Phase 1b/2 Trial Using Neoadjuvant Lurbinectedin With Concurrent Preoperative Radiation in Patients With Locally Advanced Soft Tissue Sarcomas of Extremity, Trunk, and Retroperitoneum

This is a multi-center, multi-arm open-label phase Ib/II clinical study assessing the efficacy of concurrent lurbinectedin in combination with radiotherapy in patients with locally advanced, resectable, high-grade sarcomas.

开始日期2024-10-31

申办/合作机构

The University of California, San Francisco

[+1]

NCT06496048

/ Recruiting临床3期

A Phase III, Multicenter, Randomized, Open-label Study of Lurbinectedin As Monotherapy or in Combination with Irinotecan Versus Topotecan in Patients with Relapsed Small-cell Lung Cancer (SCLC)

Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of two experimental arms consisting of Lurbinectedin monotherapy or Lurbinectedin + Irinotecan combined therapy versus Topotecan comparator in Small-cell Lung Cancer (SCLC) patients who failed one prior platinum-containing line.

开始日期2024-09-14

申办/合作机构

綠葉製藥集團有限公司

100 项与芦比替定相关的临床结果

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100 项与芦比替定相关的转化医学

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100 项与芦比替定相关的专利（医药）

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208

项与芦比替定相关的文献（医药）

2025-06-01·STAR protocols

Protocol to co-culture SCLC cells with human CD8+ T cells to measure tumor cell killing and T cell activation

Article

作者: Sen, Triparna ; Ventura, Kedwin ; Sritharan, Ramja ; Tocheva, Anna ; Chakraborty, Subhamoy ; Sridhar, Subhasree

Small-cell lung cancer (SCLC) is an aggressive malignancy with immunosuppressive tumor microenvironment limiting immunotherapy efficacy. Here, we present a protocol to assess T cell activation and the ability of lurbinectedin to enhance anti-tumor responses using in vitro co-cultures of SCLC cells and human CD8 T cells. We describe steps for cell seeding, treatment, co-culture setup, and assessing cell viability. This protocol provides a platform to study anti-tumor T cell responses and develop new SCLC therapies. For complete details on the use and execution of the protocol, please refer to Chakraborty et al.¹.

2025-06-01·JTO clinical and research reports

Combination of Lurbinectedin and Osimertinib for Treatment of EGFR-Mutated Transformed SCLC: A Brief Report

Article

作者: Schwecke, Anna ; Sridhar, Arthi ; Moffett, Nicole ; Leventakos, Konstantinos ; Dimou, Anastasios ; Patel, Manish R ; Shanshal, Mohamed ; Poddar, Aastha ; Singh, Aditi ; Parikh, Kaushal ; Mansfield, Aaron S

Third-generation tyrosine kinase inhibitors are effective treatment of EGFR-mutated NSCLC. After an initial response, patients on this therapy ultimately develop resistance leading to disease progression. One of the resistance mechanisms is histological transformation to SCLC. There is no standard of care for the management of transformed SCLC. Given the rarity of transformed SCLC, it is important to study treatment options that are safe and effective for this disease. In this case series, three patients received treatment with lurbinectedin plus osimertinib after transformation to SCLC. In our limited experience, the combination was found to be safe.

2025-05-01·Clinical Lung Cancer

Unmet Needs in Maintenance Therapy for Extensive Stage Small Cell Lung Cancer

Review

作者: Baena, Javier ; Paz-Ares, Luis ; Gupta, Brinda ; Liu, Stephen V

Small cell lung cancer (SCLC) is a highly aggressive malignancy and an exceptionally lethal disease; most patients present with extensive stage (ES) disease at diagnosis. Very little had changed in the treatment of ES-SCLC for decades until immune checkpoint inhibitor (ICI) therapy combined with chemotherapy followed by ICI maintenance monotherapy was added to standard treatment paradigms in 2019. Despite this important advance, high rates of relapse are still observed in patients with ES-SCLC and long-term survival rates remain low, with approximately 40% of patients proceeding to receive second-line treatment. There is an urgent need for novel treatment strategies to improve patient outcomes. In this review, we describe the rationale for maintenance therapy approaches in ES-SCLC and summarize the existing data on chemotherapy, ICIs, and other agents in the first-line maintenance setting. Predictive biomarkers, SCLC subtypes, and new therapeutics in development are discussed including lurbinectedin, antibody-drug conjugates, and T-cell engager molecules.

253

项与芦比替定相关的新闻（医药）

2025-05-31

·BioSpace

Jazz Is in the “Goldilocks Zone” With New Cancer Data at ASCO25

Brain tumor medical poster. Cancer, metastasis or benign in the human head or in the nerves, pituitary gland, pineal gland, and membranes that cover the surface of the brain 3D vector illustration iStock, Pikovit44 The medium-sized biopharma is showing off new results from dordaviprone and Zepzelca, both of which were acquired through Jazz Pharmaceuticals’ dealmaking over the last five years. Rob Iannone showed me the ASCO 2025 name tag he’s wearing. Below the line where it says “Jazz Pharmaceuticals” is a big yellow stripe announcing that Iannone has been a member of the American Society of Clinical Oncology for a quarter of a century. “I’ve been coming to ASCO for 25 years; that gives you a hint about my age,” he says with a sly smile. When he began attending the annual meeting in 2000, Iannone was a pediatric oncologist. “In that time, I’ve treated patients with high-grade gliomas. Debulking surgeries and radiation therapy was standard of care back then,” he said. “Here we are 25 years later, and the standard of care is debulking surgery and radiation.” Iannone, chief medical officer at California-based Jazz, is hoping that a new molecule might change that. Acquired in Jazz’s $935 million buy-out of Chimerix in March, dordaviprone is a multi-target small molecule for pediatric gliomas, a particularly aggressive and deadly brain cancer. Jazz was intrigued enough to pay a 72% premium on Chimerix’s stock to get its hands on the molecule, which has an FDA PDUFA date of August 18. Jazz is at ASCO to present, among other things, new efficacy and safety data from a Phase II trial of dordaviprone. While the drug’s specific indication (H3K27 mutated gliomas) is rare—affecting around 5,000 patients worldwide, according to Truist analysts writing at the time of the Chimerix deal— the potential applicability of the dordaviprone is much broader. Truist modeled a potential $800 million in yearly sales by 2037 for the drug, and noted that its mechanism of action might make it valuable for other cancers beyond gliomas. The Chimerix deal also brought with it a next-generation version of dordaviprone, termed ONC206, with a similar mechanism and higher potency in vitro . Iannone said he is chuffed with the results of the acquisition, noting that it “fits in well” with Jazz’s overall pipeline strategy of looking for areas of unmet needs. And Jazz is a good fit for effectively bringing dordaviprone and its successor to the market, Iannone said. Earlier in his career, Iannone bounced from a professorship in pediatrics, oncology and bone marrow transplantation at the University of Pennsylvania to work at Merck, where he contributed to the development of the mega blockbuster Keytruda. “I was at the right place at the right time” he said about his time on that project. He then had stints at AstraZeneca and Immunomedics before coming to Jazz six years ago. Compared to the tens of thousands of employees marshalled by Merck and AstraZeneca, Jazz employs a modest 3,000–3,500 people, about 800 of which are in research and development. “We are a little bit of a Goldilocks size,” Iannone said. “We have all the resources we need to accomplish our goals. We’re small enough that we don’t get in our own way. That makes us a favorable partnership, people are surprised at we can do as partners.” He noted ease of access as one example. “When we’re discussing acquisitions or licensing, companies have direct access to people like me, which might be harder at a bigger company.” That ease of liaising with other companies has brought Jazz some of its lead molecules, Iannone said. Notably, Jazz licensed its small molecule therapeutic Zepzelca from PharmaMar in 2021 for a scant $5 million up front plus up to $3 million in sales milestones, as well as tiered royalties. In addition to its presentation on dordaviprone, Jazz is in Chicago this week to present new data from the Phase III IMforte trial of Zepzelca in combination with Roche’s Tecentriq in small cell lung cancer. Adding Zepzelca to Roche’s PD-1 inhbitor improved patients’ median survival by four months compared with Tecentriq alone (17 months versus 13 months, according to Iannone), while reducing patients’ risk of death by 27%. Most encouraging was a tolerable safety profile. The combo regimen mostly resulted in neutropenia, which Iannone said can be managed and is a solid trade-off for patients who would otherwise face a rough chemotherapy regimen. The usual treatment regimen involves four to six cycles of chemo, Iannone explained. “Most patients don’t make it to six, maybe they get to four. Toxicity is such that patients stop, and potentially continue on with anti-PD-1 therapy alone. Survival after patients stop chemo drops rapidly, Iannone added. Results from IMforte indicate that Zepzelca could represent a more palatable option. The companies have already filed a BLA for the combo but the FDA has yet to set a PDUFA date. With the new survival data in hand, “I’d expect to get priority review, which would allow us to get an approval this year,” Iannone said.

并购临床结果ASCO会议临床3期临床2期

2025-05-28

·肿瘤界

2025 ASCO | 10余项中国研究入选！肺癌口头报告摘要标题一文速览

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。在此，本文特整理了本届ASCO大会中肺癌领域入选的Oral Abstract Session（口头报告专场）、Rapid Oral Abstract Session（快速口头报告专场）以及Clinical Science Symposium（临床科学研讨会）的研究，让我们先一睹为快！Oral Abstract Session口头报告专场摘要号：2004研究英文名称：A phase II study of asandeutertinib (TY-9591) in advanced NSCLC patients with EGFR-positive mutations and brain metastases.研究中文名称：asandeutertinib（TY-9591）在EGFR阳性突变和脑转移的晚期NSCLC患者中的II期研究讲者：邢力刚 | 中国医学科学院肿瘤医院摘要号：3001研究英文名称：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.研究中文名称：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NSCLC的I期临床研究：一种靶向EGFR×HER3的双特异特异性抗体驱动药物偶联物（ADC）的评估讲者：杨云鹏 | 中山大学肿瘤防治中心摘要号：3002研究英文名称：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).研究中文名称：iza-bren（BL-B01D1），一种EGFR x HER3双特异性ADC，在局部晚期或转移性小细胞肺癌（SCLC）患者中的I期研究讲者：黄岩 | 中山大学肿瘤防治中心摘要号：LBA8000研究英文名称：Overall survival with neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) in patients with resectable NSCLC in CheckMate 816.研究中文名称：CheckMate 816研究中可切除NSCLC患者新辅助纳武利尤单抗联合化疗的总生存期分析讲者：Patrick M. Forde | Trinity St. James's Cancer Institute, Trinity College Dublin摘要号：8001研究英文名称：Neoadjuvant (neoadj) osimertinib (osi) ± chemotherapy (CT) vs CT alone in resectable (R) epidermal growth factor receptor-mutated (EGFRm) NSCLC: NeoADAURA.研究中文名称：NeoADAURA研究：可切除EGFR突变NSCLC术前新辅助奥希替尼±化疗对比单纯化疗讲者：Jamie E. Chaft | Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY; Department of Medicine, Weill Cornell Medical College摘要号：8002研究英文名称：Lung cancer diagnosis rates (LCDR) in lung cancer screening (LCS) and incidental pulmonary nodule (IPN) cohorts in the Mississippi Delta.研究中文名称：密西西比三角洲地区肺癌筛查与偶然发现肺结节队列中的肺癌诊断率研究讲者：Raymond U. Osarogiagbon | Baptist Cancer Center, Multidisciplinary Thoracic Oncology Program摘要号：8003研究英文名称：SWOG/NRG S1914: Randomized phase III trial of induction/consolidation atezolizumab + SBRT versus SBRT alone in high risk, early-stage NSCLC.研究中文名称：SWOG/NRG S1914研究：高危早期NSCLC诱导/巩固期阿替利珠单抗联合SBRT对比单纯SBRT的随机III期试验讲者：Megan Eileen Daly | Department of Radiation Oncology, University of California Davis Comprehensive Cancer Center摘要号：LBA8004研究英文名称：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.研究中文名称：R-ALPS研究：贝莫苏拜单抗（TQB2450）联合或不联合安罗替尼维持治疗经同步或序贯放化疗后无进展的局部晚期不可切除（III期）NSCLC患者的随机、双盲、安慰剂对照、多中心III期临床试验讲者：陈明 | 中山大学肿瘤防治中心摘要号：LBA8005研究英文名称：Randomized phase II trial investigating whether atezolizumab after chemoradiotherapy (CRT) prolongs survival in limited stage (LS) small cell lung cancer (SCLC).研究中文名称：局限期小细胞肺癌（LS-SCLC）化放疗后使用阿替利珠单抗是否延长生存的随机II期试验讲者：Bjorn Henning Gronberg | Department of Clinical and Molecular Medicine, NTNU, Norwegian University of Science and Technology and Department of Oncology, St. Olavs Hospital摘要号：8006研究英文名称：Lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC): Primary results of the phase 3 IMforte trial.研究中文名称：III期IMforte研究：芦比替定联合阿替利珠单抗作为广泛期小细胞肺癌（ES‑SCLC）患者一线维持治疗的主要结果讲者：Luis G. Paz-Ares | Hospital Universitario 12 de Octubre, H12O-CNIO Lung Cancer Unit, Universidad Complutense and Ciberonc摘要号：8007研究英文名称：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.研究中文名称：ZG006（一种靶向CD3/DLL3/DLL3的三特异性T细胞接合器）单药治疗晚期SCLC的II期剂量扩展研究讲者：艾星浩 | 上海交通大学医学院附属胸科医院摘要号：LBA8008研究英文名称：Tarlatamab versus chemotherapy (CTx) as second-line (2L) treatment for small cell lung cancer (SCLC): Primary analysis of Ph3 DeLLphi-304.研究中文名称：Tarlatamab对比化疗（CTx）二线（2L）治疗SCLC：III期DeLLphi-304研究的主要分析讲者：Charles M Rudin | Fiona and Stanley Druckenmiller Center for Lung Cancer Research, Memorial Sloan Kettering Cancer Center摘要号：8500研究英文名称：First-line adagrasib (ADA) with pembrolizumab (PEMBRO) in patients (pts) with advanced/metastatic KRASG12C-mutated non-small cell lung cancer (NSCLC) from the phase 2 portion of the KRYSTAL-7 study.研究中文名称：II期KRYSTAL‑7研究：adagrasib联合帕博利珠单抗一线治疗晚期/转移性KRASG12C突变NSCLC患者讲者：Pasi A. Jänne | Department of Medical Oncology, Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute摘要号：8501研究英文名称：TROPION-Lung02: Datopotamab deruxtecan (Dato-DXd) plus pembrolizumab (pembro) with or without platinum chemotherapy (Pt-CT) as first-line (1L) therapy for advanced non-small cell lung cancer (aNSCLC).研究中文名称：TROPION‑Lung02研究：Dato-DXd联合帕博利珠单抗±铂类化疗一线治疗晚期NSCLC讲者：Benjamin Philip Levy | Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medicine摘要号：LBA8502研究英文名称：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.研究中文名称：CAMPASS研究：贝莫苏拜单抗联合安罗替尼对比帕博利珠单抗一线治疗晚期NSCLC：一项随机、单盲、多中心III期研究讲者：韩宝惠 | 上海交通大学医学院附属胸科医院摘要号：8503研究英文名称：Efficacy of zipalertinib in NSCLC patients with EGFR exon 20 insertion mutations who received prior platinum-based chemotherapy with or without amivantamab.研究中文名称：zipalertinib对既往接受过含或不含埃万妥单抗铂类化疗的EGFR外显子20插入突变NSCLC患者的疗效评估讲者：Helena Alexandra Yu | Memorial Sloan Kettering Cancer Center摘要号：8504研究英文名称：SOHO-01: Safety and efficacy of BAY 2927088 in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC) who were pretreated but naïve to HER2-targeted therapy or had not received any treatment for advanced disease.研究中文名称：SOHO-01研究：BAY 2927088治疗既往接受过治疗但未接受HER2靶向治疗或未接受过任何治疗的晚期HER2突变NSCLC患者的疗效和安全性研究讲者：Herbert H. Loong | 香港中文大学摘要号：LBA8505研究英文名称：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.研究中文名称：赛沃替尼联合奥希替尼对比化疗治疗EGFR-TKI治疗进展后EGFR突变伴MET扩增的晚期NSCLC：来自III期随机SACHI研究结果讲者：陆舜 | 上海市胸科医院摘要号：8506研究英文名称：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.研究中文名称：Patritumab-deruxtecan（HER3-DXd）治疗第三代EGFR-TKI治疗后耐药的EGFR突变晚期NSCLC：III期HERTHENA-Lung02研究讲者：莫树锦 | 香港中文大学摘要号：8507研究英文名称：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.研究中文名称：芦康沙妥珠单抗（sac-TMT）治疗既往接受过治疗的晚期EGFR突变NSCLC：来自OptiTROP-Lung03随机研究的结果讲者：张力 | 中山大学肿瘤防治中心Rapid Oral Abstract Session快速口头报告专场摘要号：8009研究英文名称：Association of post-surgical MRD status with neoadjuvant ctDNA dynamics, genomic mutations, and clinical outcomes in patients with resectable NSCLC (R-NSCLC) from the phase 3 AEGEAN trial.研究中文名称：III期AEGEAN研究：术后MRD状态与新辅助ctDNA动态、基因突变特征及可切除NSCLC患者预后的相关性分析讲者：Martin Reck | Lung Clinic Grosshansdorf, Airway Research Center North, German Center for Lung Research摘要号：LBA8010研究英文名称：Perioperative nivolumab (NIVO) vs placebo (PBO) in patients (pts) with resectable NSCLC: Updated survival and biomarker analyses from CheckMate 77T.研究中文名称：CheckMate 77T研究：可切除NSCLC患者围手术期纳武利尤单抗对比安慰剂治疗的生存及生物标志物更新分析讲者：Mariano Provencio | Hospital Universitario Puerta de Hierro摘要号：8011研究英文名称：ctDNA-based MRD detection in unresectable NSCLC undergoing curatively intended chemoradiotherapy and durvalumab.研究中文名称：在接受根治性放化疗及度伐利尤单抗治疗的不可切除NSCLC患者中基于ctDNA的MRD检测讲者：Aslaug Helland | University of Oslo, Clinical Medicine摘要号：8012研究英文名称：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).研究中文名称：InTRist研究：评估特瑞普利单抗联合诱导化疗，随后同步放化疗及特瑞普利单抗巩固治疗用于巨大不可切除的III期NSCLC的随机II期试验的初步结果讲者：Yu Wang | 中国医学科学院肿瘤医院摘要号：8013研究英文名称：Safety and efficacy of lurbinectedin plus atezolizumab as second-line treatment for advanced small-cell lung cancer: Results of the 2SMALL phase 1/2 study (NCT04253145).研究中文名称：I/II期2SMALL研究：芦比替定联合阿替利珠单抗作为晚期NSCLC二线治疗的疗效和安全性讲者：Santiago Ponce Aix | Hospital Universitario 12 de Octubre and Oncosur Foundation摘要号：8014研究英文名称：Clinical and molecular characteristics of early progressors (EPs) and long-term progression-free survivors (LTPs) from the phase 3 ADRIATIC trial of consolidation durvalumab (D) vs placebo (P) after concurrent chemoradiotherapy (cCRT) in limited-stage small-cell lung cancer (LS-SCLC).研究中文名称：III期ADRIATIC研究：同步放化疗后巩固度伐利尤单抗对比安慰剂治疗用于LS-SCLC患者中早期进展者与长期无进展生存者的临床与分子特征讲者：David Allen Barbie | Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute摘要号：8015研究英文名称：Alectinib as neoadjuvant treatment in potentially resectable stage III ALK-positive NSCLC: Final analysis of ALNEO phase II trial (GOIRC-01-2020-ML42316).研究中文名称：阿来替尼作为新辅助治疗用于潜在可切除III期ALK阳性NSCLC的ALNEO II期研究最终分析（GOIRC-01-2020-ML42316）讲者：Marcello Tiseo | Department of Medicine and Surgery, University of Parma; Medical Oncology Unit, University Hospital of Parma; Gruppo Oncologico Italiano di Ricerca Clinica, GOIRC摘要号：8016研究英文名称：Efficacy and safety of nivolumab plus ipilimumab for patients with pre-treated type B3 thymoma and thymic carcinoma: Results from the EORTC-ETOP NIVOTHYM phase II trial.研究中文名称：纳武利尤单抗联合伊匹木单抗治疗经治的B3型胸腺瘤和胸腺癌患者的疗效与安全性：EORTC-ETOP NIVOTHYM II期研究结果讲者：Nicolas Girard, MD | Institut du Thorax Curie Montsouris, Institut Curie, Paris, and UVSQ, Paris Saclay University摘要号：8017研究英文名称：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).研究中文名称：靶向整合素αVβ3的成像用于肺癌的识别和淋巴结转移的定位：一项前瞻性、多中心、自身对照的III期试验（TRIIL研究）讲者：Rongxi Wang | 北京协和医院摘要号：8512研究英文名称：Telisotuzumab adizutecan (ABBV-400; Temab-A), a c-Met protein–targeting antibody-drug conjugate (ADC), in patients (pts) with advanced EGFR-mutated (MT) non-squamous (NSQ) non-small cell lung cancer (NSCLC): Results from a phase 1 study.研究中文名称：靶向c-Met的抗体偶联药物（ADC）Telisotuzumab adizutecan（ABBV-400；Temab-A）治疗晚期EGFR突变非鳞NSCLC的I期研究结果讲者：David Ross Camidge | University of Colorado Cancer Center摘要号：8513研究英文名称：Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO).研究中文名称：II期SAVANNAH研究随机亚组结果：赛沃替尼联合奥希替尼对比赛沃替尼联合安慰剂的疗效及中枢神经系统结果分析讲者：Benjamin Philip Levy | Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University School of Medicine摘要号：8514研究英文名称：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).研究中文名称：贝莫苏拜单抗联合化疗，随后序贯联合安罗替尼一线治疗局部晚期或转移性鳞状NSCLC的III期研究讲者：石远凯 | 中国医学科学院肿瘤医院摘要号：8515研究英文名称：Plasma-guided adaptive first-line chemoimmunotherapy for non-small cell lung cancer (NSCLC).研究中文名称：血浆引导的NSCLC一线个体化化免治疗探索讲者：Julia K. Rotow | Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute摘要号：8516研究英文名称：Randomized trial of relevance of time-of-day of immunochemotherapy for progression-free and overall survival in patients with non-small cell lung cancer.研究中文名称：NSCLC患者免疫化疗时间与无进展生存期及总生存期相关性的随机试验讲者：张永昌 | 湖南省肿瘤医院摘要号：8517研究英文名称：Hypoxia-responsive CEA CAR-T cells therapy for relapsed or refractory non-small cell lung cancer: A single-arm, open-label, phase I trial.研究中文名称：缺氧反应型CEA CAR-T细胞疗法治疗复发或难治性NSCLC：一项单臂、开放标签、I期试验讲者：魏双 | 华中科技大学同济医学院附属同济医院摘要号：8518研究英文名称：S1900E: A phase II study examining impact of co-mutations on sotorasib for previously treated stage IV/recurrent KRAS G12C mutated (MUT) non-squamous (Non-sq) non-small cell lung cancer (NSCLC) (ECOG-ACRIN led Lung-MAP Sub-study).研究中文名称：S1900E研究：评估合并突变对sotorasib治疗经治的KRAS G12C突变IV期/复发性非鳞NSCLC疗效影响的II期研究（ECOG-ACRIN主导Lung-MAP子研究）讲者：Sukhmani Kaur Padda | Fox Chase Cancer Center/Temple Health摘要号：8519研究英文名称：Safety and efficacy of olomorasib + immunotherapy in first-line treatment of patients with KRAS G12C-mutant advanced NSCLC: Update from the LOXO-RAS-20001 trial.研究中文名称：Olomorasib联合免疫治疗用于KRAS G12C突变晚期NSCLC一线治疗的疗效和安全性：LOXO-RAS-20001研究更新讲者：Konstantin H. Dragnev | Dartmouth Cancer Center摘要号：8520研究英文名称：Sosimerasib monotherapy in patients with previously treated KRAS G12C–mutated non-small cell lung cancer: Primary results of a phase 2 study.研究中文名称：Sosimerasib单药治疗KRAS G12C突变NSCLC：II期研究的主要结果讲者：王洁 | 中国医学科学院肿瘤医院摘要号：LBA8671研究英文名称：PRAGMATICA-LUNG (SWOG S2302): A prospective, randomized study of ramucirumab plus pembrolizumab versus standard of care for participants previously treated with immunotherapy for stage IV or recurrent non-small cell lung cancer.研究中文名称：Practicala-LUNG研究（SWOG S2302）：雷莫芦单抗联合帕博利珠单抗对比标准治疗用于既往接受过免疫治疗的IV期或复发性NSCLC患者的前瞻性随机研究讲者：Konstantin H. Dragnev | Dartmouth Cancer CenterClinical Science Symposium临床科学研讨会摘要号：8509研究英文名称：First-in-class PD-1/IL-2 bispecific antibody IBI363 in patients (Pts) with advanced immunotherapy-treated non-small cell lung cancer (NSCLC).研究中文名称：首创新药PD-1/IL-2双特异性抗体IBI363治疗经免疫治疗的晚期NSCLC患者讲者：周建娅 | 浙江大学医学院附属第一医院摘要号：8510研究英文名称：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.研究中文名称：一项评估新型靶向B7-H3的ADCMHB088C治疗复发ES-SCLC的疗效与安全性的I/II期多中心研究的亚组分析讲者：周彩存 | 同济大学附属东方医院摘要号：8511研究英文名称：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.研究中文名称：首个评估BNT327/PM8002联合化疗作为不可切除恶性胸膜间皮瘤一线治疗的II期试验的疗效及安全性结果报告讲者：程颖 | 吉林省肿瘤医院备注：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

抗体药物偶联物临床结果ASCO会议临床1期

2025-05-26

·药事纵横

全球首个！联合疗法III期结果刷新ES-SCLC一线维持治疗新标准

5月23日，ASCO官网公布了由芦比替定（lurbinectedin）联合阿替利珠单抗（atezolizumab）针对小细胞肺癌（ES-SCLC）治疗的III期IMforte试验（NCT05091567）结果。作为一线维持治疗，首次在全球III期研究中显著延长了患者的无进展生存期（PFS）和总生存期（OS），为这一难治性肺癌亚型带来了突破性进展。图源：ASCO官网广泛期小细胞肺癌约占所有肺癌的15%，确诊时约70%已处于广泛期，肿瘤进展迅猛，预后极差。尽管近年来免疫治疗联合化疗成为一线诱导治疗的新标准，但患者中位生存期仍不足1年，且多数在治疗后数月内复发。维持治疗虽能延缓进展，但单药免疫的疗效有限，临床亟需更优方案，芦比替定的加入填补了这一空白。芦比替定作为海洋来源的化疗药物，通过抑制肿瘤细胞转录过程直接杀伤癌细胞，同时调节肿瘤微环境，例如减少促癌细胞因子分泌、抑制肿瘤相关巨噬细胞的活性。这种“双重打击”与阿替利珠单抗的PD-L1阻断作用形成互补：化疗药物释放的肿瘤抗原可能增强免疫治疗的应答，而免疫治疗则延长化疗的疗效持续时间。这种协同效应在PFS和OS的双重获益中得以体现，也为后续联合疗法的开发提供了思路。 IMforte研究设计660名初治ES-SCLC患者首先接受4个周期的阿替利珠单抗+卡铂+依托泊苷诱导治疗，病情稳定或缓解的483名患者进入维持阶段，随机接受芦比替定联合阿替利珠单抗或单药阿替利珠单抗治疗。结果显示，联合组中位PFS达5.4个月，较单药组的2.1个月翻倍，疾病进展风险降低46%；中位OS也从10.6个月延长至13.2个月，死亡风险下降27%。联合组的维持治疗持续时间也更长（4.1个月 vs 2.1个月），提示患者对治疗的耐受性和依从性可能更优。但联合疗法的安全性问题比较让人担忧，数据显示，联合组治疗相关不良事件（TRAE）发生率达83.5%，显著高于单药组的40.0%；3/4级TRAE发生率为25.6%（单药组5.8%），5级TRAE（致死性）发生率为0.8%（单药组0.4%）。常见不良反应包括恶心（36.4%）、贫血（31.8%）、疲劳（20.2%）等，骨髓抑制相关事件也较为突出，因此临床实践中仍需权衡疗效与毒性，尤其是对体质较弱的患者。尽管副作用发生率较高，但专家认为其“总体可控”。联合组因不良事件停药的比例仅为6.2%，且未出现新的免疫相关毒性信号，主要副作用可通过剂量调整或支持治疗管理。对于ES-SCLC这类生存期短、治疗选择少的患者，适度的毒性增加若伴随显著生存获益，仍可能被临床接受。芦比替定本身是RNA聚合酶II抑制剂，2020年在美国获批用于SCLC二线治疗，2024年12月在中国获批同类适应症，若其适应症前移至一线维持，还需解决可及性与成本问题。当前，全球ES-SCLC治疗药物市场由罗氏的阿替利珠单抗、阿斯利康的度伐利尤单抗等跨国药企主导，但中国药企如恒瑞医药的斯鲁利单抗、信达生物的阿得贝利单抗通过自主研发和License out加速布局。芦比替定联合疗法的成功可能加剧这一领域的竞争，尤其是其与现有免疫药物的协同效应或成为差异化优势。尽管IMforte研究结果积极，ES-SCLC治疗仍面临多重挑战。首先，联合疗法的PFS和OS绝对值仍偏低，分别是5.4个月和13.2个月，提示患者生存获益仍有提升空间。其次，芦比替定的毒性问题可能限制其广泛应用，尤其在高龄或合并症患者中需谨慎评估风险收益比。ES-SCLC的异质性和耐药机制复杂，单纯延长数月生存是否足够？如何筛选获益人群、优化用药顺序、探索生物标志物，将是下一步重点。此外，近年来新兴疗法如抗体偶联药物（ADC）、T细胞衔接器（TCE）等快速发展，可能对现有方案形成冲击。安进的CD3/DLL3双抗塔拉妥单抗已获FDA附条件批准，其III期临床数据即将公布；恒瑞、信达等中国药企的B7-H3、TROP-2靶向ADC也进入关键试验阶段。芦比替定联合阿替利珠单抗的IMforte研究标志着ES-SCLC治疗迈出重要一步，但其临床应用仍需综合考虑疗效、安全性和成本效益。随着ADC、TCE等新疗法的涌现，未来治疗格局可能进一步多元化。信息来源：ASCO官网药事纵横投稿须知：稿费已上调，欢迎投稿

临床结果ASCO会议临床3期免疫疗法

100 项与芦比替定相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11644	芦比替定	L01XX	DB12674

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适应症	国家/地区	公司	日期
小细胞肺癌	美国	Jazz Pharmaceuticals Ireland Ltd.	2020-06-15

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适应症	最高研发状态	国家/地区	公司	日期
广泛期小细胞肺癌	申请上市	欧盟	Pharma Mar SA	2025-05-26
平滑肌肉瘤	临床3期	美国	Pharma Mar SA	2023-09-21
平滑肌肉瘤	临床3期	奥地利	Pharma Mar SA	2023-09-21
平滑肌肉瘤	临床3期	比利时	Pharma Mar SA	2023-09-21
平滑肌肉瘤	临床3期	法国	Pharma Mar SA	2023-09-21
平滑肌肉瘤	临床3期	德国	Pharma Mar SA	2023-09-21
平滑肌肉瘤	临床3期	意大利	Pharma Mar SA	2023-09-21
平滑肌肉瘤	临床3期	葡萄牙	Pharma Mar SA	2023-09-21
平滑肌肉瘤	临床3期	西班牙	Pharma Mar SA	2023-09-21
平滑肌肉瘤	临床3期	瑞士	Pharma Mar SA	2023-09-21

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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


NCT04607954 \| NCT04358237 \| NCT06497530 \| NCT04253145 (ASCO2025)	临床1/2期	广泛期小细胞肺癌	54	Lurbinectedin + Pembrolizumab	鏇網廠糧壓壓膚壓築構(艱願鏇鏇糧窪遞繭艱選) = 鬱構廠壓積齋夢觸鹹鬱簾衊淵憲願簾遞製衊獵 (膚餘鬱獵網鑰憲餘製遞 ) 更多	积极	2025-05-30
				Lurbinectedin + Atezolizumab	鬱艱憲積範鏇齋衊鹽簾(積淵壓顧鹽窪獵襯願淵) = 築襯範遞醖顧廠衊網鏇遞淵廠簾網觸齋築積蓋 (淵壓鏇廠鹹構壓網鹹範 ) 更多
ASCO2025	N/A	广泛期小细胞肺癌二线	256	Lurbinectedin	範觸繭遞淵築積窪壓製(壓鏇製積糧簾構顧膚築) = 齋鹽積築淵憲鏇齋鹹壓窪製顧夢壓繭鹽網築窪 (簾繭鏇築餘窪壓觸憲淵, 0.681 ~ 0.685) 更多	积极	2025-05-30
NCT05091567 (IMforte, ASCO2025)	临床3期	广泛期小细胞肺癌一线 \| 维持	660	Lurbinectedin + Atezolizumab	顧襯鹽鏇選顧窪淵鏇淵(襯網膚繭繭蓋繭憲淵製): HR = 0.73 (95% CI, 0.57 ~ 0.95), P-Value = 0.0174 更多	积极	2025-05-30
				Atezolizumab
ASCO2025	N/A	小细胞肺癌二线 \| 三线	61	Lurbinectedin as second-line therapy	築餘鹽鏇淵襯簾獵築齋(醖鬱窪艱糧網繭淵範衊) = 37.5% 遞選觸鹽蓋鏇鏇繭構觸 (憲夢鹽鬱糧艱鏇獵窪壓 ) 更多	积极	2025-05-30
				Lurbinectedin as third-line therapy
AACR2025	临床1/2期	小细胞肺癌二线 Rb1 \| Trp53	24	Lurbinectedin + Atezolizumab	積衊築蓋齋醖構憲鬱鹹(願醖鹹衊襯襯顧鏇構築) = 築壓淵繭遞鏇壓遞簾選鏇鹹繭獵蓋簾顧淵窪遞 (窪簾簾繭鑰夢醖齋膚窪 ) 更多	积极	2025-04-29
NCT05126433 (JAZZ EMERGE201, CTgov)	临床2期	转移性实体瘤 \| 晚期恶性实体瘤 \| 晚期尿路上皮癌 ... 更多	47	platinum+Lurbinectedin+sacituzumab govitecan (Urothelial Cancer (UC) Cohort)	醖窪膚鹽艱糧網構醖醖 = 製遞繭網鹽餘壓衊築築糧夢夢壓鑰範積淵選齋 (淵糧窪構鹹鬱鹽鏇鹽簾, 鹽餘憲積齋襯蓋窪網構 ~ 願鹽糧壓簾襯淵鏇觸壓) 更多	-	2025-02-28
				Lurbinectedin (Poorly Differentiated Neuroendocrine Carcinomas (PD-NEC) Cohort)	醖窪膚鹽艱糧網構醖醖 = 淵壓鬱壓衊鏇鹹襯願膚糧夢夢壓鑰範積淵選齋 (淵糧窪構鹹鬱鹽鏇鹽簾, 築鑰鏇衊餘鬱繭衊選齋 ~ 衊壓製鹹淵襯網鹽鹹廠) 更多
NCT04358237 (LUPER, Pubmed) 人工标引	临床1/2期	小细胞肺癌二线	28	Lurbinectedin + pembrolizumab	積鹹襯觸顧觸選齋網餘(糧衊夢選醖願網鹹範顧) = 鬱繭觸糧觸壓築壓餘齋夢鏇繭衊繭蓋淵廠窪鹽 (獵窪鹹夢鹽襯遞願築蓋, 27.5 ~ 66.1) 更多	积极	2025-02-10
				Lurbinectedin + pembrolizumab (Platinum-resistant)	積鹹襯觸顧觸選齋網餘(糧衊夢選醖願網鹹範顧) = 鏇繭簾醖網艱鹹艱製廠夢鏇繭衊繭蓋淵廠窪鹽 (獵窪鹹夢鹽襯遞願築蓋, 12.8 ~ 64.9) 更多
ESMO_ASIA2024 人工标引	N/A	广泛期小细胞肺癌末线 \| 三线 \| 二线	47	Lurbinectedin	鏇淵鏇獵襯遞艱夢艱鹹(襯膚選餘積醖蓋夢襯積) = 鬱窪餘構壓鏇選醖鏇遞壓醖鹹鑰構齋鹽襯構夢 (鏇觸願選夢鬱鏇願衊鏇, 7.642 ~ 10.758) 更多	积极	2024-12-07
				Lurbinectedin (second-line)	鏇淵鏇獵襯遞艱夢艱鹹(襯膚選餘積醖蓋夢襯積) = 鬱衊遞鬱艱鏇衊窪廠遞壓醖鹹鑰構齋鹽襯構夢 (鏇觸願選夢鬱鏇願衊鏇, 6.945～11.455) 更多
NCT05091567 (IMforte, Company_Website) 人工标引	临床3期	广泛期小细胞肺癌维持	-	Zepzelca + atezolizumab	積網窪壓窪鏇築鏇鬱網(餘衊鹹鹽餘構製觸膚獵) = statistically significant improvement 網構衊築觸餘淵繭膚觸 (鏇壓淵憲艱顧糧糧獵積 ) 更多	积极	2024-10-16
				atezolizumab
NCT05876715 (Linnovate, ESMO2024) 人工标引	临床1/2期	软组织肉瘤	6	Lurbinectedin	鬱遞構夢簾艱積窪網廠(糧顧夢鹹遞製鏇遞鹽顧) = 積齋築鑰鑰遞選選鏇齋範鹽淵蓋壓襯窪鏇顧遞 (廠鹹選艱衊顧製憲獵簾 ) 更多	积极	2024-09-14