Patients with metastatic bladder cancer are usually treated with chemotherapy. If their cancers do not progress after chemotherapy, they can be enrolled into this study and receive a standard-of-care immunotherapy medication named avelumab plus a study drug named copanlisib.

开始日期2025-06-02

申办/合作机构

VA Office of Research and Development

[+1]

NCT06640725

/ Recruiting临床2期IIT

A Phase II Study of TPEx (Taxotere-platinum-cetuximab) Followed by a Maintenance With Avelumab and Cetuximab in First Line Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (TATIANA)

The main objective of this research is to increase the life expectancy of patients with advanced mouth and throat cancer, by adding avelumab to the standard TPEx treatment.
All participants in this research will receive the same treatment which will take place in two phases:
* 1st phase chemotherapy + immunotherapy: standard reference treatment (Docetaxel + cisplatin or carboplatin + cetuximab)
* 2nd phase immunotherapy: cetuximab combined with avelumab which is the treatment under study.

开始日期2025-01-02

申办/合作机构-

NCT06518564

/ Recruiting临床2期IIT

A Phase 2 Study of Avelumab in Combination With ATR Inhibitor M1774 in Patients With ARID1A-mutated Recurrent Endometrial Cancer Who Have Received Prior Immunotherapy

The purpose of this research study is to see if the combination of study drugs avelumab and M1774 is effective and safe for participants with endometrial cancer.
The names of the study drugs involved in this study are:
* Avelumab (a type of human IgG1 antibody)
* M1774 (a type of ATR inhibitor)

开始日期2024-11-14

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

100 项与阿维单抗相关的临床结果

登录后查看更多信息

100 项与阿维单抗相关的转化医学

登录后查看更多信息

100 项与阿维单抗相关的专利（医药）

登录后查看更多信息

1,171

项与阿维单抗相关的文献（医药）

2025-02-01·Clinical Genitourinary Cancer

Outcomes by Retrospective Eligibility for Maintenance Therapy of Patients With Advanced Urothelial Carcinoma: Post Hoc Analysis of the Phase 3 KEYNOTE-361 Trial

Article

作者: Sella, Avishay ; Mamtani, Ronac ; Chang, Yen-Hwa ; Gravis, Gwenaelle ; Joly, Florence ; Bedke, Jens ; Pino, Alvaro Montesa ; Huillard, Olivier ; Imai, Kentaro ; Şendur, Mehmet A． N. ; Moreno, Blanca Homet ; Lee, Hyo Jin ; Alva, Ajjai ; Gafanov, Rustem ; Xu, Jin Zhi ; Şendur, Mehmet A.N. ; Matsubara, Nobuaki ; Herranz, Urbano Anido ; Şendur, Mehmet A N ; Powles, Thomas

INTRODUCTION:

The phase 3 KEYNOTE-361 trial of first-line pembrolizumab with or without chemotherapy versus chemotherapy alone in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) completed enrollment before the approval of postchemotherapy maintenance avelumab for patients without progressive disease. This post hoc analysis evaluated the outcomes of patients who received chemotherapy alone in KEYNOTE-361 by retrospective eligibility for subsequent maintenance therapy.

PATIENTS AND METHODS:

Patients in the chemotherapy alone arm were retrospectively categorized as maintenance eligible (received ≥4 cycles of chemotherapy and did not die or experience disease progression within 10 weeks of chemotherapy completion), maintenance ineligible (received <4 cycles of chemotherapy or had progressive disease or died within 0-10 weeks after completion of ≥4 cycles of chemotherapy), and indeterminate eligibility for maintenance therapy (if neither maintenance eligible or ineligible). End points included progression-free survival per Response Evaluation Criteria in Solid Tumors version 1.1 by blinded independent central review and overall survival from randomization (start of chemotherapy).

RESULTS:

Median follow-up was 31.7 months (range, 22.0-42.3). Among 342 patients who received chemotherapy alone, 172 (50.3%) were maintenance eligible, 108 (31.6%) were maintenance ineligible, and 62 (18.1%) had indeterminate eligibility for maintenance therapy. The median progression-free survival was 9.0 months (95% CI 8.4-10.4) in maintenance-eligible patients, 5.1 months (4.2-6.0) in maintenance-ineligible patients, and 2.3 months (1.9-3.8) in the indeterminate group; median overall survival was 23.3 months (95% CI 19.4-26.1), 10.2 months (9.1-11.6), and 5.5 months (3.7-8.5), respectively.

CONCLUSION:

This post hoc analysis suggests that a majority of patients with untreated la/mUC who initiated chemotherapy in a clinical trial may have been considered eligible for maintenance therapy and had favorable survival outcomes compared with those considered maintenance ineligible.

2025-02-01·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Cardiotoxicity associated with immune checkpoint inhibitors: Systematic review and meta-analysis

Review

作者: Provenzani, Alessio ; Carollo, Anna ; Cutaia, Sofia ; Novara, Maria Eugenia ; Piazza, Lavinia ; Rizzo, Sergio ; Di Martino, Enrica

BACKGROUND AND AIMS:

The aim of this systematic review was to assess the risk of cardiac toxicity in patients undergoing approved PD-1 (nivolumab, pembrolizumab, cemiplimab, dostarlimab), PD-L1 (atezolizumab, avelumab, durvalumab), and CTLA-4 (ipilimumab) inhibitors.

RESULTS:

Among a total of 2272 articles, 11 phase II and III clinical trials included: 5463 patients and 175 cardiac adverse events. The most common cardiac disorder was atrial fibrillation (12 %), while cardiac arrest and cardiac failure (6 %) led to death in three cases. Overall, ICI treatment increased the risk of cardiotoxicity compared with control groups (RR=1.62, 95 %-CI= 1.18-2.24, p-value=0.0033; OR=1.71, 95 %-CI= 1.20-2.42, p-value=0.0027).

CONCLUSIONS:

This study proved that the recognition of frequency and severity of all grade cardiotoxicity associated with ICIs is still underestimated. Thus, a systematic cardiological screening becomes necessary, in order to intercept the potential cardiological complications beforehand and optimize the outcomes of the respective treatment with PD-1, PD-L1 and CTLA-4 inhibitors.

2025-02-01·Clinical Genitourinary Cancer

Real-World Treatment Patterns and Clinical Outcomes in Patients With Locally Advanced or Metastatic Urothelial Carcinoma by Eligibility for Maintenance Avelumab

Article

作者: Wright, Phoebe ; Morgans, Alicia K ; Mucha, Lisa ; Powles, Thomas ; Hepp, Zsolt ; Naga, Sai Sriteja Boppudi ; Sonpavde, Guru P ; Willmon, Candice L ; Chang, Nancy N ; Shih, Vanessa

INTRODUCTION:

1L PBC has historically been recommended for patients with la/mUC. Maintenance avelumab is recommended for patients without disease progression following 1L PBC. Real-world data on the proportion of patients eligible for maintenance avelumab are limited, and outcomes among patients ineligible for maintenance avelumab are uncertain. This study assessed the proportion of patients with la/mUC initiating 1L PBC who were maintenance-avelumab eligible and real-world outcomes following 1L PBC by maintenance-avelumab eligibility.

METHODS:

A retrospective, observational study was conducted using a longitudinal electronic health record-derived database comprising de-identified patient-level structured and unstructured data including adults with Ia/mUC who received ≥1 dose of 1L PBC (April 2020-January 2022). The proportion of patients eligible for maintenance avelumab (real-world stable disease, partial response, or complete response following 1L PBC) was estimated and median overall survival (mOS) assessed for maintenance avelumab-eligible and -ineligible patients.

RESULTS:

Of 336 patients with Ia/mUC treated with 1L PBC (55.4% received cisplatin-based treatment 44.6% carboplatin-based treatment); 181 (54%) were maintenance-avelumab eligible; and 138 (41%) maintenance-avelumab ineligible (17 [5%] were nonevaluable). Of 181 maintenance-avelumab-eligible patients, 67 (37.0%; 19.9% of all 1L PBC-treated patients) received maintenance avelumab. mOS (95% CI) among all 1L PBC-treated patients was 15.0 (12.2-19.6) months and among maintenance-avelumab-ineligible patients was 8.0 (6.7-10.3) months; whereas among maintenance-avelumab-eligible patients (including 37% who received maintenance avelumab), mOS was 27.6 (23.4-not reached) months.

CONCLUSIONS:

In this study, approximately half of 1L PBC-treated patients were maintenance-avelumab eligible, and one-fifth received it. Real-world OS remains short for the overall 1L PBC-treated population. These results support the use of treatment-guideline preferred 1L treatment options that demonstrate survival benefit for all patients with la/mUC, and are available to patients irrespective of their eligibility for cisplatin, or response to PBC.

406

项与阿维单抗相关的新闻（医药）

2025-01-09

·GlobeNewswire-Health Care

Mirror Biologics Enters Clinical Collaboration with Merck KGaA, Darmstadt, Germany in Metastatic Colorectal Cancer

Jan. 08, 2025 -- Mirror Biologics, Inc., specializing in development and manufacturing of immunotherapy products where the active ingredient is living, non-genetically altered, allogeneic (“off-the-shelf”) immune cells, announces that it has entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany. The parties will collaborate to conduct a Phase II clinical trial to evaluate the combination of an experimental immunotherapy drug, AlloStim® from Mirror, and an immune checkpoint inhibitor (ICI), avelumab (BAVENCIO®) from Merck KGaA, Darmstadt, Germany, in fourth-line metastatic colorectal cancer: NCT06557278. Colorectal cancer (CRC) is the third most common cancer and the second most common cause of cancer deaths worldwide. In 2023, approximately 153,020 individuals were diagnosed with CRC and 52,550 died from the disease in the United States. There were more than 1.9 million new CRC cases and 0.9 million deaths reported worldwide in 2020. CRC incidence is increasing, and it is estimated that the number of CRC patients worldwide could reach 2.5 million by 2035. There is a high unmet medical need to provide additional treatment options that could potentially extend life with quality for advanced metastatic CRC patients. ICI drugs have revolutionized the treatment and prognosis for several solid tumor types. The tumor types most susceptible to ICI are tumors characterized as immunologically ‘hot,’ meaning those that have high numbers of infiltrating anti-tumor immune cells. However, most solid tumors and almost all CRC tumors are immunologically ‘cold,’ having no infiltrating immune cells, making them refractory to ICI immunotherapy. This collaboration intends to use experimental AlloStim® to attempt to convert ICI-unresponsive CRC tumors into ICI-responsive tumors. If successful, this could provide a new treatment option for these patients. The combination of experimental AlloStim® and ICI has previously resulted in a rare objective tumor response in a patient with metastatic CRC, which has provided the rationale for further exploration of this combination in this indication: see: Objective response after immune checkpoint inhibitors in a chemotherapy-refractory pMMR/MSS metastatic rectal cancer patient primed with experimental AlloStim® immunotherapy. Dr. Michael Har-Noy, Founder and Chief Medical Officer of Mirror Biologics stated: “We are pleased to enter into this clinical collaboration with Merck KGaA, Darmstadt, Germany, evaluating the potential of investigational AlloStim® in combination with avelumab in patients who are suffering from advanced metastatic colorectal cancer. These patients have limited treatment options and are refractory to immunotherapy. The investigation of combination therapies may uncover additional possibilities for these patients. We look forward to working with Merck KGaA, Darmstadt, Germany to explore how we can bring the potential of immunotherapy to more patients.” Under the terms of the agreement, Mirror Biologics will be the sponsor of the clinical study, and Merck KGaA, Darmstadt, Germany will supply avelumab for the study. The Phase II open-label study is expected to accrue up to 50 patients with metastatic CRC who are both chemotherapy- and immunotherapy-refractory and who have failed at least one third-line, non-chemotherapy treatment (e.g., regorafenib, TAS-102 with or without bevacizumab or fruquintinib). The clinical study will be conducted at approximately 10 sites in the USA. Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking PD-L1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response. Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. Avelumab in combination with axitinib is approved in the US for the first-line treatment of patients with advanced renal cell carcinoma. Avelumab has also been granted approval as monotherapy for the treatment of adults and pediatric patients (12 years and older) with metastatic Merkel cell carcinoma and for patients with locally advanced or metastatic urothelial carcinoma. Mirror Biologics, Inc. is a private Delaware corporation with headquarters, blood donor center, drug depo storage, distribution, clinical research, as well as immunological and bioengineering development operations in Tampa, Florida. Mirror also has GMP manufacturing operations in Jerusalem, Israel and additional clinical operations in Thailand and Malaysia. The lead product candidate, AlloStim® is an "off-the-shelf" non-genetically manipulated, living, immune cell immunotherapy protected by over 200 issued patents worldwide and derived from precursors purified from the blood of healthy donors. AlloStim® is a platform drug, that is broadly applicable to cancer and infectious disease indications. AlloStim® is being evaluated in a Phase IIb open-label clinical study in third-line metastatic colorectal cancer at 4 sites in USA, and in a Phase II/III randomized, controlled clinical study in advanced/metastatic liver cancer at 5 sites in Thailand and 3 sites in Malaysia. In addition, AlloStim® is being evaluated in a Phase I/II clinical trial in 40 healthy adults over 65yo in the USA as a means to reverse immunosenescence and restore broad universal respiratory viral protection in seniors against both known viruses (such as influenza A and B, RSV and coronavirus) and currently unknown viral pathogens, including emerging viruses with pandemic potential. The content above comes from the network. if any infringement, please contact us to modify.

免疫疗法引进/卖出上市批准

2025-01-02

·求实药社

免疫+ADC赛道还未开卷，辉瑞率先打出王炸！

丨猎药人俱乐部研究团队整理 2024年12月28日，CDE官网显示，辉瑞的PF-08046054 (注射用冻干粉针) 的临床试验申请获得受理，受理号JXSL2400256。该药物为一款靶向 PD-L1 的 ADC 药物，由 Seagen 研发后被辉瑞收购获得。 01 关于PF-08046054PF-08046054(SGN-PDL1V)通过maleimidocaproyl-valine-citrulline (vc) linker搭载MMAE，DAR=4；其PDL1单抗相对于已获批上市的PDL1单抗，如Atezolizumab, avelumab, duvalumab，在偶联之后，有更快的内吞。在临床前研究中，它在PD-L1低表达或表达异质性高的动物模型中也展现出抗癌活性。 SGN-PDL1V于2022年开启临床1期，适应症涵盖HNSCC 、NSCLC、ESCC、TNBC，OVC等。 2024 ESMO大会上，辉瑞公布了PF-08046054的1 期临床研究中期结果：SGNPDL1V-001 (NCT05208762)招募了复发/难治性 PD-L1 表达实体瘤（非小细胞肺癌、头颈部鳞状细胞癌、三阴性乳腺癌和食道癌）患者，这些患者在标准治疗后出现进展。主要终点是安全性/耐受性和药代动力学，次要终点是抗肿瘤活性。截至 2024 年 3 月 6 日，55 名患者接受了治疗，72.7% 患者 ECOG PS 1，54.5% 患有头颈部鳞状细胞癌（HNSCC），29.1% 患有非小细胞肺癌（NSCLC），14.5% 患有三阴性乳腺癌（TNBC），1.8% 患有食道癌（EC）。研究者评估的所有剂量和肿瘤类型的 ORR 为 27.3%（cORR 12.7%），确认mDOR 为 7.9 个月。从 1.25 mg/kg 开始观察到客观缓解，并且与 PD-L1 表达无关。未见剂量限制性毒性 (DLT)；1.75 mg/kg 是评估的最高剂量。未见免疫相关 TRAE。总体 ≥ 3 级 TRAE 为 30.9%。14.5% 的患者因治疗中出现的 AE 而停止治疗。 02 关于PD-L1 ADC PD-（L）1抑制剂的诞生，是肿瘤治疗史上的里程碑事件。但PD-L1抗体有效率受肿瘤异质性及致密肿瘤基质的不良渗透的限制，因此，将ADC药物与抗PD-L1单抗结合以产生双功能PD-L1靶向ADC，成为一个非常有前景的研发方向。然而，相比当下“扎堆”研发的PD-1与ADC的联用方案，PD-L1 ADC的入局者并不算多，Seagen的SGN-PDL1V是全球首款进入临床阶段的PD-L1 ADC，于2022年进入I期临床试验，足矣体现靶向PD-L1 ADC药物研发之难。根据insight数据库，目前靶向PD-L1 ADC药物共有十余款在研，其中进入临床的项目除辉瑞PF-08046054（SGN-PDL1V）外，还包括复宏汉霖/宜联生物的HLX43和映恩生物的DB-1419（靶向PD-L1/B7H3）；HLX43复宏汉霖在二线晚期肝癌患者中已启动一项2期临床试验NCT06742892。复宏汉霖/宜联生物：HLX43 HLX43为复宏汉霖首批进入临床阶段的ADC产品之一，旨在解决PD-1/L1免疫疗法不响应或耐药问题，填补更多晚期/转移性实体瘤患者未满足的临床需求。HLX43兼具抗体分子的高度靶向性和细胞毒素的强大杀伤力，可通过与肿瘤细胞表面PD-L1 抗原特异性结合，经内吞后释放小分子毒素，从而发挥抗肿瘤作用。目前，HLX43已在临床前药理学研究、药代动力学研究及安全性评价中展现出抗肿瘤活性，且具有良好的安全性。正在开展的一项评估HLX43在晚期/转移性实体瘤患者中的安全性、耐受性及药代动力学特征的I期临床研究（NCT06115642）显示，HLX43 给药剂量已递增至4.0mg/kg，每三周静脉滴注一次（Q3W），患者耐受性良好，且既往接受了包括免疫治疗在内的标准治疗后进展的实体瘤患者（非小细胞肺癌、宫颈癌等）仍表现出对HLX43 的治疗响应。 2024年12月4日，复宏汉霖宣布，公司基于与宜联生物的合作开发的靶向程序性死亡-配体1（PD-L1）的新型抗体偶联药物（ADC）注射用HLX43，其单药或联合治疗晚期/转移性实体瘤的 Ib/II期临床试验申请获得中国国家药品监督管理局（NMPA）批准。此后不久，复宏汉霖在clinical trials网站上登记了一项PD-L1 ADC药物HLX43 ，在二线晚期肝癌患者中启动一项2期临床试验NCT06742892，该临床将于2025年2月启动，计划入组人数为90例。映恩生物：DB-1419 DB-1419是映恩生物在研的首款靶向B7-H3/PD-L1且带有拓扑异构酶 I 抑制剂的双特异性 ADC药物，由人源化 B7 - H3/PD - L1 双特异性抗体通过可裂解连接子与新型 DNA 拓扑异构酶 I 抑制剂 P1003 偶联而成。可以将毒素递送至肿瘤细胞并调节 T 细胞活化的同时作用提供了潜在的协同抗肿瘤效应。该药物采用了新型结合和内吞机制，相较于传统单抗ADC展现出更为卓越的疗效，体外和体内研究均显示，DB - 1419 的未偶联双特异性抗体具有强大的免疫检查点抑制活性，并能有效克服因单靶点表达下降导致的耐药性问题。通过有效载荷介导的细胞毒性和抗体介导的免疫治疗活性，DB - 1419 为癌症治疗提供了一种创新方法。2024年9月，该药在晚期/转移性实体瘤中的1/2a期首次人体研究获FDA批准。 03 辉瑞：2030年推出8款以上肿瘤学重磅疗法2024年3月，辉瑞（Pfizer）公司召开了肿瘤学创新日（Oncology Innovation Day），披露了该公司在肿瘤学领域的研发布局。该公司高管表示，到2030年，肿瘤学研发管线有望产出8款以上重磅疗法。该公司将聚焦小分子药物、抗体偶联药物（ADC）和双特异性抗体这三种治疗模式。其中包括：有望改变HER2阳性尿路上皮癌的治疗的Disitamab vedotin；潜在首个治疗前列腺癌的EZH2抑制剂Mevrometostat；潜在“first-in-class”整合素β6靶向抗体偶联药物Sigvotatug vedotin；潜在“first-in-class”PD-L1靶向ADC PF-08046054；潜在“best-in-class”CDK4抑制剂Atirmociclib；潜在“first-in-class”γδ T细胞靶向双特异性抗体疗法PF-08046052等。资料来源：各公司官网、新药启航、药明康德、津津药道、Insight数据库免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部责任。本公众号发布的各类文章重在分享，如有侵权请联系我们，我们将会删除。国内唯一！深度聚焦自免药物开发的峰会联系我们 AIM 2025 展位火热预定中！扫码立即咨询电话：13816031174 （同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多！

抗体药物偶联物临床1期临床结果并购临床2期

2024-12-31

·抗体圈

韩国晖教授：2024早期乳腺癌进展繁花似锦，ADC药物全面开花

新型ADC药物在早期乳腺癌新辅助治疗中展现出广阔前景。随着乳腺癌发病率逐年上升，早期乳腺癌的药物治疗逐渐成为关注焦点。围手术期新辅助或辅助治疗作为乳腺癌治疗的重要组成部分，为提高患者的治疗效果和生存率提供了机会。近年来，ADC药物和免疫治疗在不同亚型乳腺癌中的应用取得显著进展，为早期乳腺癌新辅助或辅助治疗保驾护航。医学界肿瘤频道特邀山西省肿瘤医院韩国晖教授盘点2024年度早期乳腺癌的重要研究进展，并展望未来探索方向。 ADC药物在早期乳腺癌新辅助治疗中全面开花 Dato-DXd联合免疫新辅助治疗在I-SPY2.2平台顺利“毕业” I-SPY2.2研究平台是为了让患者最大化达到病理完全缓解（pCR），但同时把升降阶梯的理念融入其中。该研究分为3个阶段：阶段A接受不含化疗的新型药物（降阶治疗），如果达到“预测残存肿瘤负荷（preRCB）”，则提前进行手术，达不到preRCB则进入阶段B。阶段B会根据疗效预测亚型（RPS），在原有新型药物基础上联合紫杉（第一次升阶梯治疗），同样达到preRCB则可手术，否则进入阶段C。阶段C则进行第二次升阶梯治疗，联合多柔比星和环磷酰胺（AC）进行挽救性化疗。 2024 ASCO大会报道的I-SPY 2.2研究，把目光聚焦在Dato-DXd之上。阶段A分别探讨了Dato-DXd单药或者+度伐利尤单抗新辅助治疗的疗效和安全性，其中Dato-DXd单药队列的103例患者中有33例（32%）提前手术；Dato-DXd＋度伐利尤单抗队列的106例患者中有35例（33%）提前手术。在Dato-DXd＋度伐利尤单抗的新辅助治疗中，免疫标志物阳性（Immune+）患者的pCR率达到了43%（20/47），模型pCR率（Modeled Rate）则高达65%，均超过阈值（40%）。此外，TNBC患者的pCR率和模型pCR率也分别达到了33%和44%[1]。图1. I-SPY 2.2研究Dato-DXd＋Durva队列的pCR结果 2024 ESMO大会数据显示，106例患者在2022年9月至2023年8月期间随机接受了Dato-DXd+度伐利尤单抗治疗。在Block A结束后，42名手术，64名进入Block B。在Block B结束后，39名手术，25名进入Block C。整个治疗阶段（包括Block A-C）观察到53名患者达到pCR（50%）。pCR在Block A、B和C后分别实现的比例为47.1%、41.5%和11.3%。15名患者从Block A早期转至B；4名从Block B早期转至C。Dato-DXd+度伐利尤单抗治疗策略在HER2−/免疫+亚型中“毕业”，模型预测pCR率为65%，超过阈值（40%）的概率达到99%。在HER2−/免疫+亚型的47名参与者中，20名达pCR。该用药组合未在其他RPS或亚型中“毕业”[2]。图2. Dato-DXd联合度伐利尤单抗组中患者获得pCR的治疗节点抗HER2 ADC药物入局HER2阳性乳腺癌新辅助治疗 FASCINATE-N研究是由复旦大学附属肿瘤医院邵志敏教授牵头，针对早期和局部晚期患者，基于“复旦分型”指导下的精准新辅助治疗平台型临床研究，共分为HR+/HER2-（SNF）、TN（FUSCC）、HER2+三个队列，旨在评估基于乳腺癌亚型的治疗疗效，并通过贝叶斯监测方法评估各亚型乳腺癌新辅助治疗的疗效。 HER2+队列265例患者按1:1:1随机分配至SHR-A1811单药组（n=87）、SHR-A1811+吡咯替尼组（n=88）和白蛋白结合型紫杉醇+卡铂+HP（PCbHP）组（n=90），分别接受8周期、8周期和6周期的新辅助治疗。主要研究终点是意向治疗（ITT）人群的pCR，次要终点包括客观缓解率（ORR）、侵袭性无病生存期（iDFS）、总生存期（OS）以及安全性。结果显示，SHR-A1811组、SHR-A1811联合吡咯替尼组和PCbHP组的pCR率没有显著差异。SHR-A1811组患者的pCR率为63.2%；SHR-A1811联合吡咯替尼组的pCR率为62.5%；而PCbHP组的pCR率为64.4%。安全性方面，SHR-A1811 单药组和 PCbHP 组 3/4 级不良反应占比分别为44.8%和38.8%，SHR-A1811单药组耐受性较好，因不良事件所致剂量减少、停药比例最低[3]。图3. 主要终点pCR数据针对HER2+早期乳腺癌新辅助治疗，既往TCbHP四药联合方案进一步升阶梯治疗的发展基本已达瓶颈：一方面加入其他药物的疗效提升充满不确定性；另一方面患者将难以耐受多药联合带来的不良事件。在此背景下，ADC是否能够替代或优化现有的化疗联合靶向治疗方案，新一代ADC药物相较于现有疗法的优势成为亟待解答的问题。DESTINY-Breast11研究被寄予厚望。在DESTINY-Breast11研究中，原计划的T-DXd单药治疗8个周期方案已停止，转而研究4个周期的T-DXd后序贯4个周期的曲妥珠单抗+帕妥珠单抗+紫杉类（THP）治疗对比剂量密集型AC方案（ddAC）后续贯THP治疗的疗效。期待结果正式公布，能充分证实T-DXd在HER2阳性早期乳腺癌新辅助治疗中的应用价值。图4. DESTINY-Breast11研究设计 HER3-DXd布局HR+/HER2-早期乳腺癌领域，开辟新辅助治疗新途径 HER3-DXd是一种首创HER3靶向ADC药物。SOLTI VALENTINE研究（NCT05569811）是一项平行、随机、非比较、开放标签研究，研究对象为可手术的II-III期高危（Ki67≥20%和/或高基因组风险）HR+/HER2-早期乳腺癌高风险患者，研究所采用的治疗方案为HER3-DXd±来曲唑或化疗组。该研究旨在评估HER3-DXd在单独使用或与来曲唑联合使用时，对高风险HR+/HER2-早期乳腺癌患者新辅助治疗的疗效和安全性。从2022.11-2023.9，共122例患者按2:2:1的比例随机分为：A组HER3-DXd 5.6mg/kg，每21天一次，共6个周期（n=50）；B组：HER3-DXd+来曲唑（n=48）；化疗组：使用4个周期的EC/AC，然后每周使用紫杉醇80mg/m2共12周（n=24）。主要终点是手术时的pCR率。结果显示：A组的pCR率为4.0%，B组为2.1%，C组为4.2%。ORR分别为70.0%、81.3%和70.8%。无论是单独使用还是与来曲唑联合应用，HER3-DXd的pCR率均达到了与标准化疗相似的水平，这一成果无疑为患者提供了治疗选择上的新视角。图5. 三组pCR率和ORR情况治疗中出现的≥3级不良事件（TEAEs）在HER3-DXd组中较少见（A组和B组分别为18.0%和16.7%），而化疗组为54.2%。A/B组中最常见的相关TEAEs为恶心（56%/72.9%）、脱发（52%/68.8%）、疲劳（50%/68.8%）和腹泻（42%/54.2%）[4]。三阴性乳腺癌：新辅助免疫治疗在早期TNBC的治疗作用更加确定，辅助免疫治疗仍需探索 TNBC新辅助免疫治疗证据进一步夯实免疫治疗是近年来TNBC治疗探索的热点。KEYNOTE-522研究前期数据显示，在新辅助治疗中，相较于仅化疗，联用帕博利珠单抗可显著提高pCR率和3年无事件生存（EFS）率。研究共入组了1174例患者，入组时间为2017.3-2018.9，患者按2:1的比例随机分配至两组,一组接受新辅助帕博利珠单抗200 mg每三周一次，另一组为安慰剂对照组，两组均同时接受4周期的紫杉醇联合卡铂化疗，随后是4周期的多柔比星或表柔比星联合环磷酰胺化疗。完成手术治疗后，患者继续接受9周期的辅助帕博利珠单抗或安慰剂治疗，直至疾病复发或出现不可耐受的毒性反应。双重主要终点为pCR率（ypT0/Tis ypN0）和EFS率。OS率是关键次要评估指标。在早期TNBC的许多临床研究中，虽然pCR率和EFS率可能有所提高，但在OS率方面往往组间无显著差异。然而，KEYNOTE-522研究却打破了这一常规。在2024年ESMO会议中，KEYNOTE-522研究首次公布了OS数据，截止至2024.3.22，中位随访时间为75.1个月, 帕博利珠单抗组和安慰剂组的5年OS率分别为86.6%和81.7%（P=0.002）。OS率结果从81.7%提高至86.6%，绝对值提高了近5%，且HR值为0.66，P值为0.0015，具有显著统计学意义。这一结果意味着，早期TNBC患者接受化疗联合免疫治疗，不仅能显著提高pCR率和EFS率，还能显著延长总生存期[5]。图6. KEYNOTE-522研究OS数据 2024 SABCS大会报告了KEYNOTE-522研究探索性生物标志物分析。这项探索性生物标志物分析的主要终点是评估肿瘤突变负荷（TMB）、T细胞炎症基因表达谱（TcellinfGEP）以及一组非T细胞炎症共识特征，包括：单核性骨髓来源抑制性细胞（mMDSC）；粒细胞性髓系抑制细胞（gMDSC）；血管生成；基质/上皮-间质转化（EMT）/TGFβ；糖酵解；缺氧；MYC；增殖；RAS；WNT，与pCR和EFS的关联。并通过全外显子测序（WES）评估TMB，通过RNA测序（RNAseq）评估TcellinfGEP和非TcellinfGEP共识特征。结果显示，TcellinfGEP与pCR和EFS在帕博利珠单抗+化疗和安慰剂+化疗两组中均呈正相关（P≤0.001）。TMB在帕博利珠单抗+化疗组中与pCR和EFS有明显关联（P≤0.001），但在安慰剂+化疗组中则无此关联（P=0.011，pCR；P=0.422，EFS）。在非TcellinfGEP共识特征中，增殖和糖酵解对pCR有积极预测作用，但对EFS则无。探索性分析揭示了TNBC新辅助/辅助免疫治疗中的预后预测意义，这可能对未来旨在提高免疫疗法效果的研究设计具有重要意义[6]。此外，2024 SABCS大会上报道了CamRelief研究，显示卡瑞利珠单抗联合化疗新辅助治疗为TNBC患者带来治疗新希望。研究共入组441例中国患者，随机分至卡瑞利珠单抗联合化疗组（n=222）及安慰剂联合化疗组（n=219）。主要终点为pCR率。在所有患者中，卡瑞利珠单抗组pCR率较安慰剂组显著提升12.2%（单侧P=0.0038）。该研究结果同步发表在JAMA期刊上。图7. 三阴性乳腺癌中新辅助免疫治疗数据汇总（一）图8. 三阴性乳腺癌中新辅助免疫治疗数据汇总（二）免疫治疗应用在术后辅助治疗阶段是否仍有作用？ 2024年ASCO大会报告了A-BRAVE研究，该研究在高风险TNBC患者中进行了辅助单药免疫治疗的探索，这些患者均接受过蒽环类和紫杉烷类化疗。研究将474名患者随机分为两组，一组接受一年的Avelumab治疗，另一组为观察组。研究的主要终点为无病生存期（DFS），次要终点为OS。结果显示，在中位随访近五年的ITT人群中，尽管3年DFS率 Avelumab组较对照组提升5.1%，HR值为0.81，但并没有统计学显著改善。然而，OS获得显著改善，绝对获益为8.5%，风险比为0.66[7]。同时，远处无病生存期（DDFS）也有所改善，这表明OS的改善有可能由远处复发事件驱动。尽管辅助单药免疫治疗没有改善DFS，但在ITT人群中，OS显示出积极信号。因此，对于高风险TNBC患者，建议术前免疫治疗联合化疗的新辅助治疗，并在术后提供个体化的系统治疗。A-BRAVE研究的数据尚不足以支持在术后环境中单独使用免疫治疗，未来研究需要进一步确认术后单药免疫治疗的潜在作用。图9. A-BRAVE研究结果 TNBC新辅助治疗是否可在特定人群中考虑化疗降阶梯？化疗联合免疫治疗的毒副作用较大，在精准化治疗的背景下，对于特定患者是否可以考虑化疗降阶梯？目前尚缺乏单独使用免疫药物治疗TNBC患者的pCR率数据。高肿瘤浸润淋巴细胞（TILs）的TNBC即使去化疗治疗仍有较好的预后，因此适合进行降阶试验。 II期BELLINI平台试验的既往队列显示，去化疗的免疫治疗可激活免疫系统。2024 ESMO大会中报告了两个新的非随机队列（队列C、队列D），评估了双免联合方案短程新辅助治疗高TILsTNBC患者的疗效。此研究首次对高TILs TNBC患者进行了去化疗，是短期新辅助免疫疗法的探索性临床试验。 I-II期、淋巴结阴性、TILs≥50%的TNBC患者在手术前接受6周纳武利尤单抗+伊匹木单抗或8周纳武利尤单抗+Relatlimab（抗LAG3）治疗。在纳武利尤单抗+Relatlimab组中，6周时影像学无缓解者进行新辅助化疗，并视为无缓解。主要研究终点为pCR。次要终点包括主要病理缓解（MPR，残余活性肿瘤≤10%）、通过MRI评估的影像学缓解率和安全性。在纳武利尤单抗+伊匹木单抗组中，5例患者达到pCR（33%），8例患者达到MPR（53%）。在纳武利尤单抗+Relatlimab组中，7例患者达到pCR（47%），11例患者达到MPR（73%）。8例（26.7%）患者出现3-4级不良事件，其中6例接受了纳武利尤单抗+伊匹木单抗治疗。基于此结果有必要进一步探索去化疗免疫疗法治疗免疫原性TNBC的疗效和安全性[8]。图10. BELLINI研究结果 HR+乳腺癌中，辅助强化治疗方案或迎来进一步优化早期乳腺癌的治疗目标是治愈，但仍有许多HR+/HER2-早期乳腺癌患者即便接受了传统辅助治疗仍会复发转移，进展为不可治愈的疾病。随着内分泌治疗理念与辅助强化治疗探索的不断深入，HR+/HER2-早期乳腺癌的预后已获得了明显改善，但仍未能满足临床需求，治疗策略需要进一步优化。monarchE研究是探索HR+早期乳腺癌在内分泌治疗基础上联合CDK4/6抑制剂的重要临床研究之一，其取得了阳性结果。在HR+乳腺癌中，ctDNA作为术后复发风险的生物标志物，其预测和治疗的潜力如何？ 2024年ASCO会议，报道了MonarchE中的ctDNA预后标志物的价值。MonarchE研究是一项前瞻性随机试验，针对高风险淋巴结阳性乳腺癌患者。患者接受为期两年的阿贝西利联合内分泌治疗或单独内分泌治疗。总共有5637名患者参与，分析队列包括910名患者，对高风险淋巴结阳性患者在基线、3个月、6个月和24个月时进行了ctDNA检测。结果表明，基线ctDNA阳性与复发风险增加有关（红线），提前约12个月可预测复发。清除ctDNA的患者预后改善（深蓝线）。ctDNA阳性是复发风险的预后指标，而ctDNA的清除可能预示着治疗的潜在获益。然而，目前尚无证据表明在早期乳腺癌中使用ctDNA检测能改善生存率。因此，需要进一步研究以优化治疗策略和确定最佳的ctDNA评估时间[9]。图11. MonarchE研究ctDNA预后结果在更广泛复发风险人群中CDK4/6抑制剂辅助强化是否能带来显著的疗效？从研究入组人群上看，monarchE研究仅纳入了淋巴结阳性、高复发风险的HR+/HER2-早期乳腺癌，排除了多数II期患者和III期N0疾病患者。与之相比，NATALEE研究则纳入了更广泛的II期和III期患者，包括N2+,全部N1患者和N0伴有高危因素患者，为中高危复发风险的HR+/HER2-早期乳腺癌强化辅助治疗带来了新的选择。 2024年ESMO会议公布了NATALEE研究4年的随访数据。该研究入组了中高风险的II期和所有的III期HR+/HER2-早期乳腺癌患者，试验组是瑞波西利3年+芳香化酶抑制剂（AI），对照组则是AI单药，首要研究终点是iDFS。4年随访研究结果显示，中位随访44.2个月后，瑞波西利组和对照组的4年iDFS率绝对获益为4.9%（88.5% vs 83.6%，HR=0.715，P＜0.0001），这意味着瑞波西利强化辅助治疗带来的iDFS绝对获益进一步扩大，从3年的2.7%扩大到4年的4.9%；并且从复发事件可以看出，瑞波西利强化辅助治疗的作用最主要体现在降低远处转移事件。图12. NATALEE研究ITT人群4年iDFS绝对获益（4.9%）同时，在II期、III期、N0和N1-3等亚组患者中，4年iDFS结果均观察到一致的获益趋势。II期亚组患者的4年iDFS绝对获益可提高4.3%，伴有高危因素的N0亚组患者可提高5.1%。在与monarchE研究重叠度较高的III期和N1-3亚组人群中，NATALEE研究也分别取得了5.9%和5.0%的iDFS绝对获益提升[10]。总之，NATALEE研究中所有II-III期的N1患者、N0伴高危因素患者及N2+患者均有一致获益，弥补了monarchE研究覆盖人群的局限性。并且4年随访数据的公布，证实了瑞波西利强化辅助治疗获益的再次提升，为更多HR+/HER2-早期乳腺癌患者提供了治愈的机会。总结 2024年早期乳腺癌新辅助及辅助治疗领域取得了重要进展。ADC药物在新辅助治疗中展现出潜力，为乳腺癌患者带来新希望。免疫治疗在早期TNBC中取得显著成就，如KEYNOTE-522研究显示了帕博利珠单抗联合化疗的积极效果，尤其在总生存期方面取得突破。未来，需要进一步探索免疫治疗在术后辅助治疗阶段的作用，以及化疗降阶梯在特定人群中的应用。随着生物标志物的研究不断深入，将有助于优化治疗策略并提高患者的生存率。在未来，不断探索新的治疗策略和个性化治疗方案将是重要的研究方向，以提供更有效的乳腺癌治疗方案。专家简介韩国晖主任医师硕士生导师山西省肿瘤医院乳腺外科副主任（主持工作）中国抗癌协会乳腺癌专业委员会委员中国临床肿瘤学会（CSCO）乳腺癌专委会委员中国医药教育协会乳腺疾病专业委员会常务委员中国医疗保健国际交流促进会乳腺疾病分会委员山西省老年健康学会乳腺疾病专委会主任委员山西省抗癌协会第六届理事会理事山西省抗癌协会乳腺癌专业委员会副主任委员山西省乳腺癌质量控制专家委员会副主任委员山西省医学会肿瘤分会委员山西省医师协会乳腺医师分会副会长山西省乳腺肿瘤专科联盟副理事长山西省抗癌协会乳腺癌专委会青委会主任委员北京乳腺病防治学会青委会副主任委员参考文献： [1] Rebecca Arielle Shatsky , Meghna S. Trivedi , Coral Oghenerukevwe Omene et al. Rates of pathologic complete response (pCR) after datopotamab deruxtecan (Dato) plus durvalumab (Durva) in the neoadjuvant setting: Results from the I-SPY2.2 trial. 2024 ASCO LBA501 [2] Trivedi MS, Shatsky RA, Nanda R, et al.Rates of pathologic complete response (pCR) after datopotamab deruxtecan (Dato) plus durvalumab (Durva) treatment strategy in the neoadjuvant setting: Results from the I-SPY 2.2 trial. 2024 ESMO.Abstract LBA15. [3] Jun-Jie Li; Zhong-Hua Wang; Li Chen et al. HER2-Directed Antibody-Drug Conjugate SHR-A1811 in the Neoadjuvant Treatment of HER2-positive Early Breast Cancer: a Prospective, Randomized, Open-label, Phase 2 Trial. 2024 SABCS GS1-04. [4] Tomás Pascual, Kepa Amillano Parraga, Javier Salvador Bofill et al. Primary results of SOLTI VALENTINE: neoadjuvant randomized phase II trial of HER3-DXd alone or in combination with letrozole for high-risk hormone receptor positive (HR+)/HER2-negative (neg) early breast cancer (EBC). 2024 SABCS LB1-06. [5] P. Schmid, J. Cortés, R.A. Dent et al. Neoadjuvant pembrolizumab or placebo plus chemotherapy followed by adjuvant pembrolizumab or placebo for high-risk early-stage TNBC: Overall survival results from the phase III KEYNOTE-522 study. 2024 ESMO LBA4. [6] Joyce O’Shaughnessy, Javier Cortes, Rebecca Dent el al. Exploratory Biomarker Analysis of the Phase 3 KEYNOTE-522 Study of Neoadjuvant Pembrolizumab or Placebo Plus Chemotherapy Followed by Adjuvant Pembrolizumab or Placebo for Early-Stage TNBC. 2024 SABCS LB1-07. [7] Pier Franco Conte , Maria Vittoria Dieci , Giancarlo Bisagni et al. A-BRAVE trial: A phase III randomized trial with avelumab in early triple-negative breast cancer with residual disease after neoadjuvant chemotherapy or at high risk after primary surgery and adjuvant chemotherapy. 2024 ASCO LBA500. [8] I. Nederlof, A.L. Rolfes, R.C.A.M. Gielen et al. Neoadjuvant nivolumab/relatlimab or nivolumab/ipilimumab in triple negative breast cancer with high tumor-infiltrating lymphocytes (TILs). 2024 ESMO LBA11 [9] Sherene Loi , Stephen R. D. Johnston , Carlos L. Arteaga et al. Prognostic utility of ctDNA detection in the monarchE trial of adjuvant abemaciclib plus endocrine therapy (ET) in HR+, HER2-, node-positive, high-risk early breast cancer (EBC). 2024 ASCO LBA507. [10] P.A. Fasching, D. Stroyakovskiy, D. Yardley et al. Adjuvant ribociclib (RIB) plus nonsteroidal aromatase inhibitor (NSAI) in patients (Pts) with HR+/HER2− early breast cancer (EBC): 4-year outcomes from the NATALEE trial. 2024 ESMO LBA13. 识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

抗体药物偶联物ASCO会议临床结果免疫疗法

100 项与阿维单抗相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D10817	阿维单抗	L01XC31	DB11945

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
肾细胞癌	澳大利亚	Merck Healthcare Pty Ltd.	2018-01-03
晚期肾细胞癌	欧盟	Merck Europe BV	2017-09-18
晚期肾细胞癌	冰岛	Merck Europe BV	2017-09-18
晚期肾细胞癌	列支敦士登	Merck Europe BV	2017-09-18
晚期肾细胞癌	挪威	Merck Europe BV	2017-09-18
局部晚期尿路上皮癌	欧盟	Merck Europe BV	2017-09-18
局部晚期尿路上皮癌	冰岛	Merck Europe BV	2017-09-18
局部晚期尿路上皮癌	列支敦士登	Merck Europe BV	2017-09-18
局部晚期尿路上皮癌	挪威	Merck Europe BV	2017-09-18
转移性Merkel细胞癌	欧盟	Merck Europe BV	2017-09-18
转移性Merkel细胞癌	冰岛	Merck Europe BV	2017-09-18
转移性Merkel细胞癌	列支敦士登	Merck Europe BV	2017-09-18
转移性Merkel细胞癌	挪威	Merck Europe BV	2017-09-18
转移性尿路上皮癌	欧盟	Merck Europe BV	2017-09-18
转移性尿路上皮癌	冰岛	Merck Europe BV	2017-09-18
转移性尿路上皮癌	列支敦士登	Merck Europe BV	2017-09-18
转移性尿路上皮癌	挪威	Merck Europe BV	2017-09-18
尿路上皮癌	美国	EMD Serono, Inc.	2017-05-09
梅克尔细胞癌	美国	EMD Serono, Inc.	2017-03-23

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
晚期癌症	临床3期	美国	Pfizer Inc.	2021-09-29
晚期癌症	临床3期	日本	Pfizer Inc.	2021-09-29
晚期癌症	临床3期	澳大利亚	Pfizer Inc.	2021-09-29
晚期癌症	临床3期	比利时	Pfizer Inc.	2021-09-29
晚期癌症	临床3期	加拿大	Pfizer Inc.	2021-09-29
晚期癌症	临床3期	丹麦	Pfizer Inc.	2021-09-29
晚期癌症	临床3期	法国	Pfizer Inc.	2021-09-29
晚期癌症	临床3期	匈牙利	Pfizer Inc.	2021-09-29
晚期癌症	临床3期	以色列	Pfizer Inc.	2021-09-29
晚期癌症	临床3期	意大利	Pfizer Inc.	2021-09-29

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


NCT04068831 (CTgov)	临床2期	转移性肾细胞癌 \| 富马酸水合酶缺乏型肾细胞癌 \| 线粒体复合体II缺乏	18	Avelumab+Talazoparib (Talazoparib and Avelumab (VHL-deficiency) (Closed to Accrual))	鑰築糧夢衊膚膚蓋壓衊(範構願製築顧餘齋窪鏇) = 願積製願顧齋遞襯憲選鑰廠遞構鏇遞鹽衊積憲 (廠選鬱膚築糧鏇選糧衊, 膚選糧範襯構積壓鬱壓 ~ 鹽壓齋繭繭衊鹹繭鏇繭) 更多	-	2024-12-27
				Avelumab+Talazoparib (Talazoparib and Avelumab (FH- or SDH-deficiency))	鑰築糧夢衊膚膚蓋壓衊(範構願製築顧餘齋窪鏇) = 夢醖齋構窪淵選夢衊餘鑰廠遞構鏇遞鹽衊積憲 (廠選鬱膚築糧鏇選糧衊, 醖製築襯範網範膚艱鏇 ~ 繭鏇鬱獵淵製憲壓積窪) 更多
AVePEm (ESMO_IO2024) 人工标引	N/A	晚期尿路上皮癌维持 \| 二线	30	Avelumab	獵憲夢願蓋鹽壓鹹淵網(築壓鏇醖衊糧構襯願衊) = 鏇壓夢觸繭繭膚醖獵鹽構窪積襯積製簾製獵鏇 (廠衊積鬱簾夢鑰餘選簾 ) 更多	相似	2024-12-12
				Pembrolizumab	獵憲夢願蓋鹽壓鹹淵網(築壓鏇醖衊糧構襯願衊) = 網簾蓋築顧齋襯遞鹹簾構窪積襯積製簾製獵鏇 (廠衊積鬱簾夢鑰餘選簾 ) 更多
NCT03563157 (CTgov)	临床1/2期	转移性结直肠癌	2	SBRT+Aldoxorubicin Hydrochloride+GI-6301+GI-4000+ETBX-061+Cetuximab+ETBX-051+Leucovorin+ETBX-011+5-Fluorouracil+ALT-803+ETBX-021+nab-paclitaxel+CYCLOPHOSPHAMIDE+Avelumab+haNK+GI-6207+Regorafenib+Oxaliplatin+Capecitabine (NANT Colorectal Cancer (CRC) Vaccine)	繭窪構構衊憲構願遞鹽(遞網繭醖製廠觸願憲餘) = 築願膚築構觸選淵窪獵餘鹹願鑰憲憲簾襯製獵 (廠簾廠製製鏇觸鏇糧簾, 衊鹽製遞構積積餘醖簾 ~ 築鏇願鹹鹽簾獵範餘鏇) 更多	-	2024-12-11
				Regorafenib (Regorafenib)	壓鏇窪積簾遞廠獵糧簾(窪衊艱構襯願製鑰膚廠) = 淵壓構觸衊網壓膚積壓夢糧鑰觸網網廠膚範簾 (遞鑰膚鹹積膚鬱夢積膚, 淵製壓襯襯襯積觸襯膚 ~ 憲艱鹹衊鑰網積憲繭積) 更多
NCT02684006 (JAVELIN Renal 101, ESMO_ASIA2024)	临床3期	晚期肾细胞癌一线	-	Avelumab + axitinib	壓顧廠獵襯觸網膚夢齋(鬱糧獵齋獵窪夢選範獵) = results did not reach statistical significance 遞簾醖壓夢鹽選餘膚繭 (鬱廠糧網範鏇醖鹹簾醖 )	积极	2024-12-07
NCT02684006 (JAVELIN renal 101, ESMO_ASIA2024)	临床3期	晚期肾细胞癌一线 IMDC risk factors	-	Avelumab + Axitinib	積衊壓壓積遞簾衊範糧(齋積願鹹壓鹽齋積衊餘) = 艱壓鏇築願齋蓋繭遞衊鏇膚築憲鹽鹽糧窪鬱選 (選餘衊壓襯鹹蓋醖範鑰 )	积极	2024-12-07
				Sunitinib	積衊壓壓積遞簾衊範糧(齋積願鹹壓鹽齋積衊餘) = 顧蓋網獵築網膚製窪蓋鏇膚築憲鹽鹽糧窪鬱選 (選餘衊壓襯鹹蓋醖範鑰 )
NCT02603432 (JAVELIN Bladder 100, ESMO_ASIA2024)	临床3期	晚期尿路上皮癌维持	453	Avelumab maintenance therapy	繭廠簾齋餘遞淵願膚醖(廠簾顧艱糧餘鬱餘窪遞) = 簾範醖築鏇簾選範窪遞網繭築選廠選網窪顧鑰 (淵廠廠範齋襯築鏇範顧, 73.7% ~ 81.5) 更多	积极	2024-12-07
				Avelumab (Age ≤64 years)	繭廠簾齋餘遞淵願膚醖(廠簾顧艱糧餘鬱餘窪遞) = 鹽築廠簾壓網壓艱鏇簾網繭築選廠選網窪顧鑰 (淵廠廠範齋襯築鏇範顧, 66.1% ~ 85.6)
NCT02684006 (JAVELIN RENAL 101, CTgov)	临床3期	晚期肾细胞癌	886	Sunitinib	醖願蓋簾糧積顧夢鬱鹹(憲鏇觸築膚製選鹽鹹製) = 繭積製獵鹹簾鏇築鏇鹽糧衊壓餘衊廠繭憲廠鑰 (憲衊獵憲獵鑰築餘網襯, 積醖衊鏇糧鏇鏇簾簾艱 ~ 築鏇鏇製選簾願壓遞糧) 更多	-	2024-10-29
NCT02994953 (COMBO \| JAVELIN IL-12, CTgov)	临床1期	局部晚期恶性实体瘤	52	Avelumab+M9241 (Part A Cohort 1: M9241 4 mcg/kg + Avelumab 10 mg/kg)	範選築鹹蓋鑰築鏇蓋範(鑰膚積憲網顧淵壓蓋觸) = 獵選願鹽鑰鑰憲製簾淵窪積鏇糧窪夢製築憲繭 (夢顧膚衊醖廠艱積醖廠, 衊鹽蓋襯窪夢鹹襯衊窪 ~ 積構廠選襯艱選齋糧廠) 更多	-	2024-09-20
				Avelumab+M9241 (Part A Cohort 2: M9241 8 mcg/kg + Avelumab 10 mg/kg)	範選築鹹蓋鑰築鏇蓋範(鑰膚積憲網顧淵壓蓋觸) = 夢憲築壓蓋觸醖廠積鹹窪積鏇糧窪夢製築憲繭 (夢顧膚衊醖廠艱積醖廠, 鹹鹽襯夢窪夢獵遞齋廠 ~ 觸餘範鏇簾鑰夢鹹繭壓) 更多
EUCTR2020-001105-24-FR (GETUG-TALASUR, ESMO2024) 人工标引	临床2期	转移性尿路上皮癌维持	47	Talazoparib Avelumab	醖壓鬱觸鑰襯夢衊襯齋(願範齋簾餘繭願糧獵網) = 餘蓋鏇鬱淵築築糧鏇廠鏇鹹淵餘獵憲選艱餘膚 (鹽窪選廠獵鹹廠範積艱, 3.7 ~ 9.1) 更多	不佳	2024-09-15
NCT02603432 (JAVELIN Bladder 100, ESMO2024) 人工标引	临床3期	晚期尿路上皮癌一线 \| 维持	350	Avelumab + Best Supportive Care	鬱餘築窪鏇築糧艱餘繭(簾糧觸衊廠廠繭夢蓋襯) = Among pts treated for ≥1 or ≥2 years, any-grade treatment-related adverse events (TRAEs) occurred after ≥1 year in 50.0% and after ≥2 years in 35.3%; grade ≥3 TRAEs occurred in 11.9% and 5.9%, respectively. 範淵鬱衊窪壓衊選觸糧 (廠襯壓鬱壓獵蓋鹹齋蓋 ) 更多	积极	2024-09-15