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更新于：2025-07-26
Granulocyte colony-stimulating factor(Shire Pharmaceuticals Services Ltd.)
更新于：2025-07-26
概要
基本信息
在研机构- |
权益机构- |
最高研发阶段无进展临床1期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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关联
14
项与 Granulocyte colony-stimulating factor(Shire Pharmaceuticals Services Ltd.) 相关的临床试验KCT0009992
A prospective, multicenter study of an etoposide plus G-CSF followed by peripheral blood CD34+ cell count-adapted plerixafor mobilization in transplant-eligible patients with multiple myeloma who have received daratumumab and/or lenalidomide containing-induction therapy: Catholic Research Network for Multiple Myeloma Study
开始日期2025-01-01 |
申办/合作机构- |
ChiCTR2500100054
A Prospective Study on the Impact of G-CSF Combined with IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation
开始日期2024-10-17 |
申办/合作机构- |
ChiCTR2400086291
A prospective, multi-center clinical study of mitoxantrone hydrochloride liposome injection combined with cladribine, cytarabine and granulocyte colony-stimulating factor in the treatment of relapsed and refractory acute myeloid leukemia
开始日期2024-07-01 |
申办/合作机构- |
100 项与 Granulocyte colony-stimulating factor(Shire Pharmaceuticals Services Ltd.) 相关的临床结果
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100 项与 Granulocyte colony-stimulating factor(Shire Pharmaceuticals Services Ltd.) 相关的转化医学
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100 项与 Granulocyte colony-stimulating factor(Shire Pharmaceuticals Services Ltd.) 相关的专利（医药）
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13,811
项与 Granulocyte colony-stimulating factor(Shire Pharmaceuticals Services Ltd.) 相关的文献（医药）2025-12-31·OncoImmunology
Uncovering common transcriptional features shared by mature peripheral blood PMN-MDSCs and tumor-infiltrating neutrophils in humans
Article
作者: Caveggion, Elena ; Cassatella, Marco A. ; Mariotti, Barbara ; Lattanzi, Chiara ; Bazzoni, Flavia ; Gasperini, Sara ; Pilotto, Sara ; Bianchetto-Aguilera, Francisco ; Brandau, Sven ; Tecchio, Cristina ; Donini, Marta ; Belluomini, Lorenzo ; Scapini, Patrizia ; Castellucci, Monica ; Cantini, Maurizio ; Pettinella, Francesca ; Tamassia, Nicola ; Signoretto, Ilaria
Human polymorphonuclear-myeloid-derived suppressor cells (PMN-MDSCs) consist of circulating low-density neutrophils (LDNs) characterized by the ability to inhibit T-cell responses. In previous studies, we demonstrated that the mature fraction of PMN-MDSCs (i.e. mPMN-MDSCs) exerts more potent immunosuppressive functions than its immature counterpart. More recently, we defined a specific gene signature of mPMN-MDSCs from cancer patients and G-CSF-treated donors (GDs) by bulk RNA sequencing (RNA-seq) experiments. In this study, by performing single-cell RNA-seq (scRNA-seq) experiments of circulating mPMN-MDSCs from non-small cell lung cancer (NSCLC) patients, we identified a major scRNA-seq cell cluster (arbitrarily named NSCLC c6) specifically displaying immunosuppressive and protumor transcriptomic features. Then, by analyzing publicly available scRNA-seq datasets from human tumor-associated neutrophils (TANs), we uncovered three TAN clusters (arbitrarily named TAN c6-c8) that were found to share with NSCLC c6 several common genes and transcription factor (TF) regulons associated with response to hypoxia, positive regulation of angiogenesis, and metabolic reprogramming. Furthermore, by performing scRNA-seq experiments of GD mPMN-MDSCs, we uncovered four scRNA-seq cell clusters (arbitrarily named GD c4-c7) that were enriched for the same genes and pathways characterizing NSCLC c6 and TAN c6-c8 cells. Altogether, these data uncover that human circulating mPMN-MDSCs and TANs from different cancer types share scRNA-seq cell clusters with transcriptomic similarities, supporting the notion that they might be strictly related.
2025-12-31·Hematology
First case report: near early T-cell precursor acute lymphoblastic leukemia with plasmacytoid dendritic cell proliferation effectively treated with Venetoclax plus HAG regimen
Article
作者: Feng, Yi ; Li, Dan ; Wang, Liping ; Chen, Zhe ; Luo, Hongqiang ; Liu, Fang ; Huang, Xin ; Han, Jiongping ; Feng, Weiying
BACKGROUND:
Near early T-cell precursor acute lymphoblastic leukemia represents a distinct subtype of T-cell acute lymphoblastic leukemia characterized by specific immunophenotypic and molecular biological characteristics. Currently, no standardized treatment protocol exists.
METHODS:
This study presents a case of near early T-cell precursor acute lymphoblastic leukemia (ETP-ALL) characterized by plasmacytoid dendritic cell proliferation, which manifested clinically through pancytopenia and generalized multiple rashes.
RESULTS:
The patient underwent successful treatment with chemotherapy consisting of Venetoclax combined with HAG regimen administered for one cycle.
DISCUSSION:
This case report provides preliminary evidence suggesting that the combination of Venetoclax with HAG (homoharringtonine, cytarabine, and granulocyte colony-stimulating factor) regimen may constitute an effective and tolerable therapeutic approach for patients with near ETP-ALL. However, these initial observations necessitate further validation through comprehensive clinical studies with larger sample sizes to definitively establish the treatment's efficacy and safety profile.
2025-12-01·Journal of Gastrointestinal Cancer
FOLFOXIRI for First-Line Treatment of Unresectable Colorectal Cancer with Liver Metastases in a Resource-Limited Setting
Article
作者: My, Doan Tien ; Anh, Le Tuan ; Trung, Lam Viet ; Bac, Nguyen Hoang ; Tri, Phan Minh ; Hao, Vuong Dinh Thy ; Vuong, Nguyen Lam
PURPOSE:
FOLFOXIRI is a standard treatment for unresectable colorectal cancer (CRC) liver metastases. However, limited data exists on its safety and effectiveness in low-to-middle-income countries (LMICs). This prospective study addresses this gap in a Vietnamese LMIC setting.
METHODS:
We enrolled 92 patients with unresectable CRC liver metastases between 2022 and 2023. All patients received FOLFOXIRI every 2 weeks, with routine G-CSF prophylaxis to prevent neutropenia. A multidisciplinary team (MDT) assessed diagnoses and treatment responses. Outcomes were R0/R1 resection rate, progression-free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR), adverse events (AEs), and recurrence-free survival (RFS) for surgical patients.
RESULTS:
The median patient age was 56 years, with a male predominance (70.7%). The primary tumors were located in the left colon (42.4%), rectum (37%), and right colon (20.7%). Thirty-two patients (34.8%) experienced severe (grade 3 or higher) AEs, with thrombocytopenia (13.1%) and anemia (9.8%) being the most frequent. Most patients (72/87, 82.9%) achieved a partial response. The ORR and DCR were 85.1% and 95.4%, respectively. Fifty-seven patients (62%) achieved resectability, and 54 (58.7%) underwent radical surgery. The R0/R1 resection rate was 88.9%. The median PFS and OS for all patients were 13 and 22 months, respectively. The median RFS of surgical patients was 14 months.
CONCLUSIONS:
FOLFOXIRI improves the response rates, R0/R1 resection rates, and survivals for patients with CRC liver metastases. Future research is necessary to improve the prognosis of patients while minimizing toxicities.
TRIAL REGISTRATION:
NCT05362825 dated 5 May 2022.
87
项与 Granulocyte colony-stimulating factor(Shire Pharmaceuticals Services Ltd.) 相关的新闻（医药）2025-06-27
·美通社
上海
2025年6月27日
/美通社/ -- 迈威生物（688062.SH），一家全产业链布局的创新型生物制药公司，
宣布其全资子公司江苏泰康生物医药有限公司（以下简称“泰康生物”）与齐鲁制药有限公司（以下简称“齐鲁制药”）就上市产品注射用阿格司亭α（商品名：迈粒生®，产品代号：8MW0511）签署《新药项目技术许可协议》。
根据许可协议，迈威生物独占许可齐鲁制药在大中华区（包括中国大陆、香港、澳门和台湾）内开发、生产、改进、利用和商业化许可产品的权利。泰康生物可获得合计最高达5亿元人民币的首付款及销售里程碑付款，另外可获得许可产品净销售额最高两位数百分比的特许权使用费。
注射用阿格司亭 α 为一款注射用重组（酵母分泌型）人血清白蛋白-人粒细胞集落刺激因子（I）融合蛋白，适用于成年非髓性恶性肿瘤患者在接受容易引起发热性中性粒细胞减少症的骨髓抑制性抗癌药物治疗时，使用本品降低以发热性中性粒细胞减少症为表现的感染发生率。
该产品为公司具有自主知识产权的新一代长效 G-CSF（高活性改构细胞因子），应用基因融合技术将高活性改构 G-CSF 与人血清白蛋白（HSA）融合，
是国内首个获批上市的采用白蛋白长效融合技术开发的药物
。G-CSF 通过与 HSA 的融合，增加分子量的同时可明显抑制 G-CSF 受体介导的清除途径，能显著延长药物体内半衰期，在临床使用中可以降低给药频率，提高治疗的依从性；同时 HSA 是人体血液中的天然成分，利用其作为载体蛋白具有较高的安全性。该产品采用毕赤酵母表达系统，相较于化学修饰类长效产品，制备过程避免了复杂的化学修饰反应，生产工艺更加简单，产品均一性更好。
关于齐鲁制药
中国领先的垂直整合制药公司之一，开发、制造和分销成品剂型（FDF）和活性药物成分（API）。齐鲁目前在全球拥有 12 家子公司、11 个国内制造基地和 36,000 多名员工。齐鲁在 2024 年位列中国医药行业前 3 名。致力于向世界提供高质量和值得信赖的药品，提高人们的福祉，齐鲁正在大力出口其产品到全球 100 多个国家和地区。迄今为止，齐鲁已经推出了 300 多款产品，其中超过 55 款产品在中国"率先推出"。公司还建立了一个强大的产品线，包括 200 多种仿制药、20 多种生物仿制药和 80 多种创新产品。齐鲁制药有限公司是齐鲁制药集团的全资子公司。
关于迈威生物
迈威生物 (688062.SH) 是一家全产业链布局的创新型生物制药公司，始终秉承"让创新从梦想变成现实"的愿景，践行"探索生命，惠及健康"的使命，通过源头创新，为患者提供疗效更好、可及性更强的生物创新药，满足全球未被满足的临床需求。2017 年成立以来，迈威生物构建了以抗体药物靶点发现与分子发现为起点，覆盖成药性研究、临床前研究、临床研究和生产转化等药品研发全周期的创新体系，实现集研发、生产、营销于一体的全产业链布局。我们专注于肿瘤和年龄相关疾病，涉及肿瘤、自身免疫、骨疾病、眼科、血液、感染等治疗领域，凭借国际领先的特色技术平台和研发创新能力，建立了丰富且具有竞争力的管线。现有 16 个品种处于不同阶段，包括 12 个创新品种和 4 个生物类似药，其中 4 个品种上市，1 个品种已提交上市许可申请前沟通（pre-NDA）会议申请，2 个品种处于 III 期关键注册临床阶段。并独立承担 1 项国家"重大新药创制"重大科技专项、2 项国家重点研发计划和多个省市级科技创新项目。迈威生物以创新为本，注重产业转化，符合中国 NMPA、美国 FDA、欧盟 EMA GMP标准的抗体和重组蛋白药物产业化基地已在江苏泰州投入使用，并已通过欧盟 QP 审计，位于上海金山和江苏泰州的大规模商业化生产基地正在建设中。欲了解更多信息，请访问：
www.mabwell.com
。
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申请上市引进/卖出
2025-06-12
Innovative Agents Highlight Growth of Targeted Protein Degradation Platform and BMS’ Leadership in Innovative Cancer Therapies
PRINCETON, NJ, USA I June 12, 2025 I
Bristol Myers Squibb
(NYSE: BMY) today announced the presentation of new data from its targeted protein degradation platform during the 2025 European Hematology Association (EHA) Annual Congress being held from June 12-15 in Milan, Italy. Presentations feature updated clinical findings on the company’s investigational oral CELMoD™ agents mezigdomide and iberdomide in multiple myeloma, and golcadomide in non-Hodgkin lymphoma, as well as the first results evaluating the company’s first-in-class, oral BCL6 ligand-directed degrader (LDD) (BMS-986458) in non-Hodgkin lymphoma.
The latest data presented for the three lead CELMoD agents and BCL6 LDD underscore the potential impact that these therapies may have in addressing significant unmet medical needs in hematologic malignancies. These agents are part of continuing research across targeted protein degradation at Bristol Myers Squibb, which also encompasses additional CELMoD agents, LDDs and degrader antibody conjugates (DACs) across blood cancers and solid tumors, as well as non-malignant hematologic disorders.
Protein degraders, like CELMoD agents and LDDs, are therapies designed to target and degrade specific proteins that drive diseases, including many proteins that are difficult to target through conventional small-molecule inhibitors. These innovative agents have the possibility to enhance the efficacy of existing therapies and overcome resistance in various malignancies, potentially improving patient outcomes.
“As a leader in the field of targeted protein degradation, we are committed to applying our decades of expertise to the development of these next wave of agents. The efficacy and safety data presented at the EHA Annual Meeting this year is promising and reinforces the potential of CELMoD agents in combination with other standard treatments,” said Anne Kerber, Senior Vice President, Head of Development, Hematology, Oncology and Cell Therapy for Bristol Myers Squibb. “These analyses also add to the body of evidence for these programs as we continue pivotal studies for each of the agents that we anticipate reading out in the next year and onwards.”
Key targeted protein degradation data being presented by Bristol Myers Squibb at the EHA Annual Congress include:
Mezigdomide (MEZI):
Abstract #4160130
: Updated results were presented from the dose-escalation phase of the MM-002 study for the combinations of mezigdomide, dexamethasone, and bortezomib (Cohort A MeziVd; n=28), and mezigdomide, dexamethasone, and carfilzomib (Cohort C MeziKd; n=27) in patients with relapsed/refractory multiple myeloma (RRMM) who had received 2–4 prior therapies:
Results from the dose-expansion cohort (Cohort D) of the study were also presented for the MeziVd combination (n=49) in patients with RRMM who had received 1–3 prior therapies:
The most common grade 3/4 treatment-emergent adverse event (TEAE) across arms was neutropenia and was managed with G-CSF and dose modifications.
Abstract #4160802
: New data was presented evaluating mezigdomide in all-oral triplet combinations with other oral novel agents in RRMM.
Iberdomide (IBER):
Abstract #4160144
: Updated results were presented from MM-001, evaluating the combination of iberdomide, bortezomib, and dexamethasone (IberVd) in patients with transplant-ineligible, newly diagnosed multiple myeloma (NDMM), confirming durable, deep responses in the study.
Golcadomide (GOLCA):
Abstract #4160953
: Updated results were presented from a study evaluating golcadomide with or without rituximab for the treatment of R/R follicular lymphoma (FL). Patients with R/R FL who had received ≥2 prior lines of treatment received golcadomide monotherapy in the dose-escalation part of the study (Part A), followed by golcadomide once daily at 0.2 or 0.4 mg with or without rituximab in the expansion part (Part B). Results continued to show promising efficacy with durable responses in heavily pre-treated patients with R/R FL.
Abstract #4161005
: Updated results were presented from a study evaluating golcadomide with or without rituximab for the treatment of R/R diffuse large b-cell lymphoma (DLBCL). Patients received golcadomide once daily at either 0.2 mg (n=39) or 0.4 mg (n=38). Results continued to show durable responses in heavily pre-treated patients with R/R DLBCL and a consistent safety profile.
Based on the results of early studies, mezigdomide, iberdomide and golcadomide are being evaluated in multiple phase 3 studies:
BMS-986458 BCL6 LDD:
Abstract #4160340:
First clinical findings were presented from the dose-escalation part of the first-in-human, multicenter, open-label study of BMS-986458 in patients with relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL). Initial results evaluating 31 heavily pre-treated patients treated with BMS-986458 were promising and support continued development for the treatment of NHL.
Bristol Myers Squibb: Creating a Better Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle.
Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
About Bristol Myers Squibb
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. For more information about Bristol Myers Squibb, visit us at
BMS.com
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SOURCE:
Bristol Myers Squibb
临床结果临床3期
2025-06-04
·奇点网
*仅供医学专业人士阅读参考在近日的2025年美国临床肿瘤学会（ASCO）年会上，全球性III期关键临床研究IMforte结果重磅发布，并同步以论文形式登上《柳叶刀》，带来了ES-SCLC一线维持治疗的全新选择：对阿替利珠单抗联合化疗一线治疗后未发生疾病进展的患者，阿替利珠单抗+芦比替定双药维持治疗，对比阿替利珠单抗单药维持治疗，取得了双主要终点-独立评审无进展生存期（PFS）和总生存期（OS）双阳性结果。这是在ES-SCLC领域首个维持治疗取得阳性结果的全球III期研究，是ES-SCLC治疗历程上又一项里程碑式的研究！程颖 教授吉林省肿瘤医院 一级教授，博士研究生导师，博士后工作站导师享受国务院特殊津贴，卫生部突出贡献中青年专家吉林省肿瘤医院 恶性肿瘤临床研究一体化诊疗中心主任吉林省癌症中心主任吉林省肺癌诊疗中心主任中国临床肿瘤学会（CSCO) 监事会副监事长北京希思科临床肿瘤学研究基金会副理事长国际肺癌研究协会（IASLC）罕见肿瘤（小细胞肺癌）专委会委员中国抗癌协会小细胞肺癌专委会主任委员CSCO临床研究专家委员会主任委员CSCO小细胞肺癌专家委员会前任主任委员CSCO非小细胞肺癌专家委员会副主任委员中华医学会肿瘤学分会肺癌专委会副主任委员中国医师协会肿瘤多学科诊疗专委会副主任委员2023、2024年度临床医学领域“全球高被引科学家”建立维持治疗新标准，引领ES-SCLC治疗持续向前IMforte研究是一项全球、多中心、随机对照III期关键临床试验，共纳入660例ES-SCLC患者，一线给予阿替利珠单抗+化疗诱导治疗4个周期，此后对疾病无进展的483例患者按1:1比例，随机至阿替利珠单抗+芦比替定维持治疗组或阿替利珠单抗单药维持治疗组，治疗至疾病进展或发生不可耐受的毒性，本研究不允许组间交叉（Crossover）。值得注意的是，IMforte研究采用开放标签设计，且未纳入存在中枢神经系统（CNS）转移的ES-SCLC患者，这两点都与芦比替定有关，一方面是因为它的不良反应，如胃肠道和血液学不良事件及处理策略（如使用止吐药、G-CSF等）较易被医生和患者识别，另一方面则是在IMforte研究启动时，芦比替定对存在CNS转移灶患者的临床获益尚不明确。IMforte研究主要疗效终点为独立评审机构（IRF）评估的患者PFS和OS，次要终点则为研究者评估的PFS，客观缓解率（ORR）、缓解持续时间（DoR）等，各项疗效数据均从维持治疗启动时开始评估。IMforte研究设计在本届ASCO年会上，IMforte研究的主要结果以口头报告形式正式公布：阿替利珠单抗+芦比替定维持治疗组患者的mPFS为5.4个月，显著优于对照组的2.1个月，联合方案维持治疗使患者疾病进展或死亡风险显著下降了46%（HR=0.54, P<0.0001），且各预设亚组获益整体一致；两组mOS则分别为13.2个月和10.6个月，联合方案维持治疗使患者死亡风险相对下降27%（HR=0.73, P=0.0174），关键预设亚组中观察到一致的生存获益。IMforte研究PFS、OS数据安全性数据显示，在阿替利珠单抗+芦比替定维持治疗组患者中位治疗时长达到4.1个月，近乎对照组两倍（2.1个月）的前提下，联合方案维持治疗组发生的大多数不良事件，尤其是血液学不良事件仍程度较轻，多数仅为1-2级，提示研究要求的G-CSF预处理策略，可有效应对芦比替定治疗相关血液学毒性；虽然联合方案组的3-4级治疗相关不良事件（TRAEs）发生率稍高，但整体永久停药率仍较低，反映不良事件大多可管可控。IMforte研究安全性数据IMforte研究PFS和OS双主要终点阳性，实现有统计学意义和临床意义的显著改善，再加上治疗安全性良好，交出的无疑是一份高分答卷，阿替利珠单抗+芦比替定方案也即将由此确立一线维持治疗新标准的地位。专家点评如何提高ES-SCLC患者的生存一直是临床不断攻坚探索的难题，尽管ES-SCLC初始治疗有效率较高，但大部分患者在诱导治疗结束后快速复发，疾病复发后进展迅速，预后极差。如何改善ES-SCLC的生存，有效的维持治疗被认为是巩固一线治疗成果，延长无进展生存时间，进而提高总生存期的重要策略。多年来，ES-SCLC的维持治疗策略不断在进行探索，在经历了非常艰难和曲折的历程后，今年终于迎来了曙光。一、ES-SCLC维持治疗的前世：在困境中的探索在含铂双药化疗作为ES-SCLC标准一线治疗方案时代，针对如何寻找适合的维持治疗策略进行了多样的探索，这时的策略是在诱导化疗结束后，对于疾病未进展的患者探寻有效的维持治疗药物，但是多年来研究进展一直举步维艰。在探索维持治疗的早期阶段，因为SCLC缺乏更多的抗肿瘤药物，对标准EC或EP方案化疗后，维持治疗的探索主要是给予不同化疗药物，几项研究应用口服依托泊苷胶囊维持治疗或者给予拓扑替康等化疗药物维持治疗，但均没有获得生存获益。此后，针对抗血管生成药物在维持治疗阶段的疗效进行了评估，但是无论是大分子的贝伐珠单抗，还是小分子抗血管抑制剂帕唑帕尼等几项II期研究均未达到主要终点。随后，靶向药物、ADC和免疫药物也进行了维持治疗的探索。在PARP抑制剂方面，应用尼拉帕利维持治疗的III期研究结果显示仅有轻微的PFS获益，但OS没有获益；在早期靶向DLL3的ADC药物方面，MERU这项III期研究应用Rova-T进行维持治疗，由于该药物的毒性维持治疗也没有显示出OS获益，并停止在SCLC的研发；进入免疫治疗时代，CheckMate-451研究作为免疫治疗领域第一个，在标准化疗4周期结束后，免疫维持治疗的III期研究，结果显示纳武利尤单抗单药或者纳武利尤单抗联合伊匹木单抗作为维持治疗，两组都没有带来OS获益。因此，无论是化疗、抗血管生成治疗、PARP抑制剂、ADC药物还是免疫治疗，一线采用标准化疗结束后给予维持治疗均纷纷折戟，维持治疗在ES-SCLC一度停滞不前。二、ES-SCLC维持治疗的今生：拨开迷雾见曙光近年来，免疫联合化疗一线治疗ES-SCLC实现了里程碑式的跨越，目前免疫联合化疗诱导治疗4~6个周期后，给予免疫单药维持治疗成为标准治疗策略。在IMpower133研究的探索性分析中发现，自维持治疗开始阿替利珠单抗组的中位OS和PFS分别为12.5个月和2.6个月，均高于安慰剂对照组的8.4个月和1.8个月，死亡风险和疾病进展风险得到进一步下降（HR为0.59和0.63），意味着在一线ES-SCLC免疫联合化疗带来的生存获益基础上，继续免疫维持治疗同样有着重要贡献。因此，ES-SCLC一线化疗联合免疫治疗后，维持治疗是提高患者生存的重要探索方向。如何能够进一步提高维持治疗的疗效，以及针对SCLC冷肿瘤的微环境特点，多种以免疫为基础的联合治疗策略进行了探索。 在免疫联合化疗维持治疗方面，此次ASCO年会上报告的IMforte研究采用阿替利珠单抗联合芦比替定维持治疗。芦比替定已获批ES-SCLC二线治疗适应证，从作用机制上看，芦比替定不仅有抑制癌基因转录、诱导癌细胞凋亡的主要功能，还在临床前研究中展现了通过减少巨噬细胞数量、抑制肿瘤新生血管形成、诱导癌细胞免疫原性死亡等方式，正向调节肿瘤微环境的作用。在临床研究方面，I期数据表明阿替利珠单抗联合芦比替定作为ES-SCLC二线治疗的ORR为58%，患者中位PFS达到4.93个月，提示该联合方案具有较好的抗肿瘤活性。IMforte研究也是首个在ES-SCLC维持治疗阶段，成功取得PFS和OS双阳性结果的III期研究，实现了在IMpower133研究基础上进一步延长患者生存的目标，在ES-SCLC维持治疗领域具有开创性的意义。在免疫联合抗血管维持治疗方面，DURABLE研究是一项度伐利尤单抗联合安罗替尼对比度伐利尤单抗维持治疗的II期研究，研究显示从诱导治疗开始，度伐利尤单抗联合安罗替尼维持治疗和度伐利尤单抗单药维持治疗组的PFS分别为9.0个月和5.6个月，OS分别为20.4个月和15.4个月，这项研究提示免疫联合多靶点抗血管药物维持治疗是具有前景的研究方向。此外，我们牵头进行的ETER701研究，在诱导化疗开始时给予安罗替尼联合贝莫苏拜单抗四药联合治疗，然后给予安罗替尼联合贝莫苏拜单抗维持治疗，PFS和OS分别6.9个月和19.3个月，PFS和OS数据均得到显著延长，OS延长7.4个月显著优于既往免疫联合化疗一线治疗的历史数据，结果进一步支持免疫联合抗血管维持治疗具有很好的疗效和安全性。在免疫联合DLL3/CD3双抗维持治疗方面，DeLLphi-303 研究是一项塔拉妥单抗联合PD-L1抑制剂维持治疗ES-SCLC的1b期研究，塔拉妥单抗联合PD-L1抑制剂维持治疗的 PFS 为 5.6 个月，安全性良好，为正在进行的塔拉妥单抗联合度伐利尤单抗维持治疗的III期研究DeLLphi-305研究提供了支持，该研究也可能成为SCLC免疫维持治疗的下一个突破口。在免疫联合PARP抑制剂维持治疗方面，SWOG S1929研究是一项评估阿替利珠单抗联合他拉唑帕利对比阿替利珠单抗维持治疗的II期研究，纳入一线阿替利珠单抗联合化疗治疗未进展且SLFN11阳性ES-SCLC患者，结果显示SLFN11阳性患者联合维持治疗PFS有一定获益趋势；一项I期研究评估奥拉帕利联合度伐利尤单抗维持治疗的疗效和安全性正在进行中，未来仍有待进一步的结果公布。此外，在免疫联合放疗维持治疗方面，一项II期研究在ES-SCLC患者接受阿得贝利单抗联合化疗4~6个周期诱导治疗后，对产生应答的患者给予阿得贝利单抗联合胸部巩固放疗，后续再给予阿得贝利单抗维持治疗。结果显示，中位PFS为10.1个月，中位OS为21.4个月，接受和未接受胸部放疗患者的中位OS分别为22.9个月和13.4个月，与仅接受免疫单药维持治疗的历史数据相比，免疫联合放疗巩固维持治疗的模式患者生存数据有一定提高，但仍需III期研究的进一步验证。三、ES-SCLC维持治疗的未来：探索分子分型和生物标记物指导的治疗在ES-SCLC维持治疗策略中，以生物标记物或分子分型指导的维持治疗策略将是重要的探索方向。目前，尚没有生物标志物来指导SCLC维持治疗的治疗决策。近年来，一些研究对SCLC免疫治疗的生物标志物进行了探索，研究结果显示RB1突变状态、MYC表达、肿瘤浸润淋巴细胞、表观遗传异常和肿瘤新抗原等生物标记物可能是SCLC免疫治疗潜在生物标志物。在一项临床前的研究中，研究者发现SLFN11高表达的细胞系对芦比替定更敏感，SLFN11低表达鼠模型对芦比替定的敏感性明显较低，SLFN11可能预测对芦比替定的敏感性。这些生物标记物在SCLC的应用还有很长的路要走，仍需要更多前瞻性研究进一步的验证。基于分子分型的研究可能为SCLC免疫治疗带来了新的方向。根据关键转录因子的表达，SCLC可分为不同的转录亚型，如SCLC - A、SCLC - N、SCLC - P和SCLC - Y/I等。不同亚型具有不同的生物学特性和治疗敏感性，SCLC - Y/I亚型免疫细胞浸润和检查点分子表达较高，患者的OS有延长趋势；SCLC-P亚型则与较差的预后相关。在免疫联合治疗策略中，SCLC-Y/I亚型显示出预测疗效的潜力；SCLC-A和SCLC-N亚型中DLL3表达较高，可能与对Tarlatamab的治疗应答有关。但转录亚型在预测 ICI 单药治疗效果时存在局限性，多组学整合研究有助于更全面地了解SCLC的生物学特性，分子分型作为免疫治疗生物标志物的可靠性还需更多前瞻性临床研究验证。四、总结芦比替定联合阿替利珠单抗维持治疗的成功标志着ES-SCLC治疗迈出重要一步，新兴治疗策略的发展为SCLC维持治疗提供了新的机遇，随着更多创新型药物在SCLC领域的不断探索以及研究结果的公布，将为ES-SCLC一线维持治疗提供更多治疗选择，未来维持治疗的格局可能进一步多元化。如何筛选维持治疗的获益人群，优化维持治疗的联合策略仍然充满着挑战，随着对SCLC生物学的深入了解和生物标记物的研发，未来有望为SCLC患者带来新的希望。参考文献：[1]Rudin C M, Liu S V, Soo R A, et al. SKYSCRAPER-02: tiragolumab in combination with atezolizumab plus chemotherapy in untreated extensive-stage small-cell lung cancer[J]. Journal of Clinical Oncology, 2024, 42(3): 324-335.[2]Ohe Y, Han B, Nishio M, et al. BEAT-SC: A randomized phase III study of bevacizumab or placebo in combination with atezolizumab and platinum-based chemotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC)[J]. Journal of Clinical Oncology, 2024, 42(16_suppl): 8001.[3]Reck M, Dziadziuszko R, Sugawara S, et al. Five-year survival in patients with extensive-stage small cell lung cancer treated with atezolizumab in the Phase III IMpower133 study and the Phase III IMbrella A extension study[J]. Lung Cancer, 2024, 196: 107924.[4]Kao S C H, Reck M, Liu S V, et al. 634P Whole exome sequencing (WES) analyses from IMpower133 and 6-year (y) overall survival (OS) from IMbrella A in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC) treated with atezolizumab (atezo)[J]. Annals of Oncology, 2024, 35: S1638.[5]Reck M, Mok T S K, Mansfield A, et al. Brief report: exploratory analysis of maintenance therapy in patients with extensive-stage SCLC treated first line with atezolizumab plus carboplatin and etoposide[J]. Journal of Thoracic Oncology, 2022, 17(9): 1122-1129.[6]Zhang S, Cheng Y. Immunotherapy for extensive-stage small-cell lung cancer: current landscape and future perspectives[J]. Frontiers in Oncology, 2023, 13: 1142081.[7]Aix S P, Navarro A, Bernabe R, et al. 464 2SMALL (NCT04253145) phase I part: lurbinectidine (LUR) in combination with atezolizumab (ATZ) for second line extensive stage small cell lung cancer (ES-SCLC) patients (pts)[J]. Journal for Immunotherapy of Cancer, 2021, 9(Suppl 2): A493.
ASCO会议临床3期临床结果CSCO会议
100 项与 Granulocyte colony-stimulating factor(Shire Pharmaceuticals Services Ltd.) 相关的药物交易
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
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| 中性粒细胞减少 | 临床1期 | - | - |
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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 |
|---|
N/A | 8,999 | G-CSF use | 鑰鏇築選蓋築醖鬱廠選(鹽襯築齋衊選衊網顧艱) = 憲廠衊簾蓋網窪醖淵蓋 襯鏇糧淵願憲夢範網獵 (構築膚夢觸齋選壓襯蓋 ) | 不佳 | 2024-09-15 | ||
No G-CSF use | 鑰鏇築選蓋築醖鬱廠選(鹽襯築齋衊選衊網顧艱) = 襯襯壓鑰糧廠簾膚鏇製 襯鏇糧淵願憲夢範網獵 (構築膚夢觸齋選壓襯蓋 ) | ||||||
N/A | 774 | Prophylactic G-CSF | 餘範窪餘觸壓壓鬱鹽鏇(餘糧獵壓廠願蓋壓廠齋): OR = 0.51 (95% CI, 0.13 ~ 1.97), P-Value = 0.33 更多 | 积极 | 2024-05-24 | ||
Control (no G-CSF) | |||||||
N/A | 局部进展期胃腺癌 G-CSF | 122 | 夢淵積蓋壓構鑰積觸願(鹹膚製積獵築鑰糧範製) = 觸壓憲遞夢衊顧夢艱憲 壓積選壓壓醖願鬱範顧 (願糧蓋壓齋鹽選艱憲鏇 ) 更多 | 不佳 | 2024-01-18 | ||
築鹽築範顧選鏇鑰齋蓋(繭遞衊鏇憲醖壓衊壓夢) = 淵範鹹遞廠鏇網願範醖 積齋憲網餘衊夢鬱壓鬱 (餘構觸廠遞鑰餘遞壓窪 ) 更多 | |||||||
N/A | 68 | 鹹鹹艱鬱獵淵鑰齋齋繭(範餘願壓蓋觸獵觸壓簾) = 齋蓋衊蓋艱艱廠鹹廠簾 範觸窪獵鏇蓋選顧鹹製 (廠窪齋廠顧鏇構襯簾繭 ) 更多 | - | 2023-12-09 | |||
鹹鹹艱鬱獵淵鑰齋齋繭(範餘願壓蓋觸獵觸壓簾) = 衊廠淵鬱製鬱遞範醖選 範觸窪獵鏇蓋選顧鹹製 (廠窪齋廠顧鏇構襯簾繭 ) 更多 | |||||||
N/A | 1,419 | G-CSF alone | 鑰憲鹹壓艱蓋積糧餘網(襯製遞齋鏇糧簾鹹簾鏇): RR = 0.53 (95% CI, 0.38 ~ 0.72) 更多 | - | 2023-11-10 | ||
No intervention or placebo | |||||||
N/A | - | 遞製鑰膚憲淵蓋夢鬱壓(壓簾構襯積範夢鑰鏇淵) = 製憲繭膚鏇鏇鑰鏇鬱餘 積繭鹽繭淵鏇鏇憲衊襯 (壓膚齋獵餘鬱廠觸鑰鬱 ) 更多 | 积极 | 2023-02-01 | |||
遞製鑰膚憲淵蓋夢鬱壓(壓簾構襯積範夢鑰鏇淵) = 觸願夢襯簾膚簾憲淵淵 積繭鹽繭淵鏇鏇憲衊襯 (壓膚齋獵餘鬱廠觸鑰鬱 ) 更多 | |||||||
临床2期 | 151 | Chemotherapy+PEG-rhG-CSF | 鏇構蓋獵願夢蓋醖選夢(繭襯網淵範鑰網顧繭齋) = 簾艱醖構衊遞襯製糧壓 衊觸獵壓艱淵鏇顧鏇淵 (淵糧膚窪衊鹽鹽願廠壓 ) 更多 | 积极 | 2022-04-27 | ||
N/A | 睾丸生殖细胞肿瘤 一线 | 辅助 | 393 | 鹽夢壓廠願構鹽製襯窪(襯觸觸築膚獵網積觸顧) = 鏇簾顧蓋蓋繭鏇遞夢願 鹹襯醖選網範網簾築鑰 (鹽繭醖齋簾築繭壓簾繭 ) | 积极 | 2020-05-25 | ||
(No primary prophylaxis) | 鹽夢壓廠願構鹽製襯窪(襯觸觸築膚獵網積觸顧) = 醖衊顧齋觸築膚遞鹽餘 鹹襯醖選網範網簾築鑰 (鹽繭醖齋簾築繭壓簾繭 ) | ||||||
N/A | 新辅助 | 辅助 | 47 | 艱製壓鹹築襯範鬱網獵(鬱範製鬱鹹構鑰鹹選鏇) = 夢獵簾壓窪範簾廠餘膚 繭夢夢鹹憲醖遞簾願鏇 (網鑰鬱夢窪膚鹹齋願鑰 ) 更多 | - | 2019-09-29 | ||
N/A | 34 | G-CSF primed bone marrow | 齋淵窪選壓衊鑰壓膚築(衊醖鏇觸鹹遞衊蓋餘窪) = 鑰醖觸築簾壓繭窪繭憲 鏇窪蓋簾艱蓋齋願鹹壓 (憲顧鬱繭窪夢鏇憲醖範, 12 ~ 36) 更多 | 积极 | 2019-03-24 |
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