An Open-label Randomised, Phase II Trial of Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer

The DIAMOND study is being carried out to evaluate if Datopotamab deruxtecan (Dato-DX) in combination with Durvalumab is more effective than Dato-DXd alone in treating PDL1-negative advanced or metastatic triple negative breast cancer (TNBC). Globally, breast cancer is the most common malignancy in women and the second most common cancer overall. The term TNBC is used to define tumours that do not express oestrogen receptors, progesterone receptors and HER2 receptors. TNBC comprises 10 -15% of all breast cancers. It remains the subtype with poorest outcome and there is a significant need to develop new therapies for this group of patients especially. Moreover, the PDL1-negative tumour has demonstrated no benefit from standard 1st line treatment of chemotherapy plus immune checkpoint inhibitors.

开始日期2025-08-01

申办/合作机构

Queen Mary University of London

[+1]

NCT06822543

/ Not yet recruiting临床2期IIT

A Single Arm, Phase 2 Study of Datopotamab Deruxtecan, Carboplatin, and Pembrolizumab for Treatment-naive Brain Metastases From NSCLC (Non-small Cell Lung Cancer)

This is a Phase II, single-arm, multicenter trial for patients with metastatic non-small cell lung cancer who have brain metastases and no known actionable mutations. Eligible patients will receive a combination of Datopotamab-deruxtecan, Carboplatin, and Pembrolizumab every three weeks for four cycles, followed by maintenance therapy with Datopotamab-deruxtecan and Pembrolizumab until disease progression or intolerable toxicity. Patients with intracranial progression but no systemic progression may receive stereotactic radiosurgery and continue treatment based on the investigator's decision.

开始日期2025-06-30

申办/合作机构

Merck Sharp & Dohme LLC

[+1]

NCT06676917

/ Not yet recruiting临床2期

A Multicenter, Open-label, Non-comparative, Single-arm, Phase II Trial of Datopotamab Deruxtecan for Non-small Cell Lung Cancer Patients with Active Brain Metastases (The TUXEDO-5 Study)

This trial will study a type of advanced lung cancer that is defined as non-squamous non-small cell lung cancer (NSCLC) with active brain metastases (BMs). This type of cancer originates in peripheral lung tissue, which is composed of cancer cells that look different from normal lung cells when viewed under a microscope and is characterized by the presence of BMs, which indicates the spreading of such cancer cells into the brain. NSCLC tumors often have specific genetic alterations or mutations that drive their growth and are known as actionable genomic alterations (AGA). This trial will include patients with NSCLC tumors characterized by the presence or absence of such AGA. Patients will be treated with datopotamab deruxtecan (Dato-DXd), a Tumor-associated calcium signal transducer 2 (TROP2)-directed antibody drug conjugate (ADC) that works by targeting TROP2 protein that is differentially expressed in cancer cells. The main purpose of the study is to analyze the efficacy (to find out how effective a treatment is) of Dato-DXd in patients who have NSCLC with active BMs. Dato-DXd efficacy will be determined by assessing the proportion of patients who experience a significant reduction in tumor size or whose cancer disappears completely, as determined at any timepoint during the study period by the investigators conducting the trial.

开始日期2025-04-01

申办/合作机构

Medica Scientia Innovation Research SL

[+1]

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项与德达博妥单抗相关的文献（医药）

2025-12-31·mAbs

Antibodies to watch in 2025

Review

作者: Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Visweswaraiah, Jyothsna ; Reichert, Janice M. ; Wang, Lin

The commercial development of antibody therapeutics is a global enterprise involving thousands of biopharmaceutical firms and supporting service organizations. To date, their combined efforts have resulted in over 200 marketed antibody therapeutics and a pipeline of nearly 1,400 investigational product candidates that are undergoing evaluation in clinical studies as treatments for a wide variety of diseases. Here, we discuss key events in antibody therapeutics development that occurred during 2024 and forecast key events related to the late-stage clinical pipeline that may occur in 2025. In particular, we report on 21 antibody therapeutics granted a first approval in at least one country or region during 2024, including bispecific antibodies tarlatamab (IMDELLTRA®), zanidatamab (Ziihera®), zenocutuzumab (BIZENGRI®), odronextamab (Ordspono®), ivonescimab (®), and antibody-drug conjugate (ADC) sacituzumab tirumotecan (®). We also discuss 30 investigational antibody therapeutics for which marketing applications were undergoing review by at least one regulatory agency, as of our last update on December 9, 2024, including ADCs datopotamab deruxtecan, telisotuzumab vedotin, patritumab deruxtecan, trastuzumab botidotin, becotatug vedotin, and trastuzumab rezetecan. Of 178 antibody therapeutics we include in the late-stage pipeline, we summarize key data for 18 for which marketing applications may be submitted by the end of 2025, such as bi- or multispecific antibodies denecimig, sonelokimab, erfonrilimab, and anbenitamab. Key trends in the development and approval of antibody formats such as bispecifics and ADCs, as well as clinical-phase transition and global approval success rates for these antibody formats, are reported.

2025-12-01·Current Neurology and Neuroscience Reports

Emerging Therapies for Brain Metastases in NSCLC, Breast Cancer, and Melanoma: A Critical Review

Review

作者: Gowda, Maya ; Camacho, Alejandra M ; Ranjan, Tulika ; Ahluwalia, Manmeet S ; Podder, Vivek

PURPOSE OF REVIEW:

Advancements in precision medicine have shifted the treatment paradigm of brain metastases (BM) from non-small cell lung cancer (NSCLC), breast cancer, and melanoma, especially through targeted therapies focused on specific molecular drivers. These novel agents have improved outcomes by overcoming challenges posed by the blood-brain barrier (BBB) and resistance mechanisms, enabling more effective treatment of BM.

RECENT FINDINGS:

In NSCLC, therapies such as osimertinib have improved efficacy in treating EGFR-mutant BM, with emerging combinations such as amivantamab and lazertinib offering promising alternatives for patients resistant to frontline therapies. In HER2-positive breast cancer, significant advancements with tucatinib and trastuzumab deruxtecan (T-DXd) have transformed the treatment landscape, achieving improved survival and intracranial control in patients with BM. Similarly, in triple-negative breast cancer (TNBC), novel therapies such as sacituzumab govitecan (SG) and datopotamab deruxtecan (Dato-DXd) offer new hope for managing BM. For melanoma, the combination of immune checkpoint inhibitors such as nivolumab and ipilimumab has proven effective in enhancing survival for patients with BM, both in BRAF-mutant and wild-type cases. Developing targeted therapies penetrating the BBB has revolutionized BM treatment by targeting key drivers like EGFR, ALK, HER2, and BRAF. Despite improved survival, challenges persist, particularly for patients with resistant genetic alterations. Future research should optimise combination therapies, overcome resistance, and refine treatment sequencing. Continued emphasis on personalized, biomarker-driven approaches offers the potential to further improve outcomes, even for complex cases.

2025-05-01·Cancer research communications

Preclinical Activity of Datopotamab Deruxtecan, an Antibody–Drug Conjugate Targeting Trophoblast Cell-Surface Antigen 2, in Uterine Serous Carcinoma

Article

作者: Santin, Alessandro D. ; Hartwich, Tobias M.P. ; Yang-Hartwich, Yang ; Demirkiran, Cem ; Santin, Niccolo G. ; Bellone, Stefania ; Papatla, Katyayani ; Sethi, Namrata ; Ettorre, Victoria M. ; Ratner, Elena ; McNamara, Blair ; Greenman, Michelle

Abstract:

Uterine serous carcinoma (USC) is a rare subset of endometrial cancer with a poor prognosis and high recurrence rate. Datopotamab deruxtecan (Dato-DXd) is a novel antibody–drug conjugate (ADC). The objective of this study was to evaluate the preclinical activity of Dato-DXd in USC in vitro against primary USC cell lines with various trophoblast cell-surface antigen 2 (TROP2) expression and in vivo in TROP2-overexpressing cell line–derived mice xenografts. USC primary tumor cell lines were treated with Dato-DXd and a control ADC (CTL ADC) to evaluate cell viability following exposure. Antibody-dependent cell-mediated cytotoxicity against TROP2-overexpressing and -nonexpressing cell lines was evaluated using a 4-hour chromium release assay. USC xenografts in mice were treated with Dato-DXd, CTL ADC, datopotamab, and vehicle to assess the in vivo effects via retro-orbital Dato-DXd administration. We found USC cell lines with TROP2 overexpression to be significantly more sensitive to killing induced by Dato-DXd compared with CTL ADC in vitro (e.g., IC50: 0.11 µmol/L vs. 30.07 µmol/L, P = 0.0074 and 0.11 µmol/L vs. 48.95 µmol/L, P = 0.0127, respectively). Dato-DXd induced antibody-dependent cell-mediated cytotoxicity in the presence of peripheral blood lymphocytes from healthy donors. TROP2-nonexpressing cell lines demonstrated minimal killing by Dato-DXd; however, when admixed with TROP2-overexpressing cells, a significant bystander effect was appreciated. In vivo, mice xenografts overexpressing TROP2 treated with Dato-DXd demonstrated tumor growth suppression and longer overall survival compared with CTL ADC–treated xenografts. These data demonstrate Dato-DXd to be highly active against TROP2-overexpressing USC in vitro and in vivo. Our preclinical activity results warrant future clinical trials for patients with advanced or recurrent USC.

Significance::

Targeted treatment of USC using the biomarker TROP2 represents a significant opportunity for further treatment options for patients already resistant to other lines of treatment. In this study, we present data showing preclinical evidence of effectiveness of this biomarker-targeted therapy in USC.

920

项与德达博妥单抗相关的新闻（医药）

2025-05-19

·PRNewswire

Compugen Reports First Quarter 2025 Results

Initiated platform trial of COM701 maintenance therapy in patients with platinum sensitive ovarian cancer in Q2 2025 Recruitment ongoing in the first in human Phase 1 trial of GS-0321 (previously COM503), a potential first-in-class anti-IL18BP antibody licensed to Gilead Partner AstraZeneca expanded their rilvegostomig program to ten Phase 3 trials across lung, gastrointestinal and endometrial cancers and plans to share early data for rilvegostomig at ASCO Solid financial position with cash runway expected to fund operations into 2027 Key leadership transitions to take effect in September 2025 HOLON, Israel, May 19, 2025 /PRNewswire/ -- Compugen Ltd. (Nasdaq: CGEN) (TASE: CGEN) a clinical-stage cancer immunotherapy company and a pioneer in computational target discovery, today reported financial results for the first quarter of 2025 and provided a corporate update. "We continued to advance our diverse innovative clinical and early-stage pipeline," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We initiated and activated the first site in our randomized placebo-controlled trial evaluating single agent COM701 maintenance therapy in patients with relapsed platinum sensitive ovarian cancer (sub-trial 1). We are working diligently to dose the first patient and activate additional sites. In addition, we continue to advance our Phase 1 trial for GS-0321 a potential first-in-class anti-IL18BP antibody licensed to Gilead." Dr. Cohen-Dayag continued, "We are encouraged by the progress our partner AstraZeneca is making with its rilvegostomig program which is notably the largest ongoing Phase 3 program in the TIGIT space. Rilvegostomig is a PD-1/TIGIT bispecific antibody, the TIGIT component of which is derived from COM902. AstraZeneca has increased the number of its Phase 3 trials with rilvegostomig to ten trials across lung, gastrointestinal and endometrial cancers. At the upcoming ASCO 2025 conference, as part of poster presentations, AstraZeneca plans to share early data for rilvegostomig in combination with the ADC Datroway in first-line advanced non-small-cell-lung cancer and in combination with chemotherapy in first-line advanced biliary tract cancer. AstraZeneca's broad development strategy for rilvegostomig to replace existing PD(L)-1 inhibitors represents a significant potential revenue source for Compugen as we are eligible for both future milestone payments and mid-single digit tiered royalties on future sales." Dr. Cohen-Dayag added, "Our solid financial position with a cash runway expected to fund our operations into 2027 allows us to advance our innovative clinical and early-stage pipeline. Additionally, it enables us to continue to leverage our AI/ML powered predictive computational discovery platform, Unigen™, to accelerate our research efforts supporting our early-stage pipeline. We are also excited about the upcoming leadership changes which will come into effect in September 2025. I will assume the newly created role of Executive Chair of the Board of Directors, and Dr. Eran Ophir, currently Chief Scientific Officer, will become President and Chief Executive Officer and will join the Board of Directors. We believe this combination of leadership ensures a solid foundation for the Company's next phase of growth." Next Planned Milestones ASCO 2025: Compugen's partner, AstraZeneca, plans to present early data as poster presentations from two ongoing Phase 2 rilvegostomig trials: First-line Dato-DXd + rilvegostomig in advanced or metastatic non-small cell lung cancer: Results from TROPION-Lung04 (cohort 5) First-line rilvegostomig plus chemotherapy in advanced biliary tract cancer: Primary analysis of GEMINI-Hepatobiliary sub-study 2 (cohort A) H2 2026: data from projected interim analysis of single agent COM701 sub-trial 1 as maintenance therapy in relapsed platinum sensitive ovarian cancer First Quarter 2025 Financial Highlights Cash: As of March 31, 2025, Compugen had approximately $103.7 million in cash, cash equivalents, short-term bank deposits, and investment in marketable securities. The cash balance includes the previously reported proceeds raised through the Company's ATM, in January and February 2025. Compugen expects that its cash and cash-related balances will be sufficient to fund its operating plans into 2027. This does not include any additional cash inflows. The Company has no debt. Revenue: Compugen reported approximately $2.3 million in revenues for the first quarter ended March 31, 2025, compared to approximately $2.6 million in revenues for the comparable period in 2024. The revenues reported in the first quarter of 2025 reflect recognition of portions of both the upfront payment and the IND milestone payment from the license agreement with Gilead. The revenues reported in the first quarter of 2024 reflect recognition of portions of the upfront payment from the license agreement with Gilead. R&D expenses for the first quarter of 2025 were approximately $5.8 million compared with approximately $6.4 million for the comparable period in 2024. G&A expenses were approximately $2.4 million for the first quarters of 2025 and 2024. Net loss for the first quarter of 2025 was approximately $7.2 million, or $0.08 per basic and diluted share, compared with a net loss of approximately $7.3 million, or $0.08 per basic and diluted share, in the first quarter of 2024. Full financial tables are included below. Conference Call and Webcast Information The Company will hold a conference call today, May 19, 2025, at 8:30 AM ET to review its first quarter 2025 results. To access the conference call by telephone, please dial 1-866-744-5399 from the United States, or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen's website, located at the following link. Following the live audio webcast, a replay will be available on the Company's website. About Compugen Compugen is a clinical-stage therapeutic discovery and development company utilizing its broadly applicable predictive computational discovery platform (Unigen™) to identify new drug targets and biological pathways for developing cancer immunotherapies. Compugen has two proprietary product candidates in Phase 1 development: COM701, a potential first-in-class anti-PVRIG antibody and COM902, a potential best-in-class antibody targeting TIGIT for the treatment of solid tumors. Rilvegostomig, a PD-1/TIGIT bispecific antibody where the TIGIT component is derived from Compugen's clinical stage anti-TIGIT antibody, COM902, is in Phase 3 development by AstraZeneca through a license agreement for the development of bispecific and multispecific antibodies. GS-0321 (previously COM503), a potential first-in-class, high affinity anti-IL-18 binding protein antibody, which is in Phase 1 development is licensed to Gilead. In addition, the Company's therapeutic pipeline of early-stage immuno-oncology programs consists of research programs aiming to address various mechanisms to enhance anti-cancer immunity. Compugen is headquartered in Israel, with offices in San Francisco, CA. Compugen's shares are listed on Nasdaq and the Tel Aviv Stock Exchange under the ticker symbol CGEN. Forward-Looking Statement This press release contains "forward-looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended, and the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on the current beliefs, expectations, and assumptions of Compugen. Forward-looking statements can be identified using terminology such as "will," "may," "expects," "anticipates," "believes," "potential," "plan," "goal," "estimate," "likely," "should," "confident," and "intends," and similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements include, but are not limited to, statements regarding our expectations to dose the first patient and activate additional sites in our randomized placebo-controlled trial evaluating single agent COM701 maintenance therapy in patients with relapsed platinum sensitive ovarian cancer (sub-trial 1); statements regarding the advancement of Phase 1 trial for GS-0321, statements regarding the potential capabilities of GS-0321, a potential first-in-class anti-IL18BPB antibody licensed to Gilead; statements regarding the progress of AstraZeneca with its rilvegostomig program; statements regarding the timing of any data announcement by AstraZeneca regarding two ongoing Phase 2 rilvegostomig trials (including the ASCO 2025 presentation); statements regarding the capability of rilvegostomig to replace existing PD(L)-1 inhibitors; statements regarding rilvegostomig as a significant potential revenue source for Compugen, and Compugen's potential receipt of future milestone payments and mid-single-digit tiered royalties on future sales; statements to the effect that our cash and cash-related balances will be sufficient to fund our operating plans into 2027; statements that our cash position will enable us to continue to leverage our AI/ML-powered predictive computational discovery platform, Unigen™, to accelerate our research efforts supporting our early-stage pipeline; and statements regarding our upcoming leadership changes and our belief that the upcoming leadership changes ensure a solid foundation for the Company's next phase of growth. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance, or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Among these risks: the clinical trials of any product candidates that Compugen, or any current or future collaborators, may develop may fail to satisfactorily demonstrate safety and efficacy to the FDA, and Compugen, or any collaborators, may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates; Compugen's business model is substantially dependent on entering into collaboration agreements with third parties and Compugen may not be successful in generating adequate revenues or commercializing aspects of its business model; Compugen's approach to the discovery of therapeutic products is based on its proprietary computational target discovery infrastructure, which is unproven clinically; general market, political and economic conditions in the countries in which Compugen operates, including Israel; the effect of the evolving nature of the recent war in Israel; and Compugen does not know whether it will be able to discover and develop additional potential product candidates or products of commercial value. These risks and other risks are more fully discussed in the "Risk Factors" section of Compugen's most recent Annual Report on Form 20-F as filed with the Securities and Exchange Commission (SEC) as well as other documents that may be subsequently filed by Compugen from time to time with the SEC. In addition, any forward-looking statements represent Compugen's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Compugen does not assume any obligation to update any forward-looking statements unless required by law. Company contact: Yvonne Naughton, Ph.D. Head of Investor Relations and Corporate Communications Email: [email protected] Tel: +1 (628) 241-0071 SOURCE Compugen Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期临床2期引进/卖出高管变更财报

2025-05-16

·九洲药业

【速递】ADC+IO的3期试验达终点：Trodelvy+K药1L治疗TNBC

首个关键性3期临床试验，旨在证明TTROP-2靶向抗体-药物偶联物Trodelvy联合Keytruda治疗一线mTNBC优于标准治疗（帕博利珠单抗（Keytruda®）；Trodelvy联合Keytruda显示出与标准治疗相比，在未经治疗的PD-L1+(CPS ≥10)mTNBC患者中总体生存率改善的早期趋势。Jiuzhou News 近日，吉利德科学公司公布了其Ⅲ期临床试验ASCENT-04/KEYNOTE-D19的积极关键结果。结果表明，Trodelvy®(sacituzumab govitecan-hziy)联合Keytruda®(pembrolizumab)疗法，相比Keytruda联合化疗，显著改善了无法手术（无法切除）的局部晚期或转移性三阴性乳腺癌(mTNBC) 且肿瘤表达PD-L1（CPS≥10）患者的无进展生存期(PFS)。该研究达到了其主要终点，PFS获得了具有统计学意义和临床意义的改善。ASCENT-04研究中，Trodelvy与Keytruda的安全性与每种药物已知的安全性一致。该组合未发现新的安全信号。吉利德科学首席医疗官、医学博士Dietmar Berger表示：“这些研究结果首次展现了抗体-药物偶联物与免疫肿瘤药物联合应用于转移性乳腺癌早期治疗的转化潜力。对于患有这种难治性乳腺癌的患者，这些结果可能为他们提供一种新的治疗途径，从而重新定义他们的治疗方案。”“对于转移性三阴性乳腺癌患者，我们迫切需要更有效的治疗方案，” Dana-Farber癌症研究所、ASCENT-04研究首席研究员、医学博士、公共卫生硕士Sara Tolaney博士说道。“这些数据表明，sacituzumab govitecan-hziy与pembrolizumab的联合疗法或将提供一种新的治疗方法——将强效抗体药物偶联物与免疫疗法相结合，以改善患者的疗效。”总生存期(OS)是关键的次要终点，在PFS主要分析时尚不成熟。然而，在 ASCENT-04研究中，Trodelvy联合Keytruda疗法的OS呈现出早期改善趋势。吉利德将继续监测OS结果，并计划持续随访患者并进行进一步分析。关于PD-L1+的TNBCTNBC是最具侵袭性的乳腺癌类型，历来难以治疗，约占所有乳腺癌的15%。TNBC在年轻女性和绝经前女性中更常见，在黑人和西班牙裔女性中更为常见。TNBC细胞没有雌激素和孕激素受体，并且HER2表达有限。由于TNBC的特性，与其他类型的乳腺癌相比，治疗选择极其有限。与其他类型的乳腺癌相比，TNBC的复发和转移概率更高。转移性TNBC的平均复发时间约为2.6年，而其他乳腺癌为5年，且五年生存率要低得多。在转移性TNBC女性中，五年生存率为12%，而其他类型转移性乳腺癌的五年生存率为28%。尽管治疗领域取得了进展，但近年来，针对表达PD-L1+的mTNBC的一线治疗获批的药物有限，迫切需要更多治疗选择。表达PD-L1的乳腺癌总体上更具侵袭性，并且与生存期缩短相关。关于ASCENT-04/KEYNOTE-D19研究2021年，吉利德与默沙东公司合作，在3期临床试验ASCENT-04/KEYNOTE-D19中研究sacituzumab govitecan联合pembrolizumab的疗效。ASCENT-04/KEYNOTE-D19研究是一项全球开放标签、随机3期试验，旨在评估sacituzumab govitecan联合pembrolizumab治疗既往未接受治疗、无法手术的局部晚期或转移性TNBC患者（肿瘤表达PD-L1）的疗效和安全性，并与化疗联合pembrolizumab治疗进行比较。该研究在多个研究中心入组了443名患者。患者按1:1的比例随机分配接受sacituzumab govitecan（10 mg/kg，静脉注射，21天为一个周期，第1天和第8天）联合pembrolizumab（200 mg，静脉注射，21天为一个周期），或化疗联合pembrolizumab治疗。化疗方案包括吉西他滨联合卡铂、紫杉醇或白蛋白结合型紫杉醇。治疗持续至经盲法独立中心审查(BICR)验证的疾病进展或出现不可接受的毒性。随机分配至化疗组的患者，在疾病进展后可交叉接受sacituzumab govitecan治疗。该研究的主要终点是无进展生存期(PFS)，由BICR根据RECIST v1.1确定。次要终点包括总生存期(OS)、客观缓解率(ORR)、缓解持续时间(DOR)、缓解起效时间(TTR)、患者报告结果(PRO)和安全性。关于 TrodelvyTrodelvy®(sacituzumab govitecan-hziy)是同类首创的Trop-2靶向抗体-药物偶联物。Trop-2是一种细胞表面抗原，在多种肿瘤类型中高表达，包括90%以上的乳腺癌和肺癌。Trodelvy特意设计了一种专有的可水解连接体，该连接体与拓扑异构酶I抑制剂SN-38连接。这种独特的组合通过旁观者效应，对表达Trop-2的细胞和肿瘤微环境均具有强效活性。小结这是TROP2 ADC药物在肿瘤的一线疗法里首次取得了佳绩。2020年吉利德花210亿美元收购Immunomedics公司，获得了Trodelvy之后，整个TROP2 ADC药物赛道就没有出现过较为振奋人心的消息了。乳腺癌方面，Trodelvy在2023年凭借TROPiCS-02试验，获得了FDA的批准，拿下了2/3L HR+/HER2-乳腺癌这个适应症，但在OS的获益方面，并不是十分明显，Trodelvy组的中位OS为14.4个月，对照药组为11.2个月，仅延长了3.2个月，风险获益比HR为0.789，p值为0.0200。好歹Trodelvy在2/3L HR+/HER2-乳腺癌这个适应症上是有生存获益的，但另一款TROP2 ADC药物Datroway就显得更加无力了。Datroway在2025年凭借TROPION-Breast01试验，获得了FDA的批准，拿下了2/3L HR+/HER2-乳腺癌这个适应症，给药组和对照组的中位OS分别为18.6个月和18.3个月，HR为1.01，P值不具有统计学意义。非小细胞肺癌方面，Trodelvy在2024年宣布其治疗末线非小细胞肺癌的EVOKE-01试验未达到主要终点OS，生存改善不具有统计学意义。另一款竞品Datroway在2023年宣布其治疗末线非小细胞肺癌的TROPION-Lung01试验达到主要终点PFS，但OS在中期分析时不具有统计学意义。事后通过分析不同病理组织特征的人群，发现在非鳞癌人群里具有一定的生存获益，而后在2024年底撤回了TROPION-Lung01试验的上市申请，转而递交2期TROPION-Lung05试验以及TROPION-Lung01试验的部分数据，寻求加速批准。这次Trodelvy在1L TNBC的数据公布，虽然OS的评估尚未成熟，但已经观察到早期的获益趋势，结合Trodelvy过去在3L TNBC以及2/3L HR+/HER2-乳腺癌的OS获益情况，或许在未来OS数据成熟的时候，也能够给患者带来较为明确的OS获益。▲临床在研的TROP2 ADC药物▲布局3期临床的TROP2 ADC药物▲披露结构式的TROP2 ADC药物参考资料1.https://www.gilead.com/news/news-details/2025/trodelvy-plus-keytruda-demonstrates-a-statistically-significant-and-clinically-meaningful-improvement-in-progression-free-survival-in-patients-with-previously-untreated-pd-l1-metastatic-trip2.https://www.gilead.com/news/news-details/2020/gilead-sciences-to-acquire-immunomedics3.https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-hr-positive-breast-cancer4.https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-hr-positive-her2-negative-breast5.https://www.gilead.com/news/news-details/2024/gilead-provides-update-on-phase-3-evoke-01-study6.https://www.astrazeneca.com/media-centre/press-releases/2023/datopotamab-deruxtecan-met-dual-primary-endpoint-of-progression-free-survival-in-patients-with-advanced-non-small-cell-lung-cancer.html7.https://www.astrazeneca.com/media-centre/press-releases/2024/dato-dxd-new-bla-submitted-nsq-bla-withdrawn.html免责声明本公众号注明原创的内容权利均属九洲药业所有，未经授权，不得擅自使用或许可他人使用。如需获得授权，请和九洲药业提前联系。已获得授权的，应在授权范围内使用，并注明来源且不得再全部或部分转授权他人。本公众号对转载、分享的内容、陈述、观点判断保持中立，不对所包含内容的合法性、准确性、可靠性或完善性提供任何明示或暗示的保证，该等内容版权归原作者所有，仅供学习参考之用，若对转载、分享的内容有任何权利疑问，烦请联系九洲药业。

临床3期免疫疗法临床结果临床成功引进/卖出

2025-05-13

·摩熵医药

4月166款新药获批临床！72款纳入特殊审评，涉及阿斯利康，百济神州…

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。4月全球在研新药月报内容亮点4月国内新药获批临床情况2025年4月共有166款新药获批临床；较上个月减少了70款，其中包括68款化药，93款生物制品，5款中药；4月获批临床受理号数量最多的新药为抗肿瘤药和免疫机能调节药物，有114个；4月共有72款药物获孤儿药/突破性/快速通道资格认定品种。全球获孤儿药/突破性/快速通道资格认定品种盘点3月共有54款药物获孤儿药/突破性/快速通道资格认定品种。全球在研创新药积极/失败临床结果最新动态速递阿斯利康抗体偶联药物Datroway 3期临床结果积极，针对乳腺癌；赛诺菲Amlitelimab 2期临床研究未达到主要终点；BriaCell Therapeutics公司癌症疫苗联合疗法2期临床结果公布，生存率提高约70%；Revolution Medicines选择性抑制剂zoldonrasib 1期临床数据公布，缓解率61%。每月相关创新药最新政策速递、国内新药注册申报、全球获孤儿药/突破性/快速通道资格认定品种盘点、全球在研创新药积极/失败临床结果TOP20、全球创新药研发进展TOP20等，摩熵咨询团队基于真实可溯源的全球医药数据，将每月推出「全球在研新药月报」，以期帮助业内人士通盘把握每月全球范围内的新药开发情况，全面而深入的了解全球新药开发动态。014月国内新药获批临床/上市情况根据摩熵医药数据库统计，2025年4月共有166款新药获批临床（共计244个受理号），较上个月减少了70款，其中包括68款化药，93款生物制品，5款中药。截图来源：摩熵咨询月报本月获批临床受理号数量最多的新药为抗肿瘤药和免疫机能调节药物，有114个，占比为47%，消化系统与代谢药物获批数量也比较多，有19个。获批剂型主要为注射剂与片剂，分别有126个，85个。截图来源：摩熵咨询月报在4月份，国内医药市场迎来了9款创新药物的获批上市，涉及上海信致医药的波哌达可基注射液，用于治疗中重度血友病B；此外还有兴和制药的佩玛贝特片，用于治疗高脂血症。截图来源：摩熵咨询月报02全球获孤儿药/突破性/快速通道资格认定品种盘点4月共有72款药物获孤儿药/突破性/快速通道资格认定。4月17日，CDE官网显示，百济神州的索托克拉片（Sonrotoclax）拟纳入优先审评，用于治疗既往接受过抗CD20治疗和BTKi治疗的套细胞淋巴瘤（MCL）成人患者和CLL/SLL。索托克拉是百济神州开发的一款新一代BCL-2抑制剂，旨在阻断可帮助肿瘤细胞存活的B细胞淋巴瘤2（BCL2）蛋白。索托克拉属于一组被称为BH3模拟物的药物，可模拟自然细胞死亡信号。实验室和早期药物开发研究结果表明，索托克拉是一种强效且具有特异性的BCL-2抑制剂，半衰期短且无蓄积。4月本月全球孤儿药/突破性/快速通道资格认定品种（部分）一览表备注：完整数据识别文末二维码下载查看03全球在研创新药积极/失败临床结果TOP20在4月全球创新药研发动态中，4月12日，阿斯利康（AstraZeneca）和第一三共（Daiichi Sankyo）联合宣布，Datroway（datopotamab deruxtecan）已获欧盟委员会批准，用于治疗接受过内分泌治疗且在晚期至少接受过一线化疗的不可切除或转移性激素受体（HR）阳性、HER2阴性乳腺癌成年患者。欧盟委员会的批准是基于3期临床试验TROPION-Breast01的结果。经BICR评估，Datroway与研究者选择的化疗相比，使HR阳性、HER2阴性转移性乳腺癌患者的疾病进展或死亡风险降低了37%（HR=0.63；95% CI：0.52-0.76；p<0.0001）。Datroway组的中位PFS为6.9个月，而化疗组为4.9个月。Datroway组的确认客观缓解率（ORR）为36%，而化疗组为23%。Datroway组的中位缓解持续时间（DoR）为6.7个月（95% CI：5.6-9.8），化疗组为5.7个月（95% CI：4.9-6.8）。截图来源：摩熵医药全球药物研发数据库此外，4月15日，赛诺菲公布了Amlitelimab治疗哮喘的2期TIDE-Asthma研究，患者在前24周每四周接受一次Amlitelimab治疗，在剩余的36周每12周接受一次治疗，直至第60周。主要终点是重度哮喘发作的年发生率，关键次要终点包括肺功能和哮喘控制。初步结果表明，在最高剂量水平下，未达到第 48 周年化恶化率的主要终点。但中等剂量组相比安慰剂组显示出“统计学显著且具有临床意义”的哮喘发作次数降低。另外，在60周时，高剂量组哮喘发作次数获得更显著的数值减少。在亚组分析中，赛诺菲特别指出amlitelimab在异质性炎症哮喘患者群体中展现出“令人信服的疗效”。公司声明称，若后续研究能验证这一发现，可能为这一长期缺乏有效疗法的患者群体带来突破性治疗方案。全球在研创新药积极/失败临床结果TOP20备注：完整数据识别文末二维码下载查看04全球创新药研发进展TOP20在4月全球创新药研发进展TOP20榜单中，亮点纷呈。4月9日，中国国家药监局药品审评中心（CDE）官网公示，先声药业旗下先祥医药申报的1类新药注射用SIM0686获批临床，拟开发治疗FGFR2b阳性的局部晚期/转移性实体瘤。公开资料显示，这是一款靶向FGFR2b的抗体偶联药物（ADC），先声药业拟开发该产品治疗胃癌和肺癌等晚期恶性肿瘤。本次是该产品首次在中国获批IND。截图来源：摩熵医药全球药物研发数据库4月14日，默沙东宣布，佳达修9[九价人乳头瘤病毒疫苗（酿酒酵母）]（后称“九价HPV疫苗”）多项新适应证已获得中国国家药品监督管理局（NMPA）的上市批准，适用于16~26岁男性接种。这一获批使佳达修9成为中国获批、可适用于适龄男性女性接种的九价HPV疫苗。佳达修9 覆盖6、11、16、18、31、33、45、52 和 58 型，共九种HPV型别。此次获批的男性适应证可预防HPV16、18引起的肛门癌，HPV6和11引起的生殖器疣（尖锐湿疣），由HPV6、11、16、18引起的以下癌前病变或不典型病变：1级、2级、3级肛门上皮内瘤样病变（AIN）。截图来源：摩熵医药全球药物研发数据库2025年4月全球在研新药月报完整报告识别下方二维码获取完整《2025年4月全球在研新药月报》PDF版本报告在每月初定期发布，敬请期待END本文为原创文章，转载请留言获取授权近期热门资源获取数据透视：中药创新药、经典验方、改良型新药、同名同方的申报、获批、销售情况-2025042023H2-2024H1中国药品分析报告-2025042024年中国1类新药靶点白皮书-202503中国AI医疗健康企业创新发展百强榜单-202502解码护肤抗衰：消费偏好洞察与市场格局分析-2025022024年FDA批准上市的新药分析报告-2025012024年NMPA批准上市的新药分析报告-2025012024年医保谈判及市场分析报告-2025.012024年中国医疗健康投融资全景洞察报告-202501小分子化药白皮书（上）-2025012024医美注射材料市场发展分析报告-202412中国放射性药物产业白皮书-202410近期更多摩熵咨询热门报告，识别下方二维码领取联系我们，体验摩熵医药更多专业服务会议合作园区服务数据库咨询定制服务媒体合作👆👆👆点击上方图片，即可开启摩熵化学数据查询点击阅读原文，申请摩熵医药企业版免费试用！

孤儿药优先审批突破性疗法临床2期临床3期

100 项与德达博妥单抗相关的药物交易

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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
晚期非小细胞肺癌	加拿大	AstraZeneca Canada, Inc.	2025-03-01
HR阳性/HER2阴性乳腺癌	日本	Daiichi Sankyo Co., Ltd.	2024-12-27

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
EGFR突变的非小细胞肺癌	申请上市	美国	Daiichi Sankyo Co., Ltd.	2024-11-12
EGFR突变的非小细胞肺癌	申请上市	美国	AstraZeneca PLC	2024-11-12
局部晚期非鳞状非小细胞肺癌	申请上市	美国	Daiichi Sankyo, Inc.	2024-02-19
局部晚期非鳞状非小细胞肺癌	申请上市	美国	AstraZeneca PLC	2024-02-19
转移性非鳞状非小细胞肺癌	申请上市	美国	AstraZeneca PLC	2024-02-19
转移性非鳞状非小细胞肺癌	申请上市	美国	Daiichi Sankyo, Inc.	2024-02-19
肺腺癌	临床3期	美国	AstraZeneca PLC	2024-10-15
肺腺癌	临床3期	日本	AstraZeneca PLC	2024-10-15
肺腺癌	临床3期	比利时	AstraZeneca PLC	2024-10-15
肺腺癌	临床3期	巴西	AstraZeneca PLC	2024-10-15

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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


NCT04484142 (TROPION-Lung05, Pubmed \| J Clin Oncol)	临床2期	转移性非小细胞肺癌 EGFR mutations \| ALK rearrangements	137	Datopotamab deruxtecan 6 mg/kg	築簾鹹糧鹹範範鑰繭構(餘範簾網憲鑰廠築簾壓) = 範膚願構膚艱繭築餘醖廠簾網願網範遞製憲壓 (蓋齋製簾築窪鹹壓構壓, 27.8 ~ 44.4) 更多	积极	2025-04-01
NCT03944772 (ORCHARD, ESMO_ELCC2025) 人工标引	临床2期	EGFR突变的非小细胞肺癌二线 EGFRm	69	Osimertinib (80 mg QD) + Datopotamab Deruxtecan (4 mg/kg Q3W)	壓鏇窪遞糧糧網蓋願憲(鏇廠製膚齋衊選壓顧艱) = 壓構繭製廠構積襯範壓簾廠簾顧選觸觸觸築夢 (鏇遞網鏇範獵構範繭遞, 31 ~ 55) 更多	积极	2025-03-26
				Osimertinib (80 mg QD) + Datopotamab Deruxtecan (6 mg/kg Q3W)	壓鏇窪遞糧糧網蓋願憲(鏇廠製膚齋衊選壓顧艱) = 膚鑰遞夢鬱蓋鏇窪鏇糧簾廠簾顧選觸觸觸築夢 (鏇遞網鏇範獵構範繭遞, 25 ~ 49) 更多
NCT05460273 (TROPION-PanTumor02, ESMO_ELCC2025)	临床1/2期	非小细胞肺癌 TROP2 quantitative continuous scoring (QCS) normalised membrane ratio (NMR)	40	datopotamab deruxtecan (TROP2 QCS-NMR+ tumors)	簾糧壓壓鏇積鑰鹹簾餘(積鬱選蓋製網窪選夢鹽) = 膚齋衊範鬱鏇艱襯網憲網蓋遞壓襯簾夢製築繭 (顧糧顧衊淵鏇築觸願鑰, 0.32 ~ 0.77) 更多	积极	2025-03-26
				datopotamab deruxtecan (TROP2 QCS-NMR- tumors)	簾糧壓壓鏇積鑰鹹簾餘(積鬱選蓋製網窪選夢鹽) = 衊構糧簾獵糧鏇遞膚淵網蓋遞壓襯簾夢製築繭 (顧糧顧衊淵鏇築觸願鑰, 0.10 ~ 0.53) 更多
NCT04656652 (TROPION-LUNG01, ESMO_ELCC2025)	临床3期	转移性非鳞状非小细胞肺癌	468	Datopotamab deruxtecan (Dato-DXd) 6 mg/kg Q3W	壓鏇艱願積餘壓醖淵簾(簾襯膚鏇鬱夢選獵簾築): HR = 1.64 (95% CI, 1.09 ~ 2.46) 更多	积极	2025-03-26
				Docetaxel 75 mg/m2 Q3W
ESMO_ELCC2025	N/A	非小细胞肺癌 TROP2	914	Datopotamab deruxtecan 6 mg/kg	壓廠襯壓艱鏇糧醖壓壓(膚積蓋襯範艱範壓積衊) = 7% 鑰襯餘鑰鹽衊繭艱獵夢 (繭簾襯窪積積顧壓鹹繭 ) 更多	积极	2025-03-26
NCT04612751 (TROPION-Lung04, ESMO_TAT2025) 人工标引	临床1期	非小细胞肺癌一线	52	Dato-DXd + Durvalumab	簾選鬱鑰淵廠網廠鹽衊(構壓網衊願築遞蓋遞壓) = 夢築繭鹹鹹鏇選憲鏇糧繭糧艱繭壓繭選選遞鏇 (蓋醖蓋醖觸選艱網鏇蓋 ) 更多	积极	2025-03-03
				Dato-DXd + Durvalumab + Carboplatin	簾選鬱鑰淵廠網廠鹽衊(構壓網衊願築遞蓋遞壓) = 鬱鑰積餘構醖積遞簾艱繭糧艱繭壓繭選選遞鏇 (蓋醖蓋醖觸選艱網鏇蓋 ) 更多
NCT03401385 (TROPION-PanTumor01, ASCO_GU2025) 人工标引	临床1期	尿路上皮癌	40	Dato-DXd 6mg/kg	觸壓網廠鹽憲顧遞鹽餘(醖繭壓蓋蓋範蓋鏇築壓) = 壓鹽鑰夢選衊蓋衊築遞鬱醖衊願膚獵鹹齋願鏇 (窪築憲鹽膚簾鬱範窪醖, 12.7 41.2) 更多	积极	2025-02-13
NCT05104866 (TROPION-Breast01, FDA_CDER) 人工标引	临床3期	HR阳性/HER2阴性乳腺癌二线 \| 三线	732	DATROWAY 6 mg/kgDATROWAY 6 mg/kg	窪網糧遞淵網構廠顧糧(簾繭繭鹹獵鹽蓋衊繭鬱) = 鏇襯鬱壓築醖觸範艱憲積艱廠觸範齋鏇繭壓壓 (鑰醖構廠遞範網構觸夢, 5.7 ~ 7.4) 更多	积极	2025-01-17
				Chemotherapy	窪網糧遞淵網構廠顧糧(簾繭繭鹹獵鹽蓋衊繭鬱) = 鬱鬱壓齋觸齋夢願醖鹹積艱廠觸範齋鏇繭壓壓 (鑰醖構廠遞範網構觸夢, 4.2 ~ 5.5) 更多
NCT04484142 (TROPION-Lung05, Pubmed) 人工标引	临床2期	转移性非小细胞肺癌末线 ALK Rearrangement \| EGFR Mutation	137	Datopotamab deruxtecan 6 mg/kg	築簾窪廠鏇築獵選遞鑰(顧齋築簾遞膚淵壓顧觸) = 築獵積製蓋壓醖齋簾鑰獵觸憲選鏇糧積蓋蓋鑰 (獵觸範憲醖淵衊壓鏇繭, 27.8 ~ 44.4) 更多	积极	2025-01-06
				Datopotamab deruxtecan 6 mg/kg (EGFR mutations)	築簾窪廠鏇築獵選遞鑰(顧齋築簾遞膚淵壓顧觸) = 壓壓鏇壓繭網繭蓋簾鏇獵觸憲選鏇糧積蓋蓋鑰 (獵觸範憲醖淵衊壓鏇繭, 32.4 ~ 55.3)
NCT05104866 (TROPION-Breast01, ESMO_ASIA2024) 人工标引	临床3期	HR阳性/HER2阴性乳腺癌 Hormone Receptor Positive \| HER2 Negative	83	Datopotamab deruxtecan (Dato-DXd) (China cohort)	醖獵齋醖構構襯齋觸膚(襯構鹹糧廠築選襯範壓) = 齋艱窪鹹鑰夢鑰醖範鏇鏇廠鹹構構鏇艱顧顧鏇 (淵鏇衊鑰製繭憲艱範鏇 ) 更多	积极	2024-12-07
				Chemotherapy (capecitabine/eribulin/gemcitabine/vinorelbine) (China cohort)	醖獵齋醖構構襯齋觸膚(襯構鹹糧廠築選襯範壓) = 鹹鹹遞繭糧襯窪構製衊鏇廠鹹構構鏇艱顧顧鏇 (淵鏇衊鑰製繭憲艱範鏇 ) 更多