This is a randomized trial evaluating the efficacy and safety of sequential dual-agent immunotherapy and risk-adapted radiotherapy for patients with locally advanced non-small cell lung cancer (NSCLC) with a PD-L1 tumor proportion score of at least 50%. Participants will be randomized between two dual-agent immunotherapy regimens: durvalumab + monalizumab versus durvalumab + oleclumab.

开始日期2026-03-01

申办/合作机构

Montefiore Medical Center

[+1]

NCT06769126

/ Recruiting临床2期IIT

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

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

开始日期2025-12-01

申办/合作机构

SWOG

[+1]

NCT06503614

/ Recruiting临床2期IIT

ENHANCE (Elevated NKG2A and HLA-E Amplify NK/CD8 Checkpoint Engagers): A Phase 2 Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer

This is a phase 2 open-label two cohort study of durvalumab plus monalizumab in patients with BCG-unresponsive or BCG-exposed CIS NMIBC. Arm A will enroll 43 participants who have cancer in situ (CIS) with or without high grade papillary urothelial cancer. Arm B will enroll 17 participants who do not have cancer in situ (CIS) but do have high grade papillary urothelial cancer. Eligible patients will be enrolled to receive up to 13 cycles of monthly combination of monalizumab and durvalumab. Both monalizumab and durvalumab will be administered intravenously (IV) every 28 days.

开始日期2025-02-24

申办/合作机构

Hoosier Cancer Research Network

[+3]

100 项与莫纳利珠单抗相关的临床结果

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100 项与莫纳利珠单抗相关的专利（医药）

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项与莫纳利珠单抗相关的文献（医药）

2025-11-21·CARCINOGENESIS

A2AR-phospho-STAT1 (Y701)-HLA-E axis as a potential immune modulatory pathway in radiotherapy-resistant triple negative breast cancer

Article

作者: Lee, Gyeong Won ; Park, Sang Won ; Lee, Ju Heon ; Kim, Hye Jung ; Lee, Jong Sil ; Lee, So Eun ; Kim, Dong Chul ; Ko, Young Shin ; Yun, Seung Pil ; Jin, Hana ; Won, Ju Yeong

Abstract:

Triple-negative breast cancer (TNBC) patients have lower survival rates and higher recurrence risks than non-TNBC patients. Moreover, radiotherapy-resistant TNBC (RT-R-TNBC) exhibits enhanced chemotherapy resistance and invasiveness. Therefore, there is a critical need for innovative treatments for RT-R-TNBC and TNBC patients. Our previous study indicated that NK cells exhibit reduced cytotoxicity against RT-R-TNBCs due to human leukocyte antigen class I histocompatibility antigen, alpha chain E (HLA-E) upregulation. Thus, this study aimed to identify the mechanism responsible for the upregulation of HLA-E and suggest potential therapeutic targets for overcoming the RT-resistance of TNBC. We found that HLA-E expression was significantly higher in TNBC tumor tissues than in normal epithelial tissues and non-TNBC tissues, correlating with A2AR levels. In addition, MDA-MB-231 (TNBC) and RT-R-MDA-MB-231 (RT-R-TNBC) showed an A2AR-dependent HLA-E overexpression. NK cell-mediated cytotoxicity against MDA-MB-231 and RT-R-MDA-MB-231 was reduced and restored by A2AR or STAT1 knockdown. Interestingly, STAT1 phosphorylation (Y701) by adenosine (ADO) aligned with the HLA-E expression pattern by ADO, and fludarabine, a STAT1 inhibitor, effectively reduced phospho-STAT1 (Y701) levels but not phospho-STAT1 (S727) levels. Fludarabine also inhibited ADO-induced HLA-E expression in MDA-MB-231 and RT-R-MDA-MB-231, including basal HLA-E expression in RT-R-MDA-MB-231. Additionally, fludarabine reduced tumor progression, lung metastasis, HLA-E expression, and phospho-STAT1 (Y701) in RT-R-MDA-MB-231-injected mice. Moreover, monalizumab, an NKG2A monoclonal antibody, significantly reduced tumor progression and lung metastasis with increased population of cytotoxic NK cells (CD25 + NK1.1+ and CD69 + NK1.1+) in the inguinal lymph nodes of RT-R-MDA-MB-231-injected mice. This study suggests that the A2AR-phospho-STAT1 (Y701)-HLA-E axis may serve as an alternative target for overcoming RT-resistance in TNBC.

2025-08-01·NATURE MEDICINE

Perioperative durvalumab plus chemotherapy plus new agents for resectable non-small-cell lung cancer: the platform phase 2 NeoCOAST-2 trial

Article

作者: McGrath, Lara ; Insa, Amelia ; Shim, Byoung Yong ; He, Yun ; Cascone, Tina ; Bielska, Agata A ; Egenod, Thomas ; Provencio Pulla, Mariano ; Forde, Patrick M ; Livi, Lorenzo ; Grenga, Italia ; Kim, Dong-Wan ; Garcia Campelo, Maria Rosario ; Guisier, Florian ; Bylicki, Olivier ; Dowson, Adam ; Bennouna, Jaafar ; Corre, Romain ; Spicer, Jonathan ; Liberman, Moishe ; Metro, Giulio ; Bonanno, Laura ; Yohannes, Alula R ; Kumar, Rakesh ; Kar, Gozde

Abstract:

In the phase II NeoCOAST-2 platform study, 202 patients with untreated, resectable stage IIA–IIIB non-small-cell lung cancer (NSCLC) were randomized to receive neoadjuvant durvalumab plus platinum-doublet chemotherapy with oleclumab, a CD73 inhibitor (Arm 1), or with monalizumab, a NKG2A inhibitor (Arm 2), or neoadjuvant durvalumab plus single-agent platinum chemotherapy with the TROP-2 antibody–drug conjugate (ADC) datopotamab deruxtecan (Arm 4), followed by surgical resection and adjuvant durvalumab with oleclumab or monalizumab (Arms 1 and 2) or durvalumab alone (Arm 4). Primary endpoints were pathological complete response (pCR) rate and safety; secondary endpoints included feasibility of surgery and major pathological response (mPR) rate. In the modified intention-to-treat population (n = 198; Arm 1, n = 74; Arm 2, n = 70; Arm 4, n = 54), pCR rates were 20.3% (15/74; 95% CI, 11.8–31.2), 25.7% (18/70; 95% CI, 16.0–37.6) and 35.2% (19/54; 95% CI, 22.7–49.4), and mPR rates were 41.9% (31/74; 95% CI, 30.5–53.9), 50.0% (35/70; 95% CI, 37.8–62.2) and 63.0% (34/54; 95% CI, 48.7–75.7) in arms 1, 2, and 4, respectively. In the safety population, 69/74 (93.2%), 66/71 (93.0%), and 51/54 (94.4%) patients underwent surgery, respectively. Overall, grade ≥3 treatment-related adverse events occurred in 27/74 (36.5%), 29/71 (40.8%) and 11/54 (20.4%) patients, respectively. In NeoCOAST-2, the first neoadjuvant trial examining an ADC plus chemo-immunotherapy in resectable NSCLC, pCR rates were highest in the datopotamab-deruxtecan-containing arm, warranting further investigation in larger trials of ADCs and checkpoint inhibition in the neoadjuvant setting. ClinicalTrials.gov identifier: NCT05061550.

2025-07-01·CLINICAL CANCER RESEARCH

INTERLINK-1: A Phase III, Randomized, Placebo-Controlled Study of Monalizumab plus Cetuximab in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

Article

Abstract:

Purpose::

Treatment options for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) after failure of immune checkpoint inhibitor treatment and platinum-based chemotherapy are limited. Preliminary data suggested that monalizumab plus cetuximab had clinical activity in R/M HNSCC.

Patients and Methods::

INTERLINK-1 (NCT04590963) was a double-blind, phase III study. Participants with R/M HNSCC who had received immune checkpoint inhibitor therapy and progressed despite platinum-based chemotherapy were randomized 2:1 to monalizumab (750 mg, every 2 weeks) or placebo, plus cetuximab (400 mg/m2 loading dose, then 250 mg/m2, weekly). The primary endpoint was overall survival (OS) in participants with non-oropharyngeal cancer or human papillomavirus (HPV)-negative oropharyngeal cancer (HPV-unrelated analysis set). Secondary endpoints included progression-free survival and objective response rate.

Results::

At data cutoff, 216 participants were randomized in the HPV-unrelated analysis set: 145 to monalizumab plus cetuximab and 71 to placebo plus cetuximab. Median OS was 8.8 months for monalizumab plus cetuximab versus 8.6 months for placebo plus cetuximab (HR, 1.00; 95% confidence interval, 0.66–1.54); median progression-free survival was 3.6 versus 3.8 months, respectively (HR, 1.11; 95% confidence interval, 0.79–1.57); and the objective response rate was 15.2% versus 23.9%, respectively. INTERLINK-1 was terminated after a preplanned interim analysis showed that futility criteria were met (predetermined futility HR >0.874). Grade 3/4 treatment–related adverse events were reported in 18.3% and 17.2% of participants treated in the monalizumab and placebo arms, respectively.

Conclusions::

Monalizumab plus cetuximab did not improve OS compared with placebo plus cetuximab. The safety profile of the combination was consistent with safety observations for cetuximab monotherapy.

142

项与莫纳利珠单抗相关的新闻（医药）

2025-12-22

·Business Wire

Number of Shares and Voting Rights of Innate Pharma as of December 18, 2025

MARSEILLE, France--(BUSINESS WIRE)--Regulatory News: Pursuant to the article L. 233-8 II of the French “Code de Commerce” and the article 223-16 of the French stock-market authorities (Autorité des Marchés Financiers, or “AMF”) General Regulation, Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) releases its total number of shares outstanding as well as its voting rights as of December 18, 2025: Total number of shares outstanding: 92,197,823 ordinary shares 6,324 Preferred Shares 2016 7,581 Preferred Shares 2017 Total number of theoretical voting rights (1): Total number of exercisable voting rights (2): 92,962,943 92,944,368 About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Leveraging its expertise on antibody-engineering and innovative target identification, Innate Pharma is developing innovative and differentiated next-generation antibody therapeutics. Innate Pharma is advancing a portfolio of differentiated potential first and/or best-in-class assets, focused on areas of high unmet medical need, including IPH4502, a differentiated Nectin-4 ADC developed in solid tumors, lacutamab, an anti-KIR3DL2 antibody developed in cutaneous T cell lymphomas and peripheral T cell lymphomas, and monalizumab, an anti-NKG2A antibody developed in collaboration with AstraZeneca in non-small cell lung cancer. Innate Pharma has established collaborations with leading biopharmaceutical companies, including Sanofi and AstraZeneca, as well as renowned academic and research institutions, to advance innovation in immuno-oncology. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X. Information about Innate Pharma shares ISIN code Ticker code LEI FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29 Disclaimer on forward-looking information and risk factors This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “intend,” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

免疫疗法临床研究

2025-11-28

·Business Wire

Number of Shares and Voting Rights of Innate Pharma as of November 27, 2025

MARSEILLE, France--(BUSINESS WIRE)--Regulatory News: Pursuant to the article L. 233-8 II of the French “Code de Commerce” and the article 223-16 of the French stock-market authorities (Autorité des Marchés Financiers, or “AMF”) General Regulation, Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the “Company”) releases its total number of shares outstanding as well as its voting rights as of November 27, 2025: Total number of shares outstanding: 92,196,523 ordinary shares 6,334 Preferred Shares 2016 7,581 Preferred Shares 2017 Total number of theoretical voting rights (1): Total number of exercisable voting rights (2): 92,962,943 92,944,368 (1) The total number of theoretical voting rights (or “gross” voting rights) is used as the basis for calculating the crossing of shareholding thresholds. In accordance with Article 223-11 of the AMF General Regulation, this number is calculated on the basis of all shares to which voting rights are attached, including shares whose voting rights have been suspended. The total number of theoretical voting rights includes voting rights attached to AGAP 2016, i.e. 130 voting rights for the AGAP 2016-1 and 111 voting rights for the AGAP 2016-2. No voting rights attached to AGAP 2017. (2) The total number of exercisable voting rights (or “net” voting rights) is calculated without taking into account the shares held in treasury by the Company, with suspended voting rights. It is released so as to ensure that the market is adequately informed, in accordance with the recommendation made by the AMF on July 17, 2007. About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Leveraging its expertise on antibody-engineering and innovative target identification, Innate Pharma is developing innovative and differentiated next-generation antibody therapeutics. Innate Pharma is advancing a portfolio of differentiated potential first and/or best-in-class assets, focused on areas of high unmet medical need, including IPH4502, a differentiated Nectin-4 ADC developed in solid tumors, lacutamab, an anti-KIR3DL2 antibody developed in cutaneous T cell lymphomas and peripheral T cell lymphomas, and monalizumab, an anti-NKG2A antibody developed in collaboration with AstraZeneca in non-small cell lung cancer. Innate Pharma has established collaborations with leading biopharmaceutical companies, including Sanofi and AstraZeneca, as well as renowned academic and research institutions, to advance innovation in immuno-oncology. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at www.innate-pharma.com and follow us on LinkedIn and X. Information about Innate Pharma shares ISIN code Ticker code LEI FR0010331421 Euronext: IPH Nasdaq: IPHA 9695002Y8420ZB8HJE29 Disclaimer on forward-looking information and risk factors This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “may,” “might,” “potential,” “intend,” “should,” “will,” or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company’s reliance on third parties to manufacture its product candidates, the Company’s commercialization efforts and the Company’s continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority (“AMF”), which is available on the AMF website http://www.amf-france.org or on Innate Pharma’s website, and public filings and reports filed with the U.S. Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company’s website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.

免疫疗法

2025-11-26

·科途医学K2Oncology

文献解读 |【深度研报】NSCLC市场全景：从300亿到560亿美元的跃迁——ICI霸主地位还能维持多久？

作者：Charlotte B. Jago & Rachel M. Webster (Clarivate) DOI: 10.1038/d41573-025-00123-w 来源：Nature Reviews Drug Discovery 科小语这是一篇基于Nature Reviews Drug Discovery(2025年11月第24卷)最新市场分析报告的深度解读。是关于非小细胞肺癌药物市场的全景分析与预测报告，聚焦于临床管线、上市药物的销售预测及竞争格局：导读非小细胞肺癌（NSCLC）作为全球致死率最高的癌症之一，其治疗格局在过去二十年间经历了从化疗到靶向治疗，再到免疫治疗的范式转移。近日，科睿唯安（Clarivate）分析师在Nature Reviews Drug Discovery上发表了关于NSCLC药物市场的最新深度分析。文章预测，得益于免疫检查点抑制剂（ICI）的持续渗透、ADC药物的入局以及早期辅助治疗适应症的拓展，NSCLC药物市场规模将在未来十年内接近翻倍。本文将从现有治疗格局、新兴管线机制、早期治疗趋势及市场量化预测四个维度，为您深度拆解这篇重磅分析。 1 治疗基石的演变：AGA与Non-AGA的二元世界当前NSCLC治疗策略的根本分水岭为是否存在可靶向的基因组改变（Actionable Genomic Alterations, AGAs）。 1.1 无AGA患者：ICI仍是绝对主导对于约占一半以上的无 AGA 患者，免疫检查点抑制剂（ICI）特别是靶向PD-1/PD-L1的单抗，构成了治疗的基石。一线治疗格局：Pembrolizumab（K药）依然是王者，无论 PD-L1 表达水平如何，其与化疗联用均是标准疗法。Nivolumab + Ipilimumab（O+Y）的双免疫方案也是重要选择。给药方式革新：文章特别指出了皮下注射制剂的趋势。Atezolizumab和Nivolumab的皮下制剂已在欧美获批，这不仅提升了患者依从性，也为医疗系统节省了资源。Pembrolizumab的皮下制剂也在监管审查中。 1.2 AGA患者：靶点细分与耐药后的新希望对于携带AGAs的患者，小分子酪氨酸激酶抑制剂（TKI）是主要手段，但在耐药后及罕见靶点上有了新突破： EGFR领域的内卷与突围：Osimertinib（奥希替尼）仍处于统治地位。但强生推出的“埃万妥单抗（Amivantamab）+ Lazertinib”组合，以及阿斯利康/第一三共的 TROP2 ADC（Datopotamab deruxtecan）正在重塑耐药后的治疗格局。罕见靶点的全覆盖：除了ALK、ROS1、BRAF外，针对HER2突变的ADC 药物（Enhertu），以及针对NRG1融合（Zenocutuzumab）和MET过表达（Telisotuzumab vedotin）的新型疗法。 2 重点关注：管线中的颠覆者重点关注：管线中的颠覆者。 1.双抗的崛起（Bispecifics）： Ivonescimab (依沃西单抗, PD-1 × VEGF)：这是目前的明星分子，其在中国两项III期临床中分别击败了 Pembrolizumab和Tislelizumab。在西方无AGA患者中的关键试验正在进行，这是一个可能挑战K药“药王”地位的潜力股。 Acasunlimab (PD-L1 × 4-1BB)：Genmab 开发的双抗，利用4-1BB激动剂活性增强免疫应答，主要针对后线治疗。 2.ADC 的泛化（ADCs）： Sacituzumab tirumotecan (TROP2 ADC)：科伦博泰/默沙东开发，正被评估用于EGFR突变耐药后的治疗。 Sigvotatug vedotin (Integrin b6 ADC)：辉瑞开发，靶向整合素b6，这是一个相对较新且具有特异性的靶点。 3.新颖检查点（Novel Checkpoints）： Oleclumab (CD73) & Monalizumab (NKG2A)：这两个药物正作为“Durvalumab 的搭档”，在不可切除III期NSCLC的巩固治疗中进行评估。这显示了阿斯利康试图通过联合疗法进一步巩固其在III期肺癌领域壁垒的策略。 3 市场量化预测：561亿美元的蓝图 Clarivate的分析师给出了极为乐观的市场增长预期。 1.总量翻倍：七大主要市场（美、法、德、意、西、英、日）的销售额预计将从2024年的317亿美元飙升至2033年的561亿美元。 2.ICI 的统治力（粉色柱状部分）：如图所示，检查点抑制剂始终占据最大的市场份额。尽管面临生物类似药的潜在冲击，但凭借适应症拓展（尤其是早期肺癌）和新分子（如Ivonescimab）的加入，其地位不可撼动。 3.AGA 靶向药的增长（红色及深蓝部分）： EGFR靶向药（红色）：预计到2033年将产生117亿美元的销售额。其他 AGA（蓝色系）：尽管针对ALK/ROS1等靶点的患者群体较小，但由于其在精准治疗中的不可替代性，收入依然可观。 4.新势力的入场（紫色部分）：请注意图中2029年和203 年出现的紫色板块——TROP2 和 Integrinb6靶向的ADC药物。虽然初期只能作为后线疗法进入市场（受限于较小的患者群），但它们代表了化疗（黑色部分，逐渐萎缩）的替代力量。 5.化疗的衰退（黑色部分）：化疗的市场份额被进一步挤压，仅维持在25-26亿美元左右，主要作为联合疗法的配角存在。总结与展望：本篇报告描绘了一个强者恒强，新星涌现的NSCLC市场图景。总结： 1.Pembrolizumab在预测期内仍将维持其市场领导者地位。 2.EGFR市场将继续由奥希替尼主导，但双抗和ADC正在蚕食耐药后的市场份额。 3.KRAS和HER2靶向药物正努力向一线治疗推进，这是它们实现商业价值最大化的关键。展望：未来的竞争焦点将不再仅仅是“谁的疗效更好”，而是“谁能更早介入”。随着生物类似药（Biosimilars）在预测期后期的潜在侵蚀，原研药企必须通过皮下制剂改良（提升便捷性）和早期辅助治疗布局（锁定患者流）来构筑防御工事。同时，以Ivonescima为代表的双特异性抗体，极有可能成为下一个十年改写 NSCLC治疗范式的黑马。欢迎各位咨询——科途官方客服：关于科途医学科途医学是一家专注于类器官培养全流程产品、类器官建模服务、类器官疾病模型库建设、临床前药物发现、转化医学CRO服务的高科技公司，可提供类器官一站式解决方案。基于分泌蛋白质组学筛选技术，公司已经建立了40多种组织的类器官培养方法。产品包括EHSgel 基质胶、多种类器官培养基、类器官相关细胞因子、组织消化酶解液、类器官分离回收液、类器官冻存液等。我们致力于提供高质量、更可靠的类器官产品，助力客户科学研究的进展，欢迎您来电咨询。使用科途医学类器官产品或模型发表的科研文献列表(部分) 订购及业务咨询：info@K2Oncology.com 技术服务咨询：TechSupport@k2oncology.com 联系电话：010-67889128，13371633638（微信同步），17778038351 网址：www.K2Oncology.com 地址： ●北京市北京经济技术开发区经海六路5号院东尚·E园10号楼1层109 ●浙江省湖州市红丰路1366号6幢10楼1001室 ●河北省廊坊市固安县新兴园肽谷生物医药加速器产业园1号楼A1-1-4室

抗体药物偶联物临床3期免疫疗法临床结果引进/卖出

100 项与莫纳利珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	莫纳利珠单抗	-	DB12824

研发状态

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
局部晚期非小细胞肺癌	临床3期	美国	AstraZeneca PLC	2022-02-07
局部晚期非小细胞肺癌	临床3期	中国	AstraZeneca PLC	2022-02-07
局部晚期非小细胞肺癌	临床3期	日本	AstraZeneca PLC	2022-02-07
局部晚期非小细胞肺癌	临床3期	澳大利亚	AstraZeneca PLC	2022-02-07
局部晚期非小细胞肺癌	临床3期	巴西	AstraZeneca PLC	2022-02-07
局部晚期非小细胞肺癌	临床3期	加拿大	AstraZeneca PLC	2022-02-07
局部晚期非小细胞肺癌	临床3期	哥伦比亚	AstraZeneca PLC	2022-02-07
局部晚期非小细胞肺癌	临床3期	法国	AstraZeneca PLC	2022-02-07
局部晚期非小细胞肺癌	临床3期	德国	AstraZeneca PLC	2022-02-07
局部晚期非小细胞肺癌	临床3期	意大利	AstraZeneca PLC	2022-02-07

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03801902 (NRG-LU004, CTgov)	临床1期	复发性非小细胞肺癌 \| 不可切除的非小细胞肺癌 \| 局部晚期非小细胞肺癌	26	Accelerated Hypofractionated Radiation Therapy+Durvalumab (Arm I (CLOSED) (Durvalumab and ACRT))	遞獵醖壓憲範衊艱襯選 = 膚糧窪鹽願蓋衊獵廠夢鬱鬱觸衊壓願憲糧鹽膚 (範鹽夢鏇憲網顧壓鑰顧, 廠齋襯窪齋網範鏇簾顧 ~ 襯鏇壓鏇憲積獵築壓窪) 更多	-	2025-06-19
				Magnetic Resonance Imaging of the Brain+Durvalumab (Arm II (CLOSED) (Durvalumab and Standard RT))	遞獵醖壓憲範衊艱襯選 = 廠鬱遞膚膚艱遞衊獵鹹鬱鬱觸衊壓願憲糧鹽膚 (範鹽夢鏇憲網顧壓鑰顧, 顧鑰繭願築範餘鏇積鹽 ~ 衊製衊鬱製築繭鑰築艱) 更多
NCT03822351 (COAST, ASCO2024) 人工标引	临床2期	不可切除的非小细胞肺癌	189	durvalumab	範齋願鏇顧範齋餘鹹糧(膚蓋製鬱窪齋繭範壓糧) = 鑰鹹網網構襯網範糧積範壓齋鏇淵積壓夢積餘 (壓選網蓋醖繭選築壓顧, 14.3 ~ 35.9) 更多	积极	2024-05-24
				durvalumab+oleclumab	範齋願鏇顧範齋餘鹹糧(膚蓋製鬱窪齋繭範壓糧) = 齋鬱鏇襯衊廠遞網糧壓範壓齋鏇淵積壓夢積餘 (壓選網蓋醖繭選築壓顧, 23.1 ~ 48.4) 更多
NCT03794544 (NeoCOAST, AACR2024) 人工标引	临床2期	可切除非小细胞肺癌新辅助	47	durvalumab	鑰觸網糧鹽蓋膚簾觸鏇(衊衊遞醖繭醖選襯廠襯) = Percent CD73+ TC and B cell abundance was higher in patients with MPR vs those without MPR in the durva + ole arm, but not in the durva monotherapy or durva + mona arms. Increased CD8 T cell and NK cell abundance was not associated with MPR in any arm. 築觸鏇廠衊醖繭憲構襯 (襯築膚膚餘鹹壓淵鬱蓋 ) 更多	积极	2024-03-22
				durvalumab+oleclumab
NCT04590963 (INTERLINK-1, CTgov)	临床3期	转移性头颈部鳞状细胞癌	370	Cetuximab+Monalizumab (Monalizumab 750 mg Q2W + Cetuximab 400 mg/m^2)	築鑰糧醖衊膚製繭蓋糧(膚網淵鏇簾憲積鏇餘憲) = 壓製糧遞鹹艱範積選選鏇夢網製窪簾蓋衊窪糧 (廠醖餘襯鹽膚鹹範糧願, 範範獵鏇積積鏇鹹獵鏇 ~ 糧膚獵網齋鹽蓋憲齋齋) 更多	-	2023-11-18
				Placebo+Cetuximab (Placebo Q2W + Cetuximab 400 mg/m^2)	築鑰糧醖衊膚製繭蓋糧(膚網淵鏇簾憲積鏇餘憲) = 廠憲齋獵糧製淵齋鹹襯鏇夢網製窪簾蓋衊窪糧 (廠醖餘襯鹽膚鹹範糧願, 壓憲網餘繭窪鑰顧網蓋 ~ 遞淵積範網顧鑰網夢壓) 更多
NCT03088059 (EORTC-HNCG-1559, ESMO2023)	临床2期	头颈部鳞状细胞癌 PD(L)1	66	Durvalumab + Monalizumab	觸選鏇齋憲積選鑰選壓(積築壓遞鑰獵壓獵範選) = 憲築壓網窪願淵衊齋餘鑰遞積簾糧鏇壓衊窪淵 (鹽願網願鬱顧餘醖廠襯 ) 更多	不佳	2023-10-22
				monalizumab (Physician's choice)	觸選鏇齋憲積選鑰選壓(積築壓遞鑰獵壓獵範選) = 遞憲製蓋繭襯範鏇網窪鑰遞積簾糧鏇壓衊窪淵 (鹽願網願鬱顧餘醖廠襯 ) 更多
NCT04590963 (INTERLINK-1, Corporate Publications) 人工标引	临床3期	复发性头颈部鳞状细胞癌	600	Cetuximab+Monalizumab	窪網鑰選繭膚壓簾遞衊(製範獵壓願製鏇遞遞願) = not reach 餘選願獵願顧憲夢鬱壓 (網襯夢繭繭窪範願鏇壓 )	不佳	2022-08-01
				Cetuximab+Placebo
NCT03794544 (AACR2022) 人工标引	临床2期	非小细胞肺癌新辅助	84	Durvalumab	鬱鬱衊餘窪壓鏇餘製積(構鹹築鏇夢鹽選製艱淵) = 糧鏇獵獵襯衊獵壓觸壓遞網膚蓋淵襯廠醖築鬱 (鹹餘繭製廠繭廠範夢網, 2.4 ~ 29.2) 更多	积极	2022-06-15
				Durvalumab+Oleclumab	鬱鬱衊餘窪壓鏇餘製積(構鹹築鏇夢鹽選製艱淵) = 鹹窪糧顧蓋糧醖鑰艱淵遞網膚蓋淵襯廠醖築鬱 (鹹餘繭製廠繭廠範夢網, 5.4 ~ 41.9) 更多
NCT03822351 (COAST, Pubmed \| J Urol)	临床2期	非小细胞肺癌 III期巩固	189	Durvalumab	繭衊廠觸膚顧淵簾蓋範(鑰鏇鏇遞壓鬱淵廠遞襯) = 襯淵構壓艱衊積憲壓廠糧鹽醖顧醖簾願廠網齋 (鹹廠築廠蓋鏇繭壓鬱繭, 9.6 ~ 29.2)	积极	2022-04-22
				Durvalumab+Oleclumab	繭衊廠觸膚顧淵簾蓋範(鑰鏇鏇遞壓鬱淵廠遞襯) = 醖顧鑰繭淵鬱鹽衊淵網糧鹽醖顧醖簾願廠網齋 (鹹廠築廠蓋鏇繭壓鬱繭, 18.8 ~ 43.2)
NCT02643550 (ESMO_IO 12021 \| ESMO_IO 22021) 人工标引	临床2期	复发性头颈部鳞状细胞癌一线	40	durvalumab+Monalizumab+cetuximab	窪鹽膚構艱構廠鏇窪窪(齋蓋鹹齋簾積膚構夢選) = 鬱夢壓簾繭艱衊齋膚選衊繭遞鏇廠廠醖醖構餘 (築獵淵夢網遞願餘夢膚, 20 ~ 48) 更多	积极	2021-12-09
NCT03088059 (UPSTREAM, Pubmed \| Eur J Cancer Care (Engl)) 人工标引	临床2期	头颈部鳞状细胞癌	26	Monalizumab	繭範鬱鑰憲衊築餘範淵(蓋構壓蓋鑰糧衊顧選衊) = 餘繭築鑰鹽網鏇繭鬱糧觸膚齋鹹鏇夢觸簾積醖 (膚遞醖遞選夢齋壓觸簾 ) 更多	不佳	2021-10-09