An Open-Label, Single-Arm, Phase II Study of Pembrolizumab, Plinabulin Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer

Monoclonal antibodies against programmed death 1 (PD-1) and its ligand PD-L1 have shown efficacy in patients with ES-SCLC in the monotherapy and combination therapy settings. Up to now, Atezolizumab and Durvalumab has been approved for first line treatment for ES-SCLC in China combined with EP or EC. Besides, KEYNOTE-604 study revealed that adding pembrolizumab to standard first-line EP significantly improves PFS in patients with ES-SCLC and is associated with durable responses in a subset of patients. 12-m PFS rate were 13.6% with pembrolizumab plus EP and 3.1% with placebo plus EP. The statistical threshold for declaring significant prolongation of OS was narrowly missed. Considering sicker pts was enrolled and the interim analysis was quite often, even though the investigators narrowly missed the OS endpoint, longer numerical OS data was observed. The latest version of NCCN SCLC guidelines still recommended pembrolizumab as an option for ES-SCLC patients.
Plinabulin received breakthrough designation from both US and China FDA for CIN (Chemotherapy Induced Neutropenia) prevention indication. As a "pipeline in a drug," plinabulin is being broadly studied in combination with various immuno-oncology agents that could boost the effects of the PD-1/PD-L1 antibodies and re-sensitize PD-1/PD-L1 antibody resistant patients. In a poster released at 2021 ASCO conference, a phase I trial of Plinabulin in combination with nivolumab and ipilimumab in patients with relapsed small cell lung cancer: Big Ten Center Research Consortium (BTCRC-LUN17-127) study. Plinabulin in combination with nivolumab and ipilimumab was safe and well tolerated with promising efficacy signal of 46% ORR.
From above, Pembrolizumab, Plinabulin plus Etoposide and Platinum as First-Line Therapy for ES-SCLC should be a promising combination therapy, as the investigators expect increased efficacy and reduced toxicity with the addition of Plinabulin. In this proof of concept phase II study, the investigators will investigate that the efficacy and safety of Pembrolizumab, Plinabulin plus Etoposide and Platinum as First-Line Therapy for ES-SCLC.

开始日期2024-03-07

申办/合作机构

华中科技大学同济医学院附属协和医院

NCT05130827

/ Active, not recruiting临床2期IIT

Pilot Trial of Plinabulin and Pegfilgrastim to Reduce the Duration of Absolute Neutropenia After Autologous Hematopoietic Cell Transplantation for Patients With Multiple Myeloma

This study will see how long it takes for white blood cell counts to return to normal in people with multiple myeloma (MM) who receive plinabulin and pegfilgrastim after undergoing an autologous hematopoietic stem cell transplant (AHCT).

开始日期2021-12-21

申办/合作机构

Memorial Sloan Kettering Cancer Center

[+1]

NCT04902040

/ Terminated临床1/2期IIT

An Open-label, Single-Center, Phase 1b/2 Study to Evaluate the Safety of Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Malignancies After Progression on PD-1 or PD-L1 Targeted Antibodies

This phase Ib/II trial studies the side effects and best dose of plinabulin in combination with radiation therapy and immunotherapy in patients with select cancers that have spread to other places in the body (advanced) after progression on PD-1 or PD-L1 targeted antibodies. Plinabulin blocks tumor growth by targeting both new and existing blood vessels going to the tumor as well as killing tumor cells. Immunotherapy may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving plinabulin in combination with radiation therapy and immunotherapy may work better in treating advanced cancers.

开始日期2021-04-14

申办/合作机构

The University of Texas MD Anderson Cancer Center

100 项与普那布林相关的临床结果

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100 项与普那布林相关的转化医学

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100 项与普那布林相关的专利（医药）

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119

项与普那布林相关的文献（医药）

2025-04-01·BIOORGANIC CHEMISTRY

Design, synthesis and anticancer evaluation of novel 1,3-imidazole-type phenylhistin derivatives: Dual mechanism via P53 induction and microtubulin inhibition

Article

作者: Shen, Zhenlu ; Ding, Zhongpeng ; Li, Jiajia ; FengLi ; Wen, Yongxiu ; Wang, Bo ; Xin, Jie ; Chen, Na ; Zhang, Bo ; Wang, Gang ; Li, Wenbao ; Wang, Shihao ; Yang, Wenqiang

To enhance biological activity and deepen the understanding of the structure-activity relationship, a systematic study was conducted on the 5-position of the 1,3-imidazol-4-yl group in phenylahistin. The interaction between phenylahistin derivative 16j and the colchicine-binding site was first analyzed in detail, leading to the development of a fragment library to replace the tert-butyl group. A series of 20 novel phenylhistin derivatives were designed, synthesized, and characterized. In vitro activity screening using the NCI-H460 human non-small cell lung cancer line showed strong inhibitory activity for most compounds. Among these, compounds 8 f and 8 g exhibited superior activities, with IC₅₀ values of 10 nM and 2 nM, respectively. Notably, 8 f displayed activity comparable to that of plinabulin, while 8 g was five times more potent. Both compounds 8 f and 8 g were further evaluated across various tumor cell lines showing nanomolar-level potency. Furthermore, detailed biological assays revealed that 8 g and 8 f disrupted microtubule integrity and significantly affected the P53 signaling pathway, strongly inducing G2/M phase arrest, and simultaneously promoting apoptosis in NCI-H460 cells. Molecular docking studies confirmed higher binding scores and stronger affinities for these derivatives at the colchicine-binding site of α, β-tubulin. These findings suggest that the apoptosis-inducing and cytotoxic activities of these derivatives may offer potential clinical value for tumor therapy.

2025-02-14·ACS Applied Nano Materials

MnO₂-Mediated cGAS-STING Signaling and Photothermal Effect Amplify Chemodynamic Therapy Induced by Fe-Based Nanoparticle in Tumor Therapy

作者: Cheng, Guodong ; Li, Chunlei ; Zheng, Xiuwen ; Liu, Chang ; Ding, Zhongpeng ; Wang, Wenjun ; Li, Lin ; Chen, Na ; Li, Xueao ; Dai, Zhichao

Iron and manganese are crucial micronutrients that play vital roles in metabolism due to their redox properties.Iron is involved in ferroptosis, an iron-dependent nonapoptotic form of regulated cell death, that endows tumor cells more sensitivity to chemotherapy drugs.Manganese is a potent immune stimulator that activates cGAS-STING signaling, which plays critical roles in the initiation of antitumor immunity and conversion of cold tumor to hot tumor, by binding directly to cGAS and sensitizing cGAS to double-stranded DNA.In this study, a multifunctional nanoparticle Fe-MOF@MnO₂@PB@HA (FMPH) was developed.We introduced Fe-based metal-organic framework (Fe-MOF) as the delivery platform, which encapsuled plinabulin (PB), a potent microtubule-destabilizing and vascular-disrupting agent that hurdles tumor growth.Fe-MOF was capped with manganese dioxide (MnO₂), which served to enhance the chemodynamic therapy of ferric ions by depleting endogenous glutathione (GSH) and producing cytotoxic hydroxyl radicals (^•OH).Besides, MnO₂ could elicit local hyperthermia under near-IR (NIR) light irradiation and activate the cGAS-STING pathway to induce tumor cell death and alert the immune system.Hyaluronic acid (HA) was used to modify the nanoparticle surface so as to improve its tumor-targeting capacity and reduce systemic toxicity.Moreover, both the in vitro and in vivo experiments revealed that FMPH could efficiently suppress tumor growth and the synergistic treatment of NIR could further improve the therapeutic effect.Therefore, the multimodal effects of FMPH made it a promising nanomedical to combat cancer.

2025-01-17·MEDICINE

Osteosarcoma biomarker analysis and drug targeting prediction based on pyroptosis-related genes

Article

作者: Zhuang, Yuxiang ; Li, Xiaofeng

Osteosarcoma is a malignant bone tumor originating from mesenchymal tissue. Recent studies have found that the tumor inflammatory microenvironment plays an important role in promoting the malignant characteristics and metastatic potential of malignant tumors. Pyroptosis, an inflammatory programmed cell death, elicits immune responses that exhibit anti-tumor effects through released factors and contents. Therefore, improving anti-tumor immunity by targeting osteosarcoma-related pyroptosis genes and pathways may be of great significance in delaying early metastasis of osteosarcoma and improving patient survival rate. The study aimed to identify pyroptosis-related genes and biomarkers in osteosarcoma, predicting therapeutic drugs targeting these genes. Gene expression profiles of osteosarcoma were retrieved from Gene Expression Omnibus and cross-referenced with GeneCards and Comparative Toxicogenomics Database to identify differentially expressed pyroptosis-related genes. We conducted enrichment analysis on intersecting genes to identify their biological processes and signaling pathways and assessed immune cell composition in the tumor microenvironment through immune infiltration analysis. In addition, we further utilized Cytoscape software to screen out the top 10 genes with Degree values among the intersected genes as hub genes and performed GSEA analysis and drug prediction based on the hub genes. A total of 22 differentially expressed pyroptosis-related genes were identified in osteosarcoma, with 10 of them (TP53, CYCS, IL-1A, IL-1B, IL-18, CASP-3, CASP-8, IL-6, TNF, CASP-1) pinpointed as hub genes. Enrichment analysis found that the 22 intersection genes are mainly associated with pyroptosis, apoptosis, immune regulation, and related biological processes. The results of data validation targeting hub genes suggest that IL-18, CASP-1, and CASP-8 may be key genes involved in the regulation of pyroptosis in osteosarcoma. Immune infiltration analysis shows statistical differences in the distribution of immune cells like naive B cells, monocytes, M2 macrophages, and dendritic/mast cells, suggesting they play a role in the osteosarcoma tumor microenvironment. Hub gene drug targets suggest Triethyl phosphate, Plinabulin, and Siltuximab as potential osteosarcoma treatments. Our findings suggest potential mechanisms of action for 22 pyroptosis-related genes in osteosarcoma and preliminarily predicted that the occurrence of osteosarcoma is closely related to pyroptosis, apoptosis, and immune regulation. Predicted Triethyl phosphate, Plinabulin, Siltuximab as potential osteosarcoma treatments.

149

项与普那布林相关的新闻（医药）

2025-05-07

·ioncology

肺癌领域中国之声亮相ASCO 2025，最新成果瞭望聚焦丨ASCO 2025

点上方蓝字“ioncology”关注我们，然后点右上角“…”菜单，选择“设为星标”ASCO 2025 微专辑扫描二维码可查看更多内容2025年美国临床肿瘤学会（ASCO）年会定于5月30日至6月3日（美国东部时间，ET）在美国芝加哥举办。作为全球规模最大、学术水平最高且最具权威性的临床肿瘤学盛会，ASCO年会汇聚了全球肿瘤学领域的医生、专业人士、患者倡导者、工业界代表以及主流媒体，共同聚焦国际前沿的研究发现与临床试验成果。近日，大会官网公布了最新摘要题目信息，其中肺癌领域70余项来自中国的研究成果入选。《肿瘤瞭望》特此整理，以飨读者。口头摘要会议非小细胞肺癌（NSCLC）摘要号：LBA8004英文标题:R-ALPS: A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial of TQB2450 with or without anlotinib as maintenance treatment in patients with locally advanced and unresectable (stage III) NSCLC without progression following concurrent or sequential chemoradiotherapy.中文标题：R-ALPS研究：一项随机、双盲、安慰剂对照、多中心III期临床试验，旨在评估贝莫苏拜单抗（TQB2450）联合或不联合安罗替尼作为维持治疗，在同步或序贯放化疗后未进展的局部晚期不可切除（III期）非小细胞肺癌患者中的疗效汇报者：陈明教授 | 中山大学肿瘤防治中心摘要号：LBA8502英文标题:CAMPASS: Benmelstobart in combination with anlotinib vs pembrolizumab in the first-line treatment of advanced non-small cell lung cancer (aNSCLC): A randomized, single-blind, multicenter phase 3 study.中文标题:CAMPASS 研究：Benmelstobart联合anlotinib对比帕博利珠单抗一线治疗晚期非小细胞肺癌（aNSCLC）：一项随机、单盲、多中心 3 期研究汇报者:韩宝惠教授｜上海市胸科医院摘要号：LBA8505英文标题:Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo) in EGFR-mutant (EGFRm) and MET-amplification (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from a randomized phase 3 SACHI study.中文标题:SACHI Ⅲ期研究：赛沃替尼联合奥希替尼对比化疗用于 EGFR 突变且 MET 扩增的晚期NSCLC患者（在 EGFR TKI治疗失败后）的随机对照结果汇报者:陆舜教授｜上海市胸科医院摘要号：3001英文标题:Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with driver genomic alterations (GA) outside of classic EGFR mutations.中文标题:BL-B01D1（iza-bren）治疗携带经典EGFR突变以外驱动基因改变的局部晚期或转移性非小细胞肺癌的I期临床研究：一种靶向EGFR×HER3的双特异性ADC的评估汇报者:杨云鹏教授 | 中山大学肿瘤防治中心摘要号：8504英文标题:SOHO-01: Safety and efficacy of BAY 2927088 in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC) who were pretreated but na?ve to HER2-targeted therapy or had not received any treatment for advanced disease.中文标题:SOHO-01：BAY 2927088 在既往接受治疗但未接受过 HER2 靶向治疗或对晚期疾病尚未进行任何治疗的 HER2 突变NSCLC患者中的安全性与疗效研究汇报者:Herbert H. Loong | 香港中文大学摘要号：8506英文标题:Patritumab deruxtecan (HER3-DXd) in resistant EGFR-mutated (EGFRm) advanced non-small cell lung cancer (NSCLC) after a third-generation EGFR TKI: The phase 3 HERTHENA-Lung02 study.中文标题:HERTHENALung02 Ⅲ期研究：Patritumab deruxtecan（HER3DXd）用于对三代 EGFR TKI 耐药的 EGFR 突变晚期NSCLC患者汇报者:莫树锦教授 | 香港中文大学摘要号：8507英文标题:Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study.中文标题:OptiTROPLung03：芦康沙妥珠单抗在既往治疗过的 EGFR 突变晚期NSCLC患者中的应用——随机对照研究结果汇报者:张力教授｜中山大学肿瘤防治中心小细胞肺癌（SCLC）及其他胸部肿瘤摘要号：3002英文标题:Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic small cell lung cancer (SCLC).中文标题:iza-bren（BL-B01D1），一种EGFR x HER3双特异性抗体驱动药物偶联物（ADC），在局部晚期或转移性小细胞肺癌（SCLC）患者中的I期研究。汇报者:黄岩教授 | 中山大学肿瘤防治中心摘要号：8007英文标题:A phase 2 dose expansion study of ZG006, a trispecific T cell engager targeting CD3/DLL3/DLL3, as monotherapy in patients with advanced small cell lung cancer.中文标题:ZG006治疗晚期小细胞肺癌的II期剂量扩展研究：靶向CD3/DLL3/DLL3的三特异性T接合器单药疗法评估汇报者:艾星浩教授｜上海市胸科医院快速口头摘要会议非小细胞肺癌（NSCLC）摘要号：8012英文标题:The preliminary results of a randomized phase II trial evaluating induction toripalimab plus chemotherapy followed by concurrent chemoradiotherapy and consolidation toripalimab in bulky unresectable stage III non-small-cell lung cancer (InTRist).中文标题:InTRist研究：特瑞普利单抗联合化疗诱导治疗序贯同步放化疗+特瑞普利单抗巩固治疗用于不可切除、肿块型III期NSCLC的随机II期研究初步结果汇报者:Yu Wang 教授｜中国医学科学院北京协和医学院肿瘤医院摘要号：8514英文标题:Phase 3 study of benmelstobart in combination with chemotherapy followed by sequential combination with anlotinib for the first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC).中文标题:评估贝莫苏拜单抗联合化疗，序贯安罗替尼一线治疗局部晚期或转移性鳞状非小细胞肺癌（sq-NSCLC）的疗效的III期临床研究汇报者:石远凯教授｜中国医学科学院肿瘤医院摘要号：8516英文标题:Randomized trial of relevance of time-of-day of immunochemotherapy for progression-free and overall survival in patients with non-small cell lung cancer.中文标题:评估免疫化疗给药时间对非小细胞肺癌患者无进展生存期和总生存期影响的随机临床试验汇报者:张永昌教授｜湖南省肿瘤医院摘要号：8517英文标题:Hypoxia-responsive CEA CAR-T cells therapy for relapsed or refractory non-small cell lung cancer: A single-arm, open-label, phase I trial.中文标题:缺氧响应性CEA CAR-T细胞治疗复发或难治性非小细胞肺癌：一项单臂、开放标签的I期临床试验汇报者:魏双教授｜华中科技大学同济医学院附属同济医院摘要号：8520英文标题:Sosimerasib monotherapy in patients with previously treated KRAS G12C–mutated non-small cell lung cancer: Primary results of a phase 2 study.中文标题:Sosimerasib单药治疗KRAS G12C突变非小细胞肺癌的II期研究主要结果汇报者:王洁教授｜中国医学科学院肿瘤医院小细胞肺癌（SCLC）及其他胸部肿瘤摘要号：8017英文标题:Integrin αVβ3-targeted imaging for identification of lung cancer and mapping of lymph-node metastases: A prospective, multicenter, self-controlled phase 3 trial (TRIIL study).中文标题:靶向整合素αVβ3显像在肺癌识别及淋巴结转移图谱绘制中的应用：TRIIL前瞻性、多中心、自身对照III期研究汇报者:Rongxi Wang 教授｜北京协和医院临床科学研讨会非小细胞肺癌（NSCLC）摘要号：8509英文标题:First-in-class PD-1/IL-2 bispecific antibody IBI363 in patients (Pts) with advanced immunotherapy-treated non-small cell lung cancer (NSCLC).中文标题:IBI363（首创PD-1/IL-2双特异性抗体）治疗经免疫治疗后的晚期非小细胞肺癌患者汇报者:周建娅教授｜浙江大学医学院附属第一医院小细胞肺癌（SCLC）及其他胸部肿瘤摘要号：8510英文标题:Efficacy and safety of MHB088C, a novel B7-H3-targeted ADC, in patients with relapsed extensive-stage small cell lung cancer (ES-SCLC): Subgroup analysis from a phase 1/2 multicenter study.中文标题:一项关于MHB088C（新型B7-H3靶向ADC）治疗复发广泛期小细胞肺癌的疗效与安全性的I/II期多中心研究的亚组分析汇报者:沈琳教授｜北京大学肿瘤医院摘要号：8511英文标题:First report of efficacy and safety results from a phase 2 trial evaluating BNT327/PM8002 plus chemotherapy (chemo) as first-line treatment (1L) in unresectable malignant mesothelioma.中文标题:BNT327/PM8002联合化疗一线治疗不可切除恶性间皮瘤的II期临床试验初步疗效与安全性结果的首次报告汇报者:程颖教授｜吉林省肿瘤医院壁报环节非小细胞肺癌（NSCLC）摘要号：1557壁报编号：343英文标题:Biologically interpretable pathomics-driven transformer model with self-supervised training for outcome prediction of immunotherapy in non-small cell lung cancer.中文标题:一种基于生物可解释的病理组学驱动的自我监督训练的转换器模型，用于预测非小细胞肺癌免疫治疗的结果。汇报者:李步托教授 | 山东省肿瘤医院摘要号：2530壁报编号：177英文标题:Comprehensive analysis of NSAIDs use and oncological outcomes in non-small cell lung cancer patients treated with immune checkpoint inhibitors.中文标题:免疫检查点抑制剂治疗非小细胞肺癌患者非甾体抗炎药使用和肿瘤预后的综合分析。汇报者: Yanlin Li | 西安交通大学第二附属医院摘要号：2552壁报编号：199英文标题:Precision medicine research on chemo-immunotherapy combination treatment for locally advanced or metastatic non-small cell lung cancer based on deep plasma proteomics.中文标题:基于深度血浆蛋白质组学的局部晚期或转移性非小细胞肺癌化疗-免疫联合治疗的精准医学研究。汇报者: Qiuchi Chen | 华中科技大学同济医学院附属协和医院摘要号：2614壁报编号：261英文标题:Stereotactic radiotherapy plus immunotherapy and influence on prognosis in driver-gene–negative non-small cell lung cancer patients with brain oligo-metastases.中文标题:立体定向放疗加免疫治疗对驱动基因阴性非小细胞肺癌脑少转移患者预后的影响。汇报者: 宫晓梅教授 | 上海市肺科医院摘要号：2623壁报编号：270英文标题:Delineation of immunotherapeutic predictive versus prognostic transcriptional programs to identify SLC22A5-centric carnitine metabolism-driven resistance to anti-PD-L1 treatment in advanced non–small-cell lung cancer.中文标题:鉴定晚期非小细胞肺癌中免疫治疗预测性与预后性转录程序，揭示 SLC22A5 为中心的肉碱代谢驱动的抗 PD-L1 治疗耐药机制。汇报者: Yuze Wang | 中山大学附属第一医院摘要号：3075壁报编号：390英文标题:Efficacy and safety of distinct regimens for individuals with advanced EGFR-mutated non-small-cell lung cancer who progressed on EGFR tyrosine-kinase inhibitors: A systematic review and network meta-analysis.中文标题:不同方案对晚期EGFR突变的非小细胞肺癌患者的疗效和安全性：一项系统综述和网络荟萃分析。汇报者: 张文刚教授 | 上海市肺科医院摘要号：8021壁报编号：142英文标题:Adjuvant icotinib of 12 months versus observation as adjuvant therapy for completely resected EGFR-mutated stage IB non-small-cell lung cancer: 5-year update from CORIN (GASTO1003).中文标题:12个月的埃克替尼辅助治疗对比观察疗法辅助治疗完全切除的EGFR突变IB期NSCLC：CORIN研究（GASTO1003）的5年更新汇报者:王思愚教授｜中山大学孙逸仙纪念医院深汕中心医院摘要号：8024壁报编号：145英文标题:Ensartinib as postoperative adjuvant therapy in patients with ALK-positive non-small cell lung cancer (NSCLC): A registered, retrospective, real-world study.中文标题:恩沙替尼作为术后辅助治疗在ALK阳性NSCLC患者中的应用：一项注册的、回顾性的真实世界研究汇报者:汪麟教授｜中国医学科学院肿瘤医院摘要号：8025壁报编号：146英文标题:Molecular profiling of neoadjuvant immunochemotherapy and identification of residual cancer cells in pCR NSCLC: A single-cell analysis of CTONG 1804 clinical trial.中文标题:新辅助免疫化疗的分子特征分析及在病理完全缓解（pCR）的NSCLC中残留癌细胞的识别：CTONG 1804临床试验的单细胞分析汇报者:刘思阳教授 | 广东省人民医院摘要号：8043壁报编号：164英文标题:Safety and efficacy of radiotherapy combined with anlotinib in locally advanced non-small cell lung cancer patients intolerant to concurrent chemoradiotherapy: Preliminary result of a phase II clinical trial.中文标题:放疗联合安罗替尼治疗不能耐受同步放化疗的局部晚期NSCLC患者的疗效和安全性: 一项II期临床试验的初步结果汇报者:Yupei Yuan | 中国医学科学院肿瘤医院摘要号：8045壁报编号：166英文标题:Neoadjuvant immunotherapy and surgery in patients with stage IIIB-IIIC (N3) non-small cell lung cancer.中文标题:新辅助免疫治疗和手术用于IIIB-IIIC期（N3）NSCLC患者汇报者:Wen-Yu Zhai | 中山大学肿瘤防治中心摘要号：8049壁报编号：170英文标题:A prospective, single-arm, phase II study to evaluate the efficacy and safety of perioperative tislelizumab in resectable non-small-cell lung cancer (NSCLC).中文标题:一项用于评估替雷利珠单抗围术期治疗可切除NSCLC的疗效和安全性的前瞻性、单臂、II期研究汇报者:孙大强教授 | 天津市胸科医院摘要号：8062壁报编号：183英文标题:Differential prognostic significance of distant and locoregional recurrence on survival in surgically resected non-small cell lung cancer post-chemotherapy: Multicenter dynamic prediction with landmark model.中文标题:手术切除的NSCLC化疗后远处和局部复发对生存的差异预后意义: landmark模型的多中心动态预测。汇报者:马泽良教授 | 国家癌症中心摘要号：8063壁报编号：184英文标题:Neoadjuvant hypofractionated radiotherapy plus tislelizumab with anlotinib followed by adjuvant tislelizumab with anlotinib in patients with resectable non-small cell lung cancer (NSCLC): Preliminary analysis of a phase II trial (NEO-PIONEER).中文标题:可切除NSCLC患者接受新辅助低分次放疗联合替雷利珠单抗和安罗替尼治疗，随后进行替雷利珠单抗和安罗替尼辅助治疗：II期NEO-PIONEER研究的初步分析。汇报者:方敏教授 | 浙江省肿瘤医院摘要号：8073壁报编号：194英文标题:Sequential versus concurrent strategy of immunotherapy and radiotherapy in advanced non-small-cell lung cancer: A territory-wide multicenter study (OCEANUS study).中文标题:晚期NSCLC免疫治疗和放疗的序贯与同期策略：一项全地区多中心研究（OCEANUS研究）。汇报者:Han Zhou | 香港大学深圳医院摘要号：8076壁报编号：197英文标题:A retrospective study of induction immunochemotherapy followed by definitive chemoradiotherapy and consolidation immunotherapy in unresectable locally advanced non-small cell lung cancer.中文标题:一项关于不可切除的局部晚期NSCLC的回顾性研究：诱导免疫化疗后进行根治性放化疗和巩固免疫治疗。汇报者:Yuliang Meng | 山东省肿瘤医院摘要号：8529壁报编号：9英文标题:Sacituzumab tirumotecan (sac-TMT) in combination with tagitanlimab (anti-PD-L1) in first-line (1L) advanced non-small-cell lung cancer (NSCLC): Non-squamous cohort from the phase II OptiTROP-Lung01 study.中文标题:芦康沙妥珠单抗 (sac-TMT) 联合塔戈利单抗(抗PD-L1) 一线治疗晚期NSCLC：II期 OptiTROP-Lung01 研究的非鳞状细胞亚组分析。汇报者:方文峰教授 | 中山大学肿瘤防治中心摘要号：8531壁报编号：11英文标题:Tumor-derived ILT5 and suppression of T cell immunity in non-small cell lung cancer.中文标题:肿瘤来源的ILT5及其在NSCLC中对T细胞免疫的抑制。汇报者:Xuebing Fu | 山东省肿瘤医院摘要号：8542壁报编号：22英文标题:Prediction of site-specific immune-related adverse events of PD-L1 blockade in advanced non-small cell lung cancer through baseline organ-metastatic landscape: Pooled post-hoc analyses of two randomized controlled trials.中文标题:通过基线器官转移情况预测晚期NSCLC癌患者在PD-L1阻断治疗过程中发生部位特异性免疫相关不良事件：两项随机对照试验的汇总事后分析。汇报者:Si-Heng Wang | 中山大学附属第一医院摘要号：8543壁报编号：23英文标题:A phase II trial to evaluate the safety and efficacy of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, as a monotherapy in patients with advanced NSCLC.中文标题:一项评估靶向PD-1和VEGF的双特异性抗体SSGJ-707单药治疗晚期NSCLC患者的疗效和安全性的II期临床试验。汇报者:邬麟教授 | 湖南省肿瘤医院摘要号：8546壁报编号：26英文标题:Association between pretreatment emotional distress and survival outcomes in patients with advanced non–small-cell lung cancer: An individual patient data meta-analysis of 4632 patients in 7 trials.中文标题:晚期NSCLC患者治疗前情绪困扰与生存结果之间的关联：基于7项试验中4632例患者的个体患者数据的荟萃分析。汇报者:周建国教授 | 遵义医科大学第二附属医院摘要号：8548壁报编号：28英文标题:Camrelizumab combined with 2 cycles of chemotherapy as first-line treatment for advanced non-small cell lung cancer (NSCLC): A two-arm, single-center, phase 2 study.中文标题:卡瑞利珠单抗联合2个周期化疗一线治疗晚期NSCLC：一项双组单中心II期研究。汇报者:刘红兵教授 | 南京医科大学第二附属医院摘要号：8553壁报编号：33英文标题:Circulating CD28-KLRG1+CD8+ T cells as prognostic indicators in advanced NSCLC chemoimmunotherapy.中文标题:循环CD28-KLRG1+CD8+ T细胞作为晚期NSCLC化学免疫治疗的预后指标。汇报者:颜次慧教授 | 天津医科大学肿瘤医院摘要号：8559壁报编号：39英文标题:Predictive value of circulating tumor DNA detection for long-term survival in patients with advanced lung cancer undergoing chemoimmunotherapy.中文标题:循环肿瘤DNA检测对于接受化学免疫治疗的晚期肺癌患者长期生存的预测价值。汇报者:李晖教授 | 浙江省肿瘤医院摘要号：8560壁报编号：40英文标题:Phase 2 study of pembrolizumab (pembro) plus plinabulin (plin) and docetaxel (doc) for patients (pts) with metastatic NSCLC after progression on first-line immune checkpoint inhibitor alone or combination therapy: Initial efficacy and safety results on immune re-sensitization.中文标题:帕博利珠单抗联合普那布林和多西他赛治疗在一线免疫检查点抑制剂单独或联合治疗后出现进展的转移性NSCLC患者的II期研究：免疫再致敏的初步疗效和安全性结果。汇报者:徐雁教授 | 中国医学科学院北京协和医院摘要号：8561壁报编号：41英文标题:A phase 2 study of HLX07 plus serplulimab with or without chemotherapy versus serplulimab plus chemotherapy as first-line therapy in advanced squamous non-small cell lung cancer.中文标题:HLX07联合斯鲁利单抗加或不加化疗对比斯鲁利单抗联合化疗一线治疗晚期鳞状NSCLC的II期研究果。汇报者:吴一龙教授 | 广东省人民医院摘要号：8564壁报编号：44英文标题:Efficacy and safety of metronomic oral vinorelbine combined with PD-1 inhibitors as first-line therapy in advanced non-small-cell lung cancer in elderly patients.中文标题:口服长程低剂量长春瑞滨联合PD-1抑制剂作为老年晚期NSCLC患者一线治疗的疗效和安全性。汇报者:Yumeng Tian | 北京大学肿瘤医院摘要号：8570壁报编号：50英文标题:SMET12 and toripalimab combined chemotherapy in patients with advanced non-small cell lung cancer who are treatment-naive or have developed resistance to standard therapy.中文标题:SMET12和特瑞普利单抗联合化疗用于初治或对标准治疗产生耐药的晚期NSCLC患者。汇报者:林景辉教授 | 福建省肿瘤医院摘要号：8571壁报编号：51英文标题:Exploratory study on the impact of intestinal low-dose radiation on the efficacy and prognosis of immunotherapy in metastatic non-small cell lung cancer.中文标题:探讨肠道低剂量放疗对转移性NSCLC免疫治疗疗效及预后的影响。汇报者:Baiyang Huang | 山东省肿瘤医院摘要号：8573壁报编号：53英文标题:First-line envafolimab in combination with recombinant human endostatin and chemotherapy for advanced squamous non-small cell lung cancer: Updated results from a prospective, single-arm, multicenter phase II study.中文标题:恩沃利单抗联合重组人血管内皮抑制素和化疗用于晚期鳞状NSCLC的一线治疗：来自一项前瞻性、单组、多中心 II 期研究的更新结果。汇报者:刘联教授 | 山东大学齐鲁医院摘要号：8600壁报编号：80英文标题:A retrospective study of anlotinib plus third-generation EGFR-TKIs in advanced non-small cell lung cancer with gradual or oligo progression after EGFR-TKIs treatment (ALTER-L058).中文标题:安罗替尼联合第三代EGFR-TKIs治疗在接受过EGFR-TKIs治疗后出现渐进性或寡进展的晚期NSCLC的回顾性研究（ALTER-L058）。汇报者:周彩存教授 | 同济大学附属东方医院摘要号：8601壁报编号：81英文标题:First-in-human phase I/II study of BYS10 in patients (pts) with locally advanced or metastatic RET-altered solid tumors: Preliminary dose escalation results.中文标题:BYS10在局部晚期或转移性RET突变的实体瘤患者中的首次人类I/II期研究：初步剂量递增结果。汇报者:王洁教授 | 中国医学科学院肿瘤医院摘要号：8602壁报编号：82英文标题:Dysregulation of DNA damage repair in lung cancer driven by MTAP loss: Mechanistic insights and target discovery.中文标题:MTAP缺失导致的肺癌DNA损伤修复失调：机制和靶点发现。汇报者:姜波教授 | 中山大学附属第八医院摘要号：8609壁报编号：89英文标题:High-dose furmonertinib combined with bevacizumab and pemetrexed in non-small cell lung cancer patients with?EGFR?mutations and leptomeningeal metastasis: A prospective real-world study.中文标题:高剂量伏美替尼联合贝伐珠单抗和培美曲塞用于伴有EGFR突变和脑膜转移的NSCLC患者：一项前瞻性真实世界研究。汇报者:Qi Zhao | 河南省肿瘤医院摘要号：8615壁报编号：95英文标题:Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutations: Preliminary results from a phase 2 study.中文标题:芦康沙妥珠单抗 (sac-TMT) 治疗既往接受过治疗且携带罕见EGFR突变的局部晚期或转移性NSCLC患者：一项II期研究的初步结果。汇报者:张力教授 | 中山大学肿瘤防治中心摘要号：8616壁报编号：96英文标题:Phase I/II study of DZD6008, a 4th-generation EGFR TKI with full BBB penetration, in EGFR-mutant NSCLC.中文标题:具有完全穿透血脑屏障能力的第四代EGFR-TKI DZD6008在EGFR突变NSCLC中的I/II期研究。汇报者:王孟昭教授 | 中国医学科学院北京协和医院摘要号：8627壁报编号：107英文标题:Osimertinib plus anlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer with concurrent gene alterations: A single-arm, prospective, multicenter phase II study.中文标题:奥希替尼联合安洛替尼治疗未治疗、EGFR突变、合并基因改变的晚期NSCLC患者：一项单组、前瞻性、多中心的II期研究。汇报者:Xiaojun Yang | 东莞市人民医院摘要号：8629壁报编号：109英文标题:Safety and efficacy of ifebemtinib (IN10018) combined with garsorasib (D-1553) in KRAS G12C mutant solid tumors from a phase Ib/II study: Results from single-arm of non-small-cell lung cancer (NSCLC) and randomized part of colorectal cancer (CRC).中文标题:Ifebermtinib（IN10018）联合garsorasib（D-1553）治疗 KRAS G12C突变实体瘤的Ib/II 期研究安全性和有效性：非小细胞肺癌（NSCLC）单臂及结直肠癌（CRC）随机部分结果。汇报者:王在琪博士 | 应世生物科技（上海）有限公司摘要号：8632壁报编号：112英文标题:Vebreltinib plus PLB1004 in EGFR-mutated NSCLC with acquired MET amplification or overexpression after failure on EGFR-TKI treatment: A phase Ib/II study.中文标题:伯瑞替尼联合PLB1004用于在EGFR-TKI治疗失败后伴随获得性MET扩增或过表达的EGFR突变NSCLC患者：一项Ib/II期研究。汇报者:周斐教授 | 上海市东方医院摘要号：8637壁报编号：117英文标题:Efficacy and omics-based insights of TROP2 ADC in non–small cell lung cancer with or without actionable genomic alterations (AGAs).中文标题:TROP2 ADC在具有或不具有可操作基因组改变 (AGAs) 的NSCLC中的疗效和基于组学的见解。汇报者:李岸霖教授 | 中山大学肿瘤防治中心摘要号：8638壁报编号：118英文标题:Real-world data on the efficacy and safety of iruplinalkib (WX-0593) in ALK-positive advanced lung adenocarcinoma patients previously treated with lorlatinib.中文标题:伊鲁阿克（WX-0593）治疗既往接受过洛拉替尼治疗的ALK阳性晚期肺腺癌患者的疗效和安全性的真实世界数据。汇报者:王芬教授 | 北京大学深圳医院摘要号：TPS8647壁报编号：127a英文标题:TROPION-Lung14: A phase 3 study of osimertinib ± datopotamab deruxtecan (Dato-DXd) as first-line (1L) treatment for patients with EGFR-mutated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC).中文标题:TROPION-Lung14：一项关于奥希替尼 ± datopotamab deruxtecan (Dato-DXd)作为EGFR突变局部晚期或转移性NSCLC患者一线治疗的III期研究。汇报者:陆舜教授 | 上海市胸科医院摘要号：TPS8661壁报编号：134a英文标题:A multicenter, open-label, single-arm phase I/II study to assess the efficacy and safety of WSD0922-FU in patients with EGFR C797Sm+ advanced non-small cell lung cancer (NSCLC) in China (NCT06631989).中文标题:WSD0922-FU治疗EGFR C797Sm+晚期非小细胞肺癌（NSCLC）中国患者的多中心开放标签单臂I/II期研究（NCT06631989）。汇报者:钟卫博士 | 威尚(上海)生物医药摘要号：10556壁报编号：281英文标题:Lung cancer combined with interstitial lung disease: Controversial role of preexisting hypertension and emphysema observed in a fully followed 20-year patient cohort.中文标题:肺癌合并间质性肺疾病：20年完整随访队列中高血压和肺气肿的争议性作用。汇报者:王志超教授 | 南京中医药大学附属医院小细胞肺癌（SCLC）及其他胸部肿瘤摘要号：3036壁报编号：351英文标题:Results from a phase 1/2 study of 7MW3711: A novel B7-H3 antibody-drug conjugate (ADC) incorporating a topoisomerase I inhibitor in patients with lung cancer.中文标题:7MW3711，一种含有拓扑异构酶I抑制剂的新型B7-H3抗体-药物偶联物（ADC）用于肺癌患者的1/2期研究结果。汇报者:李子明教授 | 上海市胸科医院摘要号：2549壁报编号：196英文标题:An exploratory study to predict the efficacy and prognosis of immunotherapy for extensive-stage small cell lung cancer based on peripheral blood dynamic immune profiles.中文标题:基于外周血动态免疫谱预测广泛期小细胞肺癌免疫治疗疗效和预后的探索性研究。汇报者:邬麟教授 | 湖南省肿瘤医院摘要号：2566壁报编号：213英文标题:Identifying peripheral cancer-associated TCR signals for the early-detection of lung cancer.中文标题:鉴别外周肿瘤相关TCR信号用于肺癌的早期检测。汇报者:陈皇教授 | 中日友好医院摘要号：8030壁报编号：151英文标题:Genomic and immunophenotypic landscape of early-stage pulmonary carcinoid tumors.中文标题:早期肺类癌肿瘤的基因组和免疫表型特征汇报者:苏春霞教授 | 上海市肺科医院摘要号：8044壁报编号：165英文标题:Clinical characteristics and prognosis of pulmonary lymphoepithelioma-like carcinoma: A multicentre retrospective study.中文标题:肺淋巴上皮瘤样癌的临床特征和预后：一项多中心回顾性研究汇报者:Zan Hou | 四川省肿瘤医院摘要号：8055壁报编号：176英文标题:Lung cancer screening in high-risk never-smokers with artificial intelligence (LC-SHIELD study).中文标题:使用人工智能对高危从不吸烟者进行肺癌筛查（LC-SHIELD研究）汇报者:Molly SC Li | 香港中文大学摘要号：8057壁报编号：178英文标题:Enhancing early detection of lung cancer: Methylation anchor probe for low-signal enrichment (MAPLE).中文标题:增强肺癌的早期检测: 低信号富集的甲基化锚定探针 (MAPLE)汇报者:钟文昭教授 | 广东省人民医院摘要号：8089壁报编号：210英文标题:A phase 1 dose escalation and expansion study of ZG006, a trispecific T cell engager targeting CD3/DLL3/DLL3, as monotherapy in patients with refractory small cell lung cancer or neuroendocrine carcinoma.中文标题:ZG006，一种靶向CD3/DLL3/DLL3的三特异性T细胞接合器，用于难治性小细胞肺癌或神经内分泌癌的单药治疗。汇报者:王启鸣教授 | 河南省肿瘤医院摘要号：8090壁报编号：211英文标题:Efficacy and safety of envafolimab plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer: A prospective, single-arm, phase II trial.中文标题:恩沃利单抗联合卡铂和依托泊苷一线治疗广泛期ES-SCLC的疗效和安全性：一项前瞻性、单臂、II期试验。汇报者:孙胜杰教授 | 中国人民解放军总医院摘要号：8093壁报编号：214英文标题:Serplulimab versus placebo plus chemotherapy as first-line treatment for extensive-stage small-cell lung cancer: Efficacy and safety from the end-of-study analysis of the international phase 3 ASTRUM-005 study.中文标题:斯鲁利单抗联合化疗对比安慰剂联合化疗作为ES-SCLC一线治疗：国际III期ASTRUM-005研究的终止研究分析中的疗效和安全性。汇报者:程颖教授 | 吉林省肿瘤医院摘要号：8097壁报编号：218英文标题:Efficacy and safety of HTMC0435 combination with temozolomide in relapsed extensive-stage small-cell lung cancer (ES-SCLC): A phase Ib/II study.中文标题:HTMC0435联合替莫唑胺治疗复发性广泛期小细胞肺癌（ES-SCLC）的疗效和安全性：Ib/II期研究。汇报者:范云教授 | 浙江省肿瘤医院摘要号：8101壁报编号：222英文标题:Multi-omic analysis and overall survival update of phase II TRIDENT study: Durvalumab plus olaparib in extensive-stage small-cell lung cancer (ES-SCLC).中文标题:II期TRIDENT研究的多组学分析和总体生存更新：度伐利尤单抗联合奥拉帕利治疗ES-SCLC。汇报者:赵媛媛教授 | 中山大学肿瘤防治中心摘要号：8105壁报编号：226英文标题:Association of IFITM3 with the efficacy of anti-PD1/PD-L1 therapy and regulation of immunosensitivity via MHC-I regulation in SCLC.中文标题:IFITM3与SCLC中抗PD1/PD-L1治疗疗效的关联及其通过MHC-I调节免疫敏感性的机制汇报者:任胜祥教授 | 同济大学附属上海市肺科医院摘要号：8109壁报编号：230英文标题:A prospective, single-arm, phase II trial of adebrelimab plus nab-paclitaxel and carboplatin in patients with unresectable advanced metastatic or recurrent thymic carcinomas.中文标题:阿得贝利单抗联合白蛋白结合型紫杉醇和卡铂治疗不可切除的晚期转移性或复发性胸腺癌的前瞻性、单臂、II期临床研究。汇报者:许宁教授 | 上海市胸科医院摘要号：8110壁报编号：231英文标题:Combining SBRT with GM-CSF and peg-IFNα to induce abscopal effects in previously treated patients with stage IV thymic tumors: A single arm, single center, phase II trial.中文标题:将立体定向体部放射治疗（SBRT）与粒细胞-巨噬细胞集落刺激因子（GM-CSF）和聚乙二醇干扰素α（peg-IFNα）结合诱导经治IV期胸腺肿瘤患者的远隔效应：单臂、单中心、II期试验。汇报者:樊旼教授 | 复旦大学附属肿瘤医院大会官网：https://conferences.asco.org/am/program排名不分先后，按照摘要类别划分；如有遗漏或任何问题，请后台留言（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。

临床结果ASCO会议临床3期抗体药物偶联物

2025-04-28

·肿瘤界

2025 ASCO | 40余项中国研究入选！肺癌壁报专区一文速览

点击蓝字关注我们前言作为肿瘤学领域的国际盛会，ASCO年会每年都吸引着来自世界各地的顶尖学者、临床专家与科研团队，共同分享最新研究成果、探讨创新疗法、展望未来趋势。随着2025年ASCO年会完整日程的正式公布，全球肿瘤学界的目光再次聚焦于此。在这场学术盛宴中，肺癌领域的中国研究入选46项。汇总如下，让我们先睹为快！摘要号：8021壁报编号：142研究名称（英文）：Adjuvant icotinib of 12 months versus observation as adjuvant therapy for completely resected EGFR-mutated stage IB non-small-cell lung cancer: 5-year update from CORIN (GASTO1003).研究名称（中文）：12个月的埃克替尼辅助治疗对比观察疗法辅助治疗完全切除的EGFR突变IB期NSCLC：CORIN研究（GASTO1003）的5年更新讲者：王思愚中山大学孙逸仙纪念医院深汕中心医院摘要号：8024壁报编号：145研究名称（英文）：Ensartinib as postoperative adjuvant therapy in patients with ALK-positive non-small cell lung cancer (NSCLC): A registered, retrospective, real-world study.研究名称（中文）：恩沙替尼作为术后辅助治疗在ALK阳性NSCLC患者中的应用：一项注册的、回顾性的真实世界研究讲者：Lin Wang 国家癌症中心摘要号：8025壁报编号：146研究名称（英文）：Molecular profiling of neoadjuvant immunochemotherapy and identification of residual cancer cells in pCR NSCLC: A single-cell analysis of CTONG 1804 clinical trial. 新辅助免疫化疗的分子特征分析及在病理完全缓解（pCR）的NSCLC中残留癌细胞的识别：CTONG 1804临床试验的单细胞分析讲者：SiYang Maggie Liu 广东省肺癌研究所摘要号：8030壁报编号：151研究名称（英文）：Genomic and immunophenotypic landscape of early-stage pulmonary carcinoid tumors.研究名称（中文）：早期肺类癌肿瘤的基因组和免疫表型特征讲者：苏春霞同济大学附属上海市肺科医院摘要号：8043壁报编号：164研究名称（英文）：Safety and efficacy of radiotherapy combined with anlotinib in locally advanced non-small cell lung cancer patients intolerant to concurrent chemoradiotherapy: Preliminary result of a phase II clinical trial.研究名称（中文）：放疗联合安罗替尼治疗不能耐受同步放化疗的局部晚期NSCLC患者的疗效和安全性: 一项II期临床试验的初步结果讲者：Yupei Yuan 中国医学科学院肿瘤医院摘要号：8044壁报编号：165研究名称（英文）：Clinical characteristics and prognosis of pulmonary lymphoepithelioma-like carcinoma: A multicentre retrospective study.研究名称（中文）：肺淋巴上皮瘤样癌的临床特征和预后：一项多中心回顾性研究讲者：Zan Hou 四川省肿瘤医院摘要号：8045壁报编号：166研究名称（英文）：Neoadjuvant immunotherapy and surgery in patients with stage IIIB-IIIC (N3) non-small cell lung cancer.研究名称（中文）：新辅助免疫治疗和手术用于IIIB-IIIC期（N3）NSCLC患者讲者：Wen-Yu Zhai 中山大学肿瘤防治中心摘要号：8049壁报编号：170研究名称（英文）：A prospective, single-arm, phase II study to evaluate the efficacy and safety of perioperative tislelizumab in resectable non-small-cell lung cancer (NSCLC)研究名称（中文）：一项用于评估替雷利珠单抗围术期治疗可切除NSCLC的疗效和安全性的前瞻性、单臂、II期研究讲者：孙大强天津市胸科医院摘要号：8055壁报编号：176研究名称（英文）：Lung cancer screening in high-risk never-smokers with artificial intelligence (LC-SHIELD study).研究名称（中文）：使用人工智能对高危从不吸烟者进行肺癌筛查（LC-SHIELD研究）讲者：Molly SC Li 香港中文大学摘要号：8057壁报变化：178研究名称（英文）：Enhancing early detection of lung cancer: Methylation anchor probe for low-signal enrichment (MAPLE).研究名称（中文）：增强肺癌的早期检测: 低信号富集的甲基化锚定探针 (MAPLE)讲者：钟文昭广东省肺癌研究所摘要号：8062壁报编号：183研究名称（英文）：Differential prognostic significance of distant and locoregional recurrence on survival in surgically resected non-small cell lung cancer post-chemotherapy: Multicenter dynamic prediction with landmark model.研究名称（中文）：手术切除的NSCLC化疗后远处和局部复发对生存的差异预后意义: landmark模型的多中心动态预测讲者：Zeliang Ma 国家癌症中心摘要号：8063壁报编号：184研究名称（英文）：Neoadjuvant hypofractionated radiotherapy plus tislelizumab with anlotinib followed by adjuvant tislelizumab with anlotinib in patients with resectable non-small cell lung cancer (NSCLC): Preliminary analysis of a phase II trial (NEO-PIONEER).研究名称（中文）：可切除NSCLC患者接受新辅助低分次放疗联合替雷利珠单抗和安罗替尼治疗，随后进行替雷利珠单抗和安罗替尼辅助治疗：II期NEO-PIONEER研究的初步分析讲者：方敏浙江省肿瘤医院摘要号：8073壁报编号：194研究名称（英文）：Sequential versus concurrent strategy of immunotherapy and radiotherapy in advanced non-small-cell lung cancer: A territory-wide multicenter study (OCEANUS study).研究名称（中文）：晚期NSCLC免疫治疗和放疗的序贯与同期策略：一项全地区多中心研究（OCEANUS研究）讲者：Han Zhou 香港大学深圳医院摘要号：8076壁报编号：197研究名称（英文）：A retrospective study of induction immunochemotherapy followed by definitive chemoradiotherapy and consolidation immunotherapy in unresectable locally advanced non-small cell lung cancer.研究名称（中文）：一项关于不可切除的局部晚期NSCLC的回顾性研究：诱导免疫化疗后进行根治性放化疗和巩固免疫治疗讲者：Yuliang Meng 山东省肿瘤医院摘要号：8090壁报编号：211研究名称（英文）：Efficacy and safety of envafolimab plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer: A prospective, single-arm, phase II trial.研究名称（中文）：恩沃利单抗联合卡铂和依托泊苷一线治疗广泛期ES-SCLC的疗效和安全性：一项前瞻性、单臂、II期试验讲者：孙胜杰解放军总医院摘要号：8093壁报编号：214研究名称（英文）：Serplulimab versus placebo plus chemotherapy as first-line treatment for extensive-stage small-cell lung cancer: Efficacy and safety from the end-of-study analysis of the international phase 3 ASTRUM-005 study.研究名称（中文）：斯鲁利单抗联合化疗对比安慰剂联合化疗作为ES-SCLC一线治疗：国际III期ASTRUM-005研究的终止研究分析中的疗效和安全性讲者：程颖吉林省肿瘤医院摘要号：8097壁报编号：218研究名称（英文）：Efficacy and safety of HTMC0435 combination with temozolomide in relapsed extensive-stage small-cell lung cancer (ES-SCLC): A phase Ib/II study.研究名称（中文）：HTMC0435联合替莫唑胺治疗复发性ES-SCLC)的疗效和安全性: Ib/II期研究讲者：范云浙江省肿瘤医院摘要号：8101壁报编号：222研究名称（英文）：Multi-omic analysis and overall survival update of phase II TRIDENT study: Durvalumab plus olaparib in extensive-stage small-cell lung cancer (ES-SCLC).研究名称（中文）：II期TRIDENT研究的多组学分析和总体生存更新：度伐利尤单抗联合奥拉帕利治疗ES-SCLC讲者：赵媛媛中山大学肿瘤防治中心摘要号：8105壁报编号：226研究名称（英文）：Association of IFITM3 with the efficacy of anti-PD1/PD-L1 therapy and regulation of immunosensitivity via MHC-I regulation in SCLC.研究名称（中文）：IFITM3与SCLC中抗PD1/PD-L1治疗疗效的关联及其通过MHC-I调节免疫敏感性的机制讲者：任胜祥同济大学附属上海市肺科医院摘要号：8109壁报编号：230研究名称（英文）：A prospective, single-arm, phase II trial of adebrelimab plus nab-paclitaxel and carboplatin in patients with unresectable advanced metastatic or recurrent thymic carcinomas.研究名称（中文）：阿得贝利单抗联合白蛋白结合型紫杉醇和卡铂治疗不可切除的晚期转移性或复发性胸腺癌的前瞻性、单臂、II期临床研究讲者：许宁上海市胸科医院摘要号：8110壁报编号：231研究名称（英文）：Combining SBRT with GM-CSF and peg-IFNα to induce abscopal effects in previously treated patients with stage IV thymic tumors: A single arm, single center, phase II trial.研究名称（中文）：将立体定向体部放射治疗（SBRT）与粒细胞-巨噬细胞集落刺激因子（GM-CSF）和聚乙二醇干扰素α（peg-IFNα）结合诱导经治IV期胸腺肿瘤患者的远隔效应：单臂、单中心、II期试验讲者：樊旼复旦大学附属肿瘤医院摘要号：8529壁报编号：9研究名称（英文）：Sacituzumab tirumotecan (sac-TMT) in combination with tagitanlimab (anti-PD-L1) in first-line (1L) advanced non-small-cell lung cancer (NSCLC): Non-squamous cohort from the phase II OptiTROP-Lung01 study.研究名称（中文）：芦康沙妥珠单抗 (sac-TMT) 联合塔戈利单抗(抗PD-L1) 一线治疗晚期NSCLC：II期 OptiTROP-Lung01 研究的非鳞状细胞亚组分析讲者：方文峰中山大学肿瘤防治中心摘要号：8531壁报编号：11研究名称（英文）：Tumor-derived ILT5 and suppression of T cell immunity in non-small cell lung cancer.研究名称（中文）：肿瘤来源的ILT5及其在NSCLC中对T细胞免疫的抑制讲者：Xuebing Fu 山东省肿瘤医院摘要号：8542壁报编号：22研究名称（英文）：Prediction of site-specific immune-related adverse events of PD-L1 blockade in advanced non-small cell lung cancer through baseline organ-metastatic landscape: Pooled post-hoc analyses of two randomized controlled trials.研究名称（中文）：通过基线器官转移情况预测晚期NSCLC癌患者在PD-L1阻断治疗过程中发生部位特异性免疫相关不良事件：两项随机对照试验的汇总事后分析讲者：Si-Heng Wang 中山大学附属第一医院摘要号：8543壁报编号：23研究名称（英文）：A phase II trial to evaluate the safety and efficacy of SSGJ-707, a bispecific antibody targeting PD-1 and VEGF, as a monotherapy in patients with advanced NSCLC研究名称（中文）：一项评估靶向PD-1和VEGF的双特异性抗体SSGJ-707单药治疗晚期NSCLC患者的疗效和安全性的II期临床试验讲者：邬麟湖南省肿瘤医院摘要号：8546壁报编号：26研究名称（英文）：Association between pretreatment emotional distress and survival outcomes in patients with advanced non–small-cell lung cancer: An individual patient data meta-analysis of 4632 patients in 7 trials.研究名称（中文）：晚期NSCLC患者治疗前情绪困扰与生存结果之间的关联：基于7项试验中4632例患者的个体患者数据的荟萃分析讲者：周建国遵义医科大学第二附属医院摘要号：8548壁报编号：28研究名称（英文）：Camrelizumab combined with 2 cycles of chemotherapy as first-line treatment for advanced non-small cell lung cancer (NSCLC): A two-arm, single-center, phase 2 study.研究名称（中文）：卡瑞利珠单抗联合2个周期化疗一线治疗晚期NSCLC：一项双组单中心II期研究讲者：刘红兵南京医科大学第二附属医院摘要号：8553壁报编号：33研究名称（英文）：Circulating CD28-KLRG1+CD8+ T cells as prognostic indicators in advanced NSCLC chemoimmunotherapy.研究名称（中文）：循环CD28-KLRG1+CD8+ T细胞作为晚期NSCLC化学免疫治疗的预后指标讲者：颜次慧天津医科大学肿瘤医院摘要号：8559壁报编号：39研究名称（英文）：Predictive value of circulating tumor DNA detection for long-term survival in patients with advanced lung cancer undergoing chemoimmunotherapy研究名称（中文）：循环肿瘤DNA检测对于接受化学免疫治疗的晚期肺癌患者长期生存的预测价值讲者：李晖浙江省肿瘤医院摘要号：8560壁报编号：40研究名称（英文）：Phase 2 study of pembrolizumab (pembro) plus plinabulin (plin) and docetaxel (doc) for patients (pts) with metastatic NSCLC after progression on first-line immune checkpoint inhibitor alone or combination therapy: Initial efficacy and safety results on immune re-sensitization.研究名称（中文）：帕博利珠单抗联合普那布林和多西他赛治疗在一线免疫检查点抑制剂单独或联合治疗后出现进展的转移性NSCLC患者的II期研究：免疫再致敏的初步疗效和安全性结果讲者：徐雁中国医学科学院北京协和医院摘要号：8561壁报编号：41研究名称（英文）：A phase 2 study of HLX07 plus serplulimab with or without chemotherapy versus serplulimab plus chemotherapy as first-line therapy in advanced squamous non-small cell lung cancer.研究名称（中文）：HLX07联合斯鲁利单抗加或不加化疗对比斯鲁利单抗联合化疗一线治疗晚期鳞状NSCLC的II期研究讲者：吴一龙广东省人民医院摘要号：8564壁报编号：44研究名称（英文）：Efficacy and safety of metronomic oral vinorelbine combined with PD-1 inhibitors as first-line therapy in advanced non-small-cell lung cancer in elderly patients.研究名称（中文）：口服长程低剂量长春瑞滨联合PD-1抑制剂作为老年晚期NSCLC患者一线治疗的疗效和安全性讲者：Yumeng Tian 北京大学肿瘤医院摘要号：8570壁报编号：50研究名称（英文）：SMET12 and toripalimab combined chemotherapy in patients with advanced non-small cell lung cancer who are treatment-naive or have developed resistance to standard therapy研究名称（中文）：SMET12和特瑞普利单抗联合化疗用于初治或对标准治疗产生耐药的晚期NSCLC患者讲者：林景辉福建省肿瘤医院摘要号：8571壁报编号：51研究名称（英文）：Exploratory study on the impact of intestinal low-dose radiation on the efficacy and prognosis of immunotherapy in metastatic non-small cell lung cancer.研究名称（中文）：探讨肠道低剂量放疗对转移性NSCLC免疫治疗疗效及预后的影响讲者：Baiyang Huang 山东省肿瘤医院摘要号：8573壁报编号：53研究名称（英文）：First-line envafolimab in combination with recombinant human endostatin and chemotherapy for advanced squamous non-small cell lung cancer: Updated results from a prospective, single-arm, multicenter phase II study.研究名称（中文）：恩沃利单抗联合重组人血管内皮抑制素和化疗用于晚期鳞状NSCLC的一线治疗：来自一项前瞻性、单组、多中心 II 期研究的更新结果讲者：刘联山东大学齐鲁医院摘要号：8600壁报编号：80研究名称（英文）：A retrospective study of anlotinib plus third-generation EGFR-TKIs in advanced non-small cell lung cancer with gradual or oligo progression after EGFR-TKIs treatment (ALTER-L058). 安罗替尼联合第三代EGFR-TKIs治疗在接受过EGFR-TKIs治疗后出现渐进性或寡进展的晚期NSCLC的回顾性研究（ALTER-L058）讲者：周彩存同济大学附属东方医院摘要号：8601壁报编号：81研究名称（英文）：First-in-human phase I/II study of BYS10 in patients (pts) with locally advanced or metastatic RET-altered solid tumors: Preliminary dose escalation results.研究名称（中文）：BYS10在局部晚期或转移性RET突变的实体瘤患者中的首次人类I/II期研究：初步剂量递增结果讲者：王洁中国医学科学院肿瘤医院摘要号：8602壁报编号：82研究名称（英文）：Dysregulation of DNA damage repair in lung cancer driven by MTAP loss: Mechanistic insights and target discovery. MTAP缺失导致的肺癌DNA损伤修复失调：机制和靶点发现讲者：Bo Jiang 中山大学附属第八医院摘要号：8609壁报编号：89研究名称（英文）：High-dose furmonertinib combined with bevacizumab and pemetrexed in non-small cell lung cancer patients with EGFR mutations and leptomeningeal metastasis: A prospective real-world study.研究名称（中文）：高剂量伏美替尼联合贝伐珠单抗和培美曲塞用于伴有EGFR突变和脑膜转移的NSCLC患者：一项前瞻性真实世界研究讲者：Qi Zhao 河南省肿瘤医院摘要号：8615壁报编号：95研究名称（英文）：Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutations: Preliminary results from a phase 2 study.研究名称（中文）：芦康沙妥珠单抗 (sac-TMT) 治疗既往接受过治疗且携带罕见EGFR突变的局部晚期或转移性NSCLC患者：一项II期研究的初步结果讲者：张力中山大学肿瘤防治中心摘要号：8616壁报编号：96研究名称（英文）：Phase I/II study of DZD6008, a 4th-generation EGFR TKI with full BBB penetration, in EGFR-mutant NSCLC.研究名称（中文）：具有完全穿透血脑屏障能力的第四代EGFR-TKI DZD6008在EGFR突变NSCLC中的I/II期研究讲者：王孟昭中国医学科学院北京协和医院摘要号：8627壁报编号：107 Osimertinib plus anlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer with concurrent gene alterations: A single-arm, prospective, multicenter phase II study.研究名称（中文）：奥希替尼联合安洛替尼治疗未治疗、EGFR突变、合并基因改变的晚期NSCLC患者：一项单组、前瞻性、多中心的II期研究讲者：Xiaojun Yang 东莞市人民医院摘要号：8632壁报编号：112研究名称（英文）：Vebreltinib plus PLB1004 in EGFR-mutated NSCLC with acquired MET amplification or overexpression after failure on EGFR-TKI treatment: A phase Ib/II study.研究名称（中文）：伯瑞替尼联合PLB1004用于在EGFR-TKI治疗失败后伴随获得性MET扩增或过表达的EGFR突变NSCLC患者：一项Ib/II期研究讲者：周斐上海市东方医院摘要号：8637壁报编号：117研究名称（英文）：Efficacy and omics-based insights of TROP2 ADC in non–small cell lung cancer with or without actionable genomic alterations (AGAs).研究名称（中文）：TROP2 ADC在具有或不具有可操作基因组改变 (AGAs) 的NSCLC中的疗效和基于组学的见解讲者：李岸霖中山大学肿瘤防治中心摘要号：8638壁报编号：118研究名称（英文）：Real-world data on the efficacy and safety of iruplinalkib (WX-0593) in ALK-positive advanced lung adenocarcinoma patients previously treated with lorlatinib.研究名称（中文）：伊鲁阿克（WX-0593）治疗既往接受过洛拉替尼治疗的ALK阳性晚期肺腺癌患者的疗效和安全性的真实世界数据讲者：王芬北京大学深圳医院摘要号：TPS8647壁报编号：27a研究名称（英文）：TROPION-Lung14: A phase 3 study of osimertinib ± datopotamab deruxtecan (Dato-DXd) as first-line (1L) treatment for patients with EGFR-mutated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC).研究名称（中文）：TROPION-Lung14：一项关于奥希替尼 ± datopotamab deruxtecan (Dato-DXd)作为EGFR突变局部晚期或转移性NSCLC患者一线治疗的III期研究讲者：陆舜上海市胸科医院备注：如有遗漏或任何问题，请给我们留言~声明：本文由“肿瘤界”整理与汇编，欢迎分享转载，如需使用本文内容，请务必注明出处。来源：医脉通胸部肿瘤编辑：lagertha审核：南星

临床结果ASCO会议临床3期临床2期免疫疗法

2025-03-27

·GlobeNewswire-Health Care

BeyondSpring Reports 2024 Year-End Financial Results and Highlights Key Clinical & Strategic Milestones

Plinabulin Final Phase 3 Data Published in The Lancet Respiratory Medicine, Demonstrating Overall Survival Benefit in 2L/3L NSCLC EGFR Wild Type vs. DocetaxelPlinabulin Phase 2 Data Highlights Potential to Resensitize Tumors Progressed on PD-1/PD-L1 Inhibitors in Metastatic NSCLCSEED Therapeutics Enters into Targeted Protein Degradation Research Collaboration with Eisai with potential payment to SEED of up to $1.5 Billion and Completes $24 Million First Close of Series A-3 FinancingSEED Therapeutics’ Lead Oncology Asset RBM39 Degrader Granted Rare Pediatric Disease and Orphan Drug Designations by the FDA FLORHAM PARK, N.J., March 27, 2025 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a global clinical-stage biopharmaceutical company developing innovative cancer therapies, today announced its financial results for the year ended December 31, 2024, and provided a business update on key clinical and corporate developments. “2024 was a pivotal year for BeyondSpring, with significant clinical progress for our first-in-class agent Plinabulin and strategic advancements for SEED Therapeutics (SEED), which BeyondSpring co-founded and owns an equity stake in. We believe these developments create value benefiting all stakeholders,” said Dr. Lan Huang, Co-Founder, Chairman, and CEO of BeyondSpring. “Plinabulin demonstrated a statistically significant survival benefit in patients with second- and third-line non-small cell lung cancer (NSCLC) (EGFR wild-type), a setting where no new therapies have been approved in over a decade. This Phase 3 data, now published in The Lancet Respiratory Medicine, strengthens our regulatory strategy as we prepare for submission to the Chinese National Medical Products Administration (NMPA) and potentially regulatory authorities in other jurisdictions.” “BeyondSpring is also advancing Plinabulin’s potential as a next-generation immuno-oncology agent, with its potent effect in dendritic cell maturation. An ongoing Phase 2 study showed that Plinabulin, in combination with a PD-1 inhibitor and docetaxel, produced promising efficacy in patients with metastatic NSCLC who had progressed on prior PD-1/PD-L1 inhibitors with good tolerability. While PD-1 and PD-L1 antibody annual sales have exceeded $50 billion, with most sales coming from lung cancer, 60% of patients across multiple cancer indications develop acquired resistance to checkpoint inhibitors, which we believe represents a significant opportunity for Plinabulin to impact the treatment landscape and create substantial value.” “SEED also made significant progress in 2024, securing a strategic research collaboration with Eisai Co., Ltd. (“Eisai”), a second global pharma partnership in addition to the Eli Lilly and Company (“Lilly”) partnership. Under this collaboration, SEED will be eligible to receive upfront payments and potential preclinical, clinical, regulatory and sales milestone payments of up to $1.5 billion, plus tiered royalties on net sales. In parallel, SEED is advancing its internal lead oncology asset, RBM39 degrader, toward clinical development. SEED’s recognition in two Nature review papers as a leader in targeted protein degradation (TPD), along with recent granting of Rare Pediatric Disease and Orphan Drug Designations by the FDA for its RBM39 degrader ST-01156, further underscore its unique platform and reinforce its leadership in this emerging field.” “With strongly anchored pipelines, key global partnerships and deliberate plans to navigate regulatory pathways, we believe BeyondSpring and SEED are well-positioned to drive transformative advancements in oncology and TPD in 2025,” Dr. Lan Huang concluded. Recent Clinical and Business Updates Plinabulin Clinical Updates Plinabulin Phase 3 Data Published in The Lancet Respiratory Medicine and Presented at the IASLC 2024 conference Demonstrated a statistically significant overall survival, PFS and ORR benefit in second- and third-line NSCLC (EGFR wild-type) compared to standard-of-care docetaxel.Supports planned regulatory submissions to NMPA and potentially regulatory authorities in other jurisdictions. Plinabulin Combination Therapy in multiple cancers which failed PD-1/PD-L1 therapies at MD Anderson Cancer Center Phase 1 investigator-initiated study of Plinabulin + PD-1/PD-L1 inhibitor + radiation showed encouraging data in re-sensitizing NSCLC, Head and Neck cancer, and Hodgkin’s Lymphoma.Responding patients showed dendritic cell maturation. Plinabulin Combination Therapy in NSCLC Ongoing Phase 2 investigator-initiated study (Study 303) of Plinabulin + PD-1 inhibitor + Docetaxel showed encouraging efficacy and safety outcomes in metastatic NSCLC patients who had progressed on prior PD-1/PD-L1 inhibitors.Supports Plinabulin’s potential to resensitize tumors to checkpoint inhibitors. Other Ongoing Clinical Trial Enrolled first patient in a Phase 2 investigator-initiated study (Study 302) of Plinabulin + PD-1 inhibitor + Etoposide/Platinum (EP) for first-line extensive-stage small-cell lung cancer (ES-SCLC). BeyondSpring Business Update Entered into definitive agreements to sell a portion of BeyondSpring’s Series A-1 Preferred Shares of SEED for gross proceeds of approximately $35.4 million to advance late-stage clinical development of Plinabulin. First closing of approximately $7.35 million completed in February 2025. SEED Updates Strategic Collaborations & Financing Research collaboration with Eisai to develop molecular glue degraders for oncology and neurodegenerative diseases with potential payments to SEED of up to $1.5 billion.$24 million Series A-3 financing first close, led by Eisai.Achieved third milestone with Lilly R&D collaboration. Industry Recognition & FDA Designations SEED was recognized in two Nature review articles as a leading company in TPD.Received Rare Pediatric Disease and Orphan Drug Designations from the FDA for RBM39 degrader ST-01156, reinforcing its potential as a breakthrough therapy for hard-to-treat cancers. Full-Year 2024 Financial Results1Continuing operations: R&D expenses: $2.6 million (vs. $7.3 million in 2023), reflecting completion of Plinabulin Dublin-3 and Protective Studies.G&A expenses: $6.1 million (vs. $7.8 million in 2023), driven by cost optimization measures.Net loss: $8.9 million (vs. $14.0 million in 2023).Cash, cash equivalents, and short-term investments: $2.9 million as of December 31, 2024. Discontinued operations: Net loss: $7.8 million (vs. $7.9 million in 2023).Current assets: $25.3 million as of December 31, 2024. Expected 2025 MilestonesPlinabulin 1H 2025: Updated data from Phase 2 of Study 303 in metastatic NSCLC progressed on PD-1/PD-L1 inhibitors.2H 2025: Preliminary data from Phase 2 of Study 302 in 1L ES-SCLC. SEED Mid-2025: Expected IND filing of RBM39 degrader.2H 2025: RBM39 degrader expected to begin patient enrollment.2H 2025: Tau degrader expected to achieve in vivo efficacy. Note: 1. As a result of BeyondSpring entering into definitive agreements to sell a portion of its Series A-1 Preferred Shares of SEED, SEED’s operations met the criteria as discontinued operations under ASC 205-20 for financial reporting purposes. About BeyondSpringBeyondSpring (NASDAQ: BYSI) is a clinical-stage biopharmaceutical company developing first-in-class therapies for high unmet medical needs. Its lead asset, Plinabulin, is in late-stage clinical development as an anti-cancer agent in NSCLC and a range of cancer indications. Plinabulin’s novel mechanism of action as a dendritic cell maturation agent supports both anti-cancer activity and immune modulation, offering a unique approach to resensitizing tumors to checkpoint inhibitors. Learn more at beyondspringpharma.com. About SEED TherapeuticsSEED Therapeutics is a biotech company pioneering targeted protein degradation (TPD). Its proprietary RITE3™ platform is advancing novel molecular glue degraders across oncology, neurodegeneration, immunology, and virology. SEED collaborates with Eli Lilly and Company and Eisai Co., Ltd. and is advancing its RBM39 degrader into clinical development. Learn more at seedtherapeutics.com. Cautionary Note Regarding Forward-Looking StatementsThis press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties, and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet the Company’s expectations regarding the potential safety, the ultimate efficacy or clinical utility of the Company’s product candidates, increased competition in the market, the Company’s ability to meet Nasdaq’s continued listing requirements, and other risks described in BeyondSpring’s most recent Form 10-K on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Investor Contact: IR@beyondspringpharma.comMedia Contact: PR@beyondspringpharma.com Financial Tables to Follow BEYONDSPRING INC.CONSOLIDATED BALANCE SHEETS(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data) As of December 31, 2023 2024 $ $ Assets Current assets: Cash and cash equivalents 5,396 2,922 Restricted Cash 9,941 - Advances to suppliers 292 240 Prepaid expenses and other current assets 168 68 Current assets of discontinued operations 2,622 25,347 Total current assets 18,419 28,577 Noncurrent assets: Property and equipment, net 317 239 Operating right-of-use assets 730 513 Other noncurrent assets 123 213 Noncurrent assets of discontinued operations 5,219 4,773 Total noncurrent assets 6,389 5,738 Total assets 24,808 34,315 Liabilities and equity Current liabilities: Accounts payable 561 295 Accrued expenses 2,347 840 Current portion of operating lease liabilities 258 282 Other current liabilities 1,069 780 Current liabilities of discontinued operations 3,723 8,813 Total current liabilities 7,958 11,010 Noncurrent liabilities: Operating lease liabilities 589 307 Deferred revenue 28,170 27,400 Other noncurrent liabilities 3,705 3,686 Noncurrent liabilities of discontinued operations 7,847 6,197 Total noncurrent liabilities 40,311 37,590 Total liabilities 48,269 48,600 Commitments and contingencies (Note 13) Mezzanine equity Contingently redeemable noncontrolling interests – discontinued operations 11,874 - Shareholders’ deficit Ordinary shares ($0.0001 par value; 500,000,000 shares authorized; 39,029,163 and 40,316,320 shares issued and outstanding as of December 31, 2023 and 2024, respectively) 4 4 Additional paid-in capital 368,599 373,185 Accumulated deficit (396,302) (407,425)Accumulated other comprehensive income 894 1,336 Total BeyondSpring Inc.’s shareholders’ deficit (26,805) (32,900)Noncontrolling interests (8,530) 18,615 Total shareholders’ deficit (35,335) (14,285) Total liabilities, mezzanine equity and shareholders’ deficit 24,808 34,315 BEYONDSPRING INC.CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS(Amounts in thousands of U.S. Dollars (“$”), except for number of shares and per share data) Year ended December 31, 2023 2024 $ $ Revenue - - Operating expenses Research and development (7,272) (2,644)General and administrative (7,809) (6,110) Loss from operations (15,081) (8,754)Foreign exchange loss, net (128) (96)Interest income 322 59 Other income, net 964 22 Loss before income tax (13,923) (8,769)Income tax expenses (92) (96) Net loss from continuing operations (14,015) (8,865) Discontinued operations Loss from discontinued operations (7,919) (7,828)Income tax expenses (14) - Net loss from discontinued operations (7,933) (7,828) Net loss (21,948) (16,693)Less: Net loss attributable to noncontrolling interests from continuing operations (922) (388)Less: Net loss attributable to noncontrolling interests from discontinued operations - (5,182)Net loss attributable to BeyondSpring Inc. (21,026) (11,123) Net loss per share, basic and diluted Continuing operations (0.34) (0.21)Discontinued operations (0.20) (0.07)Basic and diluted loss per share (0.54) (0.28) Weighted-average shares outstanding Basic and diluted 38,996,463 39,733,191 Other comprehensive loss, net of tax of nil: Foreign currency translation adjustment gain from continuing operations 760 710 Foreign currency translation adjustment (loss) gain from discontinued operations (35) 17 Comprehensive loss (21,223) (15,966)Less: Comprehensive loss attributable to noncontrolling interests from continuing operations (655) (131)Less: Comprehensive loss attributable to noncontrolling interests from discontinued operations - (5,154)Comprehensive loss attributable to BeyondSpring Inc. (20,568) (10,681)

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D09655	普那布林	-	DB05992

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
中性粒细胞减少	申请上市	中国	BeyondSpring Pharmaceuticals, Inc.	2021-08-17
中性粒细胞减少	申请上市	中国	大连万春布林医药有限公司	2021-08-17
中性粒细胞减少	申请上市	中国	Pharmaceutics International, Inc.	2021-08-17
HER2 阴性乳腺癌	临床3期	中国	BeyondSpring Pharmaceuticals, Inc.	2019-10-23
HER2 阴性乳腺癌	临床3期	乌克兰	BeyondSpring Pharmaceuticals, Inc.	2019-10-23
续存性动脉干	临床3期	中国	BeyondSpring Pharmaceuticals, Inc.	2019-10-23
续存性动脉干	临床3期	乌克兰	BeyondSpring Pharmaceuticals, Inc.	2019-10-23
乳腺癌	临床3期	美国	大连万春布林医药有限公司	2019-10-15
乳腺癌	临床3期	美国	Pharmaceutics International, Inc.	2019-10-15
乳腺癌	临床3期	中国	Pharmaceutics International, Inc.	2019-10-15

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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


NCT03575793 (BTCRC-LUN17-127, CTgov)	临床1/2期	复发性小细胞肺癌	39	Ipilimumab+Nivolumab+Plinabulin	遞築夢蓋製觸鏇範選製 = 壓衊範廠廠願遞遞憲構製觸蓋廠範觸廠築顧鏇 (觸鏇製選選範廠願鑰醖, 製襯衊壓膚築鏇衊膚觸 ~ 廠廠壓遞艱繭廠膚淵齋)	-	2024-11-12
NCT02504489 (DUBLIN-3, ESMO2024 \| Pubmed) 人工标引	临床3期	非小细胞肺癌二线 \| 三线 EGFR wild-type	559	Plinabulin+Docetaxel	範願鬱淵窪淵製網淵淵(範壓製膚廠鹹糧衊積構) = 蓋膚衊鑰窪夢膚觸齋網簾膚築遞艱夢遞構淵齋 (夢製淵醖壓顧選襯衊選, 9.34 ~ 11.87) 更多	积极	2024-09-14
				Placebo+Docetaxel	範願鬱淵窪淵製網淵淵(範壓製膚廠鹹糧衊積構) = 選壓鏇醖膚醖鹽網顧鬱簾膚築遞艱夢遞構淵齋 (夢製淵醖壓顧選襯衊選, 8.38 ~ 10.68) 更多
NCT03102606 (PROTECTIVE-1 \| Study 105 \| BPI-2358-105, CTgov)	临床3期	化疗引起的发热性中性粒细胞减少症 \| 实体瘤 \| 转移性乳腺癌 ... 更多	105	D5W Placebo (Docetaxel (75 mg/m2) + Pegfilgrastim (6 mg) + Placebo Matching Plinabulin)	廠網鏇願膚廠製醖鏇顧(願鬱餘蓋衊鹹壓醖衊觸) = 齋鏇艱窪範繭構鏇憲願窪繭繭範鏇範廠廠鬱繭 (範廠鏇網鑰淵壓齋窪齋, 積網獵繭夢顧製淵網繭 ~ 艱觸選鏇範鏇願襯範壓) 更多	-	2024-08-29
				Saline Placebo+Plinabulin (Docetaxel (75 mg/m2) + Plinabulin (40 mg) + Placebo Matching Pegfilgrastim)	廠網鏇願膚廠製醖鏇顧(願鬱餘蓋衊鹹壓醖衊觸) = 襯遞選夢膚膚艱範淵蓋窪繭繭範鏇範廠廠鬱繭 (範廠鏇網鑰淵壓齋窪齋, 齋壓齋鹹顧鬱顧憲衊鹽 ~ 簾構蓋蓋窪衊夢構淵觸) 更多
NCT04345900 (CTgov)	临床2期	化疗引起的发热性中性粒细胞减少症 \| 实体瘤 \| 转移性非小细胞肺癌	55	Pegfilgrastim+Docetaxel (Arm 1)	鬱糧築醖鹽願網構顧蓋(顧鬱願選構壓網觸夢繭) = 簾餘範鬱繭選衊獵壓膚觸願積襯廠繭窪憲壓鑰 (憲願構餘膚蓋醖糧蓋積, 0.376) 更多	-	2024-05-16
				Plinabulin+Docetaxel (Arm 2)	鬱糧築醖鹽願網構顧蓋(顧鬱願選構壓網觸夢繭) = 餘膚蓋簾顧鏇築衊積醖觸願積襯廠繭窪憲壓鑰 (憲願構餘膚蓋醖糧蓋積, 0.929) 更多
EHA2024	N/A	-	-	Plinabulin	鬱醖衊壓鹹壓壓艱夢壓(鹹艱齋窪顧獵簾簾齋窪) = 築蓋廠願齋鏇憲襯壓醖艱遞壓鹹鏇積廠鑰遞範 (蓋壓範選觸積淵觸遞壓 )	积极	2024-05-14
				Selumetinib	鬱醖衊壓鹹壓壓艱夢壓(鹹艱齋窪顧獵簾簾齋窪) = 範艱網範膚網構窪淵築艱遞壓鹹鏇積廠鑰遞範 (蓋壓範選觸積淵觸遞壓 )
IMS2023	N/A	多发性骨髓瘤	15	Plinabulin + pegfilgrastim	餘窪窪鏇構繭鹽齋鹽憲(壓憲餘襯鑰積餘蓋製製) = 壓糧艱蓋製壓獵齋觸願鏇範獵齋衊憲網齋襯鬱 (廠齋積窪顧憲淵蓋齋衊 ) 更多	-	2023-09-26
NCT02504489 (ASCO2023) 人工标引	临床2/3期	非小细胞肺癌	-	Plinabulin+Docetaxel	願鑰鏇糧遞積壓膚襯鹹(廠鏇積選獵醖壓蓋齋鹽) = With Plin, AE frequency of diarrhea was slightly higher (5.2% vs 1%; 1 Gr4 case with Plin), but was manageable, and so was hypertension (11.2% vs 1.7%; all Gr3 cases) vs Plac. Hypertension occurred around the time of infusion and was short-lasting (~2-4 hours) and typically self-limiting. Plin had less AEs of neutropenia (16.4% vs 50.3%) and leukopenia (15.5% vs 38.5%) vs Plac. 艱齋糧鏇網糧襯選餘顧 (齋憲鬱鹽鑰範淵鑰膚艱 )	积极	2023-05-31
				Placebo+Docetaxel
NCT03102606 (PROTECTIVE-1, SABCS2023)	临床3期	化疗引起的发热性中性粒细胞减少症 \| 实体瘤 \| 转移性乳腺癌 ... NCCN high FN risk factor 更多	27	Plinabulin	顧鏇簾選醖積鑰遞窪窪(夢蓋齋築繭觸壓獵壓構) = Plin was superior vs No-Treatment for Doc-induced neutropenia and HC, while maintaining QoL and with minimal AE and bone pain burden 鬱積範憲糧顧構鑰淵餘 (餘蓋鑰選選獵顧糧壓築 ) 更多	积极	2023-03-01
NCT03102606 (PROTECTIVE-1, ESMO_ASIA2022)	临床2/3期	非小细胞肺癌	30	Plinabulin	膚築願膚夢窪廠築構壓(餘蓋獵簾淵壓齋鹹淵醖) = 衊窪網觸鹹廠襯簾醖簾襯遞網窪壓淵繭廠顧選 (鹽觸壓壓簾鹽醖鏇醖築 )	积极	2022-12-03
NCT03294577 (PROTECTIVE-2, Corporate Publications) 人工标引	临床3期	中性粒细胞减少	115	Pegfilgrastim+Plinabulin	齋憲遞鹽願糧積壓憲鬱(鬱鬱夢餘廠蓋鏇築鏇廠) = 夢夢觸夢製願鏇構築餘鬱淵餘壓襯範遞繭糧齋 (蓋蓋顧鏇艱鹹廠廠願淵 )	积极	2022-10-21
				Pegfilgrastim	齋憲遞鹽願糧積壓憲鬱(鬱鬱夢餘廠蓋鏇築鏇廠) = 醖構窪網膚築顧鹽廠壓鬱淵餘壓襯範遞繭糧齋 (蓋蓋顧鏇艱鹹廠廠願淵 )