A Phase II Clinical Study on Precision Treatment of Rare Tumours in China Guided by Patient-Derived Tumor Organoids (PDO) and Next-Generation Sequencing (NGS)

The objective of this Phase II, open-label, multicenter, non-randomised controlled clinical trial is to guide precision treatment for patients with rare tumours based on Patient-Derived Organoids/Next-Generation Sequencing drug screening.

开始日期2025-01-01

申办/合作机构

北京大学深圳医院（北京大学深圳临床医学院）

NCT06563999

/ Recruiting临床2期IIT

Neoadjuvant Umbrella Trial Directed by Next Generation Sequencing for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations (Without EGFR Sensitizing Mutations)

This umbrella trial directed by next generation sequencing (NGS) includes patients with treatment-naive unresectable stage III non-small-cell lung cancer (NSCLC). The aim of the umbrella study is to evaluate the efficacy of induction NGS-directed targeted therapies followed by surgery for stage III NSCLC patients whose tumor harbors a rare mutation.

开始日期2024-11-01

申办/合作机构

中山大学

NCT06348355

/ Completed临床1期

A Phase I, Open-label, Positron-Emission Tomography Study to Determine Brain Exposure of [11C]Savolitinib in Healthy Volunteers

The purpose of this study is to measure brain exposure of [11C]savolitinib in healthy volunteers.
This study will determine brain exposure of [11C]savolitinib in up to 8 healthy volunteers under physiological conditions, ie, when the BBB is intact. The study design allows up to 3 site visits. Two PET examinations will be performed for each healthy volunteer. The first PET examination will use IV administration of [11C]savolitinib. The second PET examination using [11C]savolitinib will occur after a single oral dose of 300 mg of savolitinib. PET image analysis will include kinetic compartment modelling using arterial input function, and will generate a set of brain exposure parameters (eg, maximum %ID, maximum [11C]savolitinib concentration in brain, partition coefficients between brain and plasma).

开始日期2024-04-12

申办/合作机构

AstraZeneca PLC

100 项与赛沃替尼相关的临床结果

登录后查看更多信息

100 项与赛沃替尼相关的转化医学

登录后查看更多信息

100 项与赛沃替尼相关的专利（医药）

登录后查看更多信息

206

项与赛沃替尼相关的文献（医药）

2025-12-01·Journal of Gastrointestinal Cancer

A Phase 2 study of Savolitinib in Patients with MET Amplified Metastatic Colorectal Cancer

Article

作者: Niedzwiecki, Donna ; Lowe, Melissa ; Kortmansky, Jeremy ; Moyer, Ashley ; Bolch, Emily ; Jia, Jingquan ; Cho, May ; Kalyan, Aparna ; Strickler, John H ; Lenz, Heinz-Josef

PURPOSE:

MET amplification (amp) is a driver of acquired resistance to epidermal growth factor receptor (EGFR) antibodies in patients with RAS wild-type (WT) metastatic colorectal cancer (mCRC). Savolitinib is an oral small molecule tyrosine kinase inhibitor that has demonstrated anti-tumor activity in MET-driven advanced solid tumors. We report the results of a phase 2 study of savolitinib in patients with mCRC with MET amp detected by circulating cell free (cf)DNA.

METHODS:

Patients with chemotherapy refractory mCRC and MET amp detected by cfDNA were treated with savolitinib until unacceptable toxicity or disease progression. The primary endpoint was objective response rate. Secondary endpoints were clinical activity and safety.

RESULTS:

Five patients were enrolled and treated. Best overall response was stable disease (SD) in two patients, progressive disease (PD) in two patients, and one patient unevaluable for response. The majority of treatment-emergent adverse events (TEAEs) were grade 1 or 2. The most common TEAEs included fatigue (n = 3) and nausea (n = 3). There were no grade 4 or 5 TEAEs.

CONCLUSION:

Savolitinib was well tolerated; however, in this small group of biomarker-selected patients, we observed no evidence of anti-tumor activity.

TRIAL REGISTRATION:

Clinicaltrials.gov Identifier: NCT03592641. Registered on July 17, 2018.

2025-09-01·JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS

Brain exposure of the mesenchymal–epithelial transition inhibitor savolitinib in nonhuman primates: A positron emission tomography study

Article

作者: Schou, Magnus ; Johnström, Peter ; Miah, Kowser ; Jucaite, Aurelija ; Cortés González, Miguel A ; Halldin, Christer ; Vishwanathan, Karthick ; Cselényi, Zsolt ; Farde, Lars ; Scarfe, Graeme

The receptor tyrosine kinase mesenchymal-epithelial transition factor inhibitor savolitinib is currently being evaluated as a treatment in non-small cell lung cancer (NSCLC) in combination with osimertinib. NSCLC patients with epidermal growth factor receptor/anaplastic lymphoma kinase mutations appear to have a high incidence (50%-60%) of brain metastasis; hence, cancer drugs that can efficiently access the brain hold a critical advantage. In this study, savolitinib blood-brain barrier penetration properties were investigated in nonhuman primates using positron emission tomography and intravenous administration of microdoses of [¹¹C]savolitinib either as a bolus or a bolus-constant infusion. Following a bolus, rapid distribution of radioactivity to the brain was observed reaching a maximum radioactivity concentration (C_max) of 0.33% of injected radioactivity. An estimated value of the concentration ratio of the total brain-to-plasma ratio (K_p) of 0.35 was derived using kinetic positron emission tomography data analysis. Intriguingly, notwithstanding the low C_max, the estimated unbound brain-to-plasma ratio using predetermined in vitro values for free fractions in brain and plasma showed a favorable brain-to-plasma partition with a K_p,uu of 0.65. This apparent contrast could be explained by the high free fraction of savolitinib in brain tissue. To further build confidence in the estimated K_p,uu, a bolus-constant infusion protocol successfully established a brain-to-plasma concentration steady-state yielding values for K_p and K_p,uu of 0.32 and 0.60, respectively, in good agreement with the bolus study. Our findings confirm blood-brain barrier penetrance and exposure of savolitinib in the nonhuman primate brain. If a similar penetrance in humans is observed, it may help to prevent and/or treat brain metastasis in NSCLC patients. SIGNIFICANCE STATEMENT: Patients with brain malignancies are challenging to treat due to the blood-brain barrier limiting the exposure of therapeutics to the central nervous system. This study demonstrates blood-brain barrier penetrance and exposure of the mesenchymal-epithelial transition inhibitor savolitinib in the nonhuman primate brain. If a similar penetrance in humans is observed, it may help to prevent and/or treat brain metastasis in non-small cell lung cancer patients.

2025-09-01·Nature Reviews Clinical Oncology

Evolving roles of MET as a therapeutic target in NSCLC and beyond

Review

作者: Lee, Jii Bum ; Cho, Byoung Chul ; Shim, Joo Sung

Alterations in the proto-oncogene MET are associated with tumour development, invasion and metastasis across various solid cancers. Therapeutically actionable MET alterations include MET exon 14 skipping (METex14) mutations, MET amplification and/or MET overexpression and MET fusions, which vary in incidence by tumour type. In contrast to rare de novo MET alterations, acquired MET amplification and/or MET overexpression is a relatively common phenomenon that is associated with distinct clinical implications and responses to treatment. METex14 is a distinct oncogenic driver mutation in non-small-cell lung cancer (NSCLC). To date, the MET tyrosine-kinase inhibitors (TKIs) capmatinib, tepotinib and savolitinib have been approved for the treatment of advanced-stage METex14-mutant NSCLC. However, the treatment paradigms for MET-altered solid tumours are rapidly evolving to include diverse MET-targeted agents. Emerging data support the role of MET TKIs, anti-MET antibodies and MET-directed antibody-drug conjugates (ADCs) as monotherapy or in combination with other therapies for NSCLC or other tumour types with MET amplification and/or overexpression. Indeed, in May 2025, the MET-directed ADC telisotuzumab vedotin was approved by the FDA for patients with previously treated advanced-stage nonsquamous NSCLC overexpressing MET (≥50% of tumour cells with 3+ staining on immunohistochemistry). Understanding the unique MET-related adverse events will be crucial when incorporating these agents into daily clinical practice. In this Review, we highlight the rationale for targeting MET alterations across various solid tumour types and provide a summary of the clinical efficacy and toxicity profiles of the approved and emerging MET-targeted TKIs, monoclonal or bispecific antibodies and ADCs.

458

项与赛沃替尼相关的新闻（医药）

2025-09-12

·医脉通

赵军教授：COMPEL研究解锁耐药困局，“EGFR延续+强化”策略开启后线治疗新篇章

引言随着靶向治疗的快速发展，酪氨酸激酶抑制剂（TKI）已经改变了驱动基因阳性非小细胞肺癌（NSCLC）患者的治疗格局。针对表皮生长因子受体（EGFR）突变（Ex19del/L858R）晚期NSCLC患者，奥希替尼等第三代EGFR-TKI已成为一线治疗的标准方案，显著延长了患者的生存获益。然而，耐药问题难以避免，如何在耐药后制定合理、有效的后续治疗方案，成为当前个体化治疗中的关键难题。在本次世界肺癌大会（WCLC）上，COMPEL研究首次公布结果1，该研究旨在探讨奥希替尼联合化疗在一线奥希替尼治疗后出现非中枢神经系统（CNS）疾病进展的EGFR突变晚期NSCLC患者的疗效与安全性，为优化EGFR突变患者后线治疗提供重要依据。值此之际，医脉通特邀该研究的主要研究者之一——北京大学肿瘤医院赵军教授，深入解读研究设计与核心结果，并结合临床实践，探讨EGFR-TKI耐药后的治疗路径优化策略。医脉通：EGFR突变阳性的晚期NSCLC患者在EGFR-TKI治疗耐药后，最常见的耐药机制是什么？第三代EGFR-TKI耐药的患者在分子特征上与一/二代EGFR-TKI耐药患者有什么不同？赵军教授 EGFR突变NSCLC是最早实现靶向治疗突破的肺癌亚型，特别是随着第三代EGFR-TKI在临床中的广泛应用，患者的无进展生存期（PFS）得到了显著延长2。然而，无论是一代/二代还是三代EGFR-TKI，耐药问题均不可避免。对于一代/二代EGFR-TKI耐药患者，最常见的耐药机制为EGFR T790M突变，约占50%3，这类患者可以通过第三代EGFR-TKI实现有效的后续治疗，临床获益明确。而第三代EGFR-TKI耐药的分子图谱则更为复杂且异质性显著。既往研究显示3，接受奥希替尼一线治疗后进展的患者中，最常见的耐药机制是MET扩增、HER2扩增以及C797X突变等，耐药通路明显更加多样化。此外，还有一小部分患者出现病理类型的转化。可见，相较于一/二代以T790M为主导的耐药机制，三代EGFR-TKI耐药呈现出明显的异质性与复杂性，为后续治疗策略的制定带来了更大的挑战。医脉通：COMPEL研究评估了奥希替尼联合铂类化疗在耐药后EGFR突变阳性患者中的效果，为什么在当前治疗体系中需要探索这种联合治疗方案？赵军教授第三代EGFR-TKI耐药机制复杂多样，耐药后治疗已成为不容忽视的临床和科学难题。目前，临床中通常根据不同的耐药机制，采取不同的治疗策略：存在可靶向耐药通路者，推荐靶向联合治疗；无可靶向驱动变异者，则以化疗为基础，可考虑联合免疫或抗血管生成治疗。然而，临床实践中我们观察到一个重要现象：并非所有患者在第三代EGFR-TKI耐药后均表现为全身性、同步性进展，例如，部分患者脑转移灶仍维持稳定，而仅出现肺内、肝内或骨转移灶进展；也有患者尚未发生脑转移，但其他部位出现疾病进展。此外，第三代EGFR-TKI耐药后，不同转移灶之间可能存在克隆异质性，部分病灶仍对EGFR-TKI敏感。在这种情况下，延续TKI治疗可能有助于维持对敏感克隆（尤其是CNS病灶）的抑制，而化疗则覆盖耐药克隆，从而实现“双通路协同控制”。基于此，COMPEL研究应运而生。研究旨在探索一线奥希替尼治疗后出现疾病进展的患者中，继续使用奥希替尼联合含铂双药化疗，是否能够兼顾系统性病灶控制和CNS保护。这项研究看似简单，仅是比较奥希替尼联合化疗与单纯化疗的疗效和安全性，但特别聚焦于暂未发生脑转移或已存在脑转移但脑转移灶仍处于TKI可控制范围的患者，其背后蕴含着对耐药异质性、长期管理策略的深入思考，具有重要临床意义。医脉通：您能否为我们详细解读一下本次公布的COMPEL研究数据？您认为这一数据能为临床实践提供哪些参考和启示？赵军教授 COMPEL研究1是一项全球多中心、双盲、随机对照、Ⅲ期临床试验，探索了一线奥希替尼治疗耐药后使用奥希替尼联合化疗的疗效和安全性。研究纳入了98例一线奥希替尼治疗后出现非CNS进展的EGFR突变（Ex19del/L858R）晚期NSCLC患者，主要终点为经研究者评估的PFS，关键次要终点则包括CNS PFS、非CNS PFS及总生存期（OS）。结果显示，奥希替尼联合化疗组的中位PFS为8.4个月（95% CI：5.7-11.8），显著优于对照组的4.4个月（95% CI：3.5-5.6），疾病进展或死亡风险降低57%（HR=0.43，95% CI：0.27-0.70），这一数据尤为亮眼，因为既往针对奥希替尼耐药后的治疗方案，无论是单纯化疗、化疗联合免疫治疗，还是化免联合抗血管生成治疗，整体PFS改善均较为有限。因此，COMPEL研究中PFS的显著延长具有重要的临床意义，值得进一步关注和探讨。图1.COMPEL研究中的PFS结果1 在OS方面，奥希替尼联合化疗组的中位OS为15.9个月，相比对照组为9.8个月。尽管由于样本量较小，目前尚未达到统计学显著性差异，但这一趋势提示了潜在的生存获益。随着后续大样本前瞻性研究的推进，有望获得更多生存数据支撑。此外，奥希替尼联合化疗组不仅在非CNS PFS方面表现出改善倾向，相比对照组为8.4个月 vs. 5.2个月（HR=0.43），同时在CNS PFS上也显示出积极结果，相比对照组为15.9个月 vs. 8.6个月（HR=0.56），上述结果表明，继续使用奥希替尼并联合化疗能够有效维持对CNS病灶的控制，为患者带来额外的临床获益。图2.COMPEL研究中的非CNS PFS结果1 图3.COMPEL研究中基线无CNS转移患者的CNS PFS结果1 从安全性角度来看，奥希替尼联合化疗组整体耐受性良好，未观察到新的安全性信号，常见的≥3级治疗相关不良反应包括贫血（13%）、中性粒细胞减少（13%）以及白细胞计数下降（10%）等，安全性可控。综上所述，COMPEL研究证实了奥希替尼联合化疗用于第三代EGFR-TKI耐药后治疗的疗效和安全性，未来随着更大规模前瞻性研究的开展，我们将进一步验证该联合策略的长期生存获益及其在临床实践中的应用价值。医脉通：除了COMPEL研究外，当前围绕延缓或克服第三代EGFR-TKI耐药性这一问题，还有哪些研究正在开展？您认为未来还有哪些优化策略的探索方向？赵军教授目前的研究策略主要聚焦于两个方向，一是通过联合治疗从源头上延缓耐药，二是基于耐药机制探索精准的后续治疗路径。在延缓耐药方面，近年来多项研究显示出令人鼓舞的进展。FLAURA2研究探索了奥希替尼联合含铂双药化疗作为EGFR突变（Ex19del/L858R）晚期NSCLC一线治疗方案的可行性，结果显示联合方案组中位PFS为25.5个月，较单药组有明显提升4。值得关注的是，本次WCLC大会公布的OS数据也显示出显著获益，中位OS为47.5个月 vs. 37.6个月（HR=0.77，P=0.02）5。此外，靶向治疗与抗血管生成药物的联合也展现出良好前景，II期RAMOSE研究显示，奥希替尼联合雷莫芦单抗一线治疗EGFR 突变（Ex19del/L858R）晚期NSCLC，中位PFS为24.8个月，显著优于单药治疗的15.6个月6。与此同时，对于系统治疗后实现缓解但存在寡残留病灶的患者，局部巩固治疗（如放疗或手术）的价值也逐渐被重视。这类干预不仅可以清除微小残留病灶，还可延迟系统性进展，从而延长PFS甚至OS。在克服耐药方面，研究正朝着机制导向的个体化治疗方向发展。MET扩增为最常见的第三代EGFR-TKI耐药机制，III期SACHI研究评估了奥希替尼联合MET抑制剂赛沃替尼在MET扩增/过表达患者中的疗效，结果显示，奥希替尼联合赛沃替尼组的中位PFS达9.8个月，显著优于对照组的5.4个月（HR=0.34，P＜0.0001）7，为该类患者提供了强有力的治疗依据。此外，四代EGFR-TKI的研发也正在积极推进中，尽管多数药物尚处于早期临床阶段，但其在克服特定耐药突变方面的潜力已初步显现。未来，随着更多探索的展开，这类新型靶向药物有望与现有治疗手段有效联合，进一步拓展耐药患者的疗效边界。结语总之，COMPEL研究提出的“EGFR延续+强化”策略，为第三代EGFR-TKI耐药后治疗提供了新的临床路径，既丰富了后线治疗的选择，也为个体化联合治疗策略的探索提供了重要依据。我们有理由期待，未来随着分子机制的精准干预与新型药物的协同应用，将进一步延长EGFR突变NSCLC患者的长期生存获益。专家简介赵军教授北京大学肿瘤医院胸部肿瘤中心副主任、胸部肿瘤内一科副主任、主任医师、教授、博士研究生导师肿瘤内科教研室主任、伦理委员会副主任委员北京医学奖励基金会肺癌青年专家委员会主任委员北京肿瘤学会肺癌专委会副主任委员北京抗癌协会早癌筛查专委会肺癌学组组长中国医师协会肿瘤多学科诊疗专业委员会委员中国抗癌协会呼吸内镜分会委员精准医学与肿瘤康复专委会常委中国老年学会老年肿瘤专业委员会委员国家技术标准创新基地医疗健康大数据专业委员会委员中国肺癌杂志青年编委肿瘤防治研究杂志编委中国肿瘤临床杂志审稿专家 Chinese Journal of Cancer Research 审稿专家参考文献： 1.Pasello G, Zhao J, Tufman A, et al. COMPEL: Osimertinib + Platinum-Based Chemotherapy in Patients With EGFRm Advanced NSCLC and Progression on 1L Osimertinib. WCLC 2025; Abstract OA08.03. 2.Reungwetwattana T, Nakagawa K, Cho BC, et al. CNS Response to Osimertinib Versus Standard Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors in Patients With Untreated EGFR-Mutated Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. Published online August 28, 2018. 3.Reita D, Pabst L, Pencreach E, et al. Molecular mechanism of EGFR-TKI resistance in EGFR-mutated non-small cell lung cancer: application to biological diagnostic and monitoring[J]. Cancers, 2021, 13(19): 4926. 4.Planchard D, Jänne PA, Cheng Y, et al. Osimertinib with or without Chemotherapy in EGFR-Mutated Advanced NSCLC. N Engl J Med. 2023;389(21):1935-1948. 5.David Planchard, et al. First-Line Osimertinib + Chemotherapy Versus Osimertinib Monotherapy in EGFRm Advanced NSCLC: FLAURA2 Final Overall Survival. 2025 WCLC. PL02.06. 6.Le X, Patel JD, Shum E, et al. A Multicenter Open-Label Randomized Phase II Study of Osimertinib With and Without Ramucirumab in Tyrosine Kinase Inhibitor-Naïve EGFR-Mutant Metastatic Non-Small Cell Lung Cancer (RAMOSE trial). J Clin Oncol. 2025;43(4):403-411. 7.Lu S, Wang J, Yang N, et al. 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. 2025 ASCO. LBA8505. 撰写：eureka 审校：赵军教授排版：Zelda 执行：Zelda 本平台旨在为医疗卫生专业人士传递更多医学信息。本平台发布的内容，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。如该等信息被用于了解医学信息以外的目的，本平台不承担相关责任。本平台对发布的内容，并不代表同意其描述和观点。若涉及版权问题，烦请权利人与我们联系，我们将尽快处理。

临床结果临床研究ASCO会议

2025-09-09

·医脉通

2025 WCLC | SAVANNAH研究再迎数据更新，双靶联合引领三代EGFR-TKI耐药合并MET异常NSCLC治疗新范式

前言由国际肺癌研究协会（IASLC）主办的2025年世界肺癌大会（WCLC）正于当地时间9月6日-9日在西班牙巴塞罗那火热召开中。作为肺癌领域最具影响力的年度学术盛会之一，多项领域内研究成果在本次WCLC大会集体亮相。其中，全球首个评估赛沃替尼联合奥希替尼用于奥希替尼耐药后伴间质上皮细胞转化因子（MET）扩增和/或过表达非小细胞肺癌（NSCLC）有效性和安全性的II期SAVANNAH研究在本次WCLC大会继续更新了其生物标志物一致性分析、获得性耐药分析、以及患者报告结局（PROs），为双靶联合治疗的应用探索提供了更全面的证据支持。基于此，医脉通特邀南昌大学第一附属医院李勇教授就SAVANNAH研究的更新结果进行深入解读，并探讨双靶联合治疗的应用价值。 SAVANNAH研究既往数据提示双靶联合方案可兼顾治疗有效性与安全性在EGFR敏感突变（Ex19del/L858R）晚期NSCLC治疗领域，三代EGFR-TKI是目前公认的一线优选方案。但即使接受三代EGFR-TKI治疗，患者仍难以逃脱耐药困局。长期以来，EGFR-TKI经治耐药患者的后续策略多以化疗为主，但化疗疗效较为有限。在后续探索过程中，尽管免疫+化疗+抗血管生成药物四药联合方案[1]、双特异性抗体联合方案[2,3]亦或是TROP2 ADC方案[4]进一步丰富了EGFR-TKI经治耐药患者的治疗选择，但这些方案均未明确区分耐药人群，EGFR-TKI耐药后治疗体系仍存在精准化不足的问题。既往证据显示，MET异常（扩增/过表达）是三代EGFR-TKI经治后非EGFR依赖性耐药途径中的关键机制之一，经MET异常介导的获得性耐药在奥希替尼一线和二线治疗后占比分别可达7%~37%和5%~50%[5]。近年来，随着以赛沃替尼为代表性的高选择性MET-TKI的持续涌现，针对EGFR-TKI耐药后伴MET异常人群的精准治疗探索也逐渐兴起。 SAVANNAH研究是全球首个针对奥希替尼耐药后伴MET扩增和/或过表达的EGFR突变晚期NSCLC人群开展的II期临床研究，旨在评估赛沃替尼联合奥希替尼治疗的有效性和安全性。SAVANNAH研究方案经历了多个版本的调整，第1-6版研究方案为单臂研究，入组标准为经奥希替尼治疗进展且既往治疗线数≤3线的MET扩增（FISH5+）和/或过表达（IHC3+/≥50%）患者。第7版研究方案采用双盲设计，入组标准为经奥希替尼一线治疗进展的高水平MET扩增（FISH10+）和/或过表达（IHC3+/≥90%）患者，2:1随机分配接受赛沃替尼+奥希替尼或赛沃替尼+安慰剂治疗。研究的主要疗效分析人群为经奥希替尼一线治疗进展的高水平MET扩增和/或过表达患者（n=80）。主要终点为经研究者评估确认的客观缓解率（ORR），次要终点包括经BICR评估的ORR、缓解持续时间（DoR）、无进展生存期（PFS）、总生存期（OS）和安全性[6]。图1. SAVANNAH研究设计[7] 既往报告结果显示，研究者评估的主要疗效人群确认的ORR为56.3%，中位DoR为7.1个月，中位PFS为7.4个月[6]。BICR评估数据与研究者评估数据获益一致，确认的ORR为55.0%，中位DoR为9.9个月，中位PFS为7.5个月[6]。随机试验部分结果显示，伴高水平MET过表达和/或扩增人群接受赛沃替尼+奥希替尼较赛沃替尼+安慰剂治疗经BICR评估的ORR（58% vs 16%）和中位PFS（8.3 vs 3.6个月）数据更优，且在控制CNS病灶方面也展现出良好疗效（确认的CNS ORR分别为43%和25%）[8]。在安全性方面，双靶联合治疗整体安全性可控，耐受性良好。在本次WCLC大会上，研究者进一步更新了SAVANNAH研究的生物标志物一致性分析、获得性耐药分析及PROs结果，为双靶联合治疗的应用探索带来了更全面的证据支持。 SAVANNAH研究公布MET检测一致性分析结果，并揭示联合治疗的获得性耐药机制基于SAVANNAH研究的既往报告结果可以发现，MET扩增/过表达在MET抑制剂临床治疗中作为生物标志物具有重要指导价值，而准确检测MET扩增/过表达是精准实施MET-TKI治疗的前提。因此，研究者在本次WCLC大会上进一步报告了SAVANNAH研究ctDNA NGS与组织NGS较FISH±IHC在基线检测MET扩增±过表达方面一致性的探索性分析，同时报告了基线EGFRm ctDNA与MET IHC3+/≥90%和/或FISH10+及PFS的相关性，以及赛沃替尼±奥希替尼获得性耐药机制的血浆分析结果[9]。数据显示，在基线具有有效NGS ctDNA数据的343例患者中，229例具有高水平MET异常状态（MET IHC3+/≥90%和/或FISH10+）。在高水平MET异常患者中，基线检测到EGFRm ctDNA的患者比例为91%，高于非高水平MET异常患者（77%），提示基线检测到EGFRm ctDNA与高水平MET异常状态相关。在伴高水平MET异常且接受赛沃替尼联合奥希替尼治疗的患者中，基线未检测到EGFRm ctDNA的患者中位PFS在数值上优于检测到EGFRm ctDNA的患者（10.4 vs 5.7个月），ORR同样获益更佳（58% vs 50%）。图2. 基线EGFRm ctDNA状态与高水平MET状态及PFS的相关性分析[9] 生物标志物一致性分析显示，MET组织NGS检测与MET FISH10+结果高度吻合，阳性一致性百分比（PPA，敏感性）为95%，阴性一致性百分比（NPA，特异性）为86%。而MET ctDNA NGS检测与MET FISH10+的PPA中度一致（47%），但仍具有高特异性（86%）。当以MET IHC3+/≥90%和/或FISH10+为标准时，ctDNA NGS和组织NGS的PPA分别降至36%和62%，但仍保持高特异性（分别为89%和96%)。图3. MET NGS检测的一致性分析[9] 此外，在105例PFS≥2个月且具有配对基线及停止治疗（TD）时NGS ctDNA的患者中，赛沃替尼±奥希替尼的获得性耐药谱主要包括EGFR（13%）、BRAF（11%）、MET（10%）、RAS（8%）和ERRB2/ERBB3（5%）。图4. 赛沃替尼±奥希替尼的获得性耐药谱[9] 研究提示，MET组织NGS检测与MET FISH10+结果一致性较高，但ctDNA NGS检测的敏感性仍需进一步验证和提升，尤其是同时考虑以MET IHC3+/≥90%和/或FISH10+为标准时，ctDNA NGS和组织NGS的敏感性均进一步降低。未来需持续优化相关检测方法，并基于不同的检测方法建立标准化的检测流程和判读标准，以确保检测结果的准确性和可比性。同时，赛沃替尼±奥希替尼获得性耐药机制的明确也有望为伴MET异常的奥希替尼经治耐药人群的全程管理提供更为精准化、个性化的治疗策略。 SAVANNAH研究PROs结果公布，双靶联合治疗助力患者生活质量改善在本次WCLC大会上，SAVANNAH研究基于主要疗效人群的PROs结果也得以公布[10]。研究基于EORTC QLQ-C30/-LC13问卷评估健康相关生活质量（HRQoL）、功能和症状，通过EQ-5D-5L评估治疗/疾病对健康状态的影响，通过PRO-CTCAE评估耐受性，数据报告时间点为基线（BL）至第8周期第1天（C8D1）。结果显示，EORTC QLQ-C30/-LC13问卷评估的依从率为中至高度（基线时为80%，至C8D1访视期间为56-70%）。总体健康状况（GHS）在访视期间显示出持续、轻微改善（3-7分）；~30-50%的患者自基线起显示出具有临床意义的改善；30%-50%保持稳定。同时EORTC QLQ-C30/-LC13问卷评估显示，≥70%的患者功能及症状评分随时间推移呈现改善或稳定。基于EORTC QLQ-C30的所有功能量表均呈现轻微改善趋势（0.4-7分），呼吸困难、失眠和食欲不振症状具有临床意义的改善，疲劳、疼痛、恶心/呕吐、便秘、腹泻和经济困难评分略有改善或稳定。EORTC QLQ-LC13评估显示咳嗽症状具临床意义的改善，呼吸困难、咯血、吞咽困难和胸痛有轻微改善。EORTC QLQ-C30/-LC13问卷评估的症状改善率较高，尤其是肺癌相关症状。至恶化时间（TTD）因症状评分而异，中位TTD范围为5.52-13.90个月（EORTC QLQ-C30）和2.79个月- NR（EORTC QLQ-LC13）。此外，EQ-5D-5L的平均VAS评分和指数评分略有改善，PRO-CTCAE结果提示访视期间赛沃替尼联合奥希替尼治疗耐受性良好。图5. 基于QLQ-C30/LC13评估的症状改善率[10] 研究发现，赛沃替尼联合奥希替尼治疗能够改善或稳定疾病/治疗相关症状、功能和整体HRQoL，这些数据进一步支持赛沃替尼联合奥希替尼可作为奥希替尼耐药后伴MET异常的EGFR突变晚期NSCLC患者新的治疗选择。双靶攻坚，伴MET异常EGFR-TKI耐药人群长生存可期 SAVANNAH研究提示，对于三代EGFR-TKI耐药后伴MET扩增/过表达的EGFR突变晚期NSCLC患者，赛沃替尼联合奥希替尼是一种极具前景的精准治疗方案，在兼具优异疗效和良好安全性的同时，还可以保持较高的生活质量。同时，赛沃替尼联合奥希替尼的常见获得性耐药机制多为目前有药可医的靶点，为后续继续进行精准治疗提供了可能。尤为值得一提的是，近期发表于Transl Lung Cancer Res的一例长生存病例[11]，充分彰显了双靶联合治疗的优异效果。该病例于2015年确诊为EGFR ex19del突变肺腺癌，经一代EGFR-TKI治疗8个月后疾病进展，后续虽在继续一代EGFR-TKI治疗的基础上针对性采取了局部治疗（放疗/手术），以及联用化疗策略，但获益有限。鉴于患者进展后基因检测显示其MET扩增与EGFR ex19del突变共存，故于2017年3月入组临床试验，接受赛沃替尼联合吉非替尼双靶治疗，截至2025年4月，患者病情仍保持稳定，PFS已超8年，成为迄今首例报道PFS超8年的伴MET扩增患者。此外，该案例还通过动态ctDNA-MRD监测进一步优化用药剂量，为双靶联合治疗的长期管理树立了成功典范。同时，得益于此前报告的III期SACHI研究的优异成果，NMPA目前已批准赛沃替尼联合奥希替尼用于一线EGFR-TKI治疗后疾病进展且伴随MET扩增的EGFR突变阳性局部晚期或转移性非小细胞肺癌患者。所以我们相信该联合方案能够继续在MET异常人群中取得更多突破，进一步评估赛沃替尼联合奥希替尼在奥希替尼经治进展后伴有MET扩增和/或过表达人群中开展的III期SAFFRON 研究和评估该联合方案用于EGFR突变合并MET过表达晚期NSCLC一线治疗效果的III期SANOVO 研究均在积极开展中，值得期待。此外，为助力更多伴MET异常患者从双靶联合方案中获益，未来仍需进一步提高检测方法的特异性和灵敏度，以推动该方案在临床实践中的精准落地，为患者带来更长生存。专家简介李勇教授南昌大学一附院肿瘤科主任、主任医师、博士、博导中国老年肿瘤学会执委中国医院协会肿瘤精准治疗专业委员会副主任委员中国医药教育学会化疗专业委员会副主任委员中华医学会临床流行病学和循证医学委员会委员江西省医学会肿瘤分会副主任委员江西省医学会肿瘤内科分会候任主任委员江西省整合医学会肿瘤分会主任委员中国抗癌协会感染性肿瘤专委会常委中国抗癌协会胸膜间皮瘤专委会常委 CSCO肿瘤营养与支持治疗学会委员中国抗癌协会肿瘤免疫营养学组委员卫健委2030肺癌规范化诊疗专家组顾问国家卫健委精准医疗远程会诊专家委员会委员江西省抗癌协会淋巴瘤委员会副主任委员江西整合医学会肺癌专委会副主任委员中华肿瘤杂志编委、中华肿瘤防治杂志编委江西省科技进步一等奖、三等奖获得者参考文献： 1.Lu S, Wu L, Jian H, et al. Sintilimab plus chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer with disease progression after EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): second interim analysis from a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2023 Jul;11(7):624-636. 2.Antonio Passaro, et al. Amivantamab Plus Chemotherapy (With or Without Lazertinib) vs Chemotherapy in EGFR-mutated, Advanced NSCLC After Progression on Osimertinib MARIPOSA-2, a Phase 3, Global, Randomized, Controlled Trial. 2023 ESMO Abstract LBA15. 3.Wenfeng Fang, Yuanyuan Zhao, Yongzhong Luo, et al. Ivonescimab Plus Chemotherapy in Non-Small Cell Lung Cancer With EGFR Variant: A Randomized Clinical Trial.[J] .JAMA, 2024 Aug 20;332(7):561-570. 4.Li Zhang, et al. 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. 2025 ASCO 8507. 5.Zhou Qing, Zhao Hongyun, Lu Shun, et al. Consensus on the lung cancer management after third-generation EGFR-TKI resistance.[J] .Lancet Reg Health West Pac, 2024, 53: 101260. 6.F de Marinis, T M Kim, L Bonanno, et al. Savolitinib plus osimertinib in epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer with MET overexpression and/or amplification following disease progression on osimertinib: primary results from the phase II SAVANNAH study.[J] .Ann Oncol, 2025, 36: 920-933. 7.F de Marinis, T M Kim, L Bonanno, et al. Savolitinib plus osimertinib in epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer with MET overexpression and/or amplification following disease progression on osimertinib: primary results from the phase II SAVANNAH study.[J] .Ann Oncol, 2025, 36: 920-933.Supplementary Appendix. 8.Benjamin P. Levy, et al. Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH study comparing savolitinib (savo) + osimertinib (osi) combination with savo + placebo (PBO). 2025 ASCO Abstract 8513. 9.C. Baik, et al. SAVANNAH: Biomarker Concordance and Acquired Resistance in Patients with EGFRm MET-OverExp and / or Amp NSCLC. 2025 WCLC MA03.03. 10.S. Novello, et al. Osimertinib + Savolitinib in EGFRm Advanced NSCLC With MET Overexp And/Or Amp Post-Progression on Osimertinib: SAVANNAH PROs. 2025 WCLC PT2.12.04. 11.Liu X, Jin S, Li J, et al. Long-term survival with adaptive dual-targeted therapy in an epidermal growth factor receptor (EGFR)-mutant non-small cell lung cancer patient with mesenchymal-epithelial transition (MET) amplification guided by minimal residual disease (MRD) assessments: a case report and literature review. Transl Lung Cancer Res 2025;14(8):3270-3279. 撰写：Shirley 审校：李勇教授排版：Atai 执行：Atai 本平台旨在为医疗卫生专业人士传递更多医学信息。本平台发布的内容，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。如该等信息被用于了解医学信息以外的目的，本平台不承担相关责任。本平台对发布的内容，并不代表同意其描述和观点。若涉及版权问题，烦请权利人与我们联系，我们将尽快处理。

临床结果临床2期ASCO会议临床研究

2025-09-08

·PRNewswire

Breakthrough Therapy Designations Surge as $50B Cancer Drug Partnerships Reshape Market

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Sept. 8, 2025 /PRNewswire/ -- USA News Group News Commentary – The FDA's unprecedented wave of Breakthrough Therapy Designations through August has accelerated development timelines for life-saving cancer treatments[1], while major pharmaceutical companies deployed several multi-billion-dollar strategic partnerhips (with one topping $11 billion) to secure next-generation immunotherapies[2]. These recent designations are creating momentum for companies advancing breakthrough oncology platforms including Oncolytics Biotech Inc. (NASDAQ: ONCY), HUTCHMED (China) Limited (NASDAQ: HCM), CG Oncology, Inc. (NASDAQ: CGON), C4 Therapeutics, Inc. (NASDAQ: CCCC), and IDEAYA Biosciences, Inc. (NASDAQ: IDYA). Industry analysts expect the antibody-drug conjugate market to reach $50 billion by 2030[3], driven by 16 approved therapies and accelerating clinical pipelines. Immuno-oncology revenues jumped from $94 billion to $109.39 billion in 2025 alone[4], as leading institutions recognize the transformative potential of precision-targeted therapies and combination treatment approaches for previously untreatable cancers. Oncolytics Biotech Inc. (NASDAQ: ONCY) has announced impressive clinical data in metastatic colorectal cancer that could accelerate the company's path to registration. The latest results show pelareorep achieved a median progression-free survival of 16.6 months compared to just 5.7 months with standard treatments, representing approximately 2.5 times longer disease control in KRAS mutant colorectal cancer patients. Even more striking, overall survival reached 27.0 months versus the typical 11.2 months, representing a dramatic improvement in one of oncology's most challenging areas. This data comes from the REO 022 trial testing pelareorep with FOLFIRI and bevacizumab in second-line treatment. "These studies validate pelareorep's mechanism of action and present a clear opportunity to accelerate the pursuit of a registration-enabled study in the underserved KRAS mutant subset of mCRC patients," said Jared Kelly, CEO of Oncolytics. "Given pelareorep's activity in this difficult-to-treat cancer and other RAS-mutated gastrointestinal ("GI") tumors, including metastatic pancreatic and anal cancers, we believe pelareorep is positioned to become the premier platform immunotherapy in the GI space." The company plans to work with regulators to define a path toward registration in KRAS mutant colorectal cancer. The results extend beyond survival numbers. Translational studies confirmed pelareorep actually replicates inside tumor cells while activating immune responses, including dendritic cell maturation and CD8+ T cell activation. This proves the drug's ability to transform "cold" tumors into "hot" targets responsive to immunotherapeutic treatments. Pelareorep represents a systemically delivered oncolytic virus that reprograms the immune system against cancer. Unlike traditional chemotherapy that attacks cells indiscriminately, this immunotherapy selectively targets cancer while mobilizing the body's natural defenses. The company is simultaneously advancing toward registration-enabling trials in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC), where survival data proved equally compelling. Clinical results showed a 21.9% two-year overall survival rate compared to the 9.2% historical benchmark for standard chemotherapy protocols. Importantly, pelareorep demonstrated a 62% objective response rate when combined with chemotherapy and checkpoint inhibitors. This matters because checkpoint inhibitors currently lack approval for pancreatic cancer, suggesting pelareorep may unlock immunotherapy effectiveness in historically resistant tumors. Oncolytics recently provided updated safety data for pelareorep, which has been administered to over 1,200 patients across multiple studies. The most common side effects remain mild flu-like symptoms, with data showing pelareorep doesn't modify the safety profile of established chemotherapy regimens. The company confirmed ongoing discussions with the U.S. Food and Drug Administration (FDA) to finalize pivotal study parameters for pancreatic cancer, targeting potential trial initiation activities by Q4 2025. Pelareorep holds both Fast Track and Orphan Drug designations from the FDA for pancreatic cancer, facilitating expedited review processes. Recent leadership changes reflect an execution-focused approach. CEO Jared Kelly and Chief Business Officer Andrew Aromando both contributed to Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Oncolytics eliminated its At-the-Market and Equity Line financing facilities, suggesting confidence in current cash resources to reach key development milestones. With survival benefits approaching 3× standard care in colorectal cancer and regulatory discussions advancing for pancreatic cancer trials by Q4 2025, Oncolytics appears positioned at a critical inflection point where proof-of-concept has evolved into potential registration-enabling studies. The company's dual-track approach in gastrointestinal cancers, combined with an experienced leadership team and FDA Fast Track designation, suggests pelareorep may soon transition from clinical promise to commercial reality. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: HUTCHMED (China) Limited (NASDAQ: HCM) highlighted clinical data from multiple oncology studies at the 2025 World Conference on Lung Cancer and CSCO Annual Meeting, showcasing updated analysis from savolitinib's SACHI, SAVANNAH and Phase IIIb confirmatory studies in non-small cell lung cancer patients. The company will present first-time clinical data of HMPL-653, a novel CSF-1R inhibitor, from a Phase I study in patients with tenosynovial giant cell tumor. Savolitinib, an oral and highly selective MET tyrosine kinase inhibitor being jointly developed with AstraZeneca, continues advancing through multiple clinical programs targeting various lung cancer indications. According to Hutchmed's announcement, updated analysis from savolitinib's SACHI, SAVANNAH and a Phase IIIb confirmatory study in non-small cell lung cancer patients will be presented at WCLC 2025. The comprehensive clinical program spans investigator-initiated studies of fruquintinib and surufatinib across multiple cancer types, with HUTCHMED positioning itself as an innovative commercial-stage biopharmaceutical company committed to bringing targeted therapies from in-house discovery to patients worldwide. The company has successfully marketed its first three medicines in China, with its lead compound also approved globally, including in the US, Europe and Japan. CG Oncology, Inc. (NASDAQ: CGON) continues to demonstrate best-in-disease durability with its cretostimogene immunotherapy, reporting an additional 12 patients achieving complete response at 24 months in the BOND-003 Cohort C study. The robust 24-month complete response rate of 41.8% observed in 46 out of 110 patients with high-risk non-muscle invasive bladder cancer unresponsive to BCG treatment represents unprecedented durability in this heavily pretreated patient population. Notably, 90% of 12-month responders remained disease-free at 24 months, while 96.6% of patients were free from progression to muscle-invasive disease at 24 months. "Based on the latest data cut, I remain very encouraged that if approved, cretostimogene will represent an important, bladder-sparing advancement in the management of high risk non-muscle invasive bladder cancer in patients who have disease that is unresponsive to BCG," said Trinity J. Bivalacqua, MD, PhD, Urologic Oncology at Penn Medicine and Co-Director, Genitourinary Cancer Service Line, Abramson Cancer Center. "In my clinical experience, bladder cancer patients are seeking treatment options that offer durable and sustained results." The company is preparing to initiate its BLA submission for cretostimogene in the fourth quarter of 2025, with the Phase 3 BOND-003 Cohort C representing the largest study in this patient population to date. Cretostimogene's safety profile remains consistent with no Grade 3 or greater treatment-related adverse events or deaths reported, supporting its potential as a breakthrough backbone treatment for bladder cancer patients. C4 Therapeutics, Inc. (NASDAQ: CCCC) completed enrollment and dose escalation for its Phase 1 trial of cemsidomide in multiple myeloma, with the investigational MonoDAC degrader continuing to demonstrate a well-tolerated safety profile and compelling response rates. The company will present comprehensive data from all safety and efficacy evaluable multiple myeloma patients across all dose levels studied in the cemsidomide with dexamethasone cohort at the International Myeloma Society Annual Meeting on September 20, 2025. Cemsidomide is designed as a more potent and selective degrader of IKZF1/3 transcription factors that drive multiple myeloma and non-Hodgkin's lymphomas, with unique pharmacokinetic properties and demonstrated anti-myeloma activity and immunomodulatory effects. C4 Therapeutics will host an investor webcast on September 20, 2025, at 3 PM ET to highlight the data presentation and provide additional detail on the planned next steps of clinical development. The company is progressing its TORPEDO platform to efficiently design and optimize small-molecule degrader medicines targeting difficult-to-treat diseases, with cemsidomide representing a key advancement in harnessing the body's natural protein recycling system. IDEAYA Biosciences, Inc. (NASDAQ: IDYA) enrolled their first patient with non-small cell lung cancer in the ongoing Phase 1/2 combination trial of IDE397 and Trodelvy® in patients with MTAP-deletion solid tumors, expanding beyond the initial focus on MTAP-deletion urothelial cancer. IDE397, a potential first-in-class small molecule MAT2a inhibitor, is being combined with Gilead's Trop2-directed antibody-drug conjugate Trodelvy under a clinical study collaboration and supply agreement. MTAP-deletion is found in up to 20% of non-small cell lung cancer cases and represents an area with no approved targeted therapies, creating a significant opportunity for this novel therapeutic approach. "We are encouraged by the preliminary expansion data from our Phase 1/2 combination trial with IDE397 and Trodelvy in MTAP-deleted bladder cancer and excited to have dosed the first patient in the non-small cell lung cancer cohort," said Darrin Beaupre, Chief Medical Officer of IDEAYA Biosciences. "This marks an important step in our broader clinical strategy to evaluate the combination across multiple solid tumors with MTAP-deletion." IDEAYA retains commercial rights to IDE397 while Gilead provides Trodelvy supply, with the precision medicine oncology company building a deep pipeline focused on synthetic lethality and antibody-drug conjugates for molecularly defined solid tumor indications. The expansion into NSCLC represents a significant milestone in the company's mission to develop tailored, potentially first-in-class targeted therapies aligned to genetic drivers of disease. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCES CITED: Logo - SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果免疫疗法临床1期临床3期快速通道

100 项与赛沃替尼相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D11139	赛沃替尼	L01XE	DB12048

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
EGFR突变MET阳性非小细胞肺癌	中国	和记黄埔医药（上海）有限公司	2025-06-24
MET外显子14跳变的非小细胞肺癌	中国	和记黄埔医药（上海）有限公司	2021-06-22

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
MET基因扩增非小细胞肺癌	申请上市	中国	和记黄埔医药（上海）有限公司	2024-12-31
乳状状肾细胞癌	申请上市	-	和黄医药（中国）有限公司	2022-06-06
胃癌	申请上市	中国	和黄医药（中国）有限公司	2022-06-06
恶性上皮肿瘤	临床3期	美国	AstraZeneca PLC	2022-08-03
恶性上皮肿瘤	临床3期	日本	AstraZeneca PLC	2022-08-03
恶性上皮肿瘤	临床3期	奥地利	AstraZeneca PLC	2022-08-03
恶性上皮肿瘤	临床3期	比利时	AstraZeneca PLC	2022-08-03
恶性上皮肿瘤	临床3期	保加利亚	AstraZeneca PLC	2022-08-03
恶性上皮肿瘤	临床3期	希腊	AstraZeneca PLC	2022-08-03
恶性上皮肿瘤	临床3期	马来西亚	AstraZeneca PLC	2022-08-03

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05015608 (SACHI, ASCO2025) 人工标引	临床3期	MET基因扩增非小细胞肺癌 \| 晚期非小细胞肺癌 EGFR Mutation \| MET Amplification	211	Savolitinib + osimertinib	觸膚獵齋繭淵獵夢選觸(鏇簾膚鬱獵積襯遞製蓋) = 壓繭淵鏇醖襯積積醖鏇鏇網憲願壓襯艱願鹹鹹 (鹽蓋壓願醖鹽壓餘願膚, 6.9 ~ 11.2) 更多	积极	2025-05-30
				chemotherapy	觸膚獵齋繭淵獵夢選觸(鏇簾膚鬱獵積襯遞製蓋) = 餘鹹範顧簾醖壓夢顧鏇鏇網憲願壓襯艱願鹹鹹 (鹽蓋壓願醖鹽壓餘願膚, 3.0 ~ 5.4) 更多
NCT03778229 (SAVANNAH, ASCO2025) 人工标引	临床2期	EGFR突变的非小细胞肺癌二线 FISH10+ \| MET IHC3+/≥90%	73	Savolitinib 300 mg BID + Osimertinib 80 mg QD	獵選襯選積鹹選製網選(夢願網壓築艱膚選艱鏇) = 膚遞範衊膚淵餘夢選餘選壓艱簾餘範醖鏇網窪 (簾鏇鹹獵壓艱壓壓廠齋, 43 ~ 72) 更多	积极	2025-05-30
				SavolitinibSavolitinib 300 mg BID + Placebo	獵選襯選積鹹選製網選(夢願網壓築艱膚選艱鏇) = 繭鬱糧製醖衊餘範憲願選壓艱簾餘範醖鏇網窪 (簾鏇鹹獵壓艱壓壓廠齋, 5 ~ 36) 更多
NCT03778229 (SAVANNAH, AACR2025)	临床2期	非小细胞肺癌 EGFRm \| MET	344	Savolitinib 300 mg QD + Osimertinib 80 mg QD	積襯窪獵遞顧窪蓋積範(獵觸遞顧蓋廠鏇選鑰淵) = 鹹鹽製鏇蓋觸選齋衊鬱遞糧獵網顧廠構觸遞襯 (鹹獵範網壓襯鬱簾艱鏇 ) 更多	积极	2025-04-30
NCT04923945 (ESMO_ELCC2025) 人工标引	临床3期	MET外显子14跳变的非小细胞肺癌一线 \| 末线 \| 三线 MET Exon 14 Mutation	166	Savolitinib (Treatment-naïve (1 L))	繭鹽襯鑰鏇蓋範簾積壓(鬱憲糧鹽醖夢鑰製願構) = 憲糧襯壓觸鑰襯願鹹觸齋壓鹹範積餘遞選獵壓 (鹹廠築淵襯遞鏇繭觸餘, 17.5 ~ NE) 更多	积极	2025-03-26
				Savolitinib (previously treated (≥2 L))	繭鹽襯鑰鏇蓋範簾積壓(鬱憲糧鹽醖夢鑰製願構) = 衊鬱齋遞廠願鹹願鏇鑰齋壓鹹範積餘遞選獵壓 (鹹廠築淵襯遞鏇繭觸餘, 20.5 ~ 30.5) 更多
NCT03778229 (SAVANNAH, ESMO_ELCC2025) 人工标引	临床2期	EGFR阳性非小细胞肺癌二线 MET Overexpression \| MET Amplification \| EGFR Mutation	101	Savolitinib 300 mg BID + Osimertinib 80 mg QD	顧淵繭醖壓醖鑰憲鹽膚(艱憲餘鹹齋膚膚齋製艱) = 顧顧艱窪選製衊艱醖餘壓齋網鹹獵壓鹹鑰網壓 (顧鏇艱顧艱構願鬱蓋憲, 45 ~ 67) 更多	积极	2025-03-26
NCT02819596 (CALYPSO, ASCO_GU2025) 人工标引	临床2期	肾肿瘤	41	Durvalumab + Savolitinib (ITT)	遞膚獵願壓鏇鑰獵積襯(糧獵襯製衊鹽顧鬱鬱觸) = 遞壓淵觸齋鹹簾積繭蓋艱醖艱膚願鏇窪淵範醖 (淵築壓糧淵築顧餘繭醖, 20 ~ 51) 更多	积极	2025-02-13
				Durvalumab + Savolitinib (MET-driven)	遞膚獵願壓鏇鑰獵積襯(糧獵襯製衊鹽顧鬱鬱觸) = 顧糧築範襯壓糧繭網齋艱醖艱膚願鏇窪淵範醖 (淵築壓糧淵築顧餘繭醖, 33 ~ 82) 更多
NCT04606771 (CoC, CTgov)	临床2期	MET基因扩增非小细胞肺癌	30	Savolitinib+Osimertinib (Savolitinib Plus Osimertinib)	夢衊衊壓廠簾廠鹹繭襯 = 夢簾構獵壓積壓憲淵繭製蓋艱鑰艱艱遞憲鬱廠 (艱憲繭鑰糧鏇廠醖衊選, 網膚遞艱鑰糧醖簾壓積 ~ 鹹鏇願醖壓願繭淵獵艱) 更多	-	2024-09-24
				Placebo+Savolitinib (Savolitinib Plus Placebo)	夢衊衊壓廠簾廠鹹繭襯 = 淵鏇積膚窪築憲遞夢網製蓋艱鑰艱艱遞憲鬱廠 (艱憲繭鑰糧鏇廠醖衊選, 鏇鑰淵醖襯窪願願夢範 ~ 鬱製窪齋範鹹艱鑰製鏇) 更多
NCT04923932 (phase II study of savolitinib in patients with MET-amplified gastroesophageal junction adenocarcinomas or gastric cancer, ESMO2024)	临床2期	c-Met阳性胃食管交界处腺癌 \| 胃癌 METamp	34	Savolitinib 600/400 mg QD	襯壓積糧餘艱壓鹹鬱憲(鹽壓構製鏇遞廠觸觸製) = 衊範醖願廠簾網鬱鑰壓範鬱襯淵鏇齋選觸積壓 (淵繭齋範鹹製襯鹹壓製 )	积极	2024-09-16
				Savolitinib 300/200 mg BID	襯壓積糧餘艱壓鹹鬱憲(鹽壓構製鏇遞廠觸觸製) = 夢選艱網糧鏇餘觸窪範範鬱襯淵鏇齋選觸積壓 (淵繭齋範鹹製襯鹹壓製 )
NCT02761057 (S1500, Pubmed \| J Clin Oncol) 人工标引	临床2期	乳状状肾细胞癌二线 \| 一线	147	Sunitinib	願鏇廠餘蓋夢網觸鹽鹽(簾獵蓋鏇艱鹹鑰鹹鑰遞) = 網遞衊繭獵鏇鏇衊鏇鹹鑰鏇鹹鏇艱廠鏇觸願廠 (顧廠鹹齋鏇遞鑰壓遞積, 12.8 ~ 21.8) 更多	不佳	2024-09-10
				Cabozantinib	願鏇廠餘蓋夢網觸鹽鹽(簾獵蓋鏇艱鹹鑰鹹鑰遞) = 糧鬱廠觸簾艱繭蓋選構鑰鏇鹹鏇艱廠鏇觸願廠 (顧廠鹹齋鏇遞鑰壓遞積, 12.0 ~ 28.1) 更多
NCT04923945 (Pubmed \| Lancet Respir Med) 人工标引	临床3期	MET外显子14跳变的非小细胞肺癌一线 MET Exon 14 Skipping	87	Savolitinib 600 mg	膚積築獵築醖壓鹹鏇鏇(簾窪鏇鏇壓糧鹽襯壓積) = 憲築醖網鹽淵膚齋夢觸艱夢選獵壓襯蓋觸選製 (獵網齋遞簾構廠衊範簾, 51 ~ 72) 更多	积极	2024-09-10