accurate diagnosis and improve the quality of care and support for people living with CTCL. Kyowa Kirin provided funding to help the group organize and advance its goals. The Collaborative is focused on driving long-term change in four priority areas – improving awareness of CTCL amongst healthcare professionals (HCPs); improving time to diagnosis and awareness of disease staging; ensuring all patients have access to appropriate care; and empowering patients with the information they need to make informed decisions. The insights informing the group's work reflect global perspectives, the unique needs of the patient community, and international nuances. "As a patient organization that interacts with people from around the world, we see firsthand the challenges that our patient community members face navigating their disease," says Susan Thornton, CEO of the Cutaneous Lymphoma Foundation. "We are proud to join arms with our global patient advocacy colleagues to call attention to changes that we believe will improve lives of people impacted by cutaneous lymphoma, wherever they live." CTCL can have debilitating physical, emotional, and social challenges. These are difficult enough to contend with, but their burden may be compounded by issues in testing, diagnosis, and care. Notably, in its most prominent subtype of mycosis fungoides (MF), the average time to diagnosis is 3-4 years.3,4 Like many rare diseases, issues in diagnosis may come from limited awareness and symptoms being mistaken for more common conditions. Once diagnosed, further health system issues, such as inaccurate disease staging and inequitable access to care, represent additional barriers for some patients. The Collaborative is dedicated to addressing these unmet needs globally. "Every day, our teams see the impact that CTCL has on patients and their families across our region," says Greg Palko, Vice President, North America Regional Franchise Head, Oncology. "We are hopeful that the systemic changes suggested in this Consensus Statement will increase awareness and help address the unmet needs of this patient community that we care deeply about." To learn more about CTCL, the Global Care Collaborative, and the 12 recommendations, click here. About the CTCL Global Care Collaborative The CTCL Global Care Collaborative aims to address the unmet needs faced by people living with CTCL, which encompasses several types of rare blood cancer that primarily manifest in the skin.1,2 The Collaborative is organized and funded by Kyowa Kirin, a co-founder of the group. The Collaborative is comprised of global patient organizations – the Cutaneous Lymphoma Foundation and Lymphoma Coalition; national patient organizations – Lymphoma Action (UK), the Portuguese Association against Leukemia and Lymphoma – APCL (Portugal), the Spanish Association of People Affected by Lymphoma, Myeloma and Leukemia – AEAL (Spain), Stichting Huid Lymfoom (the Netherlands) and Haukrebs-Netzwerk Deutschland e.V. (Germany); Selbsthilfe Kutane Lymphome (Germany), Korea Blood Disease and Cancer Association (South Korea), and House086 (China); and Kyowa Kirin, a Japan based Global Specialty Pharmaceutical Company. The physical and psychosocial burdens of CTCL can have a profound impact on those living with the disease. However, these burdens may be compounded by problems with testing, diagnosis, and care. This is why the Collaborative's mission is to drive reform of healthcare systems globally and resolve the unmet needs that have persisted for those living with CTCL. About Cutaneous T-Cell Lymphoma (CTCL) CTCL can have debilitating physical, emotional, and social impacts. These are difficult enough to contend with, but their burden may be compounded by issues in testing, diagnosis, and management. CTCL encompasses T-cell lymphomas affecting the skin.2 CTCL is a rare subset of non-Hodgkin lymphomas.5 The best studied subtype of CTCL is MF, which accounts for 60% of CTCL cases.1 Beyond MF, there are various other subtypes of CTCL, including Sézary syndrome, lymphomatoid papulosis, primary cutaneous anaplastic large cell lymphoma, and pagetoid reticulosis.6 CTCL can manifest as persistent skin patches and / or raised, scaly plaques, often with constant itching.7,8 More pronounced lesions can also occur.9 In MF, these symptoms and signs can frequently be mistaken for more common, benign conditions like psoriasis or eczema.3 As a result in MF, it can take 3-4 years on average for patients to receive a confirmed diagnosis.3,4 CTCL is characterized by cancerous white blood cells (T-cells) primarily manifesting in the skin.2 For some patients, the disease may evolve to also affect the blood, lymph nodes, and internal organs.10 CTCL is treatable, but not generally considered to be curable.2 About Kyowa Kirin Kyowa Kirin aims to discover and deliver novel medicines and treatments 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 with high unmet medical needs, focusing on bone & mineral, intractable hematological diseases/hemato oncology, and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across the globe. You can learn more about the business of Kyowa Kirin at: References 1 Willemze R, et al. The 2018 update of the WHO-EORTC classification for primary cutaneous lymphomas. Blood. 2019;133(16):1703-1714. 2 Cleveland Clinic. Cutaneous T-Cell Lymphoma. Available from . Last Accessed: May 2024. 3 Wilcox RA. Cutaneous T-cell lymphoma: 2016 update on diagnosis, risk-stratification, and management. Am J Hematol. 2016;91(1):151-65. 4 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. 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. Euro J Cancer. 2017;77:57-74. 6 Girardi M, et al. The Pathogenesis of Mycosis Fungoides. New Eng J Med. 2004;350(19):1978-88. 7 Demierre M-F, et al. Significant impact of cutaneous T-cell lymphoma on patients' quality of life. Cancer. 2006;107(10):2504-2511. 8 Ni X, et al. Reduction of regulatory T cells by Mogamulizumab, a defucosylated anti-CC chemokine receptor 4 antibody, in patients with aggressive/refractory mycosis fungoides and Sézary syndrome. Clin Cancer Res. 2014;21(2):274-85. 9 Bagherani, N, et al. An Overview of Cutaneous T-Cell Lymphomas. F1000 Research. 2016;5:F1000 Faculty Rev-1882. 10 Olsen E, et al. Revisions to the staging and classification of mycosis fungoides and Sezary syndrome: a proposal of the International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC). Blood. 2007;110(6):1713-22. View original content to download multimedia: SOURCE Kyowa Kirin

15 Apr 2024

·www.prnewswire.com

First Interim Analysis of PROSPER Study Details Patient-Reported Symptom Burden of Mycosis Fungoides and Sézary Syndrome

Findings spotlighted in oral presentation at the 5th annual World Congress of Cutaneous Lymphomas meeting in Pasadena, CA PRINCETON, N.J., April 15, 2024 /PRNewswire/ -- Professor Julia Scarisbrick of University of Birmingham on Friday, April 12, 2024, presented interim findings from the Kyowa Kirin, Inc. (Kyowa Kirin, TSE: 4151)-sponsored study, "Real-World Observational Study of Mogamulizumab in Adult Patients with Mycosis Fungoides and Sézary Syndrome (PROSPER)", a prospective observational study evaluating the real-world impact of mogamulizumab on disease symptoms and health-related quality of life (HRQoL) in patients with these subtypes of cutaneous T-cell lymphoma (CTCL). CTCL is a rare form of non-Hodgkin lymphoma that most prominently affects the skin, presenting as patches, plaques, tumors, or reddening of the entire skin, and may be associated with severe itching. In a proportion of cases, the disease may spread to the lymph nodes, blood, and/or other organs. In the current interim analysis, symptom scores (mean) were reported for 20 adult patients with relapsed or refractory disease (8 MF; 12 SS) over their first 16 weeks of mogamulizumab treatment. Prior to treatment initiation, patients reported their symptom burden using a 1 – 10 numeric scale. Skin itch (6.6), skin redness (6.2), flaking skin (5.9), and skin pain (4.0). Additionally, over half of patients reported having sleep problems either "frequently" or "every night" while 47% reported difficulties regulating body temperature "frequently" or "always." Improvement in all symptoms was reported within 4 weeks of treatment initiation and by week 16, 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). Of note, the proportion of patients reporting sleep problems or difficulties regulating body temperature either "frequently" or "always" decreased to less than 20%. "We know that CTCL patients not only suffer from the stress of a cancer diagnosis, but that these stresses are compounded by visual lesions and varying levels of discomfort," says Scarisbrick, the study's principal investigator. "The PROSPER study is helping us understand these burdens better and the impact mogamulizumab may have on patients' symptoms and quality of life." About PROSPER The objective of the PROSPER (ClinicalTrials.gov ID NCT05455931) study is to gain insight into the experiences of patients with MF/SS receiving mogamulizumab and of their caregivers in real-world clinical practice through the collection of patient-reported outcomes (PRO) data, enriched with qualitative data on disease and treatment experience and burden. The study was designed with input from patients and caregivers to ensure patient-relevant outcomes were selected. The study is being conducted in up to 6 countries across North America, Europe, and the Middle East, at 19 sites known to treat and follow-up patients with MF/SS. Patients are followed for up to 50 weeks from study enrollment. POTELIGEO® (mogamulizumab-kpkc) Indication POTELIGEO injection for intravenous infusion is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. Important Safety Information WARNINGS AND PRECAUTIONS Dermatologic toxicity: Monitor patients for rash throughout the course of treatment. For patients who experienced dermatologic toxicity in Trial 1, the median time to onset was 15 weeks, with 25% of cases occurring after 31 weeks. Interrupt POTELIGEO for moderate or severe rash (Grades 2 or 3). Permanently discontinue POTELIGEO for life-threatening (Grade 4) rash or for any Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). Infusion reactions: Most infusion reactions occur during or shortly after the first infusion. Infusion reactions can also occur with subsequent infusions. Monitor patients closely for signs and symptoms of infusion reactions and interrupt the infusion for any grade reaction and treat promptly. Permanently discontinue POTELIGEO for any life-threatening (Grade 4) infusion reaction. Infections: Monitor patients for signs and symptoms of infection and treat promptly. Autoimmune complications: Interrupt or permanently discontinue POTELIGEO as appropriate for suspected immune-mediated adverse reactions. Consider the benefit/risk of POTELIGEO in patients with a history of autoimmune disease. Complications of allogeneic HSCT after POTELIGEO: Increased risks of transplant complications have been reported in patients who received allogeneic HSCT after POTELIGEO. Follow patients closely for early evidence of transplant-related complications. Adverse Reactions The most common adverse reactions (reported in ≥10% of patients) with POTELIGEO in the clinical trial were rash, including drug eruption (35%), infusion reaction (33%), fatigue (31%), diarrhea (28%), drug eruption (24%), upper respiratory tract infection (22%), musculoskeletal pain (22%), skin infection (19%), pyrexia (17%), edema (16%), nausea (16%), headache (14%), thrombocytopenia (14%), constipation (13%), anemia (12%), mucositis (12%), cough (11%), and hypertension (10%). You are encouraged to report suspected adverse reactions to Kyowa Kirin, Inc. at 1-844-768-3544 or FDA at 1-800-FDA-1088 or . Please see full Prescribing Information as well as Patient Information . Disclosure Notice In line with Good Publication Practices (GPP) the study authors were not compensated for their participation. About Kyowa Kirin Kyowa Kirin aims to discover and deliver novel treatments 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 with high unmet medical needs, focusing on bone/mineral, intractable hematological diseases/hemato oncology, and rare diseases. A shared commitment to our values, to sustainable growth, and to making people smile unites us across the globe. You can learn more about the business of Kyowa Kirin at: kkna.kyowakirin.com SOURCE Kyowa Kirin

Clinical ResultClinical Study

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.

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Paraparesis, Tropical Spastic	Phase 3	JP	Kyowa Kirin Co., Ltd.	22 May 2017
Diffuse large B-cell lymphoma recurrent	Phase 2	US	National Cancer Institute	24 Oct 2018
Diffuse large B-cell lymphoma refractory	Phase 2	US	National Cancer Institute	24 Oct 2018
Recurrent High-Grade B-Cell Lymphoma with MYC and BCL2 or BCL6 Rearrangements	Phase 2	US	National Cancer Institute	24 Oct 2018
Recurrent Transformed B-Cell Non-Hodgkin Lymphoma	Phase 2	US	National Cancer Institute	24 Oct 2018
Refractory High-Grade B-Cell Lymphoma	Phase 2	US	National Cancer Institute	24 Oct 2018
Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma	Phase 2	US	National Cancer Institute	24 Oct 2018
Advanced Malignant Solid Neoplasm	Phase 2	US	Kyowa Hakko Kirin Pharma, Inc.	01 Oct 2014
Metastatic Solid Tumor	Phase 2	US	Kyowa Hakko Kirin Pharma, Inc.	01 Oct 2014
Extranodal NK-T-Cell Lymphoma	Phase 2	JP	Kyowa Kirin Co., Ltd.	01 Sep 2010

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05455931 (PROSPER, PRNewswire) Manual	Not Applicable	Sezary Syndrome \| Mycosis Fungoides	20	mogamulizumab	rspsqktxfq(amfpatfdzm) = 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%. joycfvsqbu (qxrrntajkv )	Positive	15 Apr 2024
ICML2023	Not Applicable	Cutaneous T-Cell Lymphoma CCR4	9	Mogamulizumab	koidvczacj(ygwacflclx) = hbgwjtkgip fixfxcewea (kownpgcssm ) View more	Positive	09 Jun 2023
ICML2023	Not Applicable	Cutaneous T-Cell Lymphoma TCR clonality	65	Mogamulizumab	akatxwgbup(kedijlxqfy) = gpfmjtfrln nbgcrcpvxz (nlylzxbhlu ) View more	Positive	09 Jun 2023
				Combination therapies with Mogamulizumab	nxfxeemyvb(dkxjueugjk) = bacjwncibw smplzjcauv (vnpocwsbeh ) View more
NCT03309878 (CTgov)	Phase 1/2	Refractory High-Grade B-Cell Lymphoma \| Diffuse large B-cell lymphoma refractory \| Refractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma ... View more	8	mogamulizumab+pembrolizumab (Phase I Dose Level 1)	ccopbsbzex(vvmppzmyal) = mbifpujpkn ezaxsitqtg (jozkcppcii, fkpuxduedz - vrrqyulmgr) View more	-	07 Jun 2023
				mogamulizumab+pembrolizumab (Phase I Dose Level -1)	ccopbsbzex(vvmppzmyal) = xrluflpquq ezaxsitqtg (jozkcppcii, gfvopbpkmk - tbgteewbxa) View more
JPRN-jRCTs041180130 (ASCO2023) Manual	Phase 2	Adult T-Cell Leukemia-Lymphoma First line	50	mogamulizumab+CHOP	kuzppizlme(ujqjzrttga) = uygiukejta ymmtwizegg (mnqcujgwta, 24.9 - 47.6) View more	Positive	26 May 2023
NCT01728805 (MAVORIC, Pubmed) Manual	Phase 3	Mycosis Fungoides \| Sezary Syndrome	372	mogamulizumab	rfydrghsla(auyooxkzxb): HR = 0.42 (95% CI, 0.18 - 0.98)	Positive	09 Jun 2022
				vorinostat
NCT02705105 (Pubmed \| Clin Cancer Res) Manual	Phase 1/2	Solid tumor	114	Mogamulizumab-KPKC+Nivolumab	qqvbqitlgp(ijezdywzui) = qcqizwsenp hdjqrxhina (mncxzvbqmj, 2.3 - 3.1) View more	Negative	01 Feb 2022
NCT04185220 (CTgov)	Phase 1	Adult T-Cell Leukemia-Lymphoma \| Mycosis Fungoides \| Sezary Syndrome	6	mogamulizumab (All Participants)	vkabhbpjks(drvxosyqcz) = mybmpbxlmk cgwhipzyai (zocwfpwyrj, dukjwwoivq - wtzcuuuuug)	-	14 Dec 2021
				mogamulizumab (Dose Level 1 (Interleukin-15 2mcg/kg/Day))	jqnhhwvvah(aaxxqfzsza) = gvdgcxkvzc jgxvxqlxhl (xomlqwjzji, jcdikadctm - rtgwofkdgy) View more
NCT01728805 (MAVORIC, EHA2021)	Phase 3	Cutaneous T-Cell Lymphoma	372	Mogamulizumab	bcjomyjrpv(hqjmidfsji) = bdpvqqhrve badlosnanx (denmgwyown ) View more	-	09 Jun 2021
				Vorinostat	bcjomyjrpv(hqjmidfsji) = zcekprdvni badlosnanx (denmgwyown ) View more
NCT01226472 (CTgov)	Phase 2	Cutaneous T-Cell Lymphoma \| Peripheral T-Cell Lymphoma	1	KW-0761	antsmvmhpc(gggsbccqbw) = oggwbcmrbn twxziasnez (zrvgrkrpga, iiahnkrjnh - fxwasasdeb) View more	-	29 Dec 2020

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