Efficacy and Safety of Socazolimab Combined With Chemotherapy With or Without Bevacizumab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer: A Randomized, Double-blind, Placebo-controlled Phase III Study

The goal of this clinical trial is to evaluate the efficacy and safety of Socazolimab combined with chemotherapy with or without bevacizumab as first-Line treatment in persistent, recurrent, or metastatic cervical cancer. The main question it aims to answer is:
Does Socazolimab combined with chemotherapy with or without bevacizumab better benefit patients with persistent, recurrent, or metastatic cervical cancer as first-line treatment compared with placebo combined with chemotherapy with or without bevacizumab.
Participants will be treated with Socazolimab/placebo + chemotherapy ± bevacizumab) for 6
8 cycles (Q3w), following maintenance treatment of Socazolimab/placebo (Q3w).

开始日期2024-09-01

申办/合作机构

李氏大药厂控股有限公司

ChiCTR2300078237 / Suspended早期临床1期IIT

A single-arm exploratory clinical study of nab-paclitaxel combined with subcutaneous PD-L1 monoclonal antibody in the treatment of advanced and posterior triple-negative breast cancer

开始日期2023-12-01

申办/合作机构-

CTR20210605 / Terminated临床1/2期

一线治疗失败后局部进展或转移性黑色素瘤中Pexa-Vec（痘苗GM-CSF/TK灭活病毒）联合重组全人抗PD-L1单克隆抗体（ZKAB001）的Ib/II期、开放、对照临床研究

主要目的： Ib期：评价在一线治疗失败的局部进展或转移性黑色素瘤患者中Pexa-Vec联合ZKAB001治疗的安全性和II期推荐剂量（RP2D）； II期：评价在一线治疗失败的局部进展或转移性黑色素瘤患者中ZKAB001联合Pexa-Vec II期推荐剂量或ZKAB001单药治疗的客观缓解率（ORR）和无进展生存期（PFS）。次要目的： 1) ZKAB001联合Pexa-Vec及ZKAB001单药治疗一线治疗失败的局部进展或转移性黑色素瘤患者的总生存期（OS）、疾病控制率（DCR）和缓解持续时间（DOR）； 2) 评价Pexa-Vec联合ZKAB001治疗一线治疗失败的局部进展或转移性黑色素瘤患者的安全性； 3) 评价肿瘤组织PD-L1的表达水平与临床效应关系； 4) 评价Pexa-vec治疗前后肿瘤组织免疫微环境的变化（CD8+表达水平）。

开始日期2021-09-27

申办/合作机构

兆科（广州）肿瘤药物有限公司

100 项与索卡佐利单抗相关的临床结果

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100 项与索卡佐利单抗相关的转化医学

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100 项与索卡佐利单抗相关的专利（医药）

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项与索卡佐利单抗相关的文献（医药）

2024-10-29·PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA

O-GlcNAcylation of enolase 1 serves as a dual regulator of aerobic glycolysis and immune evasion in colorectal cancer

Article

作者: Yi, Wen ; Li, Jingchao ; Chai, Siyuan ; Hsieh-Wilson, Linda C. ; Fan, Zhiya ; Zhu, Qiang ; Lin, Bingyi ; Wang, Yong ; Wu, Liming ; Qin, Weijie ; Hu, Jiating ; Sun, Haofan

Aerobic glycolysis and immune evasion are two key hallmarks of cancer. However, how these two features are mechanistically linked to promote tumor growth is not well understood. Here, we show that the glycolytic enzyme enolase-1 (ENO1) is dynamically modified with an O -linked β- N -acetylglucosamine (O-GlcNAcylation), and simultaneously regulates aerobic glycolysis and immune evasion via differential glycosylation. Glycosylation of threonine 19 (T19) on ENO1 promotes its glycolytic activity via the formation of active dimers. On the other hand, glycosylation of serine 249 (S249) on ENO1 inhibits its interaction with PD-L1, decreases association of PD-L1 with the E3 ligase STUB1, resulting in stabilization of PD-L1. Consequently, blockade of T19 glycosylation on ENO1 inhibits glycolysis, and decreases cell proliferation and tumor growth. Blockade of S249 glycosylation on ENO1 reduces PD-L1 expression and enhances T cell–mediated immunity against tumor cells. Notably, elimination of glycosylation at both sites synergizes with PD-L1 monoclonal antibody therapy to promote antitumor immune response. Clinically, ENO1 glycosylation levels are up-regulated and show a positive correlation with PD-L1 levels in human colorectal cancers. Thus, our findings provide a mechanistic understanding of how O-GlcNAcylation bridges aerobic glycolysis and immune evasion to promote tumor growth, suggesting effective therapeutic opportunities.

2024-06-01·Current cancer drug targets

IR-780 Dye-based Targeting of Cancer-associated Fibroblasts Improves Cancer Immunotherapy by Increasing Intra-tumoral T Lymphocytes Infiltration

Article

作者: Chen, Hongdan ; Yang, Wei ; Zhang, Can ; Tan, Xu ; Chen, Zelin ; Chen, Wanchao ; Qu, Langfan ; Shi, Chunmeng ; Zheng, Jiancheng

Background:::

Immune-checkpoint inhibitors (ICIs) against programmed death (PD)-1/PD-L1 pathway immunotherapy have been demonstrated to be effective in only a subset of patients with cancer, while the rest may exhibit low response or may develop drug resistance after initially responding. Previous studies have indicated that extensive collagen-rich stroma secreted by cancer-associated fibroblasts (CAFs) within the tumor microenvironment is one of the key obstructions of the immunotherapy for some tumors by decreasing the infiltrating cytotoxic T cells. However, there is still a lack of effective therapeutic strategies to control the extracellular matrix by targeting CAFs.

Methods:::

The enhanced uptake of IR-780 by CAFs was assessed by using in vivo or ex vivo nearinfrared fluorescence imaging, confocal NIR fluorescent imaging, and CAFs isolation testing. The fibrotic phenotype down-regulation effects and in vitro CAFs killing effect of IR-780 were tested by qPCR, western blot, and flow cytometry. The in vivo therapeutic enhancement of anti-PD-L1 by IR-780 was evaluated on EMT6 and MC38 subcutaneous xenograft mice models.

Results:::

IR-780 has been demonstrated to be preferentially taken up by CAFs and accumulate in the mitochondria. Further results identified low-dose IR-780 to downregulate the fibrotic phenotype, while high-dose IR-780 could directly kill both CAFs and EMT6 cells in vitro. Moreover, IR-780 significantly inhibited extracellular matrix (ECM) protein deposition in the peri-tumoral stroma on subcutaneous EMT6 and MC38 xenografts, which increased the proportion of tumor-infiltrating lymphocytes (TILs) in the deep tumor and further promoted anti-PD-L1 therapeutic efficacy.

Conclusion:::

This work provides a unique strategy for the inhibition of ECM protein deposition in the tumor microenvironment by targeted regulating of CAFs, which destroys the T cell barrier and further promotes tumor response to PD-L1 monoclonal antibody. IR-780 has been proposed as a potential therapeutic small-molecule adjuvant to promote the effect of immunotherapy.

2024-04-01·The Annals of pharmacotherapy

Atezolizumab as the First Systemic Therapy Approved for Alveolar Soft Part Sarcoma

Review

作者: Mancuso, David ; Orr, Roger ; Vuskovich, Theresa ; Elgawly, Mariam ; Seligson, Nathan D. ; Bergsma, Emilie J.

Objective:

The objective was to review the pharmacology, efficacy, and safety of atezolizumab (Tecentriq) for the treatment of adult and pediatric patients aged 2 years and older with unresectable or metastatic alveolar soft part sarcoma (ASPS).

Data Sources:

A literature search was conducted using PubMed and MEDLINE databases, published abstracts, and ongoing studies from ClinicalTrials.gov between January 1, 1981, and May 31, 2023. Keywords included atezolizumab, Tecentriq, MPDL3280, immunotherapy, PD-L1, PD-1, pediatrics, sarcoma, and ASPS.

Study selection and data extraction:

All English-language studies involving atezolizumab for ASPS were included and discussed.

Data synthesis:

Atezolizumab is an anti-programmed death-ligand 1 (PD-L1) monoclonal antibody designed to block the interaction between PD-L1 and the programmed cell death protein 1 (PD-1) receptor. Atezolizumab was granted approval by the FDA specifically for ASPS based on a phase II clinical trial in adult and pediatric patients (n = 49), which reported an overall response rate of 24% and a durable response rate at 6 and 12 months of 67% and 42%, respectively. Common grade 3/4 adverse reactions include musculoskeletal pain (8%), followed by hypertension (6%), weight gain (6%), headache (4%), and dizziness (4%).

Relevance to patient care and clinical practice in comparison with existing drugs:

Advanced ASPS is a high-risk disease with limited treatment options. Atezolizumab appears to be a viable treatment option in ASPS demonstrating clinical efficacy and a manageable toxicity profile.

Conclusions:

With no other treatments that are FDA approved specifically for ASPS, and few demonstrating efficacy in the advanced setting, the approval of atezolizumab, including the first approval for pediatric patients, represents a landmark improvement to the therapeutic arsenal against this rare disease.

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项与索卡佐利单抗相关的新闻（医药）

2024-11-01

·PRNewswire

The Phase III clinical trial application for first-line treatment of extensive disease small cell lung cancer with Chiauranib has been approved

SHENZHEN, China, Nov. 1, 2024 /PRNewswire/ -- On November 1, Shenzhen Chipscreen Biosciences Co., Ltd. (hereinafter referred to as "Chipscreen Biosciences") and its wholly-owned subsidiary Chengdu Chipscreen Pharmaceutical Ltd., received the "Drug Clinical Trial Approval Notice" approved by the National Medical Products Administration. The company's self-developed original new drug, Chiauranib, combined with PD - (L) 1 monoclonal antibody and standard chemotherapy for the first-line treatment of extensive stage small cell lung cancer, has been approved for phase III clinical trials. Extensive disease small cell lung cancer (ES-SCLC), as a highly aggressive subtype of lung cancer, has long been a huge challenge in the field of treatment. In recent years, chemo-immunotherapy has greatly improved the survival outcomes of patients with small cell lung cancer. However, compared to other types of tumors, there is still great room for improvement in the long-term survival of patients with small cell lung cancer. Chiauranib has a multi pathway pharmacological mechanism and has unique anti-tumor activity against neuroendocrine tumors such as small cell lung cancer. At the same time, it can produce synergistic effects with immunotherapy and chemotherapy through its dual effects of anti-angiogenesis and immune regulatory activity. On the basis of first-line chemo-immunotherapy, the introduction of the new regimen of Chiauranib is expected to further improve the long-term survival of patients with extensive stage small cell lung cancer, demonstrating enormous clinical treatment potential. In addition to the approved Phase III clinical trial, the phase III clinical trial of Chiauranib monotherapy for the later-line treatment of small cell lung cancer has been completed and the Pre NDA is currently under communication. The phase III clinical trial of Chiauranib combined with chemotherapy for ovarian cancer, and the phase II clinical trial of single or combined treatment for triple negative breast cancer, soft tissue sarcoma and pancreatic cancer are also being progressed. In terms of overseas clinical trials, the phase Ib/II clinical trial of Chiauranib monotherapy for small cell lung cancer / solid tumor is in progress in the United States. About Chiauranib Chiauranib is a novel molecular entity independently designed and developed by the Chipscreen Biosciences, with global patent protection. It is a selective inhibitor of Aurora B, a key mitotic regulator. Additionally, Chiauranib targets VEGFR to inhibit tumor angiogenesis, and blocks CSF1R and DDR1 pathways to reduce the infiltration and activity of immunosuppressive cells, thereby enhancing tumor immune microenvironment. Its unique Aurora B inhibitory activity specifically targets neuroendocrine tumors, such as SCLC, making it a novel small molecule anti-tumor drug candidate. Chiauranib exerts a comprehensive anti-tumor effect by a triple-pathway mechanism that simultaneously inhibits tumor angiogenesis, prevents tumor cell mitosis, and modulates the tumor microenvironment. Chiauranib has outperformed drugs with a similar mechanism in overall efficacy and safety profile. About Chipscreen Chipscreen Biosciences is an innovative drug company driven by core technologies with globally competitive pipelines. As a pioneer in drug innovation & development in China, adhering to the concept of "Constant Innovation for Life", we focus on developing revolutionary innovative drugs with new mechanisms of action, to address patients' pressing clinical needs. Our complete industry chain that covers early exploratory discovery through commercialization allows us to provide innovative Chinese drugs for patients worldwide. With a global development strategy based on early-stage research in China, Chipscreen Biosciences has leveraged the top scientists and teams with extensive experience in related fields from the Shenzhen Small Molecule Early R&D Center and Chengdu Small Molecule Early R&D Center to create an integrated technology platform based on AI-driven design and chemical genomics, which spanned the whole process from basic science to clinical translation. We have successfully developed first-in-class and best-in-class innovative drugs. Currently, 2 drugs with 6 indications have been marketed worldwide. In addition, we have launched a number of R&D projects with differentiated advantages and global competitiveness in the five major areas, including malignant tumors, metabolic diseases, autoimmune diseases, central nervous system diseases, and antivirals. Chipscreen Biosciences has formed a global industrial layout consisting of Shenzhen Head Office/R&D Center/GMP production base, Chengdu Regional Head Office/R&D Center/GMP production base, Beijing Branch, Shanghai Branch, and Chipscreen Biosciences (USA) Co., Ltd. Meanwhile, as one of the first batches of national "innovative drug incubation bases" and national high-tech enterprises, Chipscreen Biosciences has independently undertaken many national "863" plans and national major science and technology projects, such as "10th five-year plan", "11th five-year plan", "12th five-year plan" and "13th five-year plan", and National Science and Technology primary Project for Innovative Drug Development. We have filed over 680 invention patents in China and worldwide, with over 200 granted. SOURCE Shenzhen Chipscreen Biosciences Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法临床3期临床2期上市批准

2024-11-01

·PRNewswire

Akeso Announces First Patient Enrollment in Phase 3 Trial of Ivonescimab Combination as First-Line Therapy for Biliary Tract Tumors, Compared to Durvalumab

HONG KONG, Oct. 31, 2024 /PRNewswire/ -- Akeso Biopharma (9926.HK) is pleased to announce the successful enrollment of the first patient in the AK112-309 trial, a randomized, controlled, multicenter Phase III registration study for biliary track tumor. This trial is designed to compare the ivonescimab combined regimen, a PD-1/VEGF bispecific antibody internally developed by Akeso, with the durvalumab (PD-L1) combined regimen for the first-line treatment of advanced biliary tract cancers (BTC). The primary endpoint of the AK112-309 study is overall survival (OS). This study represents the sixth registrational Phase III clinical trial featuring ivonescimab, with a PD-1/L1 monoclonal antibody as the comparator. It underscores Akeso's commitment to advancing the field of cancer immunotherapy and establishing a global standard of care for cancer treatment. Furthermore, it highlights Akeso's capability to maximize the number of cancer patients globally that can benefit from its product portfolio through a strategic approach to clinical development. Previously, the positive results from a Phase II clinical study of ivonescimab in combination with chemotherapy for the first-line treatment of BTC were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The findings demonstrated that the ivonescimab regimen exhibits significant antitumor activity and a good safety profile in BTC. The objective response rate (ORR), as assessed by investigators, was 63.6%, with an ORR of 77.8% specifically for patients with gallbladder cancer. The disease control rate (DCR) reached 100%. The median progression-free survival (PFS) was 8.5 months, with a 6-month PFS rate of 84.4%. Furthermore, the median overall survival (OS) was 16.8 months, with a 9-month OS rate of 81.8%. Notably, patients with gallbladder cancer exhibited a median OS of 16.8 months. At the time of the analysis, the median follow-up time was 13.8 months. The study included patients with a median age of 65.3 years, of whom 81.8% had an ECOG performance status of 1. All enrolled patients are presented with unresectable tumors, and 40.9% were diagnosed with gallbladder cancer. Biliary tract malignancies, originating from the bile ducts and gallbladder, represent a group of highly heterogeneous cancers associated with a poor prognosis. At the time of diagnosis, approximately 50% of biliary tract cancer patients are already in advanced stages, often with a survival period of less than one year. Although PD-1/L1 inhibitors in combination with chemotherapy have been approved as a first-line treatment for advanced biliary tract cancer, the overall survival benefit has been limited, particularly for patients with gallbladder cancer. The initial positive clinical data from the ivonescimab regimen indicates a possible advancement in the therapeutic landscape for these challenging malignancies. About Ivonescimab (AK112/SMT112) Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics's license territories, including the United States, Canada, Europe, Japan, Central America, South America, the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab's first indication has been approved in China, and Akeso is conducting 6 registrational trials versus anti-PD-1/L1 therapeutics. Akeso is also conducting multiple clinical trials of ivonescimab covering 17 indications including gastrointestinal cancer, hepatocellular carcinoma and colorectal cancer. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions.With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床3期临床结果免疫疗法上市批准ASCO会议

2024-10-08

·李氏大药厂

精彩会议回顾 | 中欧病例魔方宫颈癌专题第三期——肿瘤免疫治疗毒性管理策略

9月20日，广东省医学会肿瘤精准诊疗分会妇科学前沿论坛暨中欧病例魔方会议顺利召开，中欧病例魔方会议是由意大利帕多瓦大学联合李氏大药厂控股有限公司（简称“李氏大药厂”或“集团”，股份编号：00950）共同发起的跨国教育项目，本期也是本项目宫颈癌专题第三期会议，主题为—“肿瘤免疫治疗毒性管理策略”。本期会议特邀武汉协和医院李贵玲教授和中山大学肿瘤防治中心李俊东教授担任中方共同主席，意大利巴里大学Ettore Cicinelli教授担任欧方主席。武汉协和医院赵迎超教授、武汉协和医院杨勤教授担任中方讲者，巴里大学综合医院Carlo Ganini博士担任意方讲者。讨论嘉宾分别为巴里大学Marco Tucci教授、武汉大学中南医院邱惠教授、深圳市人民医院周亚燕教授、山西省中医院汪欣文教授、南方医科大学中西医结合医院曾朝阳教授、武汉协和医院姜瑶教授。各位专家共同就肿瘤免疫治疗相关领域热点问题进行深入交流和探讨。会议主席致辞会议伊始，会议共同主席李贵玲教授、李俊东教授对中欧方专家学者出席本次会议表示欢迎，也提出目前在肿瘤免疫治疗如火如荼进展的今天，如何更加合理有效的管控免疫治疗相关毒性，是临床迫切且需要加大关注的一类问题。学术交流 01 武汉协和医院肿瘤中心赵迎超教授：肿瘤免疫治疗毒性管理策略赵迎超教授指出肿瘤免疫治疗不良反应发生机制是因使用免疫检查点抑制剂激活自身免疫系统，过强的免疫系统可能对正常生理组织发生攻击，从而导致免疫介导的相关不良反应出现[1]。同时，不同不良反应的发生时间不同，不同类型的免疫检查点抑制剂导致的不同毒性的发生率、不同类型免疫检查点抑制剂（ICIs）的整体毒性区别[2]（ICIs的毒性排序为CTLA-4抑制剂＞PD-1抑制剂＞PD-L1抑制剂）、免疫治疗毒性管理相关流程等内容进行讲解，也对药物毒性造成的不良影响进行总结：1.影响患者生存质量；2.降低患者获益；3.造成患者重大经济负担。并分享了一例本中心经免疫治疗后出现严重皮肤毒性（G4级）的病例介绍，该患者宫颈鳞癌IV期，接受PD-1抑制剂免疫治疗后患者出现皮疹伴水疱，经处理后病情反复，陆续经糖皮质激素、输注丙球、使用抗生素控制感染、输注新鲜血浆等处理措施后，最终患者皮疹得到良好控制，但因G4毒性的发生后续未再接受ICIs的治疗。 02 武汉协和医院肿瘤中心杨勤教授：索卡佐利单抗病例分享杨勤教授带来2例晚期宫颈癌免疫治疗病例分享，2例病例皆为入组该中心索卡佐利单抗宫颈癌Ib/II期临床研究的典型病例[3]，其中第一例患者为58岁女性，该患者于2016年9月诊断为子宫鳞状细胞癌IIB（FIGO 2009分期）。2018年10月患者入组索卡佐利单抗（ZKAB-001）临床试验，10月10日首次给药治疗，因患者获益，在试验结束后仍在持续赠药维持治疗中，期间持续复查患者病灶情况，患者病灶明显消退，最近2023年11月影像学评效为CR，肿瘤完全消退。且患者仍在持续维持用药中，期间未发生明显毒性反应，最近一次用药为2024年9月12日，目前持续赠药时间为5年11个月。同时，该患者PD-L1检测显示为阴性（CPS＜1），仍从索卡佐利单抗治疗中明显获益。杨勤教授分享的另一例病例为56岁女性患者， 2015年8月诊断为宫颈鳞癌IIIB期（FIGO 2009分期），初始治疗行3周期TP方案化疗联合近距离放疗，末次治疗时间为2015年12月。后在2016-2020年期间四次复发，期间予多周期TP、DP、依托泊苷胶囊单药等方案化疗，病程仍持续进展。2020年8月患者选择入组索卡佐利单抗临床试验，于2020年8月7日首次给药开始治疗，治疗期间规律复查病灶持续缩小，影像疗效评估显示膀胱、子宫、直肠轮廓间隙逐渐正常。最近一次影像学检查为2024年6月进行，已不见明显病灶，现仍在维持用药中，期间未发生明显毒性反应，最近一次用药为2024年9月12日，持续赠药维持治疗时间达4年1个月。该例患者PD-L1表达为阳性。杨勤教授表示索卡佐利单抗治疗复发转移宫颈癌疗效令人惊喜，对PD-L1阳性及阴性的患者均有良好疗效，且在长期维持治疗中，未发生明显的毒性反应，索卡佐利单抗的良好的药物安全性令人印象深刻。 03 巴里大学综合医院 Carlo Ganini博士：宫颈癌免疫治疗相关肾毒性—病例分享 Carlo Ganini博士分享的是一例36岁女性患者，2022年1月发现宫颈部肿物，病理显示为宫颈腺癌，p16（+），ER（-），PgR（-），Ki-67 :90%。于2022年3月接受C1型根治性子宫切除术+双侧输卵管切除+盆腔淋巴结清扫术，术后病理：HPV相关型腺癌，FIGO分期：IB2期。术后予局部容积旋转调强技术（VMAT）进行放疗：50Gy/25。2023年7月复查发现肺部、肝部、腹膜区见复发肿物，进行6周期TP+帕博利珠单抗化免联合治疗，复查影像学整体病灶均有所减小，评效SD，后续继续予帕博利珠单抗单药维持治疗。2024年3月患者出现异常蛋白尿（G3级）：3.5g/24h，未暂停免疫治疗，继续观察，因后续蛋白尿有进一步恶化趋势：4.6g/24h，停用帕博利珠单抗。2024年4月进行肾组织穿刺活检后证实为免疫治疗引起的免疫介导的肾毒性，于2024年5月开始予糖皮质激素泼尼松治疗，在蛋白尿降低至G2级：1.5g/24h，重启了帕博利珠单抗治疗，2024年6月蛋白尿再次恶化至G3级，3.5g/24h，继续予低剂量泼尼松治疗，同时免疫治疗继续。后续复查患者蛋白尿持续缓解，2024年8月因患者出现糖皮质激素相关高血糖，暂停使用泼尼松。2024年9月再次出现蛋白尿水平上升至G2级，因此再次重启使用泼尼松，同时加以胰岛素控制高血糖状态，免疫治疗继续使用。2024年9月16日最后一次复查提示病情稳定，肝部病灶已消失，腹膜癌性结节进一步减少。Carlo Ganini博士表示通过对患者出现的免疫介导不良反应进行积极处理，同时持续予低剂量糖皮质激素控制相关不良反应的情况下，患者对于免疫治疗基本可耐受，同时仍可从中获益。讨论环节李俊东教授主持了讨论环节，各位教授以自身临床经验与体会围绕“肿瘤免疫治疗毒性管控”展开了热烈讨论。免疫介导不良反应的发生越来越受到临床关注，各位教授均认为对于相关毒性的预防管控、判断、治疗需临床医生进一步提高认知，强调多学科介入，以综合处理手段，因人施策，达到对患者的最大获益，因此在临床中更加精准选择安全有效的药物十分重要。其中周亚燕教授对于免疫治疗相关毒性对临床的影响进行了全面细致的总结，周亚燕教授认为肿瘤免疫治疗相关毒性的发生既增加的患者畏惧用药的情绪，降低患者医从性，使生存获益受损，同时也对个体经济也带来重大负担，而中重度不良反应的发生也易对医者自身信心造成伤害，因此在临床中应格外重视药物相关不良反应管控。同时，与会专家对索卡佐利单抗在晚期复发或转移性宫颈癌治疗中展现的疗效表示认可，尤其索卡佐利单抗对于PD-L1阴性患者依然有较高的响应率，有望惠及更多患者，为更广泛的患者带来新的希望。会议主席总结致词最后，李贵玲教授与李俊东教授为本次会议进行总结发言。两位中方主席对本次会议中欧双方专家的热烈讨论表达赞扬，也强调免疫治疗新时代下，对于药物安全性应该重点关注，对于安全有效药物的选择十分重要，并且应对疗法有全面认知，有利于更好地做到药物不良反应的管控。同时，应强化多学科讨论（MDT）的重要性，多学科早期及时全程参与，有利于患者得到最大程度生存获益。参考文献： [1] Postow MA et al, N Engl J Med. 2018 Jan 11;378(2);158-168 [2] 中国临床肿瘤学会（CSCO）《宫颈癌诊疗指南（2023）》 [3] An J, Tang J, Li BX, et al. Efficacy and Safety of the Anti-PD-L1 mAb Socazolimab for Recurrent or Metastatic Cervical Cancer: a Phase I Dose-Escalation and Expansion Study.Clin Cancer Res. 2022;28(23):5098-5106. 下滑查看更多会议视频回顾扫描二维码查看本文仅供专业人士一起探讨最有价值医学知识及相关科普，非广告用途撰稿：霍聪慧排版：黄文浩校稿：王烨馨审核：张超免责声明：本公众号发布或转载企业宣传资讯，仅供读者参考之用，并不构成收购、购买或认购依据，并不构成任何个人化的投资劝诱或建议。因本公布全部或任何部分内容而产生或因倚赖该等内容而引致的任何损失不承担任何责任。与“李”同行招商热线 020-39062882

免疫疗法临床3期

100 项与索卡佐利单抗相关的药物交易

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研发状态

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适应症	国家/地区	公司	日期
转移性宫颈癌	中国	兆科（广州）肿瘤药物有限公司	2023-12-19
复发性宫颈癌	中国	兆科（广州）肿瘤药物有限公司	2023-12-19

未上市

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适应症	最高研发状态	国家/地区	公司	日期
广泛期小细胞肺癌	申请上市	中国	兆科（广州）肿瘤药物有限公司	2024-07-13
子宫颈转移癌	临床3期	-	李氏大药厂控股有限公司	2024-09-01
骨肉瘤	临床3期	-	李氏大药厂控股有限公司	2020-06-01
转移性黑色素瘤	临床2期	中国	兆科（广州）肿瘤药物有限公司	2021-09-27
食管鳞状细胞癌	临床2期	中国	兆科（广州）肿瘤药物有限公司	2020-11-19
转移性尿路上皮癌	临床2期	中国	李氏大药厂控股有限公司	2018-10-10
尿路上皮癌	临床2期	中国	李氏大药厂控股有限公司	2018-10-10
胆道癌	临床1期	中国	兆科（广州）肿瘤药物有限公司	2021-03-24
晚期尿路上皮癌	临床1期	中国	兆科（广州）肿瘤药物有限公司	2020-09-14
肿瘤	临床前	美国	Sorrento Therapeutics, Inc.	-

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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


SITC2023	N/A	黑色素瘤	-	Snail mucus	糧獵鹽膚艱簾壓築膚網(醖襯願鏇築襯鬱鹹廠製) = PD-L1 expression was upregulated in the snail mucus-treated A375 cells 淵築餘鹽築鹽鹽繭觸鬱 (齋齋簾醖繭艱鬱鏇鏇夢 ) 更多	积极	2023-11-02
NCT04346914 (Pubmed)	临床1期	广泛期小细胞肺癌一线	20	Socazolimab	衊鬱簾廠艱憲憲淵蓋餘(獵鹽糧積顧選鏇繭築網) = 鹹廠憲鹽願鏇壓獵網廠淵艱糧顧壓獵簾鹹網艱 (鹹積廠鹽繭築醖蓋築繭, 45.72% ~ 88.11) 更多	-	2023-04-01
NCT03676959 (Pubmed)	临床1期	子宫颈转移癌	-	Socazolimab 5mg/kg	膚窪繭餘選齋艱選鑰構(衊餘淵構壓齋築憲觸膚) = 衊願蓋壓夢鹹淵築願鹹壓窪觸衊蓋醖簾遞鑰齋 (醖顧醖觸積簾窪積網餘, 8.7 ~ 24.5) 更多	积极	2022-09-22
NCT04460066 (ESMO2022) 人工标引	临床2期	局部晚期食管鳞状细胞癌新辅助	64	Socazolimab+nab-paclitaxel+cisplatin	顧醖醖簾願襯醖鏇壓鏇(壓顧夢餘壓醖鹹蓋蓋願) = 鏇餘鏇鹽廠鑰鹹築範鹹繭製願積簾網鹽膚顧鹽 (衊選糧觸窪淵膚簾蓋艱 ) 更多	积极	2022-09-10
NCT04460066 (ESMO2022) 人工标引	临床2期	局部晚期食管鳞状细胞癌新辅助	64	placebo+nab-paclitaxel+cisplatin	顧醖醖簾願襯醖鏇壓鏇(壓顧夢餘壓醖鹹蓋蓋願) = 選網製糧範簾醖鑰餘築繭製願積簾網鹽膚顧鹽 (衊選糧觸窪淵膚簾蓋艱 ) 更多	积极	2022-09-10
ESMO2022	N/A	小细胞肺癌	-	Atezolizumab plus carboplatin and etoposide (ACE)	齋淵齋簾製衊獵蓋構鏇(淵淵餘繭夢衊蓋築築願) = 顧憲衊製襯襯夢願淵齋襯廠構蓋淵夢觸齋醖蓋 (構衊廠窪齋網鹹鬱醖鹹 )	-	2022-09-10
NCT03676959 (ASCO2022) 人工标引	临床1期	子宫颈转移癌	104	socazolimab ( dose-expansion phase)	醖艱積簾淵蓋顧鏇鹽鏇(構糧願獵鬱壓積鹽齋構) = 繭齋構窪構艱鹽餘遞獵構夢艱鑰選膚醖鑰齋壓 (餘蓋蓋糧製齋鏇顧鬱膚 ) 更多	积极	2022-06-02
NCT03676959 (ASCO2022) 人工标引	临床1期	子宫颈转移癌	104	socazolimab (CPS < 1)	醖艱積簾淵蓋顧鏇鹽鏇(構糧願獵鬱壓積鹽齋構) = 獵簾獵糧網醖淵鹹淵鏇構夢艱鑰選膚醖鑰齋壓 (餘蓋蓋糧製齋鏇顧鬱膚 ) 更多	积极	2022-06-02
NCT04603846 (ASCO2022) 人工标引	临床1期	晚期尿路上皮癌一线	20	nab-paclitaxel+socazolimab	艱廠鏇觸餘壓窪遞壓夢(觸壓鹹獵鏇築鬱簾築構) = 廠鑰餘醖壓遞簾製鏇觸範網壓構鏇蓋蓋範鏇糧 (顧範選憲範簾鑰簾艱繭 ) 更多	积极	2022-06-02
NCT04346914 (ESMO_ELCC2022) 人工标引	临床1期	广泛期小细胞肺癌一线	20	Socazolimab+carboplatin+etoposide	獵獵築製積願醖觸築衊(餘鏇蓋鹹憲壓築積構選) = 鑰願簾餘鬱衊糧選鹹繭範網構夢鏇鬱願膚鑰願 (積艱鏇醖願遞選鬱築鏇 ) 更多	积极	2022-04-03
NCT03676959 (phase I plus expansion study, IGCS2021)	临床1期	子宫颈转移癌 PD-L1-positive	-	Socazolimab 5mg/kg	範鹹網構範遞鬱鹽淵糧(夢襯遞築顧簾夢網艱醖) = 鑰繭積憲蓋網壓艱繭廠繭鹽觸製夢顧範窪鹽夢 (築餘繭範網蓋範淵憲鏇, 10.9 ~ 27.4) 更多	积极	2021-11-01
ZKAB001 (CSCO2021)	临床1期	广泛期小细胞肺癌	20	ZKAB001+卡铂+依托泊苷	選鏇顧鏇糧製糧餘積膚(觸獵糧願壓衊構觸廠築) = 最常见治疗相关不良事件包括血小板计数降低(30.0%)、贫血(25%)、中性粒细胞计数降低(20%)、高血糖症(20%)和白细胞计数降低(20%) 鏇獵壓襯簾鏇願鏇範繭 (簾淵壓夢壓簾繭廠餘顧 )	-	2021-09-25