Mogamulizumab-KPKC

Clinically meaningful improvements in skin symptoms reported as early as week 4 and sustained over the 48-week study period Data presented at the 6th World Congress of Cutaneous Lymphomas meeting in Montreal, Canada PRINCETON, N.J., June 29, 2026 (GLOBE NEWSWIRE) -- Kyowa Kirin, Inc., a wholly owned subsidiary of Kyowa Kirin Co. Ltd (TSE: 4151), today announced positive results from PROSPER, a real-world observational study of mogamulizumab in adults with mycosis fungoides (MF) or Sézary syndrome (SS). In the study, patients reported clinically meaningful improvements in skin symptoms (itch, flaking, and redness) and body temperature regulation as early as week 4, with improvements in sleep and health-related quality of life (HRQoL) starting at week 12. Improvements were sustained throughout the study period, with additional gains in HRQoL reported through week 48. “Cutaneous T-cell lymphoma can affect far more than just the skin, impacting how patients feel and function every day,” said Professor Julia Scarisbrick, Principal Investigator, Honorary Professor of Dermatology, University Hospitals Birmingham NHS Foundation Trust. “These findings from the PROSPER study are encouraging because they show that in patients with MF or SS, mogamulizumab can help ease symptoms that affect everyday life, and those improvements can be long-lasting.” Mycosis fungoides and Sézary syndrome are two sub-types of cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin lymphoma that primarily affects the skin, presenting as patches, plaques, tumors, or reddening of the entire skin, and may be associated with severe itching. The disease may spread to lymph nodes, blood, and/or other organs in some patients. “Clinical studies are stronger when they are shaped by the voices and lived experiences of people living with the disease,” said Susan Thornton, study author and co-CEO, Cutaneous Lymphoma Foundation. “Collaboration between industry and the patient community is essential to designing studies that generate more relevant insights into symptom burden, quality of life, and the day-to-day treatment experience.” Key PROSPER Findings The study included 73 patients with relapsed or refractory MF or SS (n=41 MF; n=32 SS). Patient-reported outcomes were collected at baseline and throughout the study using: A CTCL-specific symptom diary assessing the severity of skin itch, pain, redness, and flaking, frequency of sleep problems, and difficulty regulating body temperature The MF/SS-CTCL-QoL questionnaire, which measured the impact of CTCL on daily life The Brief Fatigue Inventory (BFI), which assessed fatigue severity and its impact on daily functioning Mean symptom scores (mean +/- standard deviation) improved from baseline to week 48 across key skin symptoms, including itch (−2.5 ±3.4), flaking (−3.1 ±3.5), redness (−3.1 ±3.5), and pain (−1.7 ±4.4). Clinically meaningful improvements in skin itch, flaking, and redness were observed as early as week 4, and improvements in pain by week 12 (i.e., exceeding the minimum important difference (MID)). These effects were sustained through week 48. By week 48, 30% of patients reported at least a 2-point improvement in sleep, and 37% reported better body temperature regulation. Patients also showed significant, clinically meaningful improvements in disease-specific health-related quality-of-life scores (MF/SS-CTCL-QoL) beginning at week 12, with further gains through week 48. While fatigue scores changed little among patients with MF, patients with SS showed a significant improvement in total BFI scores, reaching the MID threshold at week 48. “Studies like PROSPER show why real-world data generation matters, particularly in rare cancers like mycosis fungoides and Sézary syndrome,” said Angela Williams, PhD, Global Head of Health Economics and Outcomes Research at Kyowa Kirin. “These data help broaden understanding of the lived experience of patients and care partners with mogamulizumab treatment in everyday practice, including the impact on symptoms and quality-of-life that may not be fully reflected by outcomes collected in clinical trial.” About PROSPER The objective of the PROSPER (ClinicalTrials.gov ID NCT05455931) study is to gain insight into the experiences of patients with MF or SS receiving mogamulizumab in real-world clinical practice through the collection of patient-reported outcomes (PRO) data, enriched with qualitative data on disease and treatment experience. The study was designed with input from patients and caregivers to ensure patient-relevant outcomes were selected, and it was conducted in six countries across North America, Europe, and the Middle East, at 19 sites working with patients with MF or SS. Patients were followed for up to 50 weeks from study enrollment. U.S. 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 additional Important Safety Information in full Prescribing Information as well as Patient Information . 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, such as 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 . COR-US-POT-0015 June 2026 CONTACT: CONTACT: Susan Thiele Head of Therapeutic Communications, North America susan.thiele.38@kyowakirin.com

皮科求索   J Am Acad Dermatol、Br J Dermatol、 JAMA Dermatol、J Eur Acad Dermatol Venereol 皮肤科权威杂志 最新文章抢先看 ！！省去点官网的烦恼！！   顶刊速览   *仅供医学专业人士阅读 本期介绍 本期推送2026年6月《欧洲皮肤病与性病学杂志》（JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENREOLOGY , JEADV）最新发表的文献。 https://onlinelibrary.wiley.com/journal/14683083 文献速览| 目录 注：标题粗体者可至下文浏览摘要/总结 _ 1.口服 TNFR1 信号抑制剂 Balinatunfib 治疗轻中度银屑病的 I 期研究 DOI:10.1111/jdv.70262 2.免疫检查点抑制剂作为肢端黑色素瘤辅助治疗的获益 DOI:10.1111/jdv.70136 3.探索接受辅助抗 PD-1 免疫治疗的黑色素瘤患者血液细胞生物标志物 DOI:10.1111/jdv.70164 4.单细胞 RNA 测序揭示莫格利珠单抗相关皮肤病中的抗淋巴瘤免疫反应 DOI:10.1111/jdv.70154 5.EADV 血管炎与血管病变工作组：皮肤小血管炎诊断流程推荐立场声明 DOI:10.1111/jdv.70249 6.减重干预对银屑病严重程度的影响：一项系统综述与荟萃分析 DOI:10.1111/jdv.70247 7.构建国际银屑病以患者为中心的结局指标集基础：一项范围综述 DOI:10.1111/jdv.70313 _ 8.比美吉珠单抗在中国银屑病患者中的疗效与安全性：BE SHINING III 期研究 DOI:10.1111/jdv.70350 _ 9.5% 氢氧化钾溶液对比 3% 双氯芬酸治疗光化性角化病：一项三臂随机对照试验 DOI:10.1111/jdv.70069 _ 10.基于线场共聚焦光学相干断层扫描的 AI 辅助基底细胞癌诊断：多中心回顾性研究 DOI:10.1111/jdv.70099 _ 11.维莫德吉治疗局部晚期基底细胞癌的九年真实世界经验 DOI:10.1111/jdv.70194 _ 12.银屑病中肝病的风险与患病率：一项系统综述与荟萃分析 DOI:10.1111/jdv.70202 _ 13.替尔泊肽在接受生物制剂治疗的肥胖银屑病患者中的应用：是否为机遇窗口？ DOI:10.1111/jdv.70208 _ 14.光学相干断层扫描鉴别鳞状细胞癌、鲍恩病与光化性角化病 DOI:10.1111/jdv.70216 _ 15.替班布林 1% 在 679 例光化性角化病患者夏季真实世界使用研究（SUMM-AK 研究） DOI:10.1111/jdv.70217 _ 16.细胞因子相关致病谱指导毛发红糠疹的靶向治疗 DOI:10.1111/jdv.70221 _ 17.2000–2021 年银屑病所致重度抑郁障碍的全球疾病负担 DOI:10.1111/jdv.70228 _ 18.心血管-肾脏-代谢综合征是否为银屑病的重要危险因素？ DOI:10.1111/jdv.70236 _ 19.Stevens–Johnson综合征/中毒性表皮坏死松解症病例报告与小病例系列的范围综述 DOI:10.1111/jdv.70274 _ 20.辅助抗 PD-1 抗体对比观察用于切除甲单位黑色素瘤的疗效 DOI:10.1111/jdv.70295 _ 21.超宽带光声扫描成像评估黑色素瘤无创浸润深度：诊断潜力与关键局限性 DOI:10.1111/jdv.20888 精选文献| 摘要： 1.口服 TNFR1 信号抑制剂 Balinatunfib 治疗轻中度银屑病的 I 期研究 研究目的：评估首个口服小分子TNFR1信号抑制剂Balinatunfib在轻中度斑块型银屑病中的安全性、耐受性及临床疗效，探索选择性TNFR1抑制作为炎症性疾病新型治疗策略的可行性。 研究方法：开展一项为期4周的随机、双盲、安慰剂对照I期试验，纳入38例PASI≤16且靶皮损严重度评分≥4的18-65岁患者，按2:1随机分配至Balinatunfib 200mg每日两次组或安慰剂组，主要终点为不良事件发生率，次要终点包括TLSS和PASI变化及血清IL-22、IL-17F水平。 研究结果与结论：Balinatunfib组未发生严重或重度治疗相关不良事件，最常见不良事件为味觉障碍（61.5%）和恶心（19.2%）。第2周TLSS改善17.06% vs. 6.29%（P=0.032），第4周达38.18% vs. 20.44%（P=0.012）；PASI及血清IL-22、IL-17F水平均显著降低。该研究证实TNFR1选择性口服抑制在银屑病中具有初步疗效和良好安全性，为后续II期临床试验奠定基础。 2.免疫检查点抑制剂作为肢端黑色素瘤辅助治疗的获益 研究目的：明确辅助免疫检查点抑制剂（ICI）对IIb-IV期无疾病证据肢端黑色素瘤（AM）患者的远处无转移生存期（DMFS）及无复发生存期（RFS）的实际获益，评估其风险-效益比。 研究方法：基于法国RIC-Mel多中心数据库，纳入1005例AM患者中64例接受辅助ICI治疗者，采用倾向评分匹配1:1配对64例未接受辅助治疗的对照组，通过Kaplan-Meier法及Cox模型比较两组DMFS、RFS及严重免疫相关不良事件（irAE）发生率。 研究结果与结论： 辅助ICI组与未治疗组DMFS（HR=0.94, 95%CI 0.565-1.562）及RFS（HR=0.84, 95%CI 0.534-1.324）均无显著差异，但18.8%患者出现3-4级irAE（包括肝炎、结肠炎、内分泌疾病等）。鉴于AM低肿瘤突变负荷及低PD-L1表达特征，辅助ICI治疗获益有限且毒性显著，临床决策需个体化权衡，并探索替代治疗策略。 3.探索接受辅助抗 PD-1 免疫治疗的黑色素瘤患者血液细胞生物标志物 研究目的： 探索常规血液细胞参数作为黑色素瘤辅助抗PD-1免疫治疗预后生物标志物的价值，以识别高复发风险患者并优化治疗决策。 研究方法： 回顾性分析巴西Barretos癌症医院及西班牙巴塞罗那医院诊所104例接受辅助抗PD-1治疗的高危III-IV期黑色素瘤患者基线血细胞数据，采用ROC曲线确定最佳截断值，通过Kaplan-Meier法及log-rank检验评估嗜碱性粒细胞、嗜酸性粒细胞计数及其比值与无进展生存期（PFS）和总生存期（OS）的关联。 研究结果与结论： 高嗜碱性粒细胞计数患者5年PFS显著延长（90.0% vs. 45.2%, P=0.021），高嗜酸性粒细胞计数患者OS显著改善（97.9% vs. 72.7%, P=0.015）；嗜碱性粒细胞-淋巴细胞比值及嗜碱性粒细胞-中性粒细胞比值升高均与复发风险降低相关。该研究证实常规血液学参数可作为简便、经济的预后指标，但其临床转化需前瞻性大样本验证。 4.单细胞 RNA 测序揭示莫格利珠单抗相关皮肤病中的抗淋巴瘤免疫反应 研究目的： 阐明莫格利珠单抗相关药物皮疹（MAR）的分子机制，明确其与皮肤T细胞淋巴瘤（CTCL）进展的鉴别要点，并解释MAR作为有利预后因素的原因。 研究方法： 对4例MAR、6例未治疗红皮病型CTCL及4例健康对照皮肤活检进行单细胞RNA测序（scRNA-Seq）联合TCR-αβ测序，通过Seurat、CellChat等工具进行细胞分群、克隆分析及细胞间通讯网络构建。 研究结果与结论： MAR中CCR4+恶性克隆及FOXP3+调节性T细胞显著减少，残余恶性克隆呈静默表型（中央记忆标志物SELL/CCR7下调，肿瘤抑制基因RUNX3及TIMP2上调）；多克隆T细胞耗竭标志物TIGIT/TOX降低，而细胞毒性标志物GZMA及抗肿瘤相关因子ZNF683表达升高。该研究揭示MAR皮肤微环境存在活跃的抗肿瘤免疫应答，为理解靶向治疗诱导的免疫重塑及避免误判停药提供分子依据。 注：如译文有出入，请务必以原文为准。 编者按 本号《皮肤科顶刊速览》栏目，每期将编译JAAD、BJD、JAMA Dermatology、JEADV等皮肤科顶级期刊的最新文献，并精选其中与临床密切相关的文献进行内容简介。旨在使广大皮肤科同道能够便捷、高效了解领域内前沿动态，促进交流、学习、进步。欢迎大家关注、收藏、转发！ 本文版权归作者所有，未经允许，不得转载、摘要、复制、剪辑、录制等。 - 如获得使用许可，必须注明出处，感谢您的支持。 - 欢迎您转发、分享本文，让更多人看到。