This phase II trial tests the safety and effectiveness of preoperative immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine with or without futibatinib targeted therapy in treating patients with intrahepatic cholangiocarcinoma that can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Futibatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving immunotherapy with durvalumab and chemotherapy with cisplatin and gemcitabine and/or targeted therapy with futibatinib before surgery may make the tumor smaller for resection and may help prevent the cancer from coming back. Patients whose molecular profiling test result show a genetic change called FGFR2 fusion, rearrangement, or activating mutation, receive immunotherapy, chemotherapy and targeted therapy while patients without a FGFR2 fusion, rearrangement, or activating mutation just receive immunotherapy and chemotherapy. Giving targeted therapy based on molecular profile test results prior to attempted resection for patients with intrahepatic cholangiocarcinoma that has a risk for either not being able to be removed or for coming back after it has been removed may help improve treatment outcomes in patients with resectable intrahepatic cholangiocarcinoma.

开始日期2027-12-10

申办/合作机构

Northwestern University

[+1]

NCT07168668

/ Not yet recruiting临床2期IIT

EXploring Clinical Efficacy of Partial Immune-boost TACE in unrEseCTable HCC Patients Under Systemic Treatment (EXPECT Trial)

Study Objectives： Atezolizumab (anti-programmed death-ligand 1; anti-PD-L1) combined with bevacizumab (anti-vascular endothelial growth factor; anti-VEGF) or Durvalumab (anti-programmed death-ligand 1; anti-PD-L1) combined with tremelimumab (anti-cytotoxic T-lymphocyte-associated protein 4; anti-CTLA4) have recently been established as a standard first-line systemic treatment for unresectable hepatocellular carcinoma (HCC). However, its objective response rate (ORR) is only less than 27% (1, 2), and the majority of patients died of HCC progression and liver failure. Therefore, there is an urgent need to develop a novel combination treatment strategy to overcome resistance to immunotherapy and improve patient outcomes.
Transarterial chemoembolization (TACE) remains the standard treatment for patients with intermediate-stage hepatocellular carcinoma (HCC) (3, 4). However, in our previous retrospective study (5-7), the investigators consistently observed that this combination not only improves therapeutic responses but also significantly prolongs patient survival. The tumor necrosis caused by TACE may enhance the efficacy of systemic therapies by promoting the release of neoantigens, thereby stimulating immune responses (8-14). This concept has been substantiated in two recent trials involving intermediate-stage HCC (15, 16), where the addition of immune checkpoint inhibitors to TACE resulted in improved clinical outcomes. Nevertheless, this promising approach has yet to replace the decades-old standard treatment protocols, underscoring the need for further proof-of-concept studies.
Both immunotherapy (atezolizumab/bevacizumab or durvalumab/tremelimumab) and transarterial chemoembolization (TACE) are approved treatment modalities for unresectable hepatocellular carcinoma (HCC) by the U.S. and Taiwan Food and Drug Administration (FDA). This phase II non-randomized trial is designed to prospectively evaluate the therapeutic efficacy, safety, and immunological responses in patients with unresectable HCC treated with a combination of immunotherapy and TACE. A particular focus of this study is to explore the potential immune-boosting effects of TACE, including its ability to enhance antigen presentation and stimulate anti-tumor immune responses.

开始日期2027-02-01

申办/合作机构

长庚纪念医院

NCT05403723

/ Suspended临床1期IIT

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2027-01-30

申办/合作机构

University of Maryland Baltimore

[+1]

100 项与度伐利尤单抗相关的临床结果

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100 项与度伐利尤单抗相关的转化医学

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100 项与度伐利尤单抗相关的专利（医药）

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2,594

项与度伐利尤单抗相关的文献（医药）

2026-12-31·ANNALS OF MEDICINE

Dose-Registered CT assessment of radiation-induced lung injury after chemoradiotherapy for stage III NSCLC

Article

作者: Sugahara, Shinji ; Ikeda, Norihiko ; Itonaga, Tomohiro ; Okubo, Mitsuru ; Zama, Tatsuhiko ; Mikami, Ryuji ; Saito, Kazuhiro

AIMS:

To quantify radiation-induced lung injury (RILI) on deformably registered CT images after chemoradiotherapy (CCRT) for stage III NSCLC, and to evaluate spatial and dosimetric associations between RILI and planned dose distribution in a pre-durvalumab cohort.

METHODS:

This retrospective study included 58 patients with stage III NSCLC treated with CCRT using three-dimensional conformal radiotherapy (3D-CRT) prior to the era of consolidation immunotherapy. Follow-up CT images at 6 months (acute) and 12 months (late) were registered to treatment planning CT using deformable image registration (DIR). RILI was quantified by segmented volume (mL) and isodose-line overlap (%). Dosimetric parameters (V5Gy-V60Gy, mean lung dose) and symptomatic RILI (CTCAE grade ≥2) were analysed using correlation, ROC, and logistic regression methods.

RESULTS:

Symptomatic RILI occurred in 14 patients (24.1%). RILI volume decreased by 27.7% from the acute to the late phase, with moderate-to-strong dose-volume correlations in both phases (Spearman ρ = 0.69-0.76). Symptomatic patients showed broader spatial spread into lower-dose regions (median isodose-line overlap 20% vs 40%; p < 0.001). Acute-phase RILI reaching the ≤25% isodose line (≤16.5 Gy) was an exploratory imaging marker in this cohort (AUC 0.81) that remained associated with symptomatic RILI on multivariable analysis (p < 0.01).

CONCLUSIONS:

Dose-registered CT analysis demonstrated consistent spatial associations between planned dose and RILI, providing a hypothesis-generating dosimetric-radiographic reference dataset that requires external validation in IMRT/VMAT- and durvalumab-treated cohorts before clinical application.

2026-12-31·OncoImmunology

Pooled analysis of 2 clinical trials of first-line chemoimmunotherapy for metastatic microsatellite stable colorectal cancer MEDITREME and METIMMOX studies

Article

作者: Ilie, Alis ; Truntzer, Caroline ; Flatmark, Kjersti ; Peroz, Morgane ; Derangère, Valentin ; Rageot, David ; Ree, Anne Hansen ; Bousquet, Paula Anna ; Thibaudin, Marion ; Meltzer, Sebastian ; Ghiringhelli, François

BACKGROUND:

Colorectal cancer with microsatellite stable (MSS) status is intrinsically resistant to immune checkpoint inhibitor monotherapy targeting PD-1 or PD-L1. However, emerging evidence suggests that chemotherapies may overcome this resistance when combined with immunotherapy.

METHODS:

We conducted a pooled analysis of individual patient data from two phase II trials evaluating oxaliplatin-based chemotherapy combined with checkpoint inhibitors as first-line treatment for MSS metastatic colorectal cancer. The MEDITREME trial is a single-arm study assessing durvalumab and tremelimumab with oxaliplatin-based chemotherapy, while the METIMMOX trial is a randomized study comparing standard oxaliplatin-based chemotherapy with an alternating regimen of oxaliplatin-based chemotherapy and nivolumab. We compared overall survival (OS), progression-free survival (PFS), and response rates between patients treated with chemotherapy alone versus chemoimmunotherapy, and evaluated the association between these outcomes and transcriptomic and immunoscore data.

RESULTS:

A total of 130 patients were included: 38 who received chemotherapy alone and 92 chemoimmunotherapy. The median OS was significantly improved in the chemoimmunotherapy group compared with chemotherapy alone (not reached vs. 15.3 months; HR = 0.58; 95% CI, 0.36-0.96; p = 0.03). The complete response rates were higher with chemoimmunotherapy (14% vs. 5%). No significant differences were observed in PFS. High baseline CD8⁺ T-cell infiltration was associated with improved outcomes in patients receiving chemoimmunotherapy but not in those treated with chemotherapy alone.

CONCLUSIONS:

This pooled analysis provides compelling evidence supporting the clinical benefit of first-line chemoimmunotherapy in a subset of patients with MSS mCRC. Baseline CD8⁺ T-cell infiltration may serve as a predictive biomarker for identifying patients most likely to benefit from this treatment approach.

2026-12-31·OncoImmunology

Circadian timing of first-line chemoimmunotherapy is associated with survival in extensive-stage small cell lung cancer

Article

作者: Engin Delipoyraz, Ebru ; Fidan, Sena ; Cakir, Tansel ; Terzioglu, Cihat ; Cakan Demirel, Burcin ; Muglu, Harun ; Kutlu, Yasin ; Hamdard, Jamshid ; Ozcelik, Hakan ; Seker, Mesut ; Sunger, Erdem ; Yucel, Mehmet Haluk ; Bilici, Ahmet ; Acıkgoz, Ozgur ; Mildanoglu, Maral Martin

Growing evidence suggests that circadian timing influences the efficacy of immune checkpoint inhibitors across multiple malignancies. However, evidence in extensive-stage small cell lung cancer (ES-SCLC) remains limited to a single East Asian cohort, and independent validation in other populations is lacking. We conducted a retrospective single-center cohort study of 107 patients with ES-SCLC treated with first-line platinum-etoposide plus atezolizumab or durvalumab. The time of day of administration (ToDA) was defined as the median start time of the first four immunotherapy infusions, and patients were categorized according to the cohort median ToDA. The primary endpoints were progression-free survival (PFS) and overall survival (OS). The cohort median ToDA was 11:54. Patients treated before the median ToDA had significantly longer median PFS (9.07 vs. 7.23 months, p = 0.002) and OS (21.17 vs. 11.43 months, p = 0.002) than those treated later. In multivariable Cox regression analysis, later administration remained independently associated with shorter PFS (adjusted HR 1.63, 95% CI 1.03-2.58; p = 0.038) and OS (adjusted HR 1.65, 95% CI 1.00-2.71; p = 0.049), whereas objective response rates, treatment-related toxicity, and immune-related adverse events were comparable between groups. Morning administration of first-line chemoimmunotherapy was associated with significantly longer survival without increased toxicity in patients with ES-SCLC. These findings support growing evidence that circadian timing may influence immune checkpoint inhibitor efficacy and warrant prospective evaluation of treatment timing as a readily modifiable strategy to optimize immunotherapy delivery.

3,937

项与度伐利尤单抗相关的新闻（医药）

2026-11-10

·新浪看点

进博会丨聚焦重点领域关注特殊人群进博会凸显全球医药创新风向

（来源：中国食品药品网）　　中国食品药品网讯（记者蒋红瑜）作为观察全球医药创新风向的最佳窗口，中国国际进口博览会（以下简称进博会）药品展区历来备受瞩目。第九届进博会也不例外，除了3款用于慢性病、心脑血管疾病治疗的药物被第三方机构评为黑科技展品外，跨国药企还带来其他新品，持续在肿瘤、慢性病与罕见病等治疗领域深耕。　　抗肿瘤赛道热度不减　　11月7日，阿斯利康在进博会上举办了“肿瘤健康日”活动，邀请临床专家、本土零售药店企业、患者组织等共同探讨如何提升药物可及性和创新支付模式，推动新疗法惠及更多患者。会上，阿斯利康中国肿瘤业务总经理关冬梅表示，今年，阿斯利康在肿瘤领域已在中国获批了一款创新药物和11个新适应证，覆盖肺癌、乳腺癌、肝癌、胃癌等。图为阿斯利康的曲麦利尤单抗注射液。（记者蒋红瑜摄）　　据了解，阿斯利康中国新获批的药物为曲麦利尤单抗注射液，于今年4月获批联合度伐利尤单抗注射液和含铂化疗，用于表皮生长因子受体（EGFR）敏感突变阴性和间变性淋巴瘤激酶（ALK）阴性的转移性非小细胞肺癌（NSCLC）的一线治疗。　　除了阿斯利康，拜耳、皮尔法伯、勃林格殷格翰等企业也带来了治疗肺癌的在研或获批上市的新产品。　　在勃林格殷格翰展区的“创新展台”，勃林格殷格翰重点展示了在研的双特异性免疫疗法欧布妥米单抗。据介绍，该药物可同时结合肿瘤细胞表面的DLL3和T细胞表面的CD3，从而将T细胞主动“拉近”肿瘤细胞，激活T细胞产生细胞毒作用，杀伤表达DLL3的肿瘤细胞，“已在小细胞肺癌疾病领域展现了积极临床潜力”。　　乳腺癌治疗也是今年进博会上跨国药企重点关注的领域。以罗氏为例，其不仅在展台设立了乳腺癌治疗药物专区，展出往年在中国获批的药物；还在“未来管线”区域展示了其在研的吉雷司群。据悉，该产品通过独特的“分子钳”结构，实现雌激素受体（ER）完全拮抗和降解，从而深度阻断雌激素受体信号，从源头抑制癌细胞生长。目前，该药物已在中美同步递交早期乳腺癌适应证的上市申请。　　还有企业带来了其在直肠癌治疗领域的突破性产品。皮尔法伯研发的恩考芬尼胶囊于2025年6月在中国获批上市，适用于系统性治疗失败后携带BRAF V600E突变的转移性结直肠癌患者，填补了国内该亚型精准治疗的空白。图为恩考芬尼胶囊。（记者蒋红瑜摄）　　“之所以在今年进博会上展示该产品，主要是为了让医生和患者更好地了解该产品。而且我们还在不断拓展恩考芬尼胶囊的适应证。”皮尔法伯工作人员说。据悉，该公司正在探索恩考芬尼胶囊联合西妥昔单抗和FOLFOX用于治疗BRAFV600E突变型转移性结直肠癌（CRC）成年患者的一线治疗。该适应证已于今年4月被纳入优先审评审批程序。　　减重药物研发火热　　减重药物近几年来一直是全球研发关注的焦点。从本届进博会上看，减重领域不再是双雄竞争，而是进入了“战国时代”。　　11月8日，在诺和诺德展台的聚焦肥胖症管理的沉浸式体验空间，不少观众在排队体验用VR眼镜观看脂肪肝的变化过程；也有人在进行身体成分检测，了解体脂率、骨骼肌等数据……　　在潜移默化进行患者教育的同时，诺和诺德在展台上也陈列出了“司美格鲁肽家族”产品。其中，最受关注的当属治疗糖尿病的依柯胰岛素司美格鲁肽注射液。作为全球首个且目前唯一获批的基础胰岛素/GLP-1RA周制剂，该药被评为本届进博会的黑科技展品之一，于今年3月在中国获批上市，适用于接受基础胰岛素或GLP-1RA治疗后血糖控制不佳的成人2型糖尿病患者，在饮食和运动的基础上联合口服降糖药物进行治疗。　　“今年7月，已有中国患者用上这款药物。中国是这款产品首个商业上市的国家。”诺和诺德工作人员向记者介绍。　　礼来设置的互动体验区，同样吸引了大量人流。除了让观众参与身体指标检测外，该体验区还带来“减重中国行”科普巴士来传递科学管理体重的理念。此外，礼来还设立“心血管代谢健康”专区展示了抗糖减重药物替尔泊肽注射液和口服减重药物奥氟格列隆。据悉，奥氟格列隆已于今年4月在美国获批上市，用于成人肥胖症或伴有体重相关并发症的超重患者的体重管理。　　辉瑞也将抗糖减重药物埃诺格鲁肽注射液作为本届进博会展示的核心。作为新一代偏向型GLP-1受体激动剂，该药可通过选择性激活与疗效相关的信号通路，减少激活可能导致受体脱敏的信号传导。据悉，该产品于今年1月获批上市，目前已获批用于治疗成人超重或肥胖及2型糖尿病。　　值得一提的是，埃诺格鲁肽注射液由杭州先为达生物科技股份有限公司研发。今年2月，辉瑞与该公司达成商业化战略合作，获得产品在中国大陆的独家商业化权益。图为观众在勃林格殷格翰展台了解产品。（记者蒋红瑜摄）　　记者注意到，勃林格殷格翰也在进军抗糖减重赛道。在勃林格殷翰展台，作为黑科技展品之一，其在研的索弗度肽也闪亮登场。该产品是一款新兴的GCGR/GLP-1R双受体激动剂，在减重的同时，可减少内脏脂肪和肝脏脂肪。据了解，该产品目前正在开展全球多中心Ⅲ期临床试验，未来拟在中国申请注册上市。　特殊用药人群受到关注　　除了抗糖减重药物，记者了解到，罕见病患者、儿童、高龄女性、老年人等特殊人群用药也有了更多的选择。　　在本届进博会上，武田制药带来了用于治疗1型发作性睡病的神经科学领域创新药物奥普雷顿片。该药是全球首个获批的口服高选择性食欲素2型受体（OX2R）激动剂，也是目前唯一获批用于治疗1型发作性睡病的创新药物。　　武田工作人员介绍，作为全球同步研发、同步申报的原创靶点创新药，奥普雷顿片于今年7月在中国率先获批上市。10月15日，该药物的首个处方落地。截至目前，用药患者已超过200人。　　在本届进博会上，还有吉利德、杰特贝林、赛诺菲等企业展出了最新获批的罕见病药物。其中，赛诺菲带来了全球首个且唯一的血友病siRNA创新非因子疗法芬妥司兰钠注射液。该药物于2025年12月在中国获批上市，适用于患有以下疾病的12岁及以上儿童和成人患者的常规预防治疗，以防止出血或降低出血发作的频率：存在或不存在凝血因子VIII抑制物的重型A型血友病或存在或不存在凝血因子IX抑制物的重型B型血友病。本届进博会，是该产品获批上市后的首秀。　　据悉，芬妥司兰钠注射液采用皮下注射给药，一年最少仅需6次皮下注射。今年7月，芬妥司兰钠注射液在华开出了首张处方。图为默沙东克莱罗韦单抗注射液。（记者蒋红瑜摄）　　除了罕见病治疗药物，儿童药也有“上新”。默沙东展出的克莱罗韦单抗注射液已于今年6月在中国获批上市，用于即将进入或出生在第一个呼吸道合胞病毒（RSV）流行季的新生儿和婴儿预防RSV所致的下呼吸道感染。“我们目前在积极推进第二个RSV流行季保护的相关临床试验，希望拓展产品的适应证。”默沙东工作人员说。　　诺华则重点展示了拟用于干燥综合征的Ianalumab。干燥综合征是风湿免疫科第二大高发自身免疫病，高发人群为40-50岁中年女性，属于进展性慢性炎症疾病。该药是一种全人源单克隆抗体，通过直接清除和抑制活化的双重作用机制，改善因B细胞过度激活所导致的免疫亢进。今年2月，国家药监局已正式受理Ianalumab的上市申请。图为葛兰素史克的重组RSV疫苗。（记者蒋红瑜摄）　　跟老年人相关的疫苗也有了更多的选择。葛兰素史克带来了全球首款用于老年人的重组RSV疫苗，该疫苗可将RSV的F蛋白“冻结”在融合前的构型，从而阻止其对病毒侵入的关键协助作用。该产品于2023年5月在美国获批用于预防60岁及以上人群因感染RSV引发的下呼吸道疾病，目前已在中国申请注册上市。　　安进重点展示的是罗莫索珠单抗注射液。该药是一种人源化的单克隆抗体，既能促进骨形成，又能快速提高骨密度，降低骨折风险，于2025年12月获批，适用于治疗具有骨折高风险的绝经后妇女的骨质疏松症，为患者提供了新的治疗选择。该药在今年上半年开出了首张处方。图为安进的罗莫索珠单抗注射液。（记者蒋红瑜摄）　　展台有边界，患者的需求没有边界。从“四叶草”出发，这些新药正加快走向需要它的患者。《中国医药报》社版权所有，未经许可不得转载使用。(责任编辑：常靖婕)

免疫疗法上市批准临床研究

2026-11-10

·ioncology

ESMO 国际视野丨Lorenza Rimassa教授：解析HIMALAYA研究超长随访数据，探索晚期肝细胞癌长期生存与临床实践启示

编者按：2026年欧洲肿瘤内科学会（ESMO）年会于西班牙举办，大会汇聚全球肿瘤领域专家学者，分享多项肝胆肿瘤领域重磅更新，为肝细胞癌（HCC）的临床诊疗带来全新思考。HIMALAYA研究确立了STRIDE方案在晚期HCC一线治疗中的重要地位，而意大利Humanitas大学及Humanitas研究医院Lorenza Rimassa教授在本次大会公布的7年超长随访总生存数据，进一步刷新了我们对晚期肝癌长期生存的认知。本刊特邀Lorenza Rimassa教授，围绕这项重磅研究的全新数据展开深度访谈，探讨肿瘤缓解指标对长期生存的预判价值、该方案对临床治疗决策的启示，同时分享大会中值得关注的前沿探索，为国内临床工作者传递国际前沿声音。 01 《肿瘤瞭望》：本次您公布了HIMALAYA研究7年总生存数据，同时基于肿瘤缓解指标分层分析OS。和此前随访结果相比，这份超长随访数据带来了哪些新的启示？ Lorenza Rimassa 教授意大利Humanitas大学及Humanitas研究医院 HIMALAYA是一项Ⅲ期研究，头对头对比STRIDE方案，也就是单次启动剂量曲美木单抗联合度伐利尤单抗，与索拉非尼，用于晚期/不可切除HCC患者一线治疗的疗效。研究的主要终点为STRIDE方案对比索拉非尼的总生存期。研究同时设置了度伐利尤单抗单药组，旨在验证该方案相较于索拉非尼的非劣效性。这项试验达到主要终点，STRIDE方案较索拉非尼实现了更长的总生存，目前STRIDE方案已经成为晚期HCC患者一线标准治疗方案之一。我们此前已经公布过该研究的总生存期分析数据，在ESMO 2026大会上，我们进一步公布了HIMALAYA研究7年总生存期分析结果。这是目前晚期/不可切除HCC研究中可获得的最长随访数据。我们观察到，STRIDE组入组患者中有14%在7年时仍然存活；如果把获得客观缓解以及疾病稳定、也就是实现疾病控制的患者合并分析，7年生存率可达20%。这样的结果在HCC领域是前所未有的。回顾既往数据，晚期HCC患者的历史5年生存率仅为5%，而我们现在看到14%的患者可以存活至7年。所以正如我所说，这一结果意义重大，提示即便是晚期HCC患者，也有机会实现长期生存。上下滑动查看英文对话 Oncology Frontier: You presented the 7-year overall survival (OS) data from the HIMALAYA trial, together with an analysis of OS stratified by tumor response. Compared with the results reported at earlier follow-up time points, what new insights do these long-term data offer? Professor Rimassa: HIMALAYA is a phase III trial that compared the STRIDE regimen—one single priming dose of tremelimumab followed by durvalumab—with sorafenib with as first-line treatment for patients with advanced / unresectable HCC. The primary endpoint was overall survival for STRIDE versus sorafenib. The trial also included a durvalumab monotherapy arm that was tested for non-inferiority versus sorafenib. The trial met its primary endpoint, STRIDE achieved a longer overall survival compared to sorafenib, and STRIDE is now one of the first-line standard treatment options for patients with advanced HCC. We had previously reported OS analyses from this study. At ESMO 2026, we presented the results of the 7-year OS analysis. These represent the longest follow-up data available from a trial for advanced / unresectable HCC. We observed that 14% of patients in the STRIDE arm were still alive at 7 years. When patients who achieved an objective response and those whose disease remained stable—that is, patients who achieved disease control—were analyzed together, the 7-year survival rate was 20%. These findings are unprecedented in HCC. Historically, the 5-year survival rate among patients with advanced HCC was only 5%. We are now seeing that 14% of patients can survive for 7 years. This is a highly meaningful result, suggesting that long-term survival is possible even for patients with advanced HCC. 02 《肿瘤瞭望》：在这项分析中，您将不同肿瘤缓解指标与长期OS进行关联。根据本次研究结果，在临床实践中，哪些肿瘤缓解指标更有助于医生预判接受STRIDE方案患者能否获得持久的长期生存？ Lorenza Rimassa 教授意大利Humanitas大学及Humanitas研究医院在这项7年总生存期分析中，我们证实整体有14%的患者在7年时仍然存活。随后我们按照肿瘤缓解、疾病控制、疾病稳定不同状态，评估了各组患者7年生存的概率。研究发现，实现疾病控制的患者7年生存概率最高，这一人群既包含获得客观缓解的患者，也包含疾病稳定的患者。具体来看，实现疾病控制的患者中有20%在7年时仍然存活，也就是刚才提到的客观缓解联合疾病稳定的人群。因此，疾病控制是提示患者7年生存概率更高的指标，而整个STRIDE队列的7年生存率为14%。上下滑动查看英文对话 Oncology Frontier: In this analysis, you examined the relationship between different tumor response measures and long-term OS. Based on the findings, which measures of tumor response are most useful in clinical practice for predicting whether patients receiving the STRIDE regimen are likely to achieve durable long-term survival? Professor Rimassa: In this 7-year OS analysis, we confirmed that 14% of patients overall were still alive at 7 years. We then assessed the probability of 7-year survival according to tumor response and disease status, including disease control and stable disease. The analysis showed that patients who achieved disease control had the highest probability of surviving to 7 years. This group included both patients who achieved an objective response and those whose disease remained stable. Specifically, 20% of patients who achieved disease control were still alive at 7 years, as I mentioned earlier. Therefore, disease control is an indicator associated with a higher probability of 7-year survival, compared with the 14% 7-year survival rate in the overall STRIDE cohort. 03 《肿瘤瞭望》：这份7年生存数据，是不可切除HCC一线免疫治疗III期研究中随访时间最长的数据之一。该结果对于一线不可切除HCC的患者筛选与临床治疗决策，有怎样的指导意义？ Lorenza Rimassa 教授意大利Humanitas大学及Humanitas研究医院晚期HCC患者的一线治疗存在多种可选方案。借助STRIDE方案以及这项7年总生存期分析，我们证实部分患者能够实现疾病控制、获得长期生存，取得了前所未有的结果，有患者在治疗后7年仍然存活。同时研究也提示该方案安全性良好，在初步分析以及5年总生存期分析之后，我们并未发现新增的严重不良事件。另外，研究证实，无论患者基线ALBI分级为1级还是2、3级，STRIDE方案带来的生存获益均可保持，本研究入组患者的基线肝功能均为Child-Pugh A级。因此我认为，对于以疾病控制、延长生存为治疗目标的患者，就目前已有的数据来看，STRIDE方案是优选方案。它是目前唯一拥有如此长期随访数据、可证实部分患者能够存活至7年的治疗方案。这也意味着，即便是晚期HCC患者，我们也可以将延长生存期、实现长期生存作为治疗目标。上下滑动查看英文对话 Oncology Frontier: These 7-year survival data represent one of the longest follow-up periods reported in a phase III trial of first-line immunotherapy for unresectable HCC. What implications do the findings have for patient selection and clinical treatment decisions in this setting? Professor Rimassa: Several first-line treatment options are available for patients with advanced HCC. The STRIDE regimen and this 7-year OS analysis demonstrate that some patients can achieve disease control and long-term survival—an unprecedented result, with some patients still alive 7 years after treatment initiation. The study also indicates that the regimen has a favorable safety profile. Following the initial analysis and the 5-year OS analysis, we did not identify any new serious adverse events. In addition, the study showed that the survival benefit with STRIDE was maintained regardless of whether patients had a baseline ALBI grade of 1 or grade 2 or 3. All patients enrolled in the study had Child-Pugh A liver function at baseline. Therefore, in my view, for patients whose treatment goals are disease control and prolonged survival, STRIDE is a preferred option based on the data currently available. It is the only treatment regimen with such long-term follow-up demonstrating that some patients can remain alive for as long as 7 years. This also means that, even in advanced HCC, prolonging survival and achieving long-term survival can be realistic treatment goals. 04 《肿瘤瞭望》：在本次大会上，哪一项报告给您留下的印象最深？您觉得它的亮点体现在哪里？ Lorenza Rimassa 教授意大利Humanitas大学及Humanitas研究医院一项针对经治HCC患者的新型双特异性抗体Ⅰ/Ⅱ期研究结果让我印象很深。这项研究主要在亚洲开展，采用靶向GPC3和4-1BB的双特异性抗体BGB-B2033。研究在多线治疗后的晚期HCC人群中取得了36%的客观缓解率（ORR），同时安全性表现良好。基于这些数据，后续即将在全球范围内启动一项针对经治HCC患者的Ⅲ期研究。上下滑动查看英文对话 Oncology Frontier: Which presentation at this year's congress made the strongest impression on you, and what were its key highlights? Professor Rimassa: I was particularly impressed by the results of a phase I/II study of a novel bispecific antibody in patients with previously treated HCC. The study was conducted primarily in Asia and evaluated BGB-B2033, a bispecific antibody targeting GPC3 and 4-1BB. Among patients with advanced HCC who had received multiple prior lines of therapy, the study reported an objective response rate (ORR) of 36%, with a favorable safety profile. Based on these data, a global phase III study in previously treated patients with HCC is planned to start soon. Lorenza Rimassa 教授意大利Humanitas大学及Humanitas研究医院胃肠道肿瘤内科医生，肿瘤内科副教授，同时担任意大利米兰Humanitas大学、Humanitas癌症中心肝胆胰肿瘤科主任。（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3期临床结果

2026-11-09

·集思广.生命科学

1109药讯信达信必乐 ® 单药 Ⅲ 期达终点，默沙东 DLL3 三抗入 Ⅲ 期，两企获融资，方诺生科与 TRV 达成重磅 BD 合作

信达生物临床III期成功 11月9日，信达生物宣布，其自主研发的重组全人源抗PCSK9单克隆抗体信必乐®（托莱西单抗注射液，研发代码：IBI306）在单药治疗中国非家族性高胆固醇血症和混合型高脂血症患者的多中心、随机、双盲、安慰剂对照Ⅲ期临床研究（CREDIT-5）中，于第12周成功达到主要终点。作为中国首个获批上市并纳入国家医保目录（2025年1月1日起生效）的国产PCSK9抗体药物，信必乐®至今已惠及超过100万名患者，并获得多部权威临床指南和专家共识的推荐。在药理机制上，托莱西单抗能够特异性结合PCSK9分子，减少PCSK9介导的低密度脂蛋白受体（LDLR）内吞，从而提高LDLR水平并加速低密度脂蛋白胆固醇（LDL-C）的清除。信达生物计划于近期向国家药品监督管理局（NMPA）递交该单药治疗的新适应症上市申请，期望为高脂血症患者提供更便捷的一线降脂选择。默沙东三抗MK-6070联合PD-L1启动首个III期临床 2026年11月8日，clinicaltrials平台显示。默沙东登记了一项MK-6070联合Durvalumab（度伐利尤单抗/PD-L1）治疗小细胞肺癌（SCLC）的III期临床研究，据悉这是该药启动的首个III期临床。 MK-6070又名HPN328，是默沙东今年从Harpoon收购而来，靶向CD3/HSA/DLL3，其中靶向HSA是为了增加抗体半衰期，靶向DLL3的抗体为纳米抗体，结合CD3的抗体为scFv形式。阿法纳生物，完成5000万美元A轮融资首关近日，阿法纳生物完成A轮融资首关，总规模5000万美元。首关由国中资本领投，合肥产投集团旗下生命健康公司、产投国正，安徽策源产业投资有限公司联合领投，合肥产投集团旗下创业投资引导基金公司追加投资，南京鸿景、深圳久荣、上海钦荔跟投，浩悦资本担任独家财务顾问。本轮资金将用于加速in vivo CAR-T、肿瘤疫苗等核心管线推进，持续迭代TALENT®技术平台，并加强CMC、注册开发及产业化能力。阿法纳生物成立于2021年，由中国科大教授团队创立，聚焦mRNA领域原创科研成果的转化，全面布局体内细胞工程、肿瘤疫苗和新型预防性疫苗三大领域。三优生物获清科产投独家C轮投资，累计融资近3亿元近日，三优生物宣布完成近亿元人民币C轮融资。本轮融资由清科集团旗下清科产投基金独家投资。此次融资是资本市场对三优生物技术实力、创新药研发体系及未来发展潜力的充分认可，也标志着三优生物在创新药研发与商业转化领域迈入新的发展阶段。三优生物以“成为全球创新药研发的引领者”为愿景，构建全球领先的智能超万亿分子库（AI-STAL）、干湿结合的智能新药加速器（SAI-DA）及原创新药创新工场（Clicklinks）。公司以“源头创新+智能加速+管线驱动”三维驱动，系统性破解新药源头创新瓶颈，贯通临床前研发全链条，携手合作伙伴共建新药研发新生态。最高21.6亿美元潜在款项，方诺生科与Third Rock达成AI抗体合作中国北京，2026年11月6日——AI驱动的抗体与蛋白质药物研发公司方诺生科（Funnel Biosciences）今日宣布，与 Third Rock Ventures（以下简称“TRV”）达成战略研究合作，利用方诺独家的表位导向AI抗体发现平台，围绕多个靶点开展创新生物药研发合作。合作将围绕TRV指定的靶点展开。根据合作安排，方诺将收取平台使用费，并有资格在满足协议约定条件的情况下，获得总额最高约21.6亿美元的潜在款项。传统抗体发现通常依赖动物免疫、噬菌体展示等技术，需要经过多轮筛选与优化。对于多跨膜蛋白等结构复杂的靶点，保持靶点的天然构象、获得结合特定功能表位的抗体，仍是研发中的重要挑战。生物医药行业持续创新，未来可期! 注:本文整理自行业公开信息，仅供参考！

疫苗临床3期免疫疗法并购信使RNA

100 项与度伐利尤单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10808	度伐利尤单抗	L01FF03	DB11714

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
非肌层浸润性膀胱肿瘤	美国	AstraZeneca UK Ltd.	2026-05-28
胃癌	欧盟	AstraZeneca AB	2026-03-16
胃癌	冰岛	AstraZeneca AB	2026-03-16
胃癌	列支敦士登	AstraZeneca AB	2026-03-16
胃癌	挪威	AstraZeneca AB	2026-03-16
早期胃癌	美国	AstraZeneca PLC	2025-11-25
胃食管交界处腺癌	美国	AstraZeneca UK Ltd.	2025-11-25
胃食管交界处癌	美国	AstraZeneca PLC	2025-11-25
局部晚期胃癌	美国	AstraZeneca PLC	2025-11-25
不可切除的非小细胞肺癌	中国	AstraZeneca UK Ltd.	2025-11-18
肌层浸润性膀胱癌	美国	AstraZeneca UK Ltd.	2025-03-28
子宫癌	日本	阿斯利康制药有限公司	2024-11-22
晚期子宫内膜癌	欧盟	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	冰岛	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	列支敦士登	AstraZeneca AB	2024-08-15
晚期子宫内膜癌	挪威	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	欧盟	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	冰岛	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	列支敦士登	AstraZeneca AB	2024-08-15
复发性子宫内膜癌	挪威	AstraZeneca AB	2024-08-15

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
ALK阳性非小细胞肺癌	申请上市	中国	AstraZeneca AB	2025-02-21
EGFR突变的非小细胞肺癌	申请上市	中国	AstraZeneca UK Ltd.	2025-02-21
卵巢上皮癌	申请上市	中国	AstraZeneca UK Ltd.	2024-08-16
微卫星稳定型实体瘤	临床3期	西班牙	AstraZeneca PLC	2024-12-30
晚期神经内分泌癌	临床3期	日本	AstraZeneca KK	2023-12-01
胃肠胰神经内分泌肿瘤	临床3期	日本	AstraZeneca KK	2023-12-01
小细胞癌	临床3期	日本	AstraZeneca KK	2023-12-01
PD-L1阳性三阴性乳腺癌	临床3期	美国	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	中国	AstraZeneca PLC	2023-11-23
PD-L1阳性三阴性乳腺癌	临床3期	日本	AstraZeneca PLC	2023-11-23

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


AASLD2026	N/A	不可切除的肝细胞癌一线	90	Tremelimumab plus durvalumab	廠鑰鏇壓範膚築鏇廠糧(夢廠夢醖鹹窪願網膚築) = 蓋積觸選獵積夢簾鏇繭廠醖窪鏇築遞製觸遞窪 (襯鬱製蓋網製夢艱齋鹽, 1.5 ~ 5.9) 更多	积极	2026-11-05
				Tremelimumab plus durvalumab (patients with Vp4 PVTT)	簾壓獵觸糧製鏇艱鏇齋(鹹獵襯遞簾簾鹽範艱鬱) = 膚選積鬱積餘廠觸膚獵簾襯顧鑰觸觸選襯積艱 (蓋獵築鬱製積壓鹽蓋簾 ) 更多
AASLD2026	N/A	肝细胞癌一线	1,487	Durvalumab-based regimens	鏇蓋糧構壓鹹繭艱蓋簾(顧艱膚製醖齋夢繭鑰鏇) = 襯醖範鬱淵憲遞獵廠夢憲膚鹹憲遞蓋廠範鏇壓 (淵醖襯艱願憲糧齋醖蓋 ) 更多	积极	2026-11-05
				atezolizumab+bevacizumab	憲鏇製鏇衊範膚繭選選(築窪觸觸構繭糧齋鹽遞) = 遞憲齋觸窪鹹願顧遞艱鏇顧繭憲廠壓醖淵積製 (鑰鹽鑰築齋築醖窪獵範 )
AASLD2026	N/A	不可切除的肝内胆管癌 TP53 mutations	41	gemcitabine, cisplatin, and durvalumab (GCD) or gemcitabine, cisplatin, and pembrolizumab (GCP)	齋壓糧積顧襯醖繭衊築(糧醖膚憲鏇願選壓艱構) = 膚簾膚繭餘衊鹽製齋窪鹽餘製淵憲醖蓋顧鬱糧 (夢觸壓醖鑰夢簾蓋鏇範, 4.4 ~ 10.7) 更多	积极	2026-11-05
				gemcitabine, cisplatin, and durvalumab (GCD) or gemcitabine, cisplatin, and pembrolizumab (GCP) (TP53 wild-type ICC)	齋壓糧積顧襯醖繭衊築(構網窪積夢鹹網構範選) = 顧顧範壓繭壓觸廠製積築願觸鏇艱艱製壓網齋 (鬱製膚夢繭顧網鑰憲繭, 4.4 ~ 10.7) 更多
AASLD2026	临床2/3期	晚期胆道癌一线	3,000	Durvalumab + Gemcitabine + Cisplatin	選鹽顧廠壓繭廠積醖齋(顧廠艱憲顧選窪獵糧淵): HR = 0.74 (95.0% CI, 0.63 ~ 0.87)	积极	2026-11-05
				Pembrolizumab + Gemcitabine + Cisplatin
NCT03116529 (NEXIS, CTgov)	临床1/2期	软组织肉瘤	22	Combination Radiation, Immunotherapy, Surgery	製製顧夢衊觸鑰製遞積 = 鏇壓醖衊製蓋齋齋願鏇網夢鑰壓鹹餘獵衊膚鹽 (醖蓋醖壓鹹憲壓築鹹範, 範鹹獵膚糧願網壓願餘 ~ 艱憲遞範夢餘範夢願繭) 更多	-	2026-11-05
NCT05925530 (MDT-BRIDGE, Pubmed \| Nat Med)	临床2期	可切除非小细胞肺癌新辅助	142	Neoadjuvant durvalumab plus chemotherapy	製鑰遞遞醖蓋製憲鑰糧(衊顧襯選廠壓窪選鑰憲) = 範憲觸製憲築衊鬱艱淵築構廠繭範網衊築築憲 (築顧鑰襯淵顧範壓鑰醖 ) 更多	积极	2026-10-26
NCT06211036 (DeLLphi-305, Pubmed \| N Engl J Med)	临床3期	广泛期小细胞肺癌维持	563	Tarlatamab-Durvalumab	繭鹽壓壓醖襯範鑰獵構(蓋鹽廠選積醖齋鬱獵觸) = 觸繭願遞憲壓繭網鹽願齋築簾醖築廠醖憲選壓 (鬱製願網範製壓廠範鏇, 20.8 ~ NE) 更多	积极	2026-10-24
				Durvalumab	繭鹽壓壓醖襯範鑰獵構(蓋鹽廠選積醖齋鬱獵觸) = 夢廠獵鏇齋糧鬱廠鬱蓋齋築簾醖築廠醖憲選壓 (鬱製願網範製壓廠範鏇, 11.2 ~ 14.8) 更多
ESMO2026	N/A	肝内胆管癌一线 IDH1 \| IDH2 \| KRAS ... 更多	190	Cisplatin-gemcitabine-durvalumab	淵鑰衊網齋衊築遞簾夢(願醖遞齋願選餘鏇範簾) = 顧鑰蓋艱淵襯鏇選鑰繭範醖鹹鹽鏇遞網艱襯範 (選窪鹹齋壓膚觸製齋夢 ) 更多	积极	2026-10-23
NCT03528694 (POTOMAC, ESMO2026)	临床3期	非肌层浸润性膀胱肿瘤	435	Durvalumab+BCG (Induction and Maintenance)	獵鏇觸淵夢鏇積淵襯簾(觸衊繭鑰繭構壓醖膚衊) = 糧鬱顧淵壓鹹衊壓醖夢壓餘齋艱築鬱獵夢壓積 (艱築憲膚範選餘鏇鹹齋 ) 更多	积极	2026-10-23
				BCG (Induction and Maintenance)	獵鏇觸淵夢鏇積淵襯簾(觸衊繭鑰繭構壓醖膚衊) = 夢齋範齋衊壓繭醖淵夢壓餘齋艱築鬱獵夢壓積 (艱築憲膚範選餘鏇鹹齋 ) 更多
NCT05128630 (DEDALUS, ESMO2026)	临床2期	非小细胞肺癌 III期	25	sequential chemo-durvalumab	鬱淵簾鹹網壓壓夢顧觸(餘構鏇鹽範餘廠繭膚淵) = 淵簾廠齋顧醖積窪憲構繭積壓鹹鬱願夢築襯鹽 (願襯膚醖範範膚製積齋, 10.7 ~ 18.6) 更多	积极	2026-10-23
				sequential chemo-durvalumab (patients who started maintenance without progression)	鬱淵簾鹹網壓壓夢顧觸(餘構鏇鹽範餘廠繭膚淵) = 鏇窪憲簾襯鏇襯齋襯艱繭積壓鹹鬱願夢築襯鹽 (願襯膚醖範範膚製積齋 ) 更多