A Phase 2, Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of SOT101 in Combination With Cetuximab in Patients With RAS Wild-type Colorectal Cancer

The primary objective of the study is to estimate the antitumor efficacy of nanrilkefusp alfa (SOT101) in combination with cetuximab in RAS wild-type colorectal cancer.

开始日期2022-12-22

申办/合作机构

SOTIO Biotech as

NCT05256381

/ Terminated临床2期

A Phase 2, Open-label, Single-arm, Multicenter Study of SOT101 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety in Patients With Selected Advanced/Refractory Solid Tumors

The primary objective of the study is to estimate the antitumor efficacy of nanrilkefusp alfa in combination with pembrolizumab in selected tumors.

开始日期2022-06-21

申办/合作机构

SOTIO Biotech as

[+1]

NCT04234113

/ Terminated临床1期

A Multicenter Open-label Phase 1/1b Study to Evaluate the Safety and Preliminary Efficacy of SO-C101 as Monotherapy and in Combination With Pembrolizumab in Patients With Selected Advanced/Metastatic Solid Tumors

A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of nanrilkefusp alfa as monotherapy and in combination with pembrolizumab in patients with selected advanced/metastatic solid tumors

开始日期2019-06-13

申办/合作机构

SOTIO Biotech as

[+1]

100 项与 Nanrilkefusp alfa 相关的临床结果

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100 项与 Nanrilkefusp alfa 相关的转化医学

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100 项与 Nanrilkefusp alfa 相关的专利（医药）

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项与 Nanrilkefusp alfa 相关的文献（医药）

2025-07-01·Indian Journal of Hematology and Blood Transfusion

Real-World Efficacy and Safety of the Combination of Rituximab, Lenalidomide, and Ibrutinib in Patients with Relapsed and/or Refractory Non-Hodgkin Lymphoma

Article

作者: Şahin, Uğur ; Özcan, Muhit ; Gökmen, Ayla ; Koyun, Derya

Relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) is associated with poor outcomes, and the therapeutic options are limited. In some clinical studies, rituximab, lenalidomide, and ibrutinib (RLI) have shown promising efficacy. Consequently, we evaluated RLI in a real-life setting. This retrospective, single-center study analyzed the outcomes of RLI as an off-label salvage therapy in patients with R/R NHL from June 2020 to 2024. We analyzed twenty-four patients, including diffuse large B-cell lymphoma (DLBCL) (n = 18), primary central nervous system lymphoma (PCNSL) (n = 2), mantle cell lymphoma (MCL) (n = 2), and marginal zone lymphoma (MZL) (n = 2). The most common adverse events (AEs) were fatigue (42%), neutropenia (42%), and infection (33%). The median time to response (TTR) was two months (1.7-3.8). The overall response rate (ORR) was 46% (95% CI 24%-67%), with 33% complete response (CR) and 13% partial response (PR). The median duration of response (DoR) was 31 months (range, 0.6-46+). The median overall survival (OS) was eight months (95% CI 2.2-13.7 months), and the median progression-free survival (PFS) was 6.3 months (95% CI 0.0-25.1 months). Our results suggest that RLI is a viable therapeutic option with promising activity and a favorable toxicity profile in patients with R/R NHL.

2025-02-01·Cell Reports Medicine

Nanrilkefusp alfa (SOT101), an IL-15 receptor βγ superagonist, as a single agent or with anti-PD-1 in patients with advanced cancers

Article

作者: Radek Spisek ; Joachim Kiemle-Kallee ; Peter Grell ; David Bechard ; Patricia LoRusso ; Carlos Gomez-Roca ; Aurelien Marabelle ; Vladimir Galvao ; Philippe A. Cassier ; Milan Reinis ; Richard Sachse ; Kaissa Ouali ; Aung Naing ; Iphigenie Korakis ; Andreu Schoenenberger ; Ulrich Moebius ; Sascha Tillmanns ; Romana Mikyskova ; Nada Podzimkova ; Irena Adkins ; Elena Garralda ; Stephane Champiat ; Lenka Palova Jelinkova

Nanrilkefusp alfa (nanril; SOT101) is an interleukin (IL)-15 receptor βγ superagonist that stimulates natural killer (NK) and CD8⁺ T cells, thereby promoting an innate and adaptive anti-tumor inflammatory microenvironment in mouse tumor models either in monotherapy or combined with an anti-programmed cell death protein 1 (PD-1) antibody. In cynomolgus monkeys, a clinical schedule was identified, which translated into the design of a phase 1/1b clinical trial, AURELIO-03 (NCT04234113). In 51 patients with advanced/metastatic solid tumors, nanril increased the proportions of CD8⁺ T cells and NK cells in peripheral blood and tumors. It had a favorable safety profile when administered subcutaneously on days 1, 2, 8, and 9 of each 21-day cycle as monotherapy (0.25-15 μg/kg) or combined (1.5-12 μg/kg) with the anti-PD-1 pembrolizumab (200 mg). The most frequent treatment-emergent adverse events were pyrexia, injection site reactions, and chills. Furthermore, early clinical efficacy was observed, including in immune checkpoint blockade-resistant/refractory patients.

2023-02-01·Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Smart Start: Rituximab, Lenalidomide, and Ibrutinib in Patients With Newly Diagnosed Large B-Cell Lymphoma

Article

作者: Steiner, Raphael ; Flowers, Christopher R. ; Lu, Yang ; Fowler, Nathan ; Westin, Jason ; Nastoupil, Loretta ; Griffith, Donna ; Lee, Hun Ju ; Ma, Man Chun John ; Samaniego, Felipe ; Oki, Yasuhiro ; Tewari, Sanjit ; Pinnix, Chelsea ; Wang, Michael ; Vega, Francisco ; Davis, R. Eric ; Fayad, Luis ; Green, Michael R. ; Fanale, Michelle ; Sun, Ryan ; Hagemeister, Fredrick ; Ahmed, Sairah ; McDonnell, Timothy ; Scott, David W. ; Neelapu, Sattva ; Rodriguez, Alma ; Nair, Ranjit ; Iyer, Swaminathan P. ; Feng, Lei

PURPOSE:

Chemoimmunotherapy for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) is largely unchanged for decades. Both preclinical models and clinical data suggest the combination of lenalidomide and ibrutinib may have synergy in DLBCL, particularly in the non–germinal center B-cell-like subset.

METHODS:

We enrolled 60 patients with newly diagnosed non–germinal center B-cell-like DLBCL in this investigator-initiated, single-arm phase II trial of rituximab, lenalidomide, and ibrutinib (RLI) with the sequential addition of chemotherapy (ClinicalTrials.gov identifier: NCT02636322 ). Patients were treated with rituximab 375 mg/m2 intravenous once on day 1, lenalidomide 25 mg once per day on days 1-10, and ibrutinib 560 mg once daily continuously of each 21-day cycle (RLI). After two cycles, standard chemotherapy was added to RLI for six additional cycles. The primary end points were overall response rate (ORR) after two cycles of RLI alone and complete response rate after completion of RLI with chemotherapy. In evaluable samples, circulating tumor DNA and DLBCL90 assays were performed.

RESULTS:

The median age was 63.5 years (range, 29-83 years) with 28% age 70 years or older. The revised international prognostic index identified 42% as high risk, and 62% were double expressor of MYC and BCL2 protein. The ORR after two cycles of RLI was 86.2%, and the complete response rate at the end of RLI-chemotherapy was 94.5%. With a median follow-up of 31 months, the progression-free survival and overall survival were at 91.3% and 96.6% at 2 years, respectively.

CONCLUSION:

Smart Start is the first study, to our knowledge, to treat newly diagnosed DLBCL with a targeted therapy combination before chemotherapy. RLI produced a high ORR, and RLI with chemotherapy resulted in durable responses. This establishes the potential for developing biologically driven and noncytotoxic first-line therapies for DLBCL.

项与 Nanrilkefusp alfa 相关的新闻（医药）

2025-06-21

·GlobeNewswire-Health Care

ICPO Foundation co-founded the RLT Angels Association with the aim of growing access to Radiotheranostics to one million patients

Further founding members include the European Association of Nuclear Medicine (EANM), GE HealthCare, Novartis, and RayzeBio, a Bristol Myers Squibb company. Wiesbaden, June 21, 2025 – The International Centers for Precision Oncology (ICPO) Foundation announced yesterday its role as a founding member of the RLT Angels Association together with leading organizations in the field of radiotheranostics namely the European Association of Nuclear Medicine (EANM), GE HealthCare, Novartis, and RayzeBio, a Bristol Myers Squibb company. The initiative, launched on June 20, 2025, carries the mission to improve the experience and availability of radioligand imaging (RLI) and radioligand therapies (RLT) for up to one million patients globally and expand capacity to one thousand RLT Centers. Drawing on world-leading expertise, RLT Angels aims to develop open-source best practice resources such as global blueprints and tools for process optimization to support healthcare providers. Building upon its global network of Centers of Excellence and online educational platform, the ICPO Foundation sets a standard for the RLT Angels Association with respect to the accreditation harmonization of theranostics centers and to the access and scaling of certified theranostics education. The initiative will be guided by an experienced board, including Prof. Richard P. Baum for ICPO, and supported by an independent, international Scientific Advisory Board comprised of leading clinical, economic, scientific and policy experts. The ICPO Foundation co-founding the RLT Angels Association highlights the willingness from both organizations to mutually reinforce their respective mission and sustainably grow global patient access. Thanks to strong alignment on clinical best practices, educational needs and patient outcomes, ICPO Centers of Excellence (CoE) will benefit from new resources such as medical evidence and patient advocacy, and enhance their visibility towards additional referrals and industry collaborations. The RLT Angels Association will leverage the established and active ICPO CoEs network as well as ICPO’s growing educational program and global community reach out including with patient associations. Radiotheranostics utilizes diagnostic RLI and targeted RLT to identify and fight cancer, offering precise treatment that preserves healthy tissues. RLT has demonstrated benefits in clinical trials, and commercially approved therapies are available for certain neuroendocrine tumors (NETs) and prostate cancer.1,2 With approximately 225 ongoing clinical trials, use of RLI and RLT has the potential to expand to more than 15 cancer indications, significantly increasing the number of patients who could benefit from this innovative precision-based approach.3,4 Effective delivery of radiotheranostics requires seamless coordination across supply chains, radio-safety, operational, and clinical domains. As the demand for imaging and RLT treatments continues to grow, health systems must enhance their infrastructure, processes, capacity, and skills to meet this increasing need. To address these challenges and fully realize the potential of this promising treatment modality, stakeholders across the healthcare ecosystem have united in a collaborative effort to form the RLT Angels Association. “As a founding member of RLT Angels, the ICPO Foundation believes in the power of partnership and mission alignment to drive meaningful change in healthcare. By leveraging our collective expertise – including ICPO’s education and accreditation resources, as well as our global community outreach – we can enhance accessibility and ensure that innovative therapies reach those who need them most,” said Prof. Richard P. Baum, Trustee of the ICPO Foundation and President of the ICPO Academy for Theranostics. A “Center Recognition Program” will enable RLT Centers to measure their efficiency and quality of care. Additionally, RLT Angels will provide virtual support and online expert forums to help centers efficiently leverage these resources. The program will support centers to reach accreditation levels as defined by national and international medical societies, as well as by international non-profit organizations pursuing accreditation efforts. RLT Angels will enable standardized data collection to support evidence generation and advocacy initiatives to engage policy stakeholders and the broader public. “The formation of RLT Angels Association marks a significant milestone in the evolution of Radioligand Therapy. Our commitment to collaboration will help bridge gaps in care and foster a community dedicated to improving patient outcomes through innovative practices.” said Prof. Paola Anna Erba, president of EANM. Ben Hickey, president of RayzeBio, commented: “RLT Angels represents an important multidisciplinary effort bringing together diverse expertise to address the challenges in delivering Radioligand or Radiopharmaceutical Therapy, and ensuring the full potential of this promising modality can be realized. We believe our collective efforts will pave the way for a more seamless treatment experience, increased operational efficiency and most importantly, improved clinical outcomes for patients.” "We are proud to co-found RLT Angels. This ambitious organization will make a significant and positive impact on healthcare systems and patients, ensuring that the promise of RLT is not hindered by operational barriers. We at Novartis are dedicated to this field as an essential new pillar of Oncology and have long term plans and a deep commitment to every aspect in this area which can lead to better care" commented Dr Zsuzsanna Devecseri, Global Head, Medical Affairs Oncology, at Novartis. Dr Ben Newton, Global Head of Oncology, GE HealthCare commented: “Theranostics is a highly innovative treatment modality that requires the seamless integration of advanced imaging, radiopharmaceuticals, digital and clinical workflows, along with operational excellence. Successful integration into everyday practice depends on close collaboration across leading healthcare providers, scientists, industry, and patient advocacy groups. We are proud to be a founding member of RLT Angels and to contribute to this collective effort to advance global access to RLT and improve outcomes for patients across the globe.” To learn more about the RLT Angels Association and explore opportunities for involvement, please visit the website at www.rlt-angels.com or our LinkedIn page. RLT Angels is seeking like-minded partners dedicated to enhancing patient care and improving access to radiotheranostics. About RLT Angels RLT Angels is a non-profit organization dedicated to maximizing patient access to radiotheranostics, systematically expanding health system capacity to deliver radioligand imaging (RLI) and radioligand therapies (RLT), and improving the experience and outcomes for patients receiving this treatment globally. Our objective is to deliver on the promise of the treatment modality and maximize patient access. About ICPO Foundation The International Centers for Precision Oncology Foundation (ICPO) is a nonprofit organization established in 2019 under German law by leading international medical practitioners and life sciences entrepreneurs. Recognizing a paradigm shift in cancer care from one size fits all to a personalized approach, the ICPO Foundation´s aim is to gain momentum for Radiotheranostics in cancer care worldwide and scale global patient access to this innovative therapy. About EANM The European Association of Nuclear Medicine is the largest non-profit medical organization dedicated to nuclear medicine in Europe. Since its establishment in 1985, the EANM has consistently aimed to provide an interactive platform for the sharing and discussion of cutting-edge developments in the field. The EANM collaborates with nuclear medicine professionals, national societies, EU institutions, international bodies, industry, and medical societies to leverage nuclear medicine's benefits for patient care. About GE HealthCare Technologies Inc. GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected and compassionate care, while simplifying the patient’s journey across care pathways About RayzeBio and Bristol Myers Squibb RayzeBio, Inc., a wholly-owned subsidiary of Bristol Myers Squibb Company, is a biotechnology company focused on improving outcomes for people with cancer by harnessing the power of targeted radioisotopes. Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Sources 1. Hendifar AE, Mehr SH, McHaffie DR. Best Practices for the Coordinated Care of Patients With Neuroendocrine Tumors Undergoing Peptide Receptor Radionuclide Therapy. Pancreas. 2022;51(3):213-218. 2. Ramnaraign B, Sartor O. PSMA-Targeted Radiopharmaceuticals in Prostate Cancer: Current Data and New Trials. Oncologist. 2023;28(5):392- 401. 3. Clinicaltrial.gov 4. Uijen MJM, Derks YHW, Merkx RIJ, et al. PSMA radioligand therapy for solid tumors other than prostate cancer: background, opportunities, challenges, and first clinical reports. Eur J Nucl Med Mol Imaging. 2021;48(13):4350-4368 Press photo: RLT Angels logo Media contact ICPO Foundation Susanne Simon, Head of Communication & Community Email: susanne.simon@icpo.foundation Website: www.icpo.foundation Media contact RLT Angels AssociationsWebsite: www.rlt-angels.com Attachments 2025_06_21 PR ICPO Co-founded RLT Angels final RLT_Angels Photo

2024-04-25

·药时代

全球首个IL-15药物获批！ImmunityBio的Anktiva获FDA批准用于治疗卡介苗不响应的非肌肉浸润性膀胱癌

2024年4月22日，ImmunityBio公司宣布，FDA已批准Anktiva（N-803）联合卡介苗（BCG），用于治疗卡介苗不响应的非肌层浸润性膀胱癌 (NMIBC) 伴原位癌 (CIS)，伴或不伴乳头状瘤患者。该药物预计将于 2024 年 5 月中旬在美国上市。关于N-803N-803（nogapendekin alfa inbakicept-pmln）是一种白细胞介素-15（IL-15）超激动剂复合物，由IL-15 突变体(IL-15N72D)与IL-15Rαsushi 结构域以及IgG1 Fc 融合蛋白结合而成， IL-15Rα sushi 结构域使得其无需通过像天然IL-15 所必需的反式呈递方式才能激活下游信号通路，且IgG1-Fc 片段极大延长了药物半衰期。此前，FDA 曾授予了N-803 快速通道资格和突破性疗法认定，2023 年10 月接受了N-803联合BCG的生物制剂许可申请(BLA)的重新提交。在一项单臂、多中心2期试验中，纳入了77例经尿道切除后伴有或不伴有Ta/T1乳头状病变的BCG无反应的高危NMIBC患者；患者接受N-803诱导，通过膀胱内滴注卡介苗，随后进行维持治疗长达37个月。在长达2年的时间里，每3个月通过膀胱镜检查和尿细胞学检查评估肿瘤状态，并在治疗开始后的前6个月内进行活检(随机或膀胱镜指导)。主要疗效指标为任何时间的CR和完全缓解(DOR)持续时间，CR的定义是膀胱镜检查阴性(如适用，有TURBT/活检)和尿细胞学检查阴性，结果显示：CR率为62% (95% CI: 51,73)；58%的CR患者DOR≥12个月，40%的患者DOR≥24个月。最常见的不良反应(≥15%)包括实验室检查异常，包括肌酐升高、排尿困难、血尿、尿频、尿急、尿路感染、钾升高、肌肉骨骼疼痛、寒战和发热。除了NMIBC外，N-803在胰腺癌上也展现出了一定的治疗潜力；在2022 ASCO GI上，Immunity Bio披露了N-803联合标准护理化疗、盐酸白蛋白多柔比星和PD-L1 t-haNK三线治疗胰腺癌的II期数据，结果显示：该方案的mOS达6.3m，相较于历史数据实现翻倍；安全性方面，3级及以上不良事件主要包括贫血、中性粒细胞减少和血小板减少等。此外，在《科学》杂志上发表的临床前数据表明，N-803和广泛中和抗体联合治疗，可能使免疫系统能够在不需要抗逆转录病毒治疗的情况下控制人类免疫缺陷病毒(HIV)。关于IL-15药物IL-15作为一种T 细胞生长因子，主要由单核细胞和巨噬细胞产生，与反应细胞上的IL-15 受体（IL-15R）结合，具有介导T 细胞、NK细胞和B 细胞增殖与活化，诱导细胞毒性淋巴细胞（CTL）产生等作用。IL-15 主要有两种不同的信号呈递机制，即顺式呈递和反式呈递，在顺式呈递中，IL-15 先与跨膜形式或可溶性形式存在的IL-15Rα 结合，再与IL-15Rβγ 结合。在反式呈递中，IL-15Rα 在IL-15 产生细胞（树突状细胞和巨噬细胞等）的表面表达，将IL-15 反式呈递至携带IL-15Rβ/γc 受体的应答细胞（NK 或记忆CD8+T 细胞等），这可能在协调免疫系统的先天性和适应性分支中起关键作用。IL-15 与IL-5R 的特异性结合可以激活JAK-STAT5 信号转导分子，进而导致PI3K/Akt 和Ras/Raf/MAPK等多条信号通路的级联激活，最终发挥其生物学效应。此外，IL-15Rα也可以从膜上脱落，与IL-15 结合后以游离的形式存在，与IL-15Rβ/γc受体远距离激活。由于IL-15 能够促进免疫细胞的活化和增殖，因此在免疫治疗中发挥着非常重要的作用。IL-15 不会引起活化的T 细胞凋亡，且能维持记忆性T 细胞的存活，进而实现长期治疗的目的。然而，IL-15 在免疫治疗中的应用也面临着一些挑战，例如，IL-15 过度分泌可能导致免疫系统的过度激活，进而诱发机体炎症反应、自身免疫性疾病、感染性疾病和肿瘤等。由于IL-15 信号通路需要通过IL-15Rα 的sushi 结构域实现，因此受到体内IL-15Rα 表达量限制。此外，IL-15 较短的半衰期（在人体中小于1 小时）和严格的转录后调控极大地限制了IL-15的临床应用，最常见的应对策略是通过增加分子大小来减少肾脏消除、或者融合新生儿Fc 受体（FcRn）；除此之外，考虑到IL-15 维持记忆CD8+ T 细胞稳态和增殖的独特能力，将其应用于CAR-T工程中也有望实现更强的抗肿瘤效力。据不完全统计，目前全球在研的IL-15药物仅200种，已进入临床阶段的药物约90种。除N-803外，SOTIO开发的皮下给药制剂SOT101、恒瑞医药的SHR-1501、奥赛康的ASKG315、博际生物的BJ-001等同样值得关注。关于非肌层浸润性膀胱癌膀胱尿路上皮癌（UC）是全球发病率排名第十三的常见癌症，分为NMIBC（占70%）和肌层浸润性膀胱癌（MIBC，占30%）两大类。该疾病的高发年龄为50-70岁，男性尿路上皮癌的发病率为女性的3-4倍。2020年，全球尿路上皮癌病例51.6万人，预计到2025年将达到58.6万人，到2030年预计达到66.3万人。在中国，尿路上皮癌2020年新发病例约7.7万人，预计到2025年将达到9.1万人，到2030年将达到10.6万人。NMIBC是指局限于膀胱黏膜层（Ta）及固有层（T1），肌层未见浸润的膀胱恶性肿瘤，包括Ta、T1、Tis期，其中Ta占70%，T1占20%，Tis占10%。根据复发风险及预后的不同，NMIBC分为低危NMBIC、中危NMIBC、高危NMIBC和极高危NMIBC。根据危险度分组选择手术方式、膀胱灌注及随访方案，NMIBC的常规治疗是经尿道膀胱肿瘤切除术（TURBT），由于NMIBC患者术后复发率高，推荐所有NMIBC患者进行术后辅助性膀胱灌注治疗。常用的灌注化疗药物包括丝裂霉素、吉西他滨、表柔比星等，没有证据显示采用不同化疗药物的维持灌注方案疗效有显著差别。尽管指南推荐化疗灌注和BCG膀胱灌注，仍有约50%的患者在5年内发生肿瘤复发。肿瘤复发后患者的标准疗法是根治性膀胱切除术，根治性膀胱切除术使患者失去正常的储尿和排尿功能，严重影响患者的生活质量和心理健康。因此，对于化疗和BCG无应答NMIBC患者而言，新药的研发十分关键。近年来获批的代表性药物包括：2020年1月，FDA批准帕博利珠单抗（“K药”）作为一种单药疗法，用于治疗不符合或已选择不进行膀胱切除术（切除膀胱）的卡介苗（BCG）无应答、高风险、伴CIS、伴或不伴乳头状肿瘤的NMIBC患者。2022年12月，FDA批准Ferring的基因疗法nadofaragene firadenovec-vncg（商品名为Adstiladrin）上市，用于治疗BCG无响应的高风险NMIBC患者，这些患者伴有CIS，可能携带或不携带乳头状肿瘤。关于ImmunityBioImmunityBio是一家处于临床阶段的免疫疗法公司，总部位于美国加利福利亚州，致力于研发新一代疗法，以驱动免疫原性机制，用于治疗癌症和传染病。2024年1月，Oberland Capital向ImmunityBio提供高达3.2亿美元的特许权使用费融资和股权投资，其中2.1亿美元的总收益于2023年12月29日到期。这笔额外的资金为该公司提供了重要的财务资源，以加快其商业化进程，期待获得监管部门的批准，并在更广泛的泌尿系统癌症领域拓展其产品线。此次募集资金还将用于资助正在进行的业务运营和临床试验，将N-803的适应症扩展到多种实体瘤。参考资料1、公司官网2、聂亚丹,贺毅,孙作厘,等.IL-15的免疫调节功能及其相关疾病研究进展[J/OL].生理科学进展,1-12[2024-04-23].https://doi.org/10.20059/j.cnki.pps.2024.01.1169.3、长江证券、西南证券4、泌趣横生、36氪封面图来源：pixabay版权声明/免责声明本文为授权转载文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn卷起来了！为什么是Claudin18.2「星起点」助你起飞：50万资金扶持+行业专家辅导！拜耳Co.Lab上海正式启动招募入驻企业点击阅读原文，了解更多！

临床2期突破性疗法临床结果ASCO会议临床1期

2024-04-24

·药明康德

潜在重磅！62%癌症完全缓解率，FDA批准突破性疗法

刚刚，美国FDA批准ImmunityBio旗下Altor BioScience所开发的白细胞介素-15（IL-15）超级激动剂Anktiva（nogapendekin alfa inbakicept）与卡介苗（BCG）联合使用，用于治疗对BCG无应答且伴有原位癌（CIS）的非肌层浸润性膀胱癌（NMIBC）成年患者，这些患者伴或不伴有乳头状肿瘤。值得一提的是，行业媒体Evaluate在今年初将这款疗法列为今年有望获批的10款潜在重磅疗法之一。膀胱癌是一种常见的癌症。在全球范围内，每年大概有43万人被诊断出患有该疾病。非肌层浸润性膀胱癌患者的癌细胞位于膀胱内或已长入膀胱内腔，但尚未扩散至肌肉或其他组织中。患有这种癌症的患者占所有膀胱癌患者比例的75%至85%。BCG是治疗这类患者的标准疗法，虽然有效，但是接受BCG治疗的患者的复发率和进展率很高。这种情况下，推荐的治疗方案为彻底切除膀胱（膀胱切除术），以防止癌症的扩散。这次批准主要基于QUILT-3.032的试验结果。这是一项单组、多中心的2/3期临床试验，试验对象为77名经尿道切除术后患有CIS（伴或不伴Ta/T1乳头状病变）的BCG无应答、高风险NMIBC患者。患者通过膀胱内灌注接受Anktiva诱导治疗和BCG治疗。患者每3个月进行一次膀胱镜检查和尿液细胞学检查以评估其肿瘤状态，随访时间最长可达2年，此外患者在开始治疗后的前6个月内需要进行活检检查。试验的主要终点为任意时间达成的完全缓解（CR），以及完全缓解的持续时间（DOR）。CR定义为膀胱镜检查和尿液细胞学检查阴性（在特定情形下进行活检检查）。分析显示，患者的CR率为62%（95% CI：51，73）。此外，58%达成CR患者的DOR≥12个月，40%达成CR患者的DOR≥24个月。最常见的不良反应（≥15％）包括实验室检查异常，包括肌酐升高、排尿困难、血尿、尿频、尿急、尿路感染、钾升高、肌肉骨骼疼痛、发冷和发热。 Anktiva是一款IL-15超级激动剂。IL-15通过影响自然杀伤（NK）细胞和免疫T细胞的发育、维持和功能，在免疫系统中发挥着至关重要的作用。Anktiva由与IL-15受体α/IgG1 Fc融合蛋白结合的IL-15突变体（IL-15N72D）组成。它与βγT细胞受体结合，直接特异性刺激CD8阳性T细胞和NK细胞，同时避免刺激调节性T细胞（Treg）。与天然、非复合IL-15相比，Anktiva在患者体内具有更优的药代动力学特性，且能在淋巴组织中存在更长时间，表现出增强的抗肿瘤活性。Anktiva在2019年获FDA授予突破性疗法认定，用于与BCG联合治疗此前对BCG应答不佳的非肌层浸润性原位膀胱癌患者。根据ImmunityBio官网，除了用以治疗膀胱癌，该公司也在多项2期试验中检视Anktiva作为单药或联合疗法，用于治疗肺癌、结直肠癌、卵巢癌、急性髓系白血病（AML）、胶质母细胞瘤、HIV患者。 IL-15是近年来在癌症领域中备受瞩目的靶点。除了Anktiva，此外，Obsidian Therapeutics公司也正在开发其表达与细胞膜结合IL-15的工程化肿瘤浸润淋巴细胞（TIL）疗法OBX-115。这个月所公布的1期临床试验结果显示，OBX-115用以治疗晚期或转移性黑色素瘤患者的总缓解率达50%，其中CR率为33%，中位无进展生存期尚未达到，6个月无进展生存率为67%。2021年12月，SOTIO Biotech宣布与默沙东（MSD）达成合作，评估旗下IL-15超级激动剂SOT101与重磅PD-1抑制剂Keytruda联用治疗晚期/难治性实体瘤患者的疗效与安全性。除了癌症领域，IL-15也是免疫疾病领域的新兴靶点。诺华（Novartis）在今年1月宣布收购Calypso Biotech，囊获该公司用以治疗多种免疫疾病的潜在“best-in-class”抗IL-15抗体疗法CALY-002。CALY-002目前正在1b期临床试验中评估其对乳糜泻和嗜酸性食管炎患者的治疗效果。参考资料： [1] FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. Retrieved April 22, 2024 from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle-invasive-bladder-cancer [2] Anktiva Prescribing Information. Retrieved April 22, 2024 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761336s000lbl.pdf The content above comes from the network. if any infringement, please contact us to modify.

突破性疗法临床结果

100 项与 Nanrilkefusp alfa 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
RAS 野生型结直肠癌	临床2期	比利时	SOTIO Biotech as	2022-12-22
RAS 野生型结直肠癌	临床2期	法国	SOTIO Biotech as	2022-12-22
RAS 野生型结直肠癌	临床2期	西班牙	SOTIO Biotech as	2022-12-22
晚期肝细胞癌	临床2期	美国	SOTIO Biotech as	2022-06-21
晚期肝细胞癌	临床2期	比利时	SOTIO Biotech as	2022-06-21
晚期肝细胞癌	临床2期	捷克	SOTIO Biotech as	2022-06-21
晚期肝细胞癌	临床2期	法国	SOTIO Biotech as	2022-06-21
晚期肝细胞癌	临床2期	匈牙利	SOTIO Biotech as	2022-06-21
晚期肝细胞癌	临床2期	意大利	SOTIO Biotech as	2022-06-21
晚期肝细胞癌	临床2期	波兰	SOTIO Biotech as	2022-06-21

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05619172 (CTgov)	临床2期	RAS 野生型结直肠癌	16	Nanrilkefusp Alfa+Cetuximab (Nanrilkefusp Alfa and Cetuximab)	網衊製顧獵觸獵鹽糧繭 = 顧膚壓淵膚選艱淵衊餘膚衊顧糧膚鹹範壓觸築 (壓製醖鑰膚齋襯衊鑰餘, 鏇範鑰網範襯鹹構網鑰 ~ 簾鏇範餘選憲窪膚蓋鹹) 更多	-	2025-07-24
				Nanrilkefusp Alfa+Cetuximab (Nanrilkefusp Alfa and Cetuximab 9 ?g/kg (Safety Cohort 1))	鹽壓願觸鹹廠顧餘廠糧(糧衊鹽鑰願膚製獵觸製) = 遞膚窪壓積廠醖鏇衊繭觸糧醖築範餘選醖餘鬱 (鏇選淵鏇膚鹽鬱網網觸, 觸願壓窪鏇襯蓋遞遞鑰 ~ 繭壓獵簾獵築網遞鹽鹽) 更多
NCT04234113 (AURELIO-03, ASCO2022)	临床1期	HR阳性/HER2低表达实体瘤	51	SOT101 monotherapy	網構艱製鹹齋淵窪衊製(鑰膚膚壓遞顧範構選窪) = The most common treatment-emergent adverse events (TEAEs) were transient, and included pyrexia, chills, lymphopenia, anemia, transaminase elevation and vomiting. Most TEAEs were ≤ Grade 2. No treatment-related death was reported. 廠鹽鏇獵憲膚壓鹹醖繭 (糧鑰衊廠鹽顧糧夢鬱簾 )	积极	2022-06-02
				SOT101pembrolizumab combination therapyn therapy
NCT04234113 (502, SITC2021)	临床2期	实体瘤	-	SO-C101 15 Âµg/kg	積蓋鏇範窪網網廠鹽網(遞製顧遞鏇範窪築遞蓋) = The most common adverse events (AEs) were G1 or G2 lymphopenia, local injection site reactions, transaminase increase, flu-like syndrome, and CRS-related symptoms such as fever and chills 網觸遞簾壓鹹遞糧壓襯 (醖製獵淵繭壓獵艱構襯 ) 更多	积极	2021-11-10
NCT04234113 (SITC2021)	临床1期	实体瘤	12	SO-C101 + Pembrolizumab	網窪願繭鹽餘鹽鏇餘鏇(觸網廠蓋憲衊齋獵鬱網) = CRS-related symptoms mainly G1 or G2 and resolved 蓋醖憲壓淵簾齋遞遞簾 (膚襯構壓餘夢鑰觸餘遞 ) 更多	积极	2021-11-10