Phase III Double Blinded Trial of Immune-Based Therapy With a Live Biotherapeutic MO-03 or Placebo for Frontline Therapy of Advanced Clear Cell Renal Cell Carcinoma [BioFront Trial]

This phase III trial compares the effect of adding live biotherapy, MO-03, to standard of care (SOC) immunotherapy, including ipilimumab, nivolumab, axitinib, pembrolizumab, cabozantinib, and lenvatinib, to SOC immunotherapy alone in treating patients with clear cell renal cell cancer that may have spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started to other places in the body (metastatic). Studies have shown that gut health (the gut microbiome) may impact the effectiveness of immunotherapy. The microbiome includes all of the bacteria and organisms naturally found in the digestive tract. MO-03, a type of biotherapy, contains material from living organisms that may help keep the digestive tract healthy and may help to increase the effect of immunotherapy. Immunotherapy with monoclonal antibodies, such as ipilimumab, nivolumab, pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Axitinib, cabozantinib, and lenvatinib are a type of angiogenesis inhibitor and tyrosine kinase inhibitor (TKI) that block certain proteins which may help keep tumor cells from growing and may also help prevent the growth of new blood vessels that tumors need to grow. Adding MO-03 to SOC immunotherapy may be more effective than SOC immunotherapy alone in treating patients with advanced or metastatic clear cell renal cell cancer.

开始日期2026-06-10

申办/合作机构

SWOG

[+1]

NCT07500831

/ Not yet recruitingN/AIIT

Fasting-Mimicking Diet Combined With Toripalimab Plus Axitinib for Metastatic or Unresectable Renal Cell Carcinoma: A Single-Arm, Open-Label, Single-Center Clinical Trial

This study is testing whether adding a 5-day fasting-mimicking diet (FMD) can help people with advanced kidney cancer when given together with standard first-line cancer medicines.

开始日期2026-04-01

申办/合作机构

山东大学齐鲁医院

NCT07516132

/ Not yet recruiting临床3期

A Phase 3b, Multicenter, Open-Label, Extension Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants With Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study

Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants with Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study

开始日期2026-04-01

申办/合作机构

Ocular Therapeutix, Inc.

[+1]

100 项与阿昔替尼相关的临床结果

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100 项与阿昔替尼相关的转化医学

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100 项与阿昔替尼相关的专利（医药）

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2,271

项与阿昔替尼相关的文献（医药）

2026-12-01·CURRENT TREATMENT OPTIONS IN ONCOLOGY

Systemic Therapy for Salivary Gland Cancers: A Review of Targeted and Chemotherapeutic Approaches

Review

作者: Chintakuntlawar, Ashish ; Hintze, Justin M

OPINION STATEMENT:

Systemic therapy for recurrent and metastatic salivary gland malignancies (SGMs) remains a major therapeutic challenge. Traditional chemotherapy offers modest response rates with limited durability, and its role is largely palliative. The most meaningful advances have occurred in biomarker-selected subgroups: androgen receptor blockade for AR-positive salivary duct carcinoma and HER2-directed therapy for HER2-positive tumors have demonstrated superior response rates and survival (often exceeding 50%), compared with the single digit response rates seen with unselected chemotherapy or tyrosine kinase inhibitors. Small-molecule tyrosine kinase inhibitors such as lenvatinib and axitinib may provide disease stabilization in adenoid cystic carcinoma, although tumor shrinkage is uncommon and toxicity limits their long-term use. Immunotherapy as a single agent has been disappointing, but durable responses in select patients and modest activity with combination regimens suggest it may have a future role when rationally paired with other agents. In our practice, comprehensive molecular profiling is essential at the time of recurrence to identify actionable alterations, prioritize targeted therapy where available, and guide clinical trial enrollment. For most patients without a targetable alteration, platinum-based combinations remain the pragmatic choice, though expectations for benefit should be tempered. Future strategies will likely hinge on optimizing biomarker-driven therapies, expanding access to antibody-drug conjugates, and pursuing collaborative trial designs to overcome the rarity and heterogeneity of these tumors.

2026-05-01·CURRENT OPINION IN ONCOLOGY

Unclear territory: navigating metastatic nonclear cell renal cell carcinoma

Review

作者: Singer, Eric A. ; Montenegro, Gabriela Bravo ; Goodstein, Taylor ; Wong, Vivian ; Srinivasan, Ramaprasad

Purpose of review:

To summarize recent updates in the classification, clinical trial evidence, and evolving treatment strategies for nonclear cell renal cell carcinoma (nccRCC).

Recent findings:

The 2022 WHO classification eliminated the type 1/2 papillary paradigm, refined molecularly defined tumors such as fumarate hydratase (FH)-deficient and anaplastic lymphoma kinase-rearranged RCC, while acknowledging indolent tumors like clear cell papillary renal cell tumors. Prospective and retrospective data increasingly support the use of immune checkpoint inhibitor (ICI)-based regimens, particularly ICI/ tyrosine kinase inhibitor (TKI) combinations. KEYNOTE-B61 and ARON-1 demonstrated consistent activity of pembrolizumab + lenvatinib across nccRCC subtypes, while the randomized SUNNIFORECAST trial validated ipilimumab + nivolumab as a first-line option with overall survival (OS) benefit over standard therapy. Subtype-specific approaches are also emerging: bevacizumab + erlotinib and sintilimab + axitinib showed high response rates in FH-deficient RCC, and prognostic tools such as VENUSS remain valuable for papillary RCC risk stratification. Despite progress, many studies remain limited by histologic heterogeneity and small sample sizes. Multiple ongoing trials, including ICONIC, SAMETA, and PAPMET2, are expected to further clarify optimal management strategies in 2026.

Summary:

Therapeutic advances are reshaping the management of nccRCC, with IO/TKI regimens and histology-specific therapies showing promise. Continued integration of molecular classification, rare subtype–specific trials, and international collaboration will be essential to establish evidence-based treatment standards for this diverse and understudied population.

2026-05-01·CURRENT OPINION IN OPHTHALMOLOGY

Emerging solutions for neovascular age-related macular degeneration

Review

作者: Wubben, Thomas J ; Franco, Jovany J

Purpose of review:

To summarize emerging therapeutic strategies for neovascular (wet) age-related macular degeneration (nAMD), with emphasis on recent translational and clinical developments.

Recent findings:

The nAMD treatment landscape is rapidly evolving. Gene therapies (e.g. ABBV-RGX-314, ADVM-022, and 4D-150) have demonstrated sustained intraocular anti-VEGF expression with reduced injection burden in phase 2 and 3 programs, validating the ‘biofactory’ concept. Tyrosine kinase inhibitors delivered via intravitreal or suprachoroidal implants (e.g. EYP-1901, OTX-TKI, and CLS-AX) show potential for twice-yearly or less frequent dosing. Moreover, emerging therapeutic approaches increasingly target non-VEGF pathogenic pathways, reflecting a shift toward mechanistically diverse vascular stabilization and neuroprotection strategies. These include multitargeted biologics that couple anti-angiogenic and anti-inflammatory effects (e.g. KSI-501, IBI-302, and AG-73305), as well as agents modulating FGF2 signaling, Wnt activation, complement regulation, and cellular metabolism.

Summary:

Therapeutic innovation in nAMD is transitioning from incremental refinements in intravitreal anti-VEGF delivery to strategies aimed at extending durability or targeting alternative contributory pathways. Long-term safety, efficacy, and durability will determine which of these candidates redefine standard care.

1,025

项与阿昔替尼相关的新闻（医药）

2026-04-28

·BioSpace

Ocular Therapeutix™ to Report First Quarter 2026 Financial Results on May 5, 2026

BEDFORD, Mass., April 28, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced that it plans to host a conference call and webcast on Tuesday, May 5, 2026 at 8:00 AM ET to discuss recent business progress and financial results for the first quarter ended March 31, 2026. Conference Call and Webcast Information : Date: Tuesday, May 5, 2026 at 8:00 AM ET Participant Dial-In (U.S.): 1-800-343-4136 Participant Dial-In (International): 1-203-518-9843 Conference ID: OCULAR (required for entry) Webcast Access: Please click here The live and archived webcast can also be accessed by visiting the Ocular Therapeutix website on the Events and Presentations section of the Investor Relations page. A replay of the webcasts will be archived for at least 30 days following the presentation. About Ocular Therapeutix, Inc. Ocular Therapeutix, Inc. is an integrated biopharmaceutical company committed to redefining the retina experience. AXPAXLI™ (also known as OTX-TKI), Ocular’s investigational product candidate for retinal disease, is an axitinib intravitreal hydrogel based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD), and diabetic retinal disease, including non-proliferative diabetic retinopathy (NPDR). Ocular’s pipeline also leverages the ELUTYX technology in its commercial product DEXTENZA ® , an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients and ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged two years or older, and in its investigational product candidate OTX-TIC, which is a travoprost intracameral hydrogel that has completed a Phase 2 clinical trial for the treatment of open-angle glaucoma or ocular hypertension. Ocular is currently evaluating next steps for the OTX-TIC program. Follow the Company on its website, LinkedIn, or X. DEXTENZA ® is a registered trademark of Ocular Therapeutix, Inc. The Ocular Therapeutix logo, AXPAXLI™, ELUTYX™, and Ocular Therapeutix™ are trademarks of Ocular Therapeutix, Inc. Investors & Media Ocular Therapeutix, Inc. Bill Slattery Vice President, Investor Relations bslattery@ocutx.com

临床3期临床2期财报上市批准

2026-04-27

·BioSpace

Ocular Therapeutix™ to Participate in May Scientific and Investor Conferences

BEDFORD, Mass., April 27, 2026 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ: OCUL, “Ocular”), an integrated biopharmaceutical company committed to redefining the retina experience, today announced participation in several upcoming scientific and investor conferences in May 2026. Upcoming Investor Conferences : Bank of America Health Care Conference 2026 : Date: Tuesday, May 12, 2026 Fireside Chat: 3:40 – 4:10 PM PDT Presenter: Pravin U. Dugel, MD, Executive Chairman, President and CEO Location: Las Vegas, NV Stifel 2026 Virtual Ophthalmology Forum : Date: Tuesday, May 26, 2026 Fireside Chat: 2:30 – 2:55 PM EDT Presenter: Pravin U. Dugel, MD, Executive Chairman, President and CEO Location: Virtual A live webcast of the Bank of America and Stifel fireside chats can be accessed by visiting the Ocular Therapeutix website on the Events and Presentations section of the Investor Relations page. A replay of the webcasts will be archived for at least 30 days following the presentation. Upcoming Scientific Conferences : Eyecelerator @ ARVO 2026: May 1, 2026 Denver, CO Presentation: Ocular Therapeutix: Retina Experience Redefined Presentation Date/Time: Friday, May 1, 2026, 2:18 – 2:23 PM MDT Presenter: Peter K. Kaiser, MD, Chief Development Officer at Ocular Therapeutix ARVO 2026 Annual Meeting : May 3 - 7, 2026 Denver, CO Presentation: Efficacy and Safety of Intravitreal Axitinib Hydrogel (OTX-TKI) in Neovascular Age-Related Macular Degeneration: Phase 3 SOL-1 Trial Results Presentation Date/Time: Tuesday, May 5, 2026, 1:15 – 1:30 PM MDT Presenter: Patricio G. Schlottmann, MD Poster Title: Real-World Anti-VEGF Treatment Utilization and Vision Outcomes in Neovascular Age-Related Macular Degeneration: Analysis of the Vestrum Database Session Date/Time: Thursday, May 7, 2026, 8:00 – 9:45 AM MDT Presenter: Andrew A. Moshfeghi, MD, MBA, FASRS Poster Title: Anti-VEGF Treatment Patterns and Long-Term Vision Outcomes in Patients with nAMD in the IRIS Registry Session Date/Time: Thursday, May 7, 2026, 8:00 – 9:45 AM MDT Presenter: Christina Y. Weng, MD, MBA Retina World Congress (RWC) 2026 : May 14 - 17, 2026 Fort Lauderdale, FL Presentation Title: Ocular Therapeutix: Retina Experience Redefined Presentation Date/Time: Thursday, May 14, 2026, 8:15 – 8:20 AM EDT Presenter: Peter K. Kaiser, MD, Chief Development Officer at Ocular Therapeutix Presentation Title: Update on Latest TKI data from the OTX-TKI program Presentation Date/Time: Friday, May 15, 2026, 4:30 – 4:35 PM EDT Presenter: Dilsher S. Dhoot, MD Symposium Title: Redefining the Management of nAMD: The Impact of Durability and Sustained Disease Control Symposium Date/Time: Friday, May 15, 2026, 7:15 – 8:15 PM EDT Presenters: Patricio G. Schlottmann, MD; Dilsher S. Dhoot, MD; Mark R. Barakat, MD The Royal College of Ophthalmologists Annual Congress 2026 : May 18 - 20, 2026 Manchester, UK Symposium Title: Redefining the Management of nAMD: The Impact of Durability and Sustained Disease Control Symposium Date/Time: Tuesday, May 19, 2026, 12:30 – 1:30 PM BST Presenters: Adnan Tufail, MBBS, MD, FRCOphth; Darius M. Moshfeghi, MD; Dilsher S. Dhoot, MD Exact medical conference presentation times may be subject to change. About Ocular Therapeutix, Inc. Ocular Therapeutix, Inc. is an integrated biopharmaceutical company committed to redefining the retina experience. AXPAXLI™ (also known as OTX-TKI), Ocular’s investigational product candidate for retinal disease, is an axitinib intravitreal hydrogel based on its ELUTYX™ proprietary bioresorbable hydrogel-based formulation technology. AXPAXLI is currently in Phase 3 clinical trials for wet age-related macular degeneration (wet AMD), and diabetic retinal disease, including non-proliferative diabetic retinopathy (NPDR). Ocular’s pipeline also leverages the ELUTYX technology in its commercial product DEXTENZA ® , an FDA-approved corticosteroid for the treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients and ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged two years or older, and in its investigational product candidate OTX-TIC, which is a travoprost intracameral hydrogel that has completed a Phase 2 clinical trial for the treatment of open-angle glaucoma or ocular hypertension. Ocular is currently evaluating next steps for the OTX-TIC program. Follow the Company on its website, LinkedIn, or X. DEXTENZA ® is a registered trademark of Ocular Therapeutix, Inc. The Ocular Therapeutix logo, AXPAXLI™, ELUTYX™, and Ocular Therapeutix™ are trademarks of Ocular Therapeutix, Inc. Investors & Media Ocular Therapeutix, Inc. Bill Slattery Vice President, Investor Relations bslattery@ocutx.com

临床3期临床2期上市批准

2026-04-24

·ioncology

瞭望前瞻丨ASCO泌尿肿瘤领域40余项口头报告（包括LBA）出炉，一起来看看今年有哪些重要进展？

点击上方蓝字关注我们编者按：2026年美国临床肿瘤学会年会（ASCO 2026）将于5月29日至6月2日在旧金山举行。作为全球肿瘤领域的顶尖学术盛会，本届会议汇聚了众多权威专家，分享了最新前沿进展。大会围绕前列腺癌、尿路上皮癌、肾癌等泌尿肿瘤领域公布了43项口头报告（含5项LBA），展示了该领域的最新突破。肿瘤瞭望-泌尿时讯特别整理（如有遗漏和错误，欢迎留言补充），以飨读者。 01 肾癌领域摘要号：4500 英文标题：A phase 2 randomized trial of radium-223 dichloride and cabozantinib in patients (pts) with renal cell carcinoma (RCC) with bone metastases (BM)：RADICAL (Alliance A031801). 中文标题：一项针对患有肾细胞癌骨转移患者的2期随机试验，研究了镭223和卡博替尼的疗效：RADICAL (Alliance A031801) 讲者：Rana R. McKay教授单位：UC San Diego Moores Cancer Center 摘要号：4501 英文标题：A prospective, mult -center, phase lb/II trial of first-line cadonilimab plus axitinib in advanced non-clear cell renal cell carcinoma 中文标题：一项前瞻性、多中心、I/II期临床试验，分析了卡度尼利单抗联合阿昔替尼一线治疗晚期非透明细胞肾细胞癌的疗效讲者：胡旭教授单位：四川大学华西医院摘要号：4502 英文标题：ctDNA analysis in participants with renal cell carcinoma treated with adjuvant pembrolizumab or placebo in the KEYNOTE-564 trial 中文标题：在KEYNOTE-564试验中，对接受帕博利珠单抗或安慰剂辅助治疗的肾细胞癌患者进行ctDNA分析讲者：Toni K. Choueiri教授单位：Dana-Farber Cancer Institute, Harvard Medical School 摘要号：LBA4511 英文标题：Durvalumab monotherapy versus active monitoring for resected primary renal cell carcinoma in RAMPART： An international, phase 3, randomized controlled trial. 中文标题：RAMPART研究：度伐利尤单抗单药治疗与主动监测治疗切除的原发性肾细胞癌：一项国际性3期随机对照试验讲者：James M. Larkin教授单位：The Royal Marsden NHS Foundation Trust 摘要号：4512 英文标题：Decision regret and toxicity perception following adjuvant pembrolizumab in renal cell carcinoma. 中文标题：肾细胞癌辅助治疗帕博利珠单抗后的决策后悔分析和毒性感知讲者：Elizabeth Nally教授单位：Barts Cancer Institute 摘要号：4519 英文标题：Microbial dysbiosis as predictor of beneftfrom CBM58s as an aduncto immune checkpoint blockade (CB)-based first line therapies in metastatic renal cell carcinoma (mRCC) 中文标题：微生物菌群失调作为转移性肾细胞癌一线免疫检查点阻断辅助疗法疗效的预测指标讲者：Rahul Winayak教授单位：City of Hope Comprehensive Cancer Center, Duarte, CA, Beth Israel Deaconess Medical Center 摘要号：4520 英文标题：Prospective clinical activity and preclinical basis of panitumumab-based EGFR blockade in SMARCB1-deficient renal medullary carcinoma (RMC)： A collaborative multi-institutional study. 中文标题：基于panitumumab的EGFR阻断治疗SMARCB1缺陷型肾髓质癌(RMC)的前瞻性临床活性和临床前基础：一项多机构合作研究讲者：Pavlos Msaouel教授单位：Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center 摘要号：4521 英文标题：Final results of a phase 2 trial of cabozantinib plus nivolumab (CaboNivo) in patients with non-clear cell renal cell carcinoma (nccRCC). 中文标题：卡博替尼联合纳武利尤单抗治疗非透明细胞肾细胞癌（nccRCC）患者的2期试验的最终结果讲者：Darren R. Feldman教授单位：Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College 02 尿路上皮癌领域摘要号：4503 英文标题：Intravesical recombinant BCG combined with chemo-immunotherapy (chemo-IO) as perioperative therapy for patients with muscle-invasive bladder cancer (MIBC)： Primary analysis of SAKK 06/19. 中文标题：膀胱内BCG联合化疗免疫疗法作为肌层浸润性膀胱癌患者的围手术期治疗策略：SAKK 06/19的初步分析讲者：Richard Cathomas教授单位：Division of Oncology, Cantonal Hospital Graubunden 摘要号：4504 英文标题：Feasibility and safety results from RAD-IO： A multi-stage trial of durvalumab with chemoradiotherapy with 5-fluorouracil and mitomycin C in patients with muscle-invasive bladder cancer. 中文标题：RAD-IO的可行性和安全性结果：一项多阶段试验，评估度伐利尤单抗联合5-氟尿嘧啶和丝裂霉素C化疗放疗治疗肌层浸润性膀胱癌患者的疗效讲者：Nicholas D. James教授单位：The Institute of Cancer Research and The Royal Marsden Hospital NHS Foundation Trust 摘要号：4506 英文标题：Perioperative SHR-A2102, a novel nectin-4–targeted antibody-drug conjugate, in combination with adebrelimab for patients (pts) with muscle-invasive bladder cancer： Results from a phase 2/3 study. 中文标题：围手术期SHR-A2102（一种新型的nectin-4靶向抗体偶联药物）与阿得贝利单抗联合用于治疗肌层浸润性膀胱癌患者：一项2/3期研究的结果讲者：叶定伟教授单位：复旦大学附属肿瘤医院摘要号：4507 英文标题：Enfortumab-vedotin plus pembrolizumab (EV+P) vs chemotherapy for previously untreated locally advanced or metastatic urothelial carcinoma(la/mUC)：3.5year follow-up and response analyses from the phase 3 EV-302 study 中文标题：维恩妥尤单抗联合帕博利珠单抗对比化疗在既往未接受治疗的局部晚期或转移性尿路上皮癌患者中的分析：EV-302 3期研究的3.5年随访和疗效分析讲者：Thomas Powles教授单位：Barts Cancer Centre, Queen Mary University of London 摘要号：4508 英文标题：Initial results from NEXUS-01,a phase 1 study of LY4052031, an antibody drug conjugate targeting Nectin-4,in participants with advanced or metastatic urothelial carcinoma 中文标题：NEXUS-01是一项针对晚期或转移性尿路上皮癌患者的1期研究，旨在评估LY4052031（一种靶向Nectin-4的抗体偶联药物）的疗效讲者：Gopa lyer教授单位：Department of Medicine, Memorial Sloan Kettering Cancer Center 摘要号：4510 英文标题：Health-related quality of life (HRQoL) with neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin ineligible： Phase 3 KEYNOTE-905 study 中文标题：一项针对不适合接受顺铂治疗的肌层浸润性膀胱癌患者，评估新辅助和辅助维恩妥尤单抗联合帕博利珠单抗治疗的健康相关生活质量：III期KEYNOTE-905研究讲者：Peter H. O'Donnell教授单位：University of Chicago, Chicago, L, Indiana University Melvin and Bren Simon Comprehensive Cancer Center 摘要号：4513 英文标题：Health-related quality of life (HRQOL) with pembrolizumab or observation for high-risk muscle-invasive urothelial carcinoma after surgery： Results from the AMBASSADOR randomized trial (Alliance A031501). 中文标题：术后通过帕博利珠单抗或观察治疗高危肌层浸润性尿路上皮癌的健康相关生活质量：AMBASSADOR随机试验(Alliance A031501)的结果讲者：Ronald C. Chen教授单位：University of Kansas Medical Center, Kansas City, KS, Department of Quantitative Health Sciences, Mayo Clinic Arizona 摘要号：4514 英文标题：MAIN-CAV： Phase Il randomized trial of maintenance cabozantinib and avelumab versus avelumab after first-line platinum-based chemotherapy (PBC) in patients (pts) with locally advanced/metastatic urothelial cancer (la/mUC Alliance A032901) 中文标题：MAIN-CAV：一项II期随机试验，比较卡博替尼和阿维鲁单抗维持治疗与一线铂类化疗后单独使用阿维鲁单抗治疗局部晚期/转移性尿路上皮癌患者的疗效：Alliance A032901 讲者：Shilpa Gupta教授单位：Department of Hematology and Oncology, Cleveland Clinic - Taussig Cancer Institute 摘要号：4516 英文标题：Interim analysis results from Duravelo-2： Zelenectide pevedotin (zele BT8009) + pembrolizumab in patients (pts) with previously untreated locally advanced/metastatic urothelial carcinoma (la/mUC) 中文标题：Duravelo-2中期分析结果：Zelenecide pevedotin (zele BT8009) +帕博利珠单抗治疗既往未接受治疗的局部晚期/转移性尿路上皮癌患者讲者：Yohann Loriot教授单位：University Paris Saclay, Gustave Roussy 摘要号：4517 英文标题：Initial results from EXCEED, a phase 1 study of LY4101174,an antibody drug conjugate targeting Nectin-4, in participants with advanced or metastatic urothelial carcinoma. 中文标题：EXCEED是一项针对晚期或转移性尿路上皮癌患者的1期研究，使用LY4101174（一种靶向Nectin-4的抗体偶联药物）的初步结果讲者：Xin Gao教授单位：Massachusetts General Hospital, Harvard Medical School 摘要号：4518 英文标题：Buumtatug fvedoin (BFy,9MW2821) plus toripalimab in patients with localy advanced or metastatic urothelial carcinoma (a/mUC)： Folowup resuits from a phase 1b/2 study 中文标题：Buumtatug fvedoin (BFy,9MW2821)联合特瑞普利单抗治疗局部晚期或转移性尿路上皮癌患者：一项1b/2期研究的随访结果讲者：盛锡楠教授单位：北京大学肿瘤医院摘要号：4624 英文标题：Durvalumab(D) in combination with BCG induction and maintenance (1 + M) therapy for BCG-naive, high-riskDurvalumab non-muscle-invasive bladder cancer (NMIBC)： 5 year overall survival (OS) analysis and patent-reported outcomes (PROs) from POTOMAC. 中文标题：度伐利尤单抗联合BCG诱导和维持方案用于BCG初治、高危非肌层浸润性膀胱癌(NMIBC)：POTOMAC研究中5年总生存期分析和患者报告结局讲者：Maria De Santis教授单位：Department of Urology, Charite Universitaetsmedizin Berlin 03 前列腺癌领域摘要号：108 英文标题：An Al-based pathology classifier to predict benefit from enzalutamide in metastatic hormone-sensitive prostate cancer (mHSPC) from ENZAMET (ANZUP 1304). 中文标题：来自 ENZAMET (ANZUP 1304) 的基于人工智能的病理分类器，用于预测转移性激素敏感性前列腺癌患者从恩扎卢胺治疗中获益的情况讲者：Sebastian R. Medina教授单位：Wallace H. Coulter Department of Biomedical Enaineering at Georaia Tech and Emory University Atlanta 摘要号：5000 英文标题：Clinico-transcriptomic risk stratification to guide abiraterone treatment intensification high-risk prostate cancer：A combined analysis of NRG/RTOG 9202, 9413, 9902, and 0521. 中文标题：临床转录组风险分层指导阿比特龙强化治疗高危前列腺癌：NRG/RTOG 9202、9413、9902和0521的联合分析讲者：Krishnan R. Patel教授单位：Radiation Oncoloqy Branch, National Cancer Institute, National Institutes of Health 摘要号：5001 英文标题：Assessment of the ability of Decipher Prostate Genomic Classifier (DGC) >0.85 to identify patients who benefit from adding docetaxel (DOC) to androgen deprivation therapy (ADT) plus enzalutamide (ENZ)： Level 1B evidence from the ENZAMET study 中文标题：评估Decipher前列腺基因组分类器 (DGC) >0.85识别从多西他赛联合雄激素剥夺疗法和恩扎卢胺中获益的患者的能力：来自ENZAMET研究的1B级证据讲者：Christopher Sweeney教授单位：South Australian Immunogenomics Cancer Institute, Adelaide University 摘要号：5002 英文标题：Spatial transcriptomics-guided computational pathology model to stratify docetaxel benefit in metastatic hormone-sensitive prostate cancer： CHAARTED trial (ECOG-ACRIN E3805). 中文标题：空间转录组学指导的计算病理学模型用于对转移性激素敏感性前列腺癌的多西他赛获益进行分层：CHAARTED试验（ECOG-ACRIN E3805）讲者：Md Mamunur Rahaman,教授单位：School of Computer Science and Engineering, University of New South Wales 摘要号：5004 英文标题：A phase 2 trial of androgen deprivation therapy interruption in patients responding exceptionally to androgen receptor pathway inhibitor in metastatic hormone-sensitive prostate cancer (A-DREAM/ Alliance A032101). 中文标题：一项针对转移性激素敏感性前列腺癌患者，在对雄激素受体通路抑制剂反应异常的治疗中中断雄激素剥夺疗法的2期试验（A-DREAM/ Alliance A032101）讲者：Atish D. Choudhury教授单位：Dana-Farber Cancer Institute 摘要号：5005 英文标题：Cognitive effects of darolutamide vs enzalutamide. Results of ARACOG (ACT-47, a randomized clinical trial from the Alliance for Clinical Trials in Oncology. 中文标题：达罗他胺与恩扎卢胺的认知效应：ARACOG（ACT-47）的结果，一项肿瘤临床试验联盟的随机临床试验讲者：Alicia K. Morgans教授单位：Dana-Farber Cancer Institute, Harvard Medical School 摘要号：5006 英文标题：Final results from ZZFIRST： A randomized phase 2 trial of enzalutamide (EZ) and talazoparib (TALA) in metastatic hormone-naive prostate cancer (mHNPC). 中文标题：ZZFIRST的最终结果：一项针对转移性激素敏感前列腺癌的恩扎卢胺和他拉唑帕利的随机2期试验讲者：Joaquin Mateo教授单位：Vall d'Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d'Hebron 摘要号：LBA5007 英文标题：TALAPRO-3：Talazoparib (TALA) + enzalutamide (ENZA)compared with placebo (PBO) + ENZA for the treatment of patients (pts) with metastatic castration-sensitive prostate cancer (mCSPC) harboring homologous recombination repair (HRR) gene alterations. 中文标题：TALAPRO-3：他拉帕唑利+恩扎卢胺对比安慰剂+恩扎卢胺治疗携带同源重组修复基因改变的转移性去势敏感性前列腺癌患者的疗效讲者：Neeraj Agarwal教授单位：Huntsman Cancer Institute (NCI-CCC), University of Utah 摘要号：5008 英文标题：Fuzuloparib combined with abiraterone acetate and prednisone (AA-P) as first-line (1L) treatment for metastatic castration-resistant prostate cancer (mCRPC)： Interim results from the FUZUPRO trial. 中文标题：氟唑帕利联合醋酸阿比特龙和泼尼松作为转移性去势抵抗性前列腺癌的一线治疗：FUZUPRO试验的中期结果讲者：叶定伟教授单位：复旦大学附属肿瘤医院摘要号：LBA5009 英文标题：Safety and dosimetry of 177Lu-rosopatamab tetraxetanplus SoC in patients with metastatic castration-resistant prostate cancer： Preliminary results from part 1 of phase 3 ProstACT Global study. 中文标题：177Lu-rosopatamab tetraxetan联合标准治疗在转移性去势抵抗性前列腺癌患者中的安全性和剂量学：ProstACT Global 3期研究第1部分的初步结果讲者：Pedro C. Barata教授单位：University Hospitals Seidman Cancer Center 摘要号：5010 英文标题：AcTION： Phase 1 study of [225Ac]Ac-PSMA-617 (225Ac-PSMA-617) in men with metastatic castration-resistant prostate cancer (mCRPC) with or without prior [177LulLu-PSMA (177Lu-PSMA) radioligand therapy (RLT). 中文标题：AcTION：225Ac-PSMA-617在转移性去势抵抗性前列腺癌男性患者中的1期研究，无论其之前是否接受过[177Lu-PSMA]放射性配体治疗讲者：Louise Emmett教授单位：Kinghorn Cancer Centre, St Vincent's Hospital, Sydney 摘要号：5011 英文标题：CONVERGE -01 part 3： Ac-225 rosopatamab tetraxetan (CONV01-a) in Lu-PSMA-pretreated metastatic castrationresistant prostate cancer(mcRPC) 中文标题：CONVERGE-01 第 3 部分：Ac-225 rosopatamab tetraxetan (CONV01-a) 在Lu-PSMA经治的转移性去势抵抗性前列腺癌中的应用讲者：Michael J. Morris教授单位：Memorial Sloan Kettering Cancer Center 摘要号：LBA5012 英文标题：Early results of COMPPARE, a prospective comparison of outcomes with proton and photon radiation in prostate cancer. 中文标题：COMPPARE的早期结果：这是一项前瞻性研究，旨在比较质子和光子放射治疗前列腺癌的疗效讲者：待定单位：待定摘要号：5013 英文标题：Genomic classifier-driven NCCN risk reclassification to track distinct transcriptomic signatures in early prostate cancer. 中文标题：基因组分类驱动的NCCN风险重新分类，用于追踪早期前列腺癌中不同的转录组特征讲者：Daniel Keizman教授单位：Tel Aviv Sourasky Medical Center 摘要号：5014 英文标题：A phase ,first in human (FIH) study evaluating the safety,Pharmacokinetics, and efficacy of ABBV-969 in patents with metastatic castration resistant prostate cancer (mCRPC) 中文标题：一项首次人体试验研究评估了ABBV-969在转移性去势抵抗性前列腺癌患者中的安全性、药代动力学和疗效讲者：Tanya B. Dorff教授单位：City of Hope Comprehensive Cancer Center 摘要号：5015 英文标题：Phase 2 study of YL201,an ant- B7H3 antibody-drug conjugate (ADC), in heavily pretreated metastatic castrationresistant prostate cancer (mCRPC) 中文标题：YL201（一种抗B7H3抗体偶联药物）在接受过多线治疗的转移性去势抵抗性前列腺癌 (mCRPC) 患者中的II期研究讲者：叶定伟教授单位：复旦大学附属肿瘤医院摘要号：5016 英文标题：Phase 2 muticenter trial of chemoimmunotherapy for patients with neuroendocrine or aggressive variant metastatic prostate cancer (CHAMP). 中文标题：针对神经内分泌或侵袭性变异转移性前列腺癌患者的化疗免疫疗法的2期多中心试验 (CHAMP) 讲者：Andrew J. Armstrong教授单位：Division of Medical Oncology, Duke University Medical Center, Duke Cancer Institute, Duke University 摘要号：5017 英文标题：PROTRACT： A randomized phase IIl trial comparing ctDNA-guided biomarker directed therapy vs patient/clinician's choice for metastatic castration resistant prostate cancer (mCRPC) progressing after abiraterone plus prednisone (AAP). 中文标题：PROTRACT：一项随机III期试验比较了ctDNA指导的生物标志物定向治疗与患者/临床医生选择的治疗方案，用于治疗在阿比特龙加泼尼松治疗后进展的转移性去势抵抗性前列腺癌讲者：Corinne Maurice-Dror教授单位：BC Cancer - Vancouver Centre, Vancouver 摘要号：5018 英文标题：Circulating tumor DNA-based clinical-genetic (CG) prognostic model for radiographic progression-free survival (rPFS) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)： Analysis of Alliance A031201. 中文标题：基于循环肿瘤DNA的临床遗传预后模型用于转移性去势抵抗性前列腺癌（mCRPC）患者的放射学无进展生存期（rPFS）：Alliance A031201的分析讲者：Susan Halabi教授单位：Department of Brostatistics and Bioinformaties, Duke Cancer Instute center for Prostate and Urologice Cancers, Duke Universty School of Medicne 摘要号：5019 英文标题：Canadian Cancer Trials Group (CCTG) study PR21 (PLUDO)： Results of crossover treatment from a randomized trial of 177Lu-PSMA-617 (LuP) vs docetaxel (DOC) in patients with metastatic castration-resistant prostate cancer (mCRPC). 中文标题：加拿大癌症试验组 (CCTG) PR21 (PLUDO)研究：177Lu-PSMA-617对比多西他赛治疗转移性去势抵抗性前列腺癌患者的随机试验交叉治疗结果讲者：Kim N. Chi教授单位：University of British Columbia, BC Cancer, Vancouver Cancer Centre, Vancouver 摘要号：5020 英文标题：Subgroup analyses by disease volume and de novo/recurrent mHSPC in the PSMAddition study of [177Lu]lLu-PSMA-617. 中文标题：在177Lu-PSMA-617的PSMAddition研究中，按疾病体积和新发/复发性mHSPC进行亚组分析讲者：Fred Saad教授单位：Centre Hospitalier de I'Universite de Montreal, University of Montreal, Montreal 04 其他瘤种摘要号：LBA5003 英文标题：First interim analysis of SWOG S1823： Operating characteristics of circulating microRNA 371a-3p (miR371) in predicting active germ cell malignancy (aGCM) in patients (pts) with early-stage testicular cancer. 中文标题：SWOG S1823的首次中期分析：循环microRNA 371a-3p (miR371)在预测早期睾丸癌患者的活性生殖细胞恶性肿瘤中的运行特征讲者：Lucia Nappi教授单位：BC Cancer Vancouver Centre and Vancouver Prostate Centre, Vancouver 摘要号：4515 英文标题：Phase lstudy of frontine gemctabine,5-fuorouracilleucovorih, and cisplatn (GemFLP) In advanced urachal and non urachalurinary tract adenocarcinoma. 中文标题：吉西他滨、5-氟尿嘧啶和顺铂（Gem FLP）治疗晚期脐尿管和非脐尿管泌尿道腺癌的I期研究讲者：Emanuele Crupi教授单位：Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center （来源：ASCO官网）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。

100 项与阿昔替尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03218	阿昔替尼	L01XE17	DB06626

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
转移性肾细胞癌	中国	Pfizer Europe MA EEIG	2025-04-22
不可切除的肾细胞癌	中国	Pfizer Europe MA EEIG	2025-04-22
肾细胞癌	日本	Pfizer Japan, Inc.	2012-06-29
晚期肾细胞癌	美国	PF Prism CV	2012-01-27

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
II型糖原贮积病	临床3期	美国	Ocular Therapeutix, Inc.	2026-04-01
非增殖性糖尿病视网膜病变	临床3期	美国	Ocular Therapeutix, Inc.	2025-11-17
湿性年龄相关性黄斑变性	临床3期	美国	Ocular Therapeutix, Inc.	2024-01-29
湿性年龄相关性黄斑变性	临床3期	阿根廷	Ocular Therapeutix, Inc.	2024-01-29
局部晚期肾细胞癌	临床3期	-	Merck Sharp & Dohme LLC	2016-09-16
晚期癌症	临床3期	德国	Pfizer Inc.	2011-11-01
晚期癌症	临床3期	意大利	Pfizer Inc.	2011-11-01
晚期癌症	临床3期	西班牙	Pfizer Inc.	2011-11-01
晚期癌症	临床3期	英国	Pfizer Inc.	2011-11-01
神经内分泌肿瘤	临床3期	德国	Pfizer Inc.	2011-11-01

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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


NCT01744249 (AXINET trial (GETNE1107) \| AXINET, CTgov)	临床2/3期	神经内分泌肿瘤 \| 晚期癌症 \| 无功能的胰腺内分泌肿瘤	256	Sandostatin LAR+Axitinib (Axitinib + Sandostatin LAR)	願醖襯選願鑰窪簾蓋顧(鏇鏇淵窪繭夢願壓網簾) = 積鹽蓋夢網繭衊齋餘齋壓壓鬱艱廠鬱選範築鏇 (遞齋遞糧鹽膚製顧選窪, 齋齋願選憲鑰構網獵網 ~ 鹹鹽衊糧繭醖繭鏇壓製) 更多	-	2026-04-28
				Placebo+Sandostatin LAR (Placebo + Sandostatin LAR)	願醖襯選願鑰窪簾蓋顧(鏇鏇淵窪繭夢願壓網簾) = 餘顧膚構鑰憲鹹廠衊構壓壓鬱艱廠鬱選範築鏇 (遞齋遞糧鹽膚製顧選窪, 顧齋製醖襯憲窪醖鹽壓 ~ 選網製鏇範範網鏇選鹽) 更多
NCT01744249 (AXINET, Pubmed \| J Clin Oncol)	临床3期	晚期胰腺神经内分泌肿瘤 Ki-67 index	256	Axitinib + Axitinibde LAR	簾鬱壓糧淵觸壓衊選鑰(獵齋願鬱壓繭製鏇艱築) = 鑰網繭艱膚壓獵繭壓餘網鏇襯鏇觸積壓製鑰襯 (蓋願築鹹簾憲糧淵糧憲 ) 更多	不佳	2026-03-20
				Placebo + Octreotide LAR	簾鬱壓糧淵觸壓衊選鑰(獵齋願鬱壓繭製鏇艱築) = 憲遞齋淵鑰製鬱襯鏇範網鏇襯鏇觸積壓製鑰襯 (蓋願築鹹簾憲糧淵糧憲 ) 更多
NCT04698213 (Tide-A, ASCO_GU2026)	临床3期	转移性肾细胞癌	824	Intermittent Axitinib+Avelumab	醖廠鬱觸襯構衊鬱餘糧(艱簾衊壓積製廠獵顧範) = 鹹範襯簾糧醖鹹簾齋願鏇窪繭鹹廠選醖簾壓憲 (齋鬱壓淵夢壓鑰襯繭簾 )	不佳	2026-02-26
ASCO_GU2026	N/A	肾细胞癌一线	632	Pembrolizumab-axitinib (PA)	鹹繭衊獵廠鬱選觸衊憲(築構鏇齋膚齋鏇齋鹽鏇) = 範簾壓夢憲構顧製遞獵選顧艱積願顧簾願蓋築 (遞壓窪憲鑰鑰範願觸膚 ) 更多	积极	2026-02-26
				Pembrolizumab-lenvatinib (PL)	鹹繭衊獵廠鬱選觸衊憲(築構鏇齋膚齋鏇齋鹽鏇) = 鏇積壓廠鑰餘鑰範簾膚選顧艱積願顧簾願蓋築 (遞壓窪憲鑰鑰範願觸膚 ) 更多
NCT06223958 (SOL-1, Company_Website) 人工标引	临床3期	湿性年龄相关性黄斑变性	344	AXPAXLI 0.45mg	獵蓋壓願衊鹽積膚鬱鹽(觸顧鏇餘鑰遞鑰衊淵襯) = 蓋膚範簾鏇壓壓鏇憲鏇鹽範積夢築蓋餘壓艱蓋 (膚簾觸窪繭鬱糧齋構蓋 ) 达到更多	优效	2026-02-17
				aflibercept (2 mg)	獵蓋壓願衊鹽積膚鬱鹽(觸顧鏇餘鑰遞鑰衊淵襯) = 餘網鹽顧壓顧製鬱簾鑰鹽範積夢築蓋餘壓艱蓋 (膚簾觸窪繭鬱糧齋構蓋 ) 达到更多
ESMO_ASIA2025	N/A	转移性肾细胞癌一线	194	IO-IO (nivolumab + ipilimumab)	憲觸糧製壓餘齋築鬱廠(鬱憲網淵膚鹹膚構膚艱) = 糧鑰壓簾積膚觸鑰網憲餘範顧鬱鏇衊製餘繭壓 (鬱衊鹹膚鏇蓋窪製壓鬱, 1.0 ~ 55.9) 更多	积极	2025-12-05
				IO-TKI (pembrolizumab + axitinib or lenvatinib or nivolumab + cabozantinib)	憲觸糧製壓餘齋築鬱廠(鬱憲網淵膚鹹膚構膚艱) = 範顧製壓鑰網獵餘餘醖餘範顧鬱鏇衊製餘繭壓 (鬱衊鹹膚鏇蓋窪製壓鬱, 1.0 ~ 45.2) 更多
ASN2025	N/A	晚期肾细胞癌一线	886	Axitinib plus Avelumab	遞衊齋積齋獵鹽構鑰夢(積選繭蓋衊衊選網齋選) = 積齋壓網觸艱製鬱廠淵積遞鹹顧網選製範製鹽 (鑰願齋獵夢獵獵齋積衊 ) 更多	积极	2025-11-08
				Sunitinib	顧鬱遞選壓壓廠鹽繭選(獵築窪糧繭積膚鬱網憲) = 簾衊鹹壓鹹網築顧壓觸鏇築網衊鏇積積淵廠艱 (鹹蓋鑰壓繭願淵範構夢 )
NCT04370509 (CTgov)	临床2期	转移性肾细胞癌 \| 晚期肾细胞癌 \| 肾细胞癌 ... 更多	6	Cytoreductive Nephrectomy (CN)+Pembrolizumab	鏇淵壓餘鏇鑰觸齋蓋構 = 鑰構醖壓積遞遞鹽鹹築齋夢醖願襯顧襯簾構築 (醖窪膚鏇鹹鹹願壓廠積, 餘選醖襯膚蓋蓋憲顧積 ~ 艱憲構範鬱網壓簾憲範) 更多	-	2025-11-05
JAVELIN Renal 101 (ESMO2025)	临床3期	肾细胞癌一线	50	ICI+VEGF TKI	構積襯顧膚廠顧顧夢選(構鹽艱鑰襯鹽遞壓醖積) = ER pts had significantly higher circulating levels of the pro-inflammatory cytokines IL1-Beta (p=0.033) 餘鬱膚鏇獵鹹繭蓋製範 (選鬱繭膚繭簾鏇糧夢遞 ) 更多	积极	2025-10-17
				ICI+VEGF TKI (pts with PD)
ESMO2025	临床2期	肾细胞癌	26	SintilimabAxitinibab + SintilimabAxitinib (Stereotactic Radiotherapy (SBRT))	膚鑰窪餘餘網鏇願鏇鬱(顧醖願鑰齋衊膚製積窪) = 簾積廠蓋夢憲夢鏇觸顧積鬱繭遞廠夢範艱艱襯 (遞範蓋顧齋網窪範製廠 ) 更多	积极	2025-10-17