Lacutamab

▎药明康德内容团队编辑 Innate Pharma日前宣布，美国FDA已授予其在研KIR3DL2靶向抗体lacutamab突破性疗法认定（BTD），用于治疗接受过至少两种系统性治疗（包括mogamulizumab）后的复发或难治性成人Sézary综合征患者。 皮肤T细胞淋巴瘤（CTCL）是一种主要起源于皮肤的非霍奇金淋巴瘤，由由癌变的成熟T细胞克隆引起，约占所有非霍奇金淋巴瘤的4%。其中，蕈样肉芽肿（mycosis fungoides）及Sézary综合征是最常见的亚型之一，后者的五年总生存率仅约10%。Sézary综合征患者常因严重且致残的慢性瘙痒而使得生活质量极差。尽管近年来取得了一些进展，但目前的获批疗法仍伴有较高的复发率。 此次突破性疗法认定的授予主要基于1期研究以及2期TELLOMAK研究的积极结果。TELLOMAK研究结果显示lacutamab在经过大量前期治疗、特别是mogamulizumab治疗后的晚期Sézary综合征患者中，展现出积极的疗效和良好的安全性。目前Innate正在与监管机构紧密合作，推进该疗法在CTCL患者中的确认性3期试验。 Lacutamab是一款潜在“first-in-class”的人源化KIR3DL2靶向抗体，能够诱导细胞毒性产生，目前处于治疗CTCL的临床试验阶段。KIR3DL2作为KIR家族的抑制性受体，在正常组织中的表达受到严格限制，但表达于约65%的所有CTCL亚型患者，在某些侵袭性CTCL亚型中（尤其是Sézary综合征患者）表达率可高达90%，而在蕈样肉芽肿和外周T细胞淋巴瘤患者中则约为50%。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放 参考资料： [1] Innate Pharma Announces U.S. FDA Granted Breakthrough Therapy Designation to Lacutamab for Relapsed or Refractory Sézary Syndrome. Retrieved February 21, 2025 from https://www.businesswire.com/news/home/20250216384344/en/Innate-Pharma-Announces-U.S.-FDA-Granted-Breakthrough-Therapy-Designation-to-Lacutamab-for-Relapsed-or-Refractory-S%C3%A9zary-Syndrome 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。 分享，点赞，在看，聚焦全球生物医药健康创新

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.