A Phase 1b Trial of Adaptive Stereotactic Body Radiotherapy in Combination With Durvalumab (MEDI4736), Platinum, and Etoposide in Extensive Stage Small Cell Lung Cancer

This is trial studying the safety of adaptive stereotactic body radiotherapy (SBRT) combined with durvalumab immunotherapy, platinum chemotherapy, and etoposide chemotherapy in platinum refractory extensive stage small cell lung cancer (SCLC).

开始日期2025-12-31

申办/合作机构

University of Maryland Baltimore

[+1]

NCT06769126

/ Not yet recruiting临床2期IIT

PRISM: PRecIsion in SCLC Via a Multicohort Study: Randomized Phase II Studies Evaluating Maintenance Durvalumab With or Without Biomarker-Directed Therapy for Extensive Stage Small Cell Lung Cancer (ES-SCLC)

This phase II trial tests how well biomarker tests on patients tumor tissue works in selecting personalized treatments for patients with extensive stage small cell lung cancer (ES-SCLC). Biomarker tests look for certain features in cancer cells that may give doctors more information about what is driving cancer and how to treat it. Based on the biomarker test results, study doctors can determine the subtype of ES-SCLC that study treatments can target. This study also tests different types of maintenance treatment for ES-SCLC with drugs durvalumab, saruparib, ceralasertib or monalizumab. Maintenance treatment is given after initial treatment and is given to help keep the cancer under control and prevent it from getting worse. Immunotherapy with monoclonal antibodies, such as durvalumab and monalizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Saruparib is a PARP inhibitor. PARP is a protein that helps repair damaged deoxyribonucleic acid (DNA). Blocking PARP may prevent cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Ceralasertib may stop the growth of tumor cells and may kill them by blocking some of the enzymes needed for tumor cell growth. Giving biomarker selected personalized maintenance treatment with durvalumab, saruparib, ceralasertib or monalizumab may work better in treating patients with ES-SCLC.

开始日期2025-09-08

申办/合作机构

SWOG

[+1]

NCT06820957

/ Not yet recruiting临床2/3期IIT

Randomized Phase 2/3 Trial of Vincristine-Irinotecan-Regorafenib in Combination With Vincristine-Doxorubicin-Cyclophosphamide (VDC) and Ifosfamide-Etoposide (IE) in Patients With Newly Diagnosed Metastatic Ewing Sarcoma

This phase II/III trial compares the effect of vincristine, irinotecan, and regorafenib (VIrR) in combination with vincristine, doxorubicin, cyclophosphamide (VDC), ifosfamide and etoposide (IE) to usual treatment with VDC/IE for the treatment of newly diagnosed Ewing sarcoma or other round cell sarcomas that have spread from where they first started (primary site) to other places in the body (metastatic). Vincristine is in a class of medications called vinca alkaloids. It works by stopping tumor cells from growing and dividing and may kill them. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Regorafenib, a type of kinase inhibitor and a type of antiangiogenesis agent, blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill tumor cells. It also blocks a certain enzyme needed for cell division and DNA repair. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells. It may also lower the body's immune response. Ifosfamide, a type of alkylating agent and a type of antimetabolite, attaches to DNA in cells and may kill tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Giving VIrR/VDC/IE may be more effective than usual treatment with VDC/IE in treating patients with newly diagnosed metastatic Ewing sarcoma or other round cell sarcomas.

开始日期2025-07-15

申办/合作机构

The Children's Oncology Group Foundation, Inc.

100 项与依托泊苷相关的临床结果

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100 项与依托泊苷相关的转化医学

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100 项与依托泊苷相关的专利（医药）

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35,403

项与依托泊苷相关的文献（医药）

2025-12-31·NMC case report journal

A Primary Spinal Intramedullary Mixed Germ Cell Tumor: A Case Report and Literature Review

Article

作者: SHIMAUCHI-OHTAKI, Hiroya ; HORIGUCHI, Keishi ; HIRATO, Junko ; NAKATA, Satoshi ; HONDA, Fumiaki ; YOKOO, Hideaki ; OYA, Soichi ; GOTO, Yuta ; TOMOMASA, Ran ; NAKAMURA, Shunsuke

Central nervous system germ cell tumors are rare and account for 2% to 3% of all central nervous system tumors in Japan. Here, we report an extremely rare case of a primary spinal intramedullary mixed germ cell tumor. A 33-year-old man presented with a chief report of dysuria and numbness in the right lower extremity. Magnetic resonance imaging revealed a mass lesion on the left side of the intramedullary spinal cord at the Th10-11 vertebral body level with hyperintensity on T2-weighted images, isointensity on T1-weighted images, and uniform contrast in gadolinium. Cerebrospinal fluid examination revealed a few atypical cells. Although tumor removal using the posterior median sulcus approach was attempted, only a biopsy was performed because intraoperative rapid pathology suggested a possible diagnosis of germinoma. Permanent pathology revealed a mixed germ cell tumor (mainly comprising a germinoma with a yolk sac tumor). Postoperatively, cerebrospinal irradiation and 8 courses of the carboplatin and etoposide regimen were administered. No recurrence or new lesions were observed on magnetic resonance imaging at 94 months postoperatively. Our extensive literature search found only 4 cases of a mixed germ cell tumor of primary intramedullary origin in the spinal cord. Most spinal germ cell tumors described in the literature are either germinomas or mature teratomas; however, mixed germ cell tumors can also occur, albeit infrequently. Although additional cases need to be accumulated, our case suggests that yolk sac elements in spinal mixed germ cell tumors might not be directly associated with poor life expectancy.

2025-12-31·JOURNAL OF ENZYME INHIBITION AND MEDICINAL CHEMISTRY

Synthesis, in vitro and in silico studies of a novel chrysin-ferrocene Schiff base with potent anticancer activity via G1 arrest, caspase-dependent apoptosis and inhibition of topoisomerase II

Article

作者: Break, Mohammed Khaled Bin ; Alkahtani, Hamad M. ; Ansari, Siddique Akber ; Alshammari, Maali D. ; Katamesh, Ahmed A. ; Albadari, Najah

A novel chrysin-ferrocene Schiff base (CFSB) was synthesised as a potential anticancer agent. CFSB demonstrated high cytotoxicity against cancer cells with HepG2 (liver) being the most susceptible (IC₅₀ = 3.11 µM). The compound was less toxic towards normal MRC5 cells and exhibited ∼5-fold selectivity towards most cancer cells. CFSB caused G1-phase arrest, induced caspase-dependent apoptosis by increasing Bax/Bcl2 ratio and reduced metastasis by decreasing MMP9 in HepG2. Furthermore, CFSB was inactive against CDK2, EGFR, TrkA and VEGFR, but it strongly inhibited topoisomerase II (IC₅₀ = 20 µM) with potency comparable to etoposide (IC₅₀ = 15 µM), while weak inhibition was observed against tubulin (IC₅₀ = 76 µM). DFT calculations revealed that CFSB had desirable reactivity, while docking indicated high binding affinity with topoisomerase II. Molecular dynamics and MM-GBSA analyses showed that CFSB-topoisomerase II complex was stable with favourable binding energies, while in silico ADMET studies showed drug-like properties for CFSB.

2025-12-31·ANNALS OF MEDICINE

Construction of a novel prognostic model based on lncRNAs-related to DNA damage repair for predicting the prognosis of clear cell renal cell carcinoma

Article

作者: Chen, Peng ; Li, Jian ; Tian, Renli

BACKGROUND:

CcRCC has the characteristics of high aggression, high metastasis, high mortality, wide tumour heterogeneity and variable clinical course. The purpose of this study was to explore the potential value of lncRNAs-related to DNA damage repair (DDR) in predicting the prognosis of ccRCC by construction and verification a novel prognostic model.

METHODS:

RNA-seq data and clinical data of ccRCC were downloaded from public databases. Subsequently, Pearson correlation analysis and differential expression analysis were performed to identify DElncRNAs-related to DDR. Then, through univariate Cox analysis and LASSO analysis, the DElncRNAs-related to DDR associated with prognosis were screened for the construction of novel risk score prognostic model. In addition, functional annotation, tumour mutation burden, immune correlation and drug sensitivity analyses were performed based on risk score to assess the characteristics of patients in different risk score groups.

RESULTS:

Based on univariate Cox analysis and LASSO analysis, four best DElncRNAs-related to DDR were selected. Subsequently, a novel risk score prognostic model based on these four DElncRNAs was constructed through LASSO. Multivariate Cox analysis showed that risk score and age were independent prognostic factors for ccRCC (p < 0.05). Functional enrichment analysis showed that DDR-related biological processes were mainly enriched in the high risk group. The highly mutated genes in the high and low risk groups were the same (VHL, PBRM1 and TTN), but they also had their own unique mutated genes. Pearson correlation analysis showed that the risk score was significantly (p < 0.05) positively correlated with the infiltration degree of CD8 T cells evaluated by six algorithms. In addition, it was found that the high and low risk groups had different sensitivities to the drugs Etoposide, Imatinib, Sorafenib, Bosutinib and Sunitinib.

CONCLUSION:

A novel prognostic model was constructed based on four DElncRNAs-related to DDR. The model has satisfactory accuracy in predicting survival of ccRCC patients.

752

项与依托泊苷相关的新闻（医药）

12 小时之前

·ioncology

ASCO中国之声丨史业辉教授：优替德隆联合方案为HER2阴性乳腺癌脑转移患者带来新希望

编者按：2025年ASCO年会正在大洋彼岸进行的如火如荼，乳腺癌领域众多由中国研究者主导的临床研究成果在此次盛会上大放异彩。其中，天津医科大学肿瘤医院史业辉教授代表团队在ASCO大会上报告了优替德隆联合依托泊苷和贝伐珠单抗治疗HER2阴性乳腺癌脑转移患者的II期前瞻性单臂研究数据。面对当前HER2阴性乳腺癌脑转移治疗手段匮乏、全身治疗疗效欠佳的困境，该研究创新性地采用了三药联合方案，并取得了令人瞩目的成果：结果显示，患者的中枢神经系统客观缓解率（CNS-ORR）达67.6%，中枢神经系统临床获益率（CNS-CBR）达88.2%，中枢神经系统无进展生存期更是突破性地延长至15个月。此方案为HER2阴性脑转移乳腺癌患者开辟了新的治疗路径，彰显了其卓越的临床价值与潜力。报告结束后，肿瘤瞭望特邀史业辉教授为我们深度解读研究数据及其重大意义。01《肿瘤瞭望》：首先请您为我们简要介绍一下该研究背景及您在本次大会上报告的相关数据。史业辉教授天津医科大学肿瘤医院目前，乳腺癌引起的脑转移是第二大常见的颅内转移，仅次于肺癌引起的脑转移。且与可从多种抗HER2治疗中获益的HER2阳性乳腺癌相比，伴有脑转移的HER2阴性乳腺癌患者的治疗选择有限。此外，由于血脑屏障（BBB）的存在，全身治疗未能产生令人满意的效果，当前各项指南未对HER2阴性乳腺癌脑转移患者给出全身给药方案推荐。优替德隆可以穿透血脑屏障，这一点已通过临床前药物组织分布研究和多项临床试验得到证实。因此，我们设计了优替德隆联合依托泊苷和贝伐珠单抗治疗HER2阴性脑转移患者的II期前瞻性单臂研究，以探索优替德隆联合依托泊苷和贝伐珠单抗的三药联合方案，在HER2阴性脑转移乳腺癌患者治疗的有效性和安全性。本次大会上，我报道了该研究的中期分析结果。该研究入组的34例患者中，包括11例三阴性乳腺癌患者和23例Luminal型乳腺癌患者。中位年龄为52岁（范围34-74岁），中位治疗线数为3线。截至2024年12月2日，中位随访时间为11.5个月，中枢神经系统客观缓解率（CNS-ORR）达到了67.6%，中枢神经系统临床获益率（CNS-CBR）达到了88.2%。此外，我们还观察到了患者的生存获益，中位无进展生存期（PFS）为6个月（95%CI：4.265-7.735个月），而中枢神经系统无进展生存期（CNS-PFS）达到了15个月（95%CI：6.760-23.240个月），CNS-PFS实践显著长于中位PFS时间，为患者提供了更好的治疗选择。患者主要不良反应为周围神经病变，其中3级（主要为感觉型）占8.8%（3/34）。大多数治疗相关不良反应为1级或2级，被认为可控且可逆。02《肿瘤瞭望》：在当前针对HER2阴性乳腺癌脑转移患者的治疗手段中，您认为本研究所采用的优替德隆联合依托泊苷和贝伐珠单抗方案，最大的创新突破点体现在哪些方面？优替德隆作为新型微管抑制剂，您认为其在联合治疗方案中起到了怎样的关键作用？史业辉教授天津医科大学肿瘤医院本方案最大的创新点在于采用了三药联合方案进行治疗。考虑到患者颅内、颅外肿瘤负荷的存在，治疗中不仅需要缓解颅内肿瘤，还需对颅外转移如肝转移、肺转移、骨转移、淋巴结转移等进行治疗。既往优替德隆在我国获批的适应症是联合卡培他滨用于复发或转移性乳腺癌患者，其中既往的化疗方案应包含一种蒽环类或紫杉类药物。在本研究中，我们采用依托泊苷替换了卡培他滨，因为卡培他滨作为常用药物，在前序治疗中多数患者已经使用过，而依托泊苷作为后线不常使用的药物，与优替德隆联合进行治疗，既有效又具有创新性。最终研究结果显示，该方案具有高缓解率和较长的缓解时间。我认为优替德隆在方案中起到了核心药物的作用。研究发现，优替德隆可以穿透血脑屏障，且优替德隆在颅内转移肿瘤中的药物浓度明显升高，这是也是本研究的创新之一。03《肿瘤瞭望》：研究结果显示，患者CNS-ORR达67.6%，CNS-CBR达88.2%，中位CNS-PFS为15个月。与现有治疗方案相比，这一数据的公布有何重要意义？您如何看待该方案在延长患者生存期和改善生活质量方面的双重价值？史业辉教授天津医科大学肿瘤医院结合既往发表的相关文献数据，我们得出三药联合方案获得的中枢神经系统客观缓解率（CNS-ORR）是目前报道中最高的，且患者也获得了最长的无进展生存期。这些数据为HER2阴性脑转移乳腺癌患者带来了更多生存希望。更重要的是，我们研究中入组的患者相对偏后线，既往治疗线数从一线到七线不等，平均经过3线治疗，仍能获得较好的生存结果，对未来工作具有重要指导意义。该方案在延长患者生存期和改善生活质量方面具有双重价值。通过获得较高缓解率和较长的缓解时间，患者能获得更长的生存；同时，三药联合治疗方案的相对安全性和可管理性也有助于改善患者的生活质量，对我们未来的工作具有一定指导意义。史业辉教授主任医师天津医科大学肿瘤医院乳腺肿瘤内科主任中国抗癌协会乳腺癌专业委员会常务委员中国医药生物技术协会临床研究专业委员会常务委员中国医药教育协会化疗专业委员会常务委员中国医药教育协会乳腺疾病专业委员会常务委员天津市抗癌协会抗肿瘤药物临床试验专业委员会主任委员天津市医学会临床试验分会副主任委员天津市药学会临床试验伦理审查专业委员会副主任委员天津市抗癌协会化疗专业委员会候任主委（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2期

2025-06-03

·医药魔方Info

打破纪录！国产PD-L1双抗闪耀ASCO

ASCO大会作为全球肿瘤临床治疗进展的风向标，一直是众多创新药物争相展示的舞台。凭借这一盛会，也确实有很多改变临床实践的新药一战成名，比如K药、DS8201等。而在今年的ASCO会议上，也出现了一匹黑马——LBL-024。作为全球首款进入关键临床阶段的国产PD-L1×4-1BB双抗，维立志博开发的LBL-024已连续两年登上ASCO口头报告，以突破性的临床数据持续吸引着全球目光。突破性的疗效数据，填补临床空白在本次ASCO大会上，LBL-024联合化疗作为肺外神经内分泌癌（EP-NEC）一线疗法的Ib/II期临床数据（NCT06157827）尤为亮眼。在52例患者中，所有剂量水平下的客观缓解率（ORR）达75.0%，疾病控制率（DCR）高达92.3%；进一步亚组分析显示，泌尿生殖系统NEC、胰腺NEC、SCLC、食管NEC患者ORR分别为100.0%、83.3%、100.0%、77.8%；在15 mg/kg剂量优化组的18例可评估患者中，ORR达83.3%，DCR达100%。这一疗效远超传统化疗方案30%-55%的历史数据，堪称EP-NEC治疗领域的里程碑[1~3]。回顾去年ASCO大会上的数据，LBL-024同样表现出色。针对接受过至少一线化疗但失败的EP-NEC患者（NCT05170958），LBL-024单药治疗显示出良好的安全性和强有力的有效信号。在15mg/kg剂量下，LBL-024二线治疗EP-NEC的ORR为37.5%，DCR为50.0%，初步展现出作为EP-NEC后线疗法的临床潜力。值得注意的是，在该研究中，PD-L1阴性（CPS<1）患者的ORR为54.5%，提示无论PD-L1在肿瘤组织中的表达如何，患者都可以从LBL-024治疗中获益。EP-NEC作为一种高度恶性、侵袭性强的罕见肿瘤，大多数患者在诊断时分期较晚或已伴有远处转移，疾病进展迅速且预后较差，即使接受全身治疗，患者的中位总生存期（OS）通常也很难超过1年[4]。由于其罕见性，医学界对EP-NEC系统性疗法的研究长期不足，临床实践中多借鉴小细胞肺癌（SCLC，肺神经内分泌癌的一种）的标准化疗方案用于其一线治疗，而后线治疗领域更是缺乏有效疗法，至今尚未形成统一的标准治疗方案[5-6]。然而，EP-NEC和SCLC这两者无论是在起源、临床病程还是生存期等方面都存在着根本性的差异，这使得EP-NEC的治疗需求始终未能得到精准满足。随着该病发病率呈现上升趋势，EP-NEC领域亟待建立系统化、针对性的治疗[5-6]。而LBL-024凭借目前展现出的突破性临床数据以及“全线覆盖”潜力——一线联合化疗使疗效大幅增长，突破现有治疗天花板；后线单药治疗，无论PD-L1表达状态均获益显著——有望为这一“无药可用”的领域引入创新、高效的治疗新选择。全球领先的研发破局之路LBL-024的创新性和具有突破性的临床试验数据源于其独特的“双管齐下”机制。该药是维立志博自主研发的一种同时靶向PD-L1和4-1BB的四价双特异性抗体，一方面可以高亲和力结合PD-L1，阻断PD-L1/PD-1免疫抑制通路；另一方面，在肿瘤微环境中条件性激活4-1BB共刺激通路，将肝毒性降至最低并扩大治疗窗口，激活T细胞发挥强效的免疫作用，具有较PD-1/L1抑制剂更强的广谱癌症治疗潜力，而LBL-024这类基于PD-(L)1的双抗也代表着免疫疗法迭代的新方向。4-1BB是癌症治疗领域非常重要的靶点，原因有二：1. 其广泛表达于人体器官，是一个所谓广谱的靶点，潜在适用于众多癌种；2. 4-1BB是一个激动剂，能激活T细胞，尤其是肿瘤微环境中被抑制或耗竭的T细胞，能够使得它们成千上万的扩增，恢复并增强人体免疫力，从而打败肿瘤细胞。目前还没有一款激动剂靶点的双抗成药。然而，基于4-1BB靶点开发的药物始终绕不开安全性问题。因全身性、非选择性的4-1BB激活机制，导致系统性毒副作用，尤其是严重的肝毒性，使得4-1BB药物不得不以较低剂量使用，从而限制了其临床疗效的充分发挥。LBL-024在安全性问题的解决上表现尤为出色，目前各临床研究已入组300余病患，未发生剂量限制性毒性（DLT）且未达最大耐受剂量（MTD），基本和PD-1一样安全可控。据公开资料，在4-1BB这一靶点上，维立志博LBL-024是目前全球唯一一款已公布的达到成药标准安全性和有效性数据的候选创新药。2024年4月30日，LBL-024获中国国家药品监督管理局药品审评中心批准开展单臂关键注册临床研究，这意味着LBL-024的上市进程驶入了快车道，较传统上市路径时间大幅缩短，有望成为治疗EP-NEC的首款获批药物。凭借其突出的临床价值，LBL-024接连获得NMPA的突破性治疗药物认定和FDA的孤儿药认定。国产双抗适应症广阔鉴于4-1BB在抗肿瘤细胞毒性T细胞上的表达及其关键的共刺激作用，以及PD-L1在多种癌症类型中的广泛表达，LBL-024拥有广阔的适应症扩展机会。维立志博对LBL-024的临床开发策略也极具前瞻性，首先是创新性选择EP-NEC作为首发适应症，精准切入临床急需的蓝海市场，体现其出对临床需求与研发策略的精准把控。其次，"单臂注册+快速扩展"策略，有望基于突破性治疗认定实现加速上市，为市场竞争赢得了宝贵的时间，同时同步开展针对SCLC、非小细胞肺癌（NSCLC）、卵巢癌、食管鳞癌、胆道癌、胃癌、肝癌等大癌种的临床研究，在更多适应症中探索其应用潜力。在SCLC领域，LBL-024的治疗潜力同样不容小觑，早期研究显示，LBL-024联合化疗作为SCLC的一线治疗方案，可评估患者的ORR达84.2%(16/19)，DCR达100%。尽管研究样本量相对较小，但在这一向来以难治性著称的治疗领域，能够取得如此出色的结果，已经证明了LBL-024的实力。目前，LBL-024在非小细胞肺癌（NSCLC）治疗方面的研究已顺利推进至Ib/II期临床阶段，预示着其有望进一步拓宽应用范围。除EP-NEC和SCLC之外，LBL-024在其他大癌种中也已产生初步疗效信号，有望使LBL-024成为一款针对广泛适应症的有效抗肿瘤药物，为众多癌症患者带来新的治疗选择。总结展望未来，LBL-024有潜力成为First-in-Class的肿瘤免疫治疗药物，推动4-1BB成为继PD-(L)1、CTLA-4及LAG3之后第四大可成药的免疫检查点。若LBL-024成功率先获批，其意义将超越单一产品的范畴，也将成为中国自主研发的首个可成药免疫检查点药物的开拓者。LBL-024的进阶之路，恰是中国创新药产业升级的微观映射。当国内很多热门赛道因同质化陷入内卷时，像维立志博这样的创新型企业已悄然进化：在双抗、TCE（CD3 T-Cell Engager）、下一代ADC等前沿领域，中国企业技术平台与国际并跑，创新质量实现了显著跃升，展现出国际领先的研发效率。从Fast-Follow到First-in-Class的突破，需要跨越的不仅是技术鸿沟，更是创新体系的系统性升级。LBL-024的案例证明，当靶点选择、研发策略、临床开发形成闭环时，中国药企也可能领跑下一代疗法的发展。随着越来越多“中国智造”的创新分子进入全球临床管线，一个更具全球影响力的东方创新极正在崛起，这或许才是LBL-024带给行业最深远的启示。- 上下滑动查看参考资料 - [1]Ohmoto A, Fujiwara Y, Horita N, Nakano K, Takahashi S. Platinum-doublet chemotherapy for advanced gastroenteropancreatic neuroendocrine carcinoma: a systematic review and meta-analysis. Discov Oncol. 2022;13(1):40. Published 2022 May 30. doi:10.1007/s12672-022-00499-w[2]Morizane C, Machida N, Honma Y, et al. Effectiveness of Etoposide and Cisplatin vs Irinotecan and Cisplatin Therapy for Patients With Advanced Neuroendocrine Carcinoma of the Digestive System: The TOPIC-NEC Phase 3 Randomized Clinical Trial.JAMA Oncol. 2022;8(10):1447-1455. doi:10.1001/jamaoncol.2022.3395[3]Frizziero M, Spada F, Lamarca A, et al. Carboplatin in Combination with Oral or Intravenous Etoposide for Extra-Pulmonary, Poorly-Differentiated Neuroendocrine Carcinomas.Neuroendocrinology. 2019;109(2):100-112. doi:10.1159/000497336[4]Andreatos N, McGarrah PW, Sonbol MB, et al. Managing Metastatic Extrapulmonary Neuroendocrine Carcinoma After First-Line Treatment.Curr Oncol Rep. 2023;25(10):1127-1139. doi:10.1007/s11912-023-01438-w[5]Stelwagen J, de Vries EGE, Walenkamp AME. Current Treatment Strategies and Future Directions for Extrapulmonary Neuroendocrine Carcinomas: A Review.JAMA Oncol. 2021;7(5):759-770. doi:10.1001/jamaoncol.2020.8072[6]中国抗癌协会神经内分泌肿瘤专业委员会.中国抗癌协会神经内分泌肿瘤诊治指南（2025年版）[J]中国癌症杂志, 2025, 35(1): 85-142.Copyright © 2025 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

ASCO会议临床结果

2025-06-03

·BioSpace

Roche and Jazz Link Drug Combo to Improved Survival in Phase III Lung Cancer Trial

iStock, Liudmila Chernetska Analysts said the data suggest “a strong treatment effect.” Jazz has filed for FDA approval for the combination, which could offer an alternative to monotherapy treatments from Roche and AstraZeneca. Roche and Jazz Pharmaceuticals have shared updated Phase III data on a combination of their medicines Tecentriq and Zepzelca, furthering plans to win FDA approval for the drug cocktail in small cell lung cancer in a first-line maintenance setting this year. Investigators shared the results in an abstract for the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and a paper published in The Lancet . Truist Securities analysts said in a note to investors that researchers provided “incremental updates” in an oral ASCO presentation, adding that the latest look at the data was consistent with the abstract and the paper. Jazz has filed for FDA approval for the combination. Rob Iannone, chief medical officer at Jazz, recently told BioSpace he expects “to get priority review, which would allow us to get an approval this year.” Amal Melhem-Bertrandt, oncology therapy area head at Jazz, said at a Bank of America event last month that amid changes at the FDA the company had not “seen any disruption, thankfully, and things continue to go on time.” If the filing is approved, Zepzelca will offer an alternative to Tecentriq or AstraZeneca’s rival checkpoint inhibitor Imfinzi in maintenance therapy. The new study, which is sponsored by Roche and co-funded by Jazz, enrolled 660 people with extensive-stage small cell lung cancer (SCLC). Patients received four cycles of carboplatin, etoposide and Roche’s checkpoint inhibitor Tecentriq as induction therapy. After induction, investigators randomized 483 eligible patients without disease progression to receive just Tecentriq or Jazz’s Zepzelca together with Tecentriq. The cocktail extended patients’ progression-free (PFS) and overall survival (OS). Median PFS was 5.4 months in the combination arm, compared to 2.1 months in people treated with Tecentriq alone. Median OS was 13.2 months and 10.6 months, respectively, in the combination and monotherapy arms. The differences in PFS and OS between the arms were statistically significant. Currently, patients have access to Tecentriq or AstraZeneca’s rival checkpoint inhibitor Imfinzi in maintenance therapy. Median PFS in Tecentriq and Imfinzi trials was 5.2 months and 5.1 months, respectively, according to an analyst note from Truist on Monday. Though cross-trial comparisons can be flawed, the data suggest that Zepzelca is about as effective as Tecentriq or Imfinzi, and Truist analysts said Jazz and Roche’s combo has “a strong treatment effect.” Other companies are also seeking to improve on Imfinzi and Tecentriq. BioNTech is running a Phase III trial of its PD-L1xVEGF-A bispecific in SCLC. The candidate, which Bristol Myers Squibb is co-developing through a deal worth up to $11.1 billion , achieved median PFS and OS of 6.9 months and 16.8 months, respectively, in a Phase II trial. Daiichi Sankyo and Amgen are also targeting SCLC maintenance therapy. Zepzelca is already approved in second-line SCLC. Sales of the drug fell 16% to $63 million in the first quarter. Jazz CFO Philip Johnson discussed the dip at the Bank of America event last month, explaining that the roll out of Amgen’s Imdelltra as a second-line treatment and “great data” on Imfinzi in first-line, limited-stage patients hurt sales. Improved initial therapies delay the need for second-line drugs such as Zepzelca.

临床结果临床3期ASCO会议上市批准临床2期

100 项与依托泊苷相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00125	依托泊苷	L01CB01	DB00773

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
膀胱癌	日本	Clinigen Ltd.	1987-04-30
白血病	日本	Clinigen Ltd.	1987-04-30
淋巴瘤	日本	Nippon Kayaku Co., Ltd.	1987-03-31
卵巢癌	日本	Nippon Kayaku Co., Ltd.	1987-03-31
宫颈癌	日本	Nippon Kayaku Co., Ltd.	1987-03-31
小细胞肺癌	美国	Corden Pharma Latina SpA	1983-11-10
睾丸肿瘤	美国	Corden Pharma Latina SpA	1983-11-10

未上市

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
铂耐药性卵巢癌	临床3期	中国	江苏恒瑞医药股份有限公司	2019-08-16
原发部位不明恶性肿瘤	临床3期	美国	Pharmacia & Upjohn, Inc.	2003-09-01
原发部位不明恶性肿瘤	临床3期	美国	AstraZeneca PLC	2003-09-01
原发部位不明恶性肿瘤	临床3期	美国	Eli Lilly & Co.	2003-09-01
广泛期小细胞肺癌	临床3期	美国	GSK Plc	2001-04-01
广泛期小细胞肺癌	临床3期	中国	GSK Plc	2001-04-01
广泛期小细胞肺癌	临床3期	奥地利	GSK Plc	2001-04-01
广泛期小细胞肺癌	临床3期	比利时	GSK Plc	2001-04-01
广泛期小细胞肺癌	临床3期	巴西	GSK Plc	2001-04-01
广泛期小细胞肺癌	临床3期	保加利亚	GSK Plc	2001-04-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ASCO2025	临床2期	高风险神经母细胞瘤	34	HITS (Irinotecan, Temozolomide, Naxitamab, GM-CSF)	艱艱醖遞齋衊製膚艱製(襯範顧蓋願鬱鬱醖製製) = 選夢鑰築衊網餘製齋鹽製窪鬱齋襯鑰廠獵鹹鑰 (壓願餘齋選獵壓築鑰顧 ) 更多	积极	2025-05-30
ASCO2025	临床2期	高风险神经母细胞瘤	34	NICE (Naxitamab, GM-CSF, Ifosfamide, Carboplatin, Etoposide)	艱艱醖遞齋衊製膚艱製(襯範顧蓋願鬱鬱醖製製) = 願構衊鑰蓋襯鬱鑰襯積製窪鬱齋襯鑰廠獵鹹鑰 (壓願餘齋選獵壓築鑰顧 ) 更多	积极	2025-05-30
NCT03980925 (GETNE T1913, CTgov)	临床2期	胃肠道神经内分泌肿瘤 \| 胃肠胰神经内分泌肿瘤	37	Nivolumab+Etoposide+Carboplatin	構繭獵獵鬱獵獵餘憲觸 = 鹽壓壓齋艱網蓋繭艱構憲選夢壓願糧製製製築 (艱築構窪齋獵觸繭鹽遞, 餘壓壓願製簾襯鑰鏇齋 ~ 積選鏇夢選獵積艱築艱) 更多	-	2025-01-13
NCT02705508 (Pubmed \| Hematology) 人工标引	临床2期	结外NK-T细胞淋巴瘤一线	34	PEG (pegaspargase, etoposide, gemcitabine)	鏇積選鑰願築構糧夢憲(齋夢製鏇壓願積鑰衊網) = 繭衊窪醖餘艱築夢膚積築糧選觸簾壓積觸鹽鹹 (壓顧構網膚衊鹽願願積 ) 更多	积极	2024-12-31
NCT04923776 (CTgov)	临床2期	广泛期小细胞肺癌	2	Stereotactic Body Radiation Therapy (SBRT)+Etoposide+Carboplatin+Atezolizumab	鏇齋鏇蓋遞獵齋齋鹹簾(齋範顧淵鏇選築廠餘顧) = 膚範夢觸遞衊壓簾夢襯艱獵鑰簾蓋廠衊艱窪願 (衊糧蓋鹹夢蓋壓餘壓餘, 淵顧鑰憲蓋鹹簾淵繭繭 ~ 鑰衊齋蓋膚餘鏇築衊簾) 更多	-	2024-12-30
NCT00801216 (SCNSL1, CTgov)	临床2期	B细胞淋巴瘤	40	etoposide+cyclophosphamide+carmustine+Rituximab+methotrexate+Thiotepa+cytarabine	鹽網糧選繭齋憲獵鏇範 = 醖鹹網鹹糧蓋窪範鑰顧憲糧遞齋觸鹽鹽齋壓獵 (齋鑰獵襯憲鹽齋襯製窪, 範艱選構獵窪遞衊膚鑰 ~ 繭繭廠積衊鏇膚膚蓋獵) 更多	-	2024-12-10
ASH2024	N/A	多发性骨髓瘤	-	Etoposide + G-CSF	製鏇簾鬱鹽齋醖襯鏇艱(鹽淵夢壓鏇襯願鏇網獵) = The primary adverse events were grade III-IV bone marrow suppression (100%) and febrile neutropenia (22.7%), with no documented bloodstream infections or hepatorenal toxicity 遞淵衊襯膚餘顧齋構鬱 (鬱膚構壓鏇憲餘衊鏇艱 )	-	2024-12-07
ESMO_ASIA2024	N/A	广泛期小细胞肺癌一线	274	Cisplatin (CDDP)+Etoposide (ETP)+Durvalumab (DUR)	鑰鹹繭鹹簾鏇簾製簾範(鏇構窪構醖窪網憲遞選) = 8% vs. 4% 齋膚網遞遞鹹構選鏇製 (築廠鬱衊鹹範簾觸醖膚 ) 更多	积极	2024-12-07
ESMO_ASIA2024	N/A	广泛期小细胞肺癌一线	274	Carboplatin (CBDCA)+ETP+Atezolizumab (ATZ)		积极	2024-12-07
NCT04951115 (CTgov)	临床2期	小细胞肺癌	6	Stereotactic Body Radiotherapy+Etoposide+Carboplatin+cisplatin+Durvalumab	醖夢簾鏇築積夢遞淵醖 = 餘醖糧醖鏇選積積鏇艱膚觸鹹壓壓鬱遞積蓋選 (蓋簾淵網構積觸醖網網, 選鏇憲獵鑰膚鹹鑰顧壓 ~ 築衊構壓製衊夢糧鏇鏇) 更多	-	2024-11-26
NCT03923179 (ESMO2024) 人工标引	临床2期	HER2阳性转移性乳腺癌 HER2 Positive	22	Pyrotinib 400mg per dayetoposide	網壓選範衊夢糧網淵淵(鏇壓糧餘積廠簾夢鏇築) = 鹹遞廠築齋壓顧製顧醖鹽願鬱簾繭製繭衊範鹽 (獵製獵選獵蓋鹽簾憲餘, 7.6 ~ 10.4) 更多	积极	2024-09-16
ESMO2024 人工标引	N/A	弥漫性大B细胞淋巴瘤 G6PD deficiency	82	RituximabCyclophosphamideDoxorubicin HydrochlorideVincristine SulfatePrednisone	廠醖鏇艱鹹觸膚積淵壓(選簾願蓋觸夢餘構夢醖) = 壓壓衊廠夢選餘顧範窪衊醖醖夢遞觸鹹夢夢糧 (鑰衊鑰蓋壓鬱鹽網願窪 ) 更多	不佳	2024-09-15
ESMO2024 人工标引	N/A	弥漫性大B细胞淋巴瘤 G6PD deficiency	82	RituximabCyclophosphamideEtoposideVincristine SulfatePrednisone	廠醖鏇艱鹹觸膚積淵壓(選簾願蓋觸夢餘構夢醖) = 鑰壓觸鹹鹽鹽鑰鹹艱築衊醖醖夢遞觸鹹夢夢糧 (鑰衊鑰蓋壓鬱鹽網願窪 ) 更多	不佳	2024-09-15