This clinical trial tests how well entrectinib works to treat patients less than 3 years of age with NTRK 1/2/3 or ROS1 fused, high grade glioma or other central nervous system (CNS) tumors.

开始日期2025-08-01

申办/合作机构

St. Jude Children's Research Hospital, Inc.

[+1]

NCT07021989

/ Not yet recruiting临床2期IIT

Pembrolizumab and GVD With ctDNA-guided Consolidation in Patients With Relapsed or Refractory Classic Hodgkin Lymphoma: A Multicenter Phase 2 Study of the University of California Hematologic Malignancies Consortium

This is a single arm, open-label, multicenter, phase II study of pembrolizumab (pembro), gemcitabine, vinorelbine, and liposomal doxorubicin (GVD) in patients with relapsed or refractory classic Hodgkin lymphoma (cHL) with response-adapted consolidation. This study will investigate using circulating tumor DNA (ctDNA) at pre-determined time points using Foresight CLARITY LDT, an ultra-sensitive liquid biopsy platform that detects Minimal residual disease (MRD) in patients with B-cell lymphomas using the phased variant enrichment and sequencing technology (PhasEDq) to determine response to study interventions.

开始日期2025-07-31

申办/合作机构

The University of California, San Francisco

[+2]

NCT06616987

/ Not yet recruiting临床2期IIT

A Multicenter, Open-label, Single-arm, Phase II Clinical Trial to Evaluate the Preventive Effect of Pegylated G-CSF (PG) on Neutropenia in Patients With Metastatic Triple-negative Breast Cancer (mTNBC) Receiving Sacituzumab Govitecan (SG)

Prevention of Sacituzumab Govitecan-related Neutropenia in Patients with metastatic Triple Nagative Breast Cancer who have received at least one, and no more than two, prior standard of care chemotherapy regimens

开始日期2025-06-30

申办/合作机构

Samsung Medical Center

100 项与培非格司亭（安进）相关的临床结果

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100 项与培非格司亭（安进）相关的转化医学

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100 项与培非格司亭（安进）相关的专利（医药）

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147

项与培非格司亭（安进）相关的文献（医药）

2025-08-01·AMERICAN JOURNAL OF CLINICAL ONCOLOGY-CANCER CLINICAL TRIALS

Efficacy and Safety of Pegylated Filgrastim as Primary Prophylaxis Following Pediatric Dose-intensive Chemotherapy

Article

作者: Gupta, Aditya K. ; Meena, Jagdish P. ; Chopra, Anita ; Haldorai, Meena ; Pandey, Ravindra M. ; Seth, Rachna

Objectives::

Large trials and meta-analyses in adults suggest a similar efficacy and safety of a single dose of peg-filgrastim compared with daily filgrastim in the prevention of chemotherapy-induced neutropenia. However, there is no large prospective data in the pediatric population. This trial was designed to demonstrate the efficacy and safety of peg-filgrastim in children.

Methods::

This was an open-labelled randomized trial. Children with solid tumors receiving chemotherapy in which growth factor support was indicated were screened before chemotherapy and randomized to either the filgrastim arm (5 mcg/kg daily) or peg-filgrastim arm (100 mcg/kg single dose 24 h postchemotherapy). Patients were followed up till absolute neutrophil count (ANC) recovery clinically as well as by thrice weekly complete blood counts. The primary outcome was the incidence of FN, and secondary outcomes included the reduction in the depth of ANC nadir, shortening of the duration of grade-4 neutropenia, reduction in ANC recovery time, and adverse events.

Results::

A total of 344 chemotherapy cycles were screened. After the exclusion of 29 cycles, 315 chemotherapy cycles in 61 patients were randomized to peg-filgrastim (n=160) and filgrastim arm (n=155). The median age of included patients was 3 years (2; 6.5), and males were predominant. The incidence of FN in peg-filgrastim and filgrastim arms was 8% and 18% (P=0.01) (RR: 0.45; 95% CI: 0.24-0.84). Duration of ANC recovery, depth of ANC nadir, and adverse events reported were not significantly different in both arms.

Conclusions::

The incidence of FN in the peg-filgrastim arm was significantly lesser. No significant adverse events attributable to the study drug were reported.

2025-05-20·Cureus Journal of Medical Science

A Rare Presentation of Priapism From Pegylated Filgrastim During Treatment of Urothelial Cancer in an African-American Patient With Sickle Cell Trait

Article

作者: Drakaki, Alexandra ; Damron, Leland ; Hernandez, Sandy C ; Hart, Steven D ; Kathuria-Prakash, Nikhita

Priapism is a complication of sickle cell disease resulting in organ-threatening vaso-occlusive crisis and has been reported rarely in patients with sickle cell trait. We report a case of a patient with urothelial carcinoma undergoing chemotherapy and growth factor support with pegylated filgrastim with stuttering priapism triggered by pegylated filgrastim. This is the first case reported, to our knowledge, of stuttering priapism triggered by pegylated filgrastim, and we hope to raise awareness of this potentially organ-threatening complication in this vulnerable population.

2025-04-04·RADIATION RESEARCH

A Combined Therapy of Pegylated G-CSF with Ciprofloxacin Mitigates Damage Induced by Lethal Ionizing Radiation to the Bone Marrow, Spleen, and Ileum by Increasing AKT Activation but Decreasing IL-18, C3, and miR-34a

Article

作者: Zhai, Min ; Kiang, Juliann G ; Cannon, Georgetta ; Xu, Feng ; Olson, Matthew G ; Woods, Akeylah K ; Cleveland, Katherine S ; Ellery, Hengying ; Xiao, Mang

Ciprofloxacin (CIP) was found to enhance pegylated G-CSF therapy (PEG, Neulasta®)-induced survival from 30% to 85% after ionizing radiation exposure. This combined therapy significantly mitigated radiation-induced brain hemorrhage through its capability to improve platelet recovery. This study tested whether this combined treatment also mitigated gastrointestinal damage from radiation. B6D2F1 female mice were exposed to 60Co γ radiation. CIP was fed daily to mice for up to 14 days. PEG was injected on day 1, and then weekly up to day 14. For the early time point study, blood, femurs, spleen, and ileum were collected on days 2, 4, 9, and 15 postirradiation. Bone marrow cells were counted; spleen weights and splenocyte counts were measured; and ileum histopathology was examined and analyzed. AKT, ERK, JNK, p38, claudin 2, NF-kB, Bax, Bcl-2, and gasdermin D were measured in ileum lysates using Western blotting while miR-34a was measured by reverse transcription followed by real-time-PCR, and citrulline was measured by colorimetric assay. In serum, interleukin-18 (IL-18) was measured by Luminex assay and complement protein 3 (C3) was detected by ELISA. The bacterial DNA load in livers was measured by real-time PCR. Radiation depleted bone marrow cells in femurs beginning day 2 through day 15 postirradiation, which was mitigated by PEG or CIP+PEG on day 9 through day 15 and by CIP on day 15, respectively. Radiation exposure led to decreased spleen weight on day 2 through day 15, while PEG or CIP+PEG significantly mitigated the reduction on day 9 through day 15. Radiation exposure reduced splenocyte counts on day 2 through day 15 postirradiation, but that was mitigated by PEG or CIP+PEG on day 15. Ileum histology showed that radiation decreased villus height on day 2 through day 15; CIP mitigated the reduction on day 15, whereas PEG+CIP mitigated it on day 2 through 15. Villus widths were increased on day 2 through day 15, while PEG+CIP effectively decreased them on day 4 through day 15. Crypt depth was reduced by radiation on day 2, but returned to the baseline on day 4 through 15. CIP or CIP+PEG transiently increased the depth only on day 4. Crypt counts were reduced by radiation on days 2 and 4, but returned to the baseline on days 9 and 15, regardless of individual drugs or combinations. Citrulline data confirmed the villus height recovery. Radiation significantly increased pro-inflammatory cytokine IL-18 on days 4 and 9, which was mitigated by PEG alone or PEG+CIP, but not by CIP alone. Radiation increased C3 on day 9 in ileum and serum. The serum C3 was positively associated with the serum IL-18 levels and negatively correlated with the crypt depth. Radiation-induced decreases in claudin 2 (a tight junction marker) in ileum and increases in bacterial DNA in livers were mitigated by PEG+CIP. Radiation did not reduce NF-kB and its activation but reduced Bcl-2 expression, which was not significantly recovered by any individual drug or combination. However, the PEG and CIP combination significantly decreased NF- kB and BAX. In contrast, radiation increased miR-34a and cleaved gasdermin D, which CIP+PEG effectively mitigated. This was confirmed by immunohistochemistry. The results taken together suggest that PEG+CIP combined treatment was effective in mitigating the radiation-induced bone marrow, spleen, and ileum injury. The mitigative effect of this combined treatment was mediated by increases in G-CSF levels that suppress miR-34a, thereby probably leading to decreased gasdermin D-mediated pyroptosis.

283

项与培非格司亭（安进）相关的新闻（医药）

2025-07-25

·ioncology

速览！目前已有30余项中国研究入选2025年ESMO大会口头发言

编者按：一年一度的欧洲肿瘤内科学会（ESMO）年会将于2025年10月17-21日在德国柏林举行。ESMO官网已更新发布入选大会发言的摘要题目。据当前统计，2025年ESMO大会上，中国有30余项研究成果入选大会口头报告发言（如有错误或遗漏，请留言更正），包括特邀论文报告（Proffered Paper session）、小型口头报告（Mini Oral session）。目前重磅的延迟突破性摘要（Late breaking abstract，LBA）尚未公布。01特邀论文报告Proffered Paper session头颈肿瘤英文题目：Perioperative camrelizumab plus chemotherapy in locally advanced squamous cell carcinoma of the head and neck (CAMORAL): A multicenter, open-label, randomized, phase II Study中文题目：卡瑞利珠单抗联合化疗围手术期治疗局部晚期头颈部鳞癌的多中心、开放、随机对照II期临床研究（CAMORAL）摘要号：1319O汇报者：何悦（上海交通大学医学院附属第九人民医院）英文题目：Concurrent Chemoradiotherapy with/without Adjuvant Capecitabine in Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized Controlled Phase III Trial中文题目：局部晚期鼻咽癌同步放化疗联合/不联合卡培他滨辅助治疗：一项随机、对照、III期临床试验摘要号：1321O汇报者：苗菁菁（中山大学肿瘤防治中心）血液肿瘤英文题目：CD19/CD22 Bispecific CAR-T Cell Therapy for Relapsed/Refractory Large B-cell Lymphoma: a Prospective, Single-arm, Single-center, Phase 2 Clinical Trial中文题目：CD19/CD22双特异性CAR-T细胞治疗复发/难治性大B细胞淋巴瘤：一项前瞻性、单臂、单中心、II期临床试验摘要号：1240O汇报者：王亮（首都医科大学附属北京同仁医院）英文题目：Anti-PD-1-Antibody (Tislelizumab) Combined with Chidamide, Lenalidomide and Etoposide for the treatment of refractory/relapsed Extranodal Natural Killer/T Cell Lymphoma, Nasal Type (r/r-ENKTL): Preliminary Results from a Prospective, Multicenter, Single -Arm, Phase II Trial中文题目：抗PD-1抗体（替雷利珠单抗）联合西达本胺、来那度胺和依托泊苷治疗难治性/复发性结外NK/T细胞淋巴瘤,鼻型：一项前瞻性、多中心、单臂、II期试验的初步结果摘要号：1241O汇报者：张蕾（郑州大学第一附属医院）中枢神经系统肿瘤英文题目：Proton versus Carbon Ion Radiotherapy in Skull Base Chordoma and Chondrosarcoma: Initial Clinical Outcomes from a Phase II Randomized Trial中文：质子束与碳离子束放射治疗颅底脊索瘤和软骨肉瘤：一项 II 期随机试验的初步临床结果摘要号：656O汇报者：黄清廷（上海市质子重离子医院）英文题目：A randomized, controlled, multicenter, phase II/III clinical study to evaluate the safety and efficacy of chlorogenic acid for injection in the treatment of recurrent grade IV glioblastoma (GBM)中文题目：一项随机、对照、多中心、II/III期临床研究，评估注射用绿原酸治疗复发性IV级胶质母细胞瘤（GBM）的安全性和有效性摘要号：657O汇报者：李文斌（首都医科大学附属北京天坛医院）英文题目：Molecular diagnosis and management of leptomeningeal metastases with evolving therapeutic paradigm in advanced lung cancer中文题目：晚期肺癌轻脑膜转移的分子诊断和治疗与不断发展的治疗模式摘要号：659O汇报者：Meimei Zheng（中国广州）英文题目：Locoregional bispecific CAR-T cells targeting CD44 and CD133 show safety and efficacy in recurrent high-grade glioma in a first-in-human investigator-initiated trial中文题目：在一项由研究者发起的首次人体试验中，靶向 CD44 和 CD133 的局部区域双特异性 CAR-T 细胞在复发性高级别神经胶质瘤中显示出安全性和有效性摘要号：1511O汇报者：翟优（首都医科大学附属北京天坛医院）妇科肿瘤英文题目：Fuzuloparib (FZPL) monotherapy or in combination with apatinib (APA) as first-line (1L) maintenance therapy in advanced ovarian cancer (OC): final analysis of the FZOCUS-1 trial中文题目：FZOCUS-1研究的最终分析：氟唑帕利（FZPL）单药或联合阿帕替尼（APA）一线（1L）维持治疗晚期卵巢癌（OC）患者摘要号：1063O汇报者：李宁（中国医学科学院肿瘤医院）软组织肉瘤英文题目：ARTEMIS-002: A Phase 2 Study of HS-20093 in Patients with Relapsed or Refractory Sarcomas中文题目：II期ARTEMIS-002研究：HS-20093治疗复发性或难治性肉瘤患者摘要号：2684O汇报者：谢璐（北京大学人民医院）甲状腺癌英文题目：Efficacy and Safety of Dabrafenib Plus Trametinib (D+T) in Patients With Radioactive Iodine (RAI)-Refractory BRAF V600-Mutant Differentiated Thyroid Cancer (DTC)中文题目：达拉非尼联合曲美替尼（D+T）在放射性碘（RAI）-难治性 BRAF V600 突变型分化型甲状腺癌（DTC）患者中的疗效与安全性摘要号：2987O汇报者：高明（天津医科大学肿瘤医院）实体瘤英文题目：HRS-7058, a KRAS G12C inhibitor (G12Ci), in advanced solid tumors with KRAS G12C mutation: a phase 1, multi-center, first-in-human study中文题目：I期、多中心、首次人体研究：KRAS G12C抑制剂（G12Ci）HRS-7058治疗伴KRAS G12C突变晚期实体瘤患者摘要号：914O汇报者：黄鼎智（天津医科大学肿瘤医院）英文题目：KRAS G12D inhibitor HRS-4642 in patients with KRAS G12D-mutant advanced solid tumors: a phase 1 trial中文题目：I期研究：KRAS G12D抑制剂HRS-4642治疗伴KRAS G12D突变晚期实体瘤患者摘要号：915O汇报者：周彩存（同济大学附属东方医院）英文题目：First-in-human phase 1 study of TCR-T therapy targeting KRAS G12V in metastatic solid tumors中文题目：靶向 KRAS G12V 的 TCR-T 疗法治疗转移性实体瘤的首次人体I期研究摘要号：1514O汇报者：白雪莉（浙江大学医学院附属第一医院）02小型口头报告Mini Oral session血液肿瘤英文题目：Risk Stratification for Diffuse Large B-Cell Lymphoma by Integrating Interim 18F-FDG PET-CT Analysis and the NCCN-IPI: A Multicentre Retrospective Study中文题目：通过整合中期18F-FDG PET-CT分析和NCCN-IPI对弥漫性大B细胞淋巴瘤的风险分层：一项多中心回顾性研究摘要号：1243MO汇报者：王杰松（福建省肿瘤医院）英文题目：Combination of Mitoxantrone Hydrochloride Liposome with Chidamide in Patients with Relapsed or Refractory Peripheral T Cell Lymphoma: Updated Results of the Phase II Study中文题目：盐酸米托蒽醌脂质体联合西达本胺治疗复发性或难治性外周T细胞淋巴瘤：II期研究的最新结果摘要号：1245MO汇报者：李志铭（中山大学肿瘤防治中心）英文题目：Single-Cell Atlas of Circulating Immunity identifies shared specific DLBCL signatures for predicting Response to R-CHOP and Anti-CD19 CAR T Therapies中文题目：循环免疫单细胞图谱确定了可预测对R-CHOP和抗CD19 CAR-T疗法的应答的共同特异性DLBCL特征摘要号：1246MO汇报者：张思聪（天津医科大学肿瘤医院）英文题目：Molecular Landscape of Distinct Follicular Lymphoma Histologic Grades: Insights from Genomic and Transcriptome Analyses中文题目：不同滤泡性淋巴瘤组织学分级的分子情况：来自基因组和转录组分析的见解摘要号：1247MO汇报者：孙聪（天津医科大学肿瘤医院）英文题目：Changes in Peripheral Blood Leukemia Stem Cells, Immune Cell Subsets, Cytokines, and Cellular Differentiation Status Before and After Venetoclax-Containing Regimen Treatment for Acute Myeloid Leukemia中文题目：急性髓系白血病含维奈克拉方案治疗前后外周血白血病干细胞、免疫细胞亚群、细胞因子和细胞分化状态的变化摘要号：1248MO汇报者：Xinyu Sun（中国合肥）肝细胞癌英文题目：Liver resection versus continued atezolizumab plus bevacizumab (atezo/bev) in locally advanced hepatocellular carcinoma (HCC) after atezo/bev treatment (TALENTop): a multicenter, open-label, randomized phase III trial.中文题目：肝切除术对比持续阿替利珠单抗联合贝伐珠单抗用于经阿替利珠单抗联合贝伐珠单抗治疗后局部晚期肝细胞癌（HCC）的研究（TALENTop）：一项多中心、开放标签、随机 Ⅲ 期临床试验摘要号：1469MO汇报者：孙惠川（复旦大学附属中山医院）英文题目：Perioperative Camrelizumab plus Rivoceranib in Resectable Hepatocellular Carcinoma (CARES-009): A Randomized, Multicenter, Phase 3 Trial中文题目：围手术期卡瑞利珠单抗联合阿帕替尼用于可切除肝细胞癌（CARES-009）：一项随机、多中心 Ⅲ 期试验摘要号：1470MO汇报者：周俭（复旦大学附属中山医院）胰腺癌英文题目：HRS-4642 Combined with Gemcitabine and Nab-paclitaxel in KRAS-G12D Mutant Advanced Pancreatic Cancer: A Phase Ib/II Study中文题目：HRS-4642 联合吉西他滨与白蛋白结合型紫杉醇治疗 KRAS-G12D 突变的晚期胰腺癌：一项 Ib/II 期研究摘要号：2215MO汇报者：王理伟（上海交通大学医学院附属仁济医院）肺癌英文题目：Phase 2 Study of Firmonertinib in Patients with Previously Treated Advanced/Metastatic Non-Small Cell Lung Cancer (mNSCLC) with EGFR Exon 20 Insertion (Ex20ins) Mutations中文题目：伏美替尼在经治的EGFR外显子20插入（ex 20ins）突变晚期/转移性非小细胞肺癌（mNSCLC）患者中的II期研究摘要号：1848MO汇报者：Ying Cheng（中国长春）英文题目：Surgery versus radiotherapy after induction therapy with serplulimab combined with chemotherapy for unresectable stage IIIB-IIIC non-small cell lung cancer: a randomized controlled, open-label, phase 2 trial中文题目：不可切除 IIIB-IIIC 期NSCLC接受斯鲁利单抗联合化疗诱导治疗后进行手术与放疗的比较：一项随机对照、开放标签、II 期试验摘要号：1818MO汇报者：Suyu Wang（上海市肺科医院）神经内分泌癌英文题目：A Phase 2 Dose Expansion Study of ZG006, a Trispecific T Cell Engager Targeting DLL3/DLL3/CD3, as Monotherapy in Patients with Refractoy Neuroendocrine Carcinoma中文题目：ZG006（一种靶向 DLL3/DLL3/CD3 的三特异性 T 细胞衔接器）单药治疗难治性神经内分泌癌患者的II期剂量扩展研究摘要号：1707MO汇报者：赵传华（中国人民解放军总医院）英文题目：ZG005 in combination with etoposide and cisplatin for the first-line treatment of advanced neuroendocrine carcinoma中文题目：ZG005 联合依托泊苷与顺铂用于晚期神经内分泌癌的一线治疗摘要号：1708MO汇报者：Sisi Ye（中国北京）中枢神经系统肿瘤英文题目：Update on the phase II study: to explore the efficacy and safety of luvometinib (FCN-159) in recurrent or progressive pediatric low-grade glioma with MAPK pathway-activated中文题目：II期研究更新：luvometinib（FCN-159）在伴有 MAPK 通路激活的复发性或进行性低级别儿童脑胶质瘤中的疗效及安全性摘要号：661MO汇报者：李文斌（首都医科大学附属北京天坛医院）英文题目：DNA methylation-based epigenetic signatures for classification and non-invasive diagnosis of gliomas中文题目：基于 DNA 甲基化表观遗传特征的胶质瘤分类及无创诊断摘要号：665MO汇报者：王正锋（郑州大学第一附属医院）肾癌英文题目：Fruquintinib (FRUQ) plus sintilimab (SIN) versus axitinib (AXI) or everolimus (EVE) monotherapy as 2L treatment in pts with locally advanced or metastatic renal cell carcinoma (RCC): results from phase 3 part of a randomized, open-label, active-controlled phase 2/3 study (FRUSICA-2)中文题目：呋喹替尼（FRUQ）联合信迪利单抗（SIN）对比阿昔替尼（AXI）或依维莫司（EVE）单药作为二线治疗方案在局部晚期或转移性肾细胞癌（RCC）患者中的疗效：一项随机、开放标签、活性对照的II/III期研究（FRUSICA-2）的III期部分结果摘要号：2592MO汇报者：叶定伟（复旦大学附属肿瘤医院）软组织肉瘤英文题目：A phase II trial of the combination of Chidamide and Toripalimab in patients with advanced sarcoma中文题目：II期研究：西达本胺联合特瑞普利单抗治疗晚期肉瘤患者摘要号：2689MO汇报者：张星（中山大学肿瘤防治中心）甲状腺癌英文题目：Patient-Derived Organoids Predict Clinical Response and Guide Personalized Therapy in Advanced Thyroid Cancer中文题目：患者来源类器官预测晚期甲状腺癌的临床疗效并指导个性化治疗摘要号：2988MO汇报者：刘嘉烨（四川大学华西医院）实体瘤及其他英文题目：Timing of Pegfilgrastim Administration and Pegfilgrastim-Induced Bone Pain: A Prospective, Randomized Phase 3 Trial中文题目：培非格司亭给药时机与培非格司亭诱导的骨痛：一项前瞻性随机III期试验摘要号：297MO汇报者：Peiyong Li（广东省人民医院）英文题目：Updated ongoing Phase I/II clinical trial results of AMT-116, a first-in-class anti-CD44v9 antibody-drug conjugate (ADC), in patients with advanced solid tumors中文题目：I/II期研究数据更新：首个first-in-class抗CD44v9抗体药物偶联物（ADC）AMT-116治疗晚期实体瘤患者摘要号：922MO汇报者：宋正波（浙江省肿瘤医院）（来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

细胞疗法临床2期免疫疗法临床结果临床1期

2025-07-20

·研发客

中年安进，如何安全度过专利悬崖期？

// • 第一核心支柱Prolia将在2025年下半年迎接生物类似药的竞争；• 第二大核心支柱Enbrel增速放缓，2025年Q1销售额同比下降10% ；• 多款产品将在未来5年内陆续面临专利到期；• 今年上半年安进股价上涨16.55%，减重管线的临床数据可圈可点。市值站上1615亿美元（美东时间7月10日），安进挤掉辉瑞，排在了全球制药企业的第九位。作为上世纪80年代成长起来的biotech，安进无疑是相当成功的，过去十年股价涨幅超过220%。而与安进同期的Celgene，因个中原因没能迈过成为pharma的门槛，在2019年被BMS以740亿美元收购；再生元依靠自免明星度普利尤单抗，当前市值591亿美元；一直跑在CNS领域的Biogen市值193亿美元，一贯保持着biotech的身份；即使是吉利德，以目前1390亿美元市值，仍然难与安进比肩。很多biotech渴望成为安进，不过，安进也有自己的危机。以猎人的姿态近期，安进公布了靶向FGFR2b 单抗bemarituzumab的Ⅲ期临床顶线结果。中期分析显示，在不可切除的局部晚期或转移性胃癌或胃食管交界处癌症患者中，与安慰剂+化疗相比，bemarituzumab联合化疗，在总生存期（OS）方面显示出具有统计学意义和临床意义的改善，达到主要终点。这些患者为FGFR2b过表达且非HER2阳性。再鼎医药参与了这项临床试验。2021年，安进以19亿美元收购Five Prime，从而囊获bemarituzumab。而早在2017年，再鼎已与Five Prime达成了bemarituzumab的授权合作协议。据安进披露，一项关于bemarituzumab联合化疗和nivolumab用于一线胃癌患者的Ⅲ期研究也在进行中，预计2025 年下半年公布数据。对于白手起家的制药公司来说，要么成为猎物，要么成为猎人，安进选择了后者。也正是因为一系列收购动作，让它逐渐走出一条成为pharma的路。1989年，促红细胞生成素Epogen的横空出世，让安进拿到了第一桶金。不久之后，治疗放化疗引起的白细胞减少症Neupogen大放异彩。之后还接连开发了Epogen长效产品Aranesp、Neupogen的长效产品Neulasta，不断巩固其在血液病领域的江湖地位。然而，对安进来说，“红白药”的故事更像一个遥远的救世主，它并没有打算在这个舒适区里待得太久。2002年，安进出手160亿美金，收购了自免药物研发公司Immunex。第一次并购让它拿到了自免产品Enbrel（依那西普），用于治疗类风湿关节炎和强制性脊柱炎。直到现在，Enbrel仍然是安进的第二大核心支柱。安进各产品销售收入占比来源|安进研报此后的20年里，凭借猎人的嗅觉，安进以收购的方式不断扩张管线和产品。通过收购Onyx，拿到了银屑病治疗药物Kyprolis。2024年，该药为安进贡献了15.63亿美元，占整体销售额的4.69%。通过收购Micromet，安进拥有了一款双特异性T细胞衔接器疗法Blincyto。去年，FDA 批准该药用于治疗CD19阳性费城染色体阴性B细胞前体急性淋巴细胞白血病患者的巩固阶段治疗。而在这之前，Blincyto已获批两项针对白血病的适应症。2024年，该产品销售收入12.16亿美元，占整体3.8%。2025年Q1，Blincyto销售额3.7 亿美元，同比增长52%。2022年，安进以近40亿美元收购 Chemocentryx，获得了全球首款口服给药的选择性补体5a（C5a）受体抑制剂Tavneos。目前，这款产品已经在中国和全球多个国家获批，治疗中性粒细胞胞质抗体相关血管炎。2024年，Tavneos销售额2.83亿美元，占整体的0.88%。2025年Q1，Tavneos卖出9000万美元，同比增长 76%。可能面临的失速从财务状况来看，安进2024年全年总营收334亿美元，同比增长19%。2025年Q1营收81亿美元，同比增长9%。但是，失速的风险已经扑面而来。2024年，Enbrel卖出了33.16亿美元，同比增长14%，占整体销售的10.35%。业绩贡献能力仅次于骨科明星产品Proila。不过，与2022、2023年相比，增长速度在放缓（见上图）。并且，在2025年Q1，Enbrel销售额同比下降 10%，至 5.1 亿美元。尽管安进给出了净售价下降等多个解释，但是，昔日的明星产品正在失速，是不可回避的事实。Enbrel的专利将在2028年到期，并早已过了销售峰值。实际上，安进的多款产品将在未来5年内陆续面临专利到期（见下图）。安进产品专利期限总览来源|安进研报Prolia（地舒单抗）的隐忧更为突出。尽管2025年Q1销售额仍有11亿美元，同比增长了10%。但是安进自己也预判2025年下半年生物类似药的竞争，将会导致Prolia的业绩下滑。2024年，FDA批准了两款生物类似药，来自Sandoz的Jubbonti和Wyost。此外，收购Horizon Therapeutics获得的三款罕见病产品，能否为安进带来业绩助力仍然不明朗。2023年，安进决定以278亿美元收购Horizon。这笔交易惊动了联邦交易委员会（FTC）。FTC认为，这将有可能巩固Horizon旗下的甲状腺眼病药物Tepezza和慢性痛风药物Krystexxa的垄断地位。最终，安进做出了一系列妥协，包括不将旗下任何产品与上述两款产品捆绑销售等等。这一妥协似乎导致了两款产品的销售乏力。2025年Q1，Tepezza仅卖出了3.81亿美元，同比下降10%；Krystexxa的销售额与去年同期持平，为2.36 亿美元。只有治疗视神经脊髓炎谱系疾病的Uplizna表现不俗，2024年的销售额为3.79亿美元，同比增长483%；2025年Q1销售额9100万美元，同比增长14%。长效减重的后起之秀当然，即将面临低空飞行的安进，并不是只有收购一条路。今年上半年，安进股价上涨了16.55%。市值排名第一的礼来仅微涨1.7%，强生股价涨幅为9.8%，诺和诺德甚至跌去了18.55%。显然，资本市场把更多的热情给到了安进的减重管线。在不久前的ADA年会上，安进交出了减重产品MarTide（maridebart cafraglutide）的Ⅱ期临床数据。无2型糖尿病的肥胖患者，52周平均减重约 20%（安慰剂组平均减重为2.6%），同时改善心血管代谢指标。在患有2型糖尿病的肥胖人群中，接受MariTide治疗体重平均减轻了约 17%（安慰剂组平均减重1.4%），并改善了糖化血红蛋白水平。值得留意的是，在第52周时，体重仍未达到平台期，意味着进一步减重的潜力。作为一款每月或更少频次给药的减重治疗药物，MarTide的表现确实可圈可点。不过，MarTide的安全性一直是悬在安进头上的达摩克斯利剑。目前公布的数据显示，该产品因任何不良事件而停药的比例约为11%，因胃肠道相关不良事件而停药的比例低于8%。Ⅱ期数据中提到，在剂量递增组中，胃肠道不良事件而停药的比例最高为7.8%，低于非剂量递增组。而礼来在今年4月公布的SURMOUNT-5研究结果显示，替尔泊肽组因胃肠道不良事件的停药率为2.7%，司美格鲁肽因相同原因停药为5.6%。安进在研管线来源|安进研报严格来说，减重代谢领域并不是安进最熟悉的战场，不过它的决心不容小觑。目前，MarTide针对超重或肥胖成人（伴或不伴 2 型糖尿病）慢性体重管理的Ⅱ期研究第二部分正在进行中，预计数据读出将在 2025 年下半年。针对多个适应症的MARITIME Ⅲ期研究的规划仍在按计划进行，预计2025年全年将启动更多研究。另一款减重管线AMG513的临床试验曾遭遇FDA暂停，不过在解除禁止之后， AMG513的Ⅰ期临床研究正在招募肥胖患者。在心血管领域，安进有一款具有BIC潜力的靶向Lp(a)的siRNA产品olpasiran，可减少肝脏中Lp(a)的合成。目前，安进正在开展一项OCEAN(a)-Outcomes试验，针对患有动脉粥样硬化性心血管疾病且Lp(a)升高患者的Ⅲ期心血管结局研究。预计在2025年下半年/2026年上半年启动一项针对Lp(a)升高且心血管事件高风险患者的Ⅲ期心血管结局研究。其实，安进已经有一款PSCK9抑制剂Repatha，正在开展两项研究：VESELIUS-CV 是一项针对Repatha的Ⅲ期心血管结局研究，正在高心血管风险但无既往心肌梗死或中风的患者中进行，预计在2025 年下半年公布结果。EVOLVE-MI 是一项Ⅳ期研究，评估在急性心肌梗死发生后10天内使用Repatha以降低心血管事件风险的效果。编辑 | 姚嘉yao.jia@PharmaDJ.com总第2505期访问研发客网站，深度报道和每日新闻抢鲜看www.PharmaDJ.com

并购专利到期生物类似药临床3期

2025-05-08

·正大天晴药业集团

艾贝格司亭α双项研究亮相AACR：同步放化疗与日间化疗的“白细胞保卫战”

近日，2025年美国癌症研究协会（AACR）年会在芝加哥成功举办，正大天晴联合开发的长效粒细胞集落刺激因子（G-CSF）药物艾贝格司亭α注射液（亿立舒®）的两项临床研究数据重磅发布，为同步放化疗及日间化疗患者的中性粒细胞减少症（CIN）防治提供了新的选择方案。此外，正大天晴还有2款创新药TQB3002、TQB3019的临床前研究被大会收录。13.89%vs41.67%，CIN发生率降低在头颈部鳞癌、肺癌、食管癌、鼻咽癌、宫颈癌等恶性肿瘤治疗中，同步放化疗（CCRT）是核心手段之一[1-4]。然而，同步放化疗（CCRT）存在显著血液学毒性，引发的中性粒细胞减少症（CIN）不仅影响患者的治疗耐受性，导致治疗延迟甚至中断，甚至会增加患者感染风险，严重威胁生命[5-7]。因此，预防中性粒细胞减少症（CIN）的发生是同步放化疗（CCRT）临床实践中的重要课题。Guard-01研究[8]是一项多中心、随机、对照的临床试验，拟纳入120例计划接受根治性同步放化疗（CCRT）的患者。研究的主要终点是同步放化疗（CCRT）期间3-4级中性粒细胞减少症的发生率。研究结果显示，同步放化疗（CCRT）期间，艾贝格司亭α组3-4级中性粒细胞减少的发生率较对照组显著下降（13.89% vs 41.67%，P=0.0058）。在不同化疗方案的分层分析中，也观察到同样的趋势。在艾贝格司亭α组中，外周血中性粒细胞绝对值（ANC）谷值显著高于对照组（中位值3.09×10⁹/L vs 1.16×10⁹/L，P<0.0001）。艾贝格司亭α的安全性数据符合预期，未报告任何3级或以上的治疗相关不良事件。本研究前瞻性评估了艾贝格司亭α在同步放化疗（CCRT）相关中性粒细胞减少症（CIN）预防中的疗效和安全性，有望改善患者的治疗耐受性和生活质量。24小时以内，给药时间的优化实践传统观点认为长效粒细胞集落刺激因子（G-CSF）需与化疗间隔至少24-48小时后用药，但如果能在化疗当日给予长效粒细胞集落刺激因子（G-CSF）则可减少患者的就诊次数，进而减轻医保负担[9-11]。基于一项Ⅲ期临床结果，艾贝格司亭α获得国家药品监督管理局（NMPA）批准可在每周期抗肿瘤药物给药结束24小时后用药。Guard-02研究则在此基础上，进一步探索化疗后24小时以内的给药方案。Guard-02研究[12]是一项多中心、前瞻性、单臂临床研究，计划纳入52例接受EC（表柔比星+环磷酰胺）辅助或新辅助方案化疗的乳腺癌患者。研究结果显示，Guard-02研究在4周期化疗期间的3-4级中性粒细胞减少发生率为21.62%。4周期化疗期间的发热性中性粒细胞减少症（FN）发生率为2.70%，受试者在第1、3、4周期均未发生发热性中性粒细胞减少症（FN）。整个研究期间的外周血中性粒细胞绝对值（ANC）最低值中位数为2.08×10⁹/L（低于2.0×10⁹/L为中性粒细胞减少症），受试者对于在化疗后24小时以内给予艾贝格司亭α的耐受性良好。艾贝格司亭α作为全球首个第三代长效G-CSF-Fc融合蛋白，在中、美、欧三地获批，成为全球临床肿瘤治疗的重要支持力量。此次两项研究进一步拓展其应用场景：Guard-01验证了其在同步放化疗复杂场景中的保护作用，Guard-02则通过进一步缩短给药时间优化治疗便利性，为临床提供更优选择。参考文献：[1] Lin JC, Jan JS, Hsu CY, et al. Phase Ⅲ study of concurrent chemoradiotherapy versus radiotherapy alone for advanced nasopharyngeal carcinoma positive effect on overall and progression-free survival [J]. J Clin Oncol, 2003, 21(4): 631-637.[2] Pearcey R, Brundage M, Drouin P, et al. Phase Ⅲ trial comparing radical radiotherapy with and without cisplatin chemotherapy in patients with advanced squamous cell cancer of the cervix [J]. J Clin Oncol, 2002, 20(4):966-972.[3] Curran WJ, Jr Paulus R, Langer CJ, et al. Sequential vs. concurrent chemoradiation for stage Ⅲ non-small cell lung cancer randomized phase Ⅲ trial RTOG 9410 [J]. J Natl Cancer Recher, 2011, 103(19):1452-1460.[4] Cooper JS, Guo MD, Herskovic A et al. Chemoradiotherapy of locally advanced esophageal cancer long-term follow-up of a prospective randomized trial RTOG 85-01. Radiation Therapy Oncology Group [J]. JAMA, 1999, 281(17): 1623-1627.[5] O’Rourke N, Roque IFM, Farre-Bernado N, et al. Concurrent chemoradiotherapy in non-small cell lung cancer[J]. Cochrane Database Syst Rev, 2010(6): CD002140.[6] Yang H, Liu H, Chen Y et al. Neoadjuvant chemoradiotherapy followed by surgery versus surgery alone for locally advanced squamous cell carcinoma of the esophagus (NEOCRTEC5010): a phase Group [J]. JAMA, 1999, 281(17): 1623-1627. 631-6l [J]. J Clin Oncol, 2018, 36(27): 2796-2803.[7] Videtic GM, Fung K, Tomiak AT, et al. Using treatment interruptions to palliate the toxicity from concurrent chemoradiation for limited small cell lung cancer decreases survival and disease control [J]. Lung Cancer, 2001, 33(2-3):249-258.[8] MingChen ,yuanyuanChen ,et al. Efficacy and safety of efbemalenograstim alfa as primary prophylaxisfor concurrent chemo-radiotherapy induced neutropenia.2025 AACR 4686/13.[9] Eckstrom J, Bartels T, Abraham I, et al. A single-arm, retrospective analysis of the incidence of febrile neutropenia using same-day versus next-day pegfilgrastim in patients with gastrointestinal cancers treated with FOLFOX or FOLFIRI[J]. Support Care Cancer, 2019, 27(3): 873-878.[10] McBride A，Alrawashdh N, Bartels T, et al. Same-day versus next-day pegfilgrastim or pegfilgrastim-cbqv in patients with lymphoma receiving CHOP-like chemotherapy[J]. Future Oncol, 2021, 17(26): 3485–3497.[11] Kitchen K, Mosier MC. Real-world febrile neutropenia rates with same-day versus next-day pegfilgrastim after myelosuppressive chemotherapy[J]. Future Oncol, 2022, 18(23): 2551-2560.[12] YueyinPan ,ShoubingChen ,et al.Safety and efficacy of same-day administration of novel long-acting G-CSF efbemalenograstim α in breast cancer patients undergoing cytotoxic chemotherapy.2025 AACR 800/19.▲ 上下滑动查看更多声明：1.新闻稿旨在促进医药信息的沟通和交流，仅供医疗卫生专业人士参阅，非广告用途。2.本公司不对任何药品和/或适应症作推荐。3.本新闻稿中涉及的信息仅供参考，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。 ● 强强联合！中国生物制药携手京东健康深化战略合作两款重磅新品首发● 全国人大常委会副委员长武维华一行到正大天晴调研● 12项口头报告创中国药企最高纪录，正大天晴多瘤种创新管线闪耀2025ASCO● 双适应症申报获受理！贝莫苏拜方案“头对头”优于替雷联合化疗、覆盖Ⅲ期肺癌巩固治疗

AACR会议临床结果临床3期申请上市

100 项与培非格司亭（安进）相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06889	培非格司亭（安进）	L03AA13	DB00019

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
干细胞动员	日本	Kyowa Kirin Co., Ltd.	2022-02-25
中性粒细胞减少	欧盟	Amgen Europe BV	2002-08-22
中性粒细胞减少	冰岛	Amgen Europe BV	2002-08-22
中性粒细胞减少	列支敦士登	Amgen Europe BV	2002-08-22
中性粒细胞减少	挪威	Amgen Europe BV	2002-08-22
粒细胞减少性发热	美国	Amgen, Inc.	2002-01-31

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临床结果

适应症

分期

评价

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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


NCT04294641 (CTgov)	临床2期	慢性移植物抗宿主病	10	Ibrutinib	蓋繭衊窪膚網鹹窪窪淵 = 獵餘衊顧醖製觸觸餘繭廠願夢繭艱鹽觸鹽糧窪 (顧網窪顧淵膚製觸鬱餘, 淵齋範夢鏇築鹹積膚顧 ~ 廠夢構襯襯願窪構醖窪) 更多	-	2025-01-22
ASCO_GU2024 人工标引	N/A	生殖细胞和胚胎肿瘤	196	bleomycin+Pegfilgrastim	糧範鑰淵夢餘網餘憲衊(遞鹽鹽繭壓膚艱觸齋積) = 夢鬱憲觸繭衊願鏇觸鏇鹽範糧獵醖鏇遞鑰鬱範 (簾製築鑰選鹽糧艱齋淵 ) 更多	积极	2024-01-25
ASCO_GU2024 人工标引	N/A	生殖细胞和胚胎肿瘤	196	bleomycin	糧範鑰淵夢餘網餘憲衊(遞鹽鹽繭壓膚艱觸齋積) = 淵襯獵醖遞顧網網鑰糧鹽範糧獵醖鏇遞鑰鬱範 (簾製築鑰選鹽糧艱齋淵 ) 更多	积极	2024-01-25
JPRN-UMIN000028055 (ASCO_GI2024) 人工标引	临床2期	胰腺腺癌	34	5-fluorouracil+leucovorin+irinotecan+ oxaliplatin (without pegfilgrastim)	艱遞壓簾顧鏇鹹鬱糧選(顧繭觸鑰鹽網繭淵膚衊) = 艱選壓願憲鹽鏇廠醖遞獵觸齋壓構網廠壓糧鬱 (築積蓋艱襯觸鹽願顧壓 ) 更多	积极	2024-01-18
EHA2022	N/A	多发性骨髓瘤	57	Pegfilgrastim	繭糧簾憲夢餘壓鬱膚糧(築壓觸艱遞選獵網選顧) = 衊獵鏇鬱構觸糧鬱蓋襯憲衊衊衊膚鬱襯獵鬱觸 (選醖窪襯膚襯窪觸觸衊 ) 更多	-	2022-06-10
NCT02698891 (CTgov)	临床2期	早期乳腺癌	127	Neulasta+Paclitaxel	艱蓋艱膚窪蓋窪壓醖製 = 積衊夢衊網築築壓觸製夢廠遞鏇膚夢廠窪鬱膚 (獵鬱獵醖齋壓鑰構鏇簾, 蓋積窪鏇艱鑰積憲蓋鑰 ~ 構餘齋網壓積遞蓋獵構) 更多	-	2022-05-06
JPRN-UMIN000017538 (Pubmed \| Int J Clin Oncol)	临床2期	胰腺癌	22	FOLFIRINOX with primary prophylactic pegfilgrastim	選鹹製艱顧淵艱鏇鏇鹽(構製遞網憲鬱廠壓網餘) = 網獵憲願製憲製鬱製網築選廠窪淵齋襯鏇觸憲 (餘淵齋糧鏇夢廠淵觸鑰, 0.5 ~ 40.3) 更多	-	2021-11-01
PROTECTIVE-2(BPI-2358-106) (CSCO2021)	临床3期	伴有中性粒细胞减少的皮肤异色病	221	普那布林 40mg+培非格司亭 6mg	繭糧遞選蓋網簾餘鏇獵(網獵顧醖簾廠願艱窪鏇) = 壓衊夢襯築夢繭觸壓夢顧糧願構遞觸廠憲鏇廠 (鹹構鑰壓鏇繭鑰願醖鏇 ) 更多	-	2021-09-25
PROTECTIVE-2(BPI-2358-106) (CSCO2021)	临床3期	伴有中性粒细胞减少的皮肤异色病	221	培非格司亭 6mg+安慰剂	繭糧遞選蓋網簾餘鏇獵(網獵顧醖簾廠願艱窪鏇) = 壓網製襯夢構艱鬱遞構顧糧願構遞觸廠憲鏇廠 (鹹構鑰壓鏇繭鑰願醖鏇 ) 更多	-	2021-09-25
NCT02578732 (BrUOG 318, CTgov)	临床2期	局部晚期胰腺腺癌	28	FOLFOXA	醖繭廠網鹹糧衊積艱繭 = 獵簾觸衊鏇製顧鑰網膚製鏇簾鏇膚選範簾壓網 (網鏇膚積廠窪築壓壓壓, 齋鹽襯範構淵繭膚獵襯 ~ 鑰鬱願範糧網衊齋鹹獵) 更多	-	2021-08-13
NCT03511378 (CTgov)	临床4期	乳腺癌	138	Lupin's Pegfilgrastim (Lupin's Pegfilgrastim)	廠製遞壓鹹廠繭鏇網淵 = 糧襯觸範願鹽鹽獵範繭糧齋蓋醖鏇蓋鹹遞鏇築 (築鏇餘窪衊構顧簾鏇鑰, 鹹窪壓構鬱淵顧鑰顧範 ~ 獵餘選製鏇積蓋選遞簾) 更多	-	2021-06-15
NCT03511378 (CTgov)	临床4期	乳腺癌	138	Neulasta® (Neulasta®)	廠製遞壓鹹廠繭鏇網淵 = 觸鹹積膚繭齋衊蓋艱簾糧齋蓋醖鏇蓋鹹遞鏇築 (築鏇餘窪衊構顧簾鏇鑰, 夢構觸壓膚窪鬱鏇壓鏇 ~ 膚積鬱網淵夢艱蓋淵築) 更多	-	2021-06-15
ASCO2020 \| IMS2020	N/A	多发性骨髓瘤	57	Pegfilgrastim	壓餘鏇製獵製積壓獵齋(醖膚顧築積醖衊繭廠鏇) = main side effects were mild fever and bone pain (21.2%) 鏇淵製網廠簾廠淵衊製 (鹽壓憲範製遞醖顧觸鑰 )	积极	2020-05-25
ASCO2020 \| IMS2020	N/A	多发性骨髓瘤	57	Filgrastim		积极	2020-05-25