A Phase 1/2 Trial of Ivonescimab With Dato-DXd or Osimertinib in Patients With Metastatic EGFR-mutant Non-small Cell Lung Cancer That Progressed on EGFR TKI Therapy

The researchers are doing this study to find out whether ivonescimab in combination with datopotamab deruxtecan- (Dato-DXd) or osimertinib are safe and effective treatments in people with non-small cell lung cancer (NSCLC) that has an EGFR mutation. The researchers will test different doses of the Dato-DXd or osimertinib with an unchanging (fixed) dose of ivonescimab to find the best dose that causes few or mild side effects in participants. Once the dose is found the researchers will test ivonescimab with Dato-DXd or osimertinib in a new group of participants to see if it is effective in treating their NSCLC with an EGFR mutation.

开始日期2026-04-09

申办/合作机构

Memorial Sloan Kettering Cancer Center

[+1]

NCT07471776

/ Recruiting临床2期IIT

Study on Using TROP2-PET and 18F-FDG PET to Predict the Efficacy of Anti TROP2 ADC Treatment in Advanced Breast Cancer

This study aims to evaluate whether ^68Ga-TROP2 PET/CT, combined with ^18F-FDG PET/CT, can predict the efficacy of anti-TROP2 antibody-drug conjugates in patients with advanced HER2-negative breast cancer. Baseline and dynamic imaging parameters will be used to develop prediction models (primary endpoint: AUC), and their associations with clinical outcomes and tumor TROP2 status will be explored.

开始日期2026-03-11

申办/合作机构

复旦大学

NCT07357597

/ Not yet recruiting临床4期

A Phase IV, Open-Label, Single-Arm Study of Prophylaxis for Datopotamab Deruxtecan-related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer (TROPION-SWISH)

This is a multicenter, open-label, single-arm study of prophylaxis for Dato-DXd-related stomatitis in eligible patients with metastatic or inoperable locally recurrent breast cancer or locally advanced or metastatic Epidermal Growth Factor Receptor-Mutated (EGFRm) non-small cell lung cancer.

开始日期2026-02-27

申办/合作机构

AstraZeneca PLC

[+1]

100 项与德达博妥单抗相关的临床结果

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100 项与德达博妥单抗相关的转化医学

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100 项与德达博妥单抗相关的专利（医药）

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130

项与德达博妥单抗相关的文献（医药）

2026-06-01·ANNALS OF ONCOLOGY

Osimertinib plus datopotamab deruxtecan in patients with EGFR-mutated advanced NSCLC after progression on first-line osimertinib: ORCHARD

Article

作者: Halvorsen, T O ; Morabito, A ; Yu, H A ; Ambrose, H ; Cho, B C ; Brustugun, O T ; Goldman, J W ; Marrone, K A ; Bonanno, L ; Shiraishi, Y ; Piotrowska, Z ; FraenkeI, P G ; Kim, Y J ; Hendriks, L E L ; Le, X ; Riess, J W ; Smith, P E ; Tang, K H ; de Langen, A J ; Lehman, J M ; Goldberg, S B

BACKGROUND:

ORCHARD (NCT03944772) was a phase II platform study conducted to characterize resistance mechanisms and evaluate novel treatment combinations following progressive disease (PD) on first-line osimertinib. Datopotamab deruxtecan (Dato-DXd) is an anti-TROP2 antibody-drug conjugate approved as monotherapy in EGFR-mutated advanced non-small-cell lung cancer (NSCLC). We report final data from the osimertinib plus Dato-DXd module.

METHODS:

Eligible patients had EGFR-mutated advanced NSCLC and PD on first-line osimertinib. Patients received oral osimertinib (80 mg once daily) plus intravenous Dato-DXd (4 or 6 mg/kg every 3 weeks). The primary endpoint was investigator-assessed confirmed objective response rate (ORR) per RECIST v1.1. Secondary endpoints were progression-free survival (PFS), duration of response (DoR), overall survival (OS), and safety.

RESULTS:

Sixty-nine patients received study treatment. Among patients in the 4 mg/kg (N = 35) and 6 mg/kg (N = 34) cohorts, respectively, confirmed ORR was 43% [80% confidence interval (CI) 32% to 55%] and 36% (80% CI 25% to 49%); median PFS was 9.5 months (95% CI 7.2-9.8 months) and 11.7 months (95% CI 8.3-21.7 months); median DoR was 6.3 months (95% CI 3.8-8.1 months) and 20.5 months [95% CI 6.2 months-not calculable (NC); estimated median of at least 16 months]; and median OS was 19.8 months (95% CI 13.5-23.3 months) and 26.2 months (95% CI 14.8 months-NC; estimated median greater than or equal to the 4 mg/kg cohort). In the 4 mg/kg and 6 mg/kg cohorts, respectively, grade ≥3 adverse events (AEs) were reported in 49% and 76% of patients; AEs leading to Dato-DXd dose reduction in 23% and 59%; and adjudicated interstitial lung disease/pneumonitis in 3% and 15%.

CONCLUSIONS:

Osimertinib plus Dato-DXd demonstrated clinical benefit in patients with EGFR-mutated advanced NSCLC who progressed on first-line osimertinib. AEs in the 6 mg/kg cohort were of higher frequency and severity but could be managed with prophylaxis, careful monitoring, and dose reduction. The safety profile was consistent with the known profiles of the individual drugs. Considering the overall benefit-risk profile, 6 mg/kg is suggested as the preferred Dato-DXd starting dose for combining with osimertinib 80 mg.

CLINICAL TRIAL NUMBER:

ClinicalTrials.govNCT03944772.

2026-05-01·ANNALS OF PHARMACOTHERAPY

Targeting TROP2 Across Solid Tumors: The Clinical Profile and Role of Datopotamab Deruxtecan

Review

作者: Lucky, Rachel ; Thornburg, Lauren ; Halford, Zachery

Objective::

To evaluate the pharmacology, efficacy, safety, and clinical use of datopotamab deruxtecan (Dato-DXd), a recently approved trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC), in the treatment of advanced solid tumors.

Data sources::

A comprehensive English-language literature search was conducted on PubMed and ClinicalTrials.gov from January 2010 through September 2025 using the search terms datopotamab, datroway, breast cancer , or nonsmall cell lung cancer .

Study selection and data extraction::

Evidence was gathered from clinical trials, relevant articles, guidelines, abstracts, and package inserts.

Data synthesis::

Dato-DXd received accelerated approval by the Food and Drug Administration (FDA) in 2025 for hormone receptor-positive, HER2-negative (HR+/HER2–) breast cancer, and epidermal growth factor receptor (EGFR)-mutant nonsmall cell lung cancer (NSCLC). In the TROPION-Breast01 trial, Dato-DXd demonstrated superior efficacy with a response rate of 36.4% versus 22.9% for chemotherapy and median progression-free survival of 6.9 versus 4.9 months. In NSCLC, TROPION-Lung01 showed a response rate of 26.4% with Dato-DXd compared with 12.8% with docetaxel. For the approved EGFR-mutant NSCLC indication, the TROPION-Lung05 trial demonstrated a response rate of 35.8% with Dato-DXd. Treatment-related adverse events included stomatitis, nausea, alopecia, and ocular events, with interstitial lung disease/pneumonitis representing the most clinically significant safety concern.

Relevance to patient care and clinical practice::

The TROP2-directed ADC appears to be a viable therapeutic alternative for select patients with previously treated HR+/HER2– breast cancer or EGFR-mutant NSCLC after progression on targeted therapy.

Conclusions::

Dato-DXd offers a promising treatment option for heavily pretreated patients with HR+/HER2– breast cancer and EGFR-mutant NSCLC, providing meaningful clinical benefit with a manageable safety profile. Optimal sequencing and positioning within the rapidly shifting ADC landscape requires further investigation.

2026-05-01·APPLIED IMMUNOHISTOCHEMISTRY & MOLECULAR MORPHOLOGY

Quantitative Assays for TROP2 Measurement in Breast Cancer and Comparison to H-Score

Article

作者: Zhan, Haiying ; Moutafi, Myrto ; Bates, Katherine ; Kahila, Mohamed ; Chan, Nay N.N. ; Liu, Matthew ; Krishnamurti, Uma ; Fulton, Regan ; Benanto, Julia ; Liebler, Daniel C. ; Colón-Cartagena, Lorraine ; He, Mengni ; Robbins, Charles J. ; Rimm, David L. ; Yaghoobi, Vesal

Trophoblast cell surface antigen 2 (TROP2) is a popular current antibody-drug conjugate target due to its high expression in various solid tumor types. With the recent FDA-approval of sacituzumab govitecan and datopotamab deruxtecan in breast cancer, TROP2-targeting therapies showed promising clinical outcomes. Despite the prevalent expression of TROP2 in breast cancer (about 90%), the objective response rates from clinical trials are around 30% with nonsignificant hazard ratios for benefit from sacituzumab govitecan in low TROP2-expressing tumors. This suggests that there may be value in a companion diagnostic assay to measure TROP2 protein expression in tumor samples, but H-score assessment is not required. Here, we develop a quantitative immunofluorescence (QIF) assay and a quantitative hematoxylin-DAB (QH-DAB) assay for potential use as a future companion diagnostic test. TROP2 peptide concentrations were measured in cell lines using mass spectrometry to convert fluorescent signal or chromogen optical density to protein concentrations in amol/mm 2 . Coupled with QuPath-based image analysis tool Qymia, our QIF and QH-DAB assays have limits of detection of 90 amol/mm 2 and 667 amol/mm 2 , and limits of quantifications of 272 amol/mm 2 and 2021 amol/mm 2 , respectively. Using these assays, we measured the TROP2 expression in a breast cancer serial cohort (N=264) and a triple-negative breast cancer cohort (N=100) from Yale New Haven Hospital, identifying a broad dynamic range of TROP2 expression in breast cancer samples. Since the H-score method is the current standard of practice in the clinics, we selected 68 breast cancer biopsies and compared the measurements from our assays to H-scores evaluated by 5 certified pathologists. There is an overall agreement between our QIF and QH-DAB measurements and pathologists’ readings. However, the quantitative assay has better sensitivity and less subjectivity. In summary, these assays allow for an accurate and reproducible TROP2 protein measurement that could be incorporated into a clinical workflow. This work represents only analytic validation, but work on clinical validation has begun. In the future, this assay may help identify patients who are more likely to benefit from TROP2-targeted therapies.

1,881

项与德达博妥单抗相关的新闻（医药）

2026-05-28

·BioSpace

Daiichi Sankyo Showcases Progress Across Industry-Leading Oncology Portfolio with Latest Research Updates at ASCO

New analyses from five landmark trials of Enhertu® and Datroway® in breast and gastric cancer alongside pipeline data across other tumor types demonstrate continued oncology leadership Early phase trials-in-progress featuring potential medicines with novel mechanisms highlight the company’s commitment to identifying new breakthrough generating technologies for patients with cancer TOKYO--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio with more than 25 abstracts in multiple cancers at the 2026 American Society of Clinical Oncology Annual Meeting (#ASCO26). Data at ASCO will highlight the company’s progress toward advancing new standards of care for patients with cancer, including new analyses from five landmark trials in breast and gastric cancer, including the DESTINY-Breast05 (# 516 ), DESTINY-Breast06 (# 1063 ), DESTINY-Breast09 (# 1021 ) and DESTINY-Gastric04 (# 4111 ) phase 3 trials of Enhertu ® (trastuzumab deruxtecan), and the TROPION-Breast02 (# 1002 ) phase 3 trial of Datroway ® (datopotamab deruxtecan). Additional results from earlier phase trials as well as trials-in-progress across new medicines being developed through the company’s breakthrough generating technology (BGT), a platform-based drug discovery model designed to deliver innovative medicines to patients faster, will be highlighted. Data from DESTINY-Breast05 formed the basis of one of two new Enhertu indications recently approved in the U.S. for certain patients with early-stage HER2 positive breast cancer and data from DESTINY-Gastric04 was included as part of a label update to expand the use of Enhertu in Japan and China to include the second-line treatment of patients with HER2 positive metastatic gastric cancer. Additionally, results from TROPION-Breast02 formed the basis of the recent U.S. approval of Datroway in patients with metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy, the first antibody drug conjugate (ADC) to be approved in this setting of TNBC. “The approvals received just prior to ASCO for Enhertu and Datroway, two of our leading DXd antibody drug conjugates, together with the strong science being showcased across our pipeline, highlight the momentum of our oncology portfolio,” said John Tsai, MD, Global Head, R&D, Daiichi Sankyo. “Daiichi Sankyo is committed to creating new standards of care for patients with cancer and continues to leverage its scientific and technological expertise to advance innovation.” Additional Enhertu Data Spans Broad Range of HER2 Expressing Cancers Additional research updates across several additional HER2 expressing cancers include oral and poster sessions highlighting the preliminary safety run-in results from the DESTINY-Ovarian01 (# 5554 ) phase 3 trial evaluating Enhertu in combination with bevacizumab compared to bevacizumab monotherapy as a first-line maintenance therapy in patients with HER2 expressing ovarian cancer; the primary analysis from part 1 of the DESTINY-PanTumor03 (# 3026 ) phase 2 trial evaluating Enhertu in pretreated patients in China with HER2 positive (IHC 3+) solid tumors (excluding breast and gastric cancer); and, findings from the MYTHOS (# 6011 ) phase 2 trial evaluating Enhertu in patients with HER2-low recurrent or metastatic salivary gland cancer. Additional breast and gastric cancer data for Enhertu include an oral presentation from one arm of the DESTINY-Breast07 (# 1012 ) phase 1b/2 trial evaluating Enhertu in combination with durvalumab as a first-line treatment in patients with HER2 positive metastatic breast cancer and a poster presentation highlighting a safety analysis from the DESTINY-Gastric03 (# 4022 ) phase 1b/2 trial evaluating Enhertu in combination with chemotherapy and immunotherapy as a first-line treatment in patients with HER2 expressing metastatic gastric cancer, gastroesophageal junction (GEJ) adenocarcinoma or esophageal adenocarcinoma. Results from cohort two of the EPOC2203 (# 4024 ) phase 1b/2 trial evaluating Enhertu in combination with nivolumab and capecitabine and oxaliplatin in patients with HER2 low gastroesophageal adenocarcinoma and an exploratory analysis of translational data from the EPOC2003 (# 3129 ) phase 2 trial evaluating neoadjuvant chemotherapy in combination with Enhertu in patients with HER2 positive gastric cancer will be highlighted as poster presentations. New Data and Trials-in-Progress Presentations Across Oncology Portfolio Poster presentations will include a trial-in-progress update of REJOICE-Ovarian01 ( TPS5637 ) for the phase 3 part of a phase 2/3 trial evaluating raludotatug deruxtecan (R-DXd) compared to treatment of physician’s choice in patients with platinum-resistant ovarian cancer. Two additional poster presentations will highlight an exposure-response analysis (# 5570 ) and a population pharmacokinetic analysis (# 5571 ) of data from both the REJOICE-Ovarian01 phase 2/3 trial and the phase 1 trial evaluating raludotatug deruxtecan in patients with advanced ovarian cancer or renal cell carcinoma. An oral presentation will highlight results from a phase 1/2 trial (# 6504 ) of Vanflyta® (quizartinib) plus decitabine and venetoclax in patients with newly diagnosed or relapsed/refractory FLT3 -ITD acute myeloid leukemia. Trials-in-progress poster presentations across the DXd ADC portfolio include the TROPION-Urothelial03 ( TPS4642 ) phase 2/3 trial evaluating Datroway and platinum chemotherapy compared to gemcitabine plus platinum chemotherapy in patients with locally advanced or metastatic urothelial carcinoma; the HERTHENA-Breast04 ( TPS1149 ) phase 3 trial evaluating patritumab deruxtecan (HER3-DXd) compared to treatment of physician’s choice in patients with HR positive, HER2 negative unresectable locally advanced or metastatic breast cancer; and the DESTINY-PanTumor04 ( TPS11202 ) hybrid observational trial evaluating Enhertu in patients with HER2 positive (IHC 3+) solid tumors. Trials-in-Progress Presentations Highlight Breakthrough Generating Technology Focus Daiichi Sankyo is leveraging its strength in science and technology to create new medicines for patients with cancer through its BGT approach which is designed to deliver innovative medicines to patients faster and with a higher probability of success. Trials-in-progress poster presentations featuring three potential new medicines include DS3610 ( TPS3159 ), a STING (stimulator of interferon genes) ADC, in patients with advanced or metastatic solid tumors; DS5361 ( TPS2680 ), a small-molecule, nonsense-mediated mRNA decay inhibitor, in patients with advanced or metastatic solid tumors; and, DS9051 ( TPS3179 ), a novel targeted protein degradation molecule, in patients with advanced or metastatic adrenocortical carcinoma or metastatic castration-resistant prostate cancer. Overview of clinical data and trials-in-progress from oncology pipeline of Daiichi Sankyo include: Presentation Title Author Abstract Presentation (CDT) Breast A DESTINY-Breast09 analysis of treatment duration and clinical outcomes by best response to trastuzumab deruxtecan (T-DXd) + pertuzumab Y. Park 1021 Rapid Oral Presentation Sunday, May 31 11:30 am – 1:00 pm Secondary safety analysis of trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in DESTINY-Breast05: clinical and demographic risk factors of interstitial lung disease and radiation pneumonitis M. Untch 516 Rapid Oral Presentation Monday, June 1 9:45 – 11:15 am Neoadjuvant rilvegostomig (R) + trastuzumab deruxtecan (T-DXd) in high-risk HER2-negative breast cancer: Results from the I-SPY 2.2 trial C. O’Sullivan LBA514 Rapid Oral Presentation Monday, June 1 9:45 – 11:15 am Trastuzumab deruxtecan (T-DXd) + durvalumab in patients with previously untreated HER2 positive unresectable/metastatic breast cancer (mBC): final analysis from DESTINY-Breast07 S. Loi 1012 Oral Presentation Sunday, May 31 8:30 – 10:00 am First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple negative breast cancer for whom immunotherapy was not an option: additional efficacy endpoints from the TROPION-Breast02 study D. Cescon 1002 Oral Presentation Tuesday, June 2 9:45 am – 12:45 pm Impact of adherence to interstitial lung disease (ILD)/pneumonitis toxicity management guidelines on ILD/pneumonitis outcomes: a retrospective analysis of patients treated with trastuzumab deruxtecan (T-DXd) in DESTINY-Breast06 C. Mateo 1063 Poster Session Monday, June 1 1:30 – 4:30 pm HERTHENA-Breast04: a phase 3, randomized, open-label study evaluating the efficacy and safety of patritumab deruxtecan (HER3-DXd) versus treatment of physician’s choice in hormone receptor positive (HR +)/HER2-) unresectable locally advanced or metastatic breast cancer B. Pistilli TPS1149 Poster Session Monday, June 1 1:30 – 4:30 pm Identifying patients with human epidermal growth factor receptor 2 (HER2) low and ultralow breast cancer: use of digital, artificial intelligence-based computational algorithms to assist HER2 scoring by pathologists S. Krishnamurthy 1022 Poster Session Monday, June 1 1:30 – 4:30 pm Gastric Additional health-related quality of life analysis from DESTINY-Gastric04, a randomized phase 3 study of trastuzumab deruxtecan (T-DXd) vs ramucirumab + paclitaxel in patients with HER2 positive unresectable/metastatic gastric cancer/gastroesophageal junction adenocarcinoma K. Shitara 4111 Poster Session Saturday, May 30 9:00 am – 12:00 pm First-line trastuzumab deruxtecan (T-DXd)-based regimens in advanced HER2 expressing gastric cancer, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma: safety results from DESTINY-Gastric03 Part 2 arms D and F, and Part 4 Y. Janjigian 4022 Poster Session Saturday, May 30 9:00 am – 12:00 pm An open-label phase 1b/2 study of trastuzumab deruxtecan combined with nivolumab and CAPOX in patients with HER2 low gastroesophageal adenocarcinoma (EPOC2203) Y. Aoki 4024 Poster Session Saturday, May 30 9:00 am – 12:00 pm Tumor and immune microenvironment remodeling with neoadjuvant trastuzumab deruxtecan in HER2 positive gastric cancer: exploratory analyses from the phase 2 EPOC2003 study A. Kawazoe 3129 Poster Session Saturday, May 30 1:30 – 4:30 pm Ovarian Trastuzumab deruxtecan (T-DXd) + bevacizumab (BEV) as first-line (1L) maintenance therapy in patients with HER2 expressing ovarian cancer: results from the DESTINY-Ovarian01 safety run-in A. Gonzalez Martin 5554 Poster Session Monday, June 1 9:00 am – 12:00 pm REJOICE-Ovarian01: phase 3 part of a phase 2/3 study evaluating raludotatug deruxtecan (R-DXd) versus treatment of physician’s choice in patients with platinum-resistant ovarian cancer D. Richardson TPS5637 Poster Session Monday, June 1 9:00 am – 12:00 pm Exposure-response analyses of efficacy and safety with raludotatug deruxtecan (R-DXd), a CDH6-directed ADC, to inform dose selection for phase 3 development in platinum-resistant ovarian cancer F. Hurtado 5570 Poster Session Monday, June 1 9:00 am – 12:00 pm Population pharmacokinetic analysis of raludotatug deruxtecan (R-DXd), a CDH6-directed ADC, in patients with advanced ovarian cancer or renal cell carcinoma F. Hurtado 5571 Poster Session Monday, June 1 9:00 am – 12:00 pm Urothelial TROPION-Urothelial03: a phase 2/3 study of datopotamab deruxtecan (Dato-DXd) + platinum chemotherapy vs gemcitabine + platinum chemotherapy in participants with locally advanced or metastatic urothelial carcinoma with progression on or after enfortumab vedotin + pembrolizumab M. Galsky TPS4642 Poster Session Sunday, May 31 9:00 am – 12:00 pm Salivary Trastuzumab deruxtecan in patients with HER2 low recurrent/metastatic salivary gland carcinoma: results from the phase 2 MYTHOS trial I. Kinoshita 6011 Oral Presentation Monday, June 1 8:00 – 9:30 am AML Quizartinib in combination with decitabine and venetoclax for newly diagnosed and relapsed/refractory FLT3 mutated acute myeloid leukemia M. Yilmaz 6504 Oral Presentation Tuesday, June 2 9:45 am – 12:45 pm Pan Tumor Trastuzumab deruxtecan (T-DXd) for pretreated patients in China with HER2 IHC 3+ solid tumors: DESTINY-PanTumor03 Part 1 primary analysis Y. Zhang 3026 Poster Session Saturday, May 30 1:30 – 4:30 pm A pragmatic, hybrid observational study evaluating the effectiveness of trastuzumab deruxtecan (T-DXd) in patients with HER2 IHC3+ solid tumors: DESTINY-PanTumor04 B. Monk TPS11202 Poster Session Monday, June 1 9:00 am – 12:00 pm HER2 independent antitumor and pharmacodynamic responses to trastuzumab deruxtecan in patients with advanced solid tumors S. Shin 3031 Poster Session Saturday, May 30 1:30 – 4:30 pm Topoisomerase 1 and DNA damage: pharmacodynamic responses and mechanism of trastuzumab deruxtecan in HER2-expressing advanced solid tumors D. Wilsker 3092 Poster Session Saturday, May 30 1:30 – 4:30 pm BGT A phase 1, first-in-human study of DS3610, a stimulator of interferon genes (STING) agonist ADC, in patients with advanced/metastatic solid tumors S. Koganemaru TPS3159 Poster Session Saturday, May 30 1:30 – 4:30 pm A phase 1, first-in-human study of DS5361, a small-molecule, nonsense-mediated mRNA decay inhibitor, in patients with advanced/metastatic solid tumors (Parts 1 and 2) S. Sen TPS2680 Poster Session Saturday, May 30 1:30 – 4:30 pm A phase 1, first-in-human study of DS9051, a novel targeted protein degradation molecule, in patients with advanced/metastatic adrenocortical carcinoma or metastatic castration-resistant prostate cancer M. Patel TPS3179 Poster Session Saturday, May 30 1:30 – 4:30 pm About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of eight ADCs in clinical development crafted from ADC technology discovered in-house by Daiichi Sankyo. The DXd ADC Technology platform of Daiichi Sankyo consists of seven ADCs in clinical development where each ADC is comprised of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADCs include Enhertu and Datroway, which are being jointly developed and commercialized globally with AstraZeneca, and ifinatamab deruxtecan (I-DXd), raludotatug deruxtecan (R-DXd) and patritumab deruxtecan (HER3-DXd), which are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939 and DS3790 are being developed by Daiichi Sankyo. An additional ADC being developed by Daiichi Sankyo is DS3610, which consists of an antibody attached to a novel payload that acts as an agonist of STING. Ifinatamab deruxtecan, raludotatug deruxtecan, patritumab deruxtecan, DS-3939, DS3610 and DS3790 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. About Daiichi Sankyo Daiichi Sankyo (TSE: 4568) is a global healthcare company committed to becoming a trusted healthcare innovator, transforming the lives of people through its strength in science and technology. The company discovers and develops new standards of care to address diverse medical needs to fulfill its purpose of contributing to the enrichment of quality of life around the world. With a strategic focus on oncology, Daiichi Sankyo is advancing an industry-leading antibody drug conjugate portfolio along with identifying new breakthrough generating technologies to deliver practice-changing medicines to patients, healthcare professionals and society. For more information, please visit . Contacts MEDIA CONTACTS: Global: Jennifer Brennan jennifer.brennan@daiichisankyo.com +1 908 900 3183 (mobile) Japan: DS-PR_jp@daiichisankyo.com INVESTOR RELATIONS CONTACT: DaiichiSankyoIR_jp@daiichisankyo.com

临床3期临床结果临床1期ASCO会议临床2期

2026-05-26

·药事纵横

国产ADC双线突破，2000亿肿瘤市场谁主沉浮？

2026年5月，国产ADC赛道迎来密集进展。科伦博泰两款核心产品接连斩获关键临床成果，TROP2 ADC全球III期成功、CLDN18.2 ADC新适应症获批。然而，这不仅是科伦博泰的胜利，更是国产ADC群体突围的缩影。一、TROP2 ADC全球III期成功，国产药物首证OS/PFS双终点长期以来，TROP2 ADC赛道由吉利德Trodelvy、阿斯利康/第一三共Dato-DXd两大海外产品主导，国产同类药物始终缺乏全球多中心III期临床的硬核疗效证据，尤其难以实现总生存期（OS）与无进展生存期（PFS）的双重统计学获益，这也成为国产ADC追赶国际一线的核心短板。而2026年5月18日，科伦博泰与默沙东联合开发的芦康沙妥珠单抗（sac-TMT，佳泰莱®），凭借TroFuse-005关键性III期研究的圆满成功，彻底打破这一局面。此次针对晚期或复发性子宫内膜癌的TroFuse-005研究，是全球首个且唯一在该患者群体中，证实相较于标准化疗可实现OS、PFS双重显著获益的III期临床试验，填补了晚期子宫内膜癌靶向治疗的临床空白。相较于传统化疗方案，芦康沙妥珠单抗可显著降低患者死亡与疾病进展风险，凭借稳健的双重终点获益，验证了国产ADC在实体瘤治疗中的硬核疗效，也标志着国产ADC首次在妇科肿瘤领域拿到全球最高等级临床证据。值得关注的是，该研究为全球多中心临床试验，从试验设计、患者筛选、过程执行到数据统计分析，均遵循全球最高临床标准，充分证明国产ADC的临床研发体系、质量管控能力已全面比肩国际一线水平，彻底摆脱过去“国产ADC仅能做区域小样本试验”的刻板印象。横向对标全球TROP2 ADC三强，芦康沙妥珠单抗形成了差异化的竞争特色与成长潜力。吉利德Trodelvy作为全球首款获批的TROP2 ADC，凭借先发优势率先抢占三阴乳腺癌、尿路上皮癌市场，2026年Q1销售额同比大涨37%，且联合Keytruda的III期数据登顶NEJM，巩固了一线治疗地位，但该药存在毒性偏高、治疗窗口有限的短板。阿斯利康/第一三共Dato-DXd依托顶级DXd平台，药物活性更强、安全性更优，前瞻性布局生物标志物分层精准治疗，但适应症拓展节奏偏慢，早期管线落地效率不足。相较之下，芦康沙妥珠单抗的核心优势在于全球化布局速度与联合疗法矩阵的完备性。依托默沙东全球化商业化能力，该药目前已布局覆盖乳腺癌、肺癌、妇科肿瘤、消化道肿瘤的17项全球III期临床试验，其中仅妇科肿瘤赛道就布局10项III期研究，形成碾压式的适应症覆盖优势。此次子宫内膜癌III期阳性结果，是其全球临床矩阵落地的首个重磅成果，为后续十余项跨瘤种研究奠定了统计学基础。短板则在于上市时间较晚，2024年11月才在国内获批三阴乳腺癌适应症，市场切入滞后于两款海外竞品，短期需要依靠差异化瘤种布局抢占细分市场。整体来看，芦康沙妥珠单抗实现了国产TROP2 ADC从“疗效跟随”到“证据领跑”的跨越，有望打破海外双雄垄断的行业格局。二、CLDN18.2赛道升温在TROP2赛道实现全球突破的同时，科伦博泰自研CLDN18.2 ADC SKB315的新适应症临床申请获批，为国产消化道肿瘤精准治疗再添利器，也推动CLDN18.2正式接替HER2，成为国产ADC内卷与突围的核心新赛道。此次获批的新适应症，为联合替雷利珠单抗±卡培他滨治疗晚期胃腺癌或胃食管结合部腺癌，精准瞄准我国高发、高致死的胃癌临床刚需。 SKB315具备极具竞争力的差异化技术特质，完美适配实体瘤精准治疗需求。该药采用科伦博泰自主OptiDC™ ADC平台打造，选用新型中度毒性TOPO1抑制剂作为载荷，搭配自研人源化抗体与高DAR值偶联工艺，结合不可逆半胱氨酸偶联技术与pH敏感性可裂解连接子。多重技术叠加，既保证了药物在血液循环中的高度稳定性，降低脱靶毒性，又能在肿瘤微环境中精准裂解、释放载荷，依托靶向杀伤、旁杀效应与免疫激活三重机制杀灭肿瘤细胞，同时最大程度保护正常胃组织，安全性与有效性实现双向平衡。从靶点价值来看，CLDN18.2的赛道潜力毋庸置疑。作为紧密连接蛋白家族成员，CLDN18.2在正常组织中表达高度受限，但在胃癌、胰腺癌、胆管癌等多种实体瘤中高表达，其中胃癌阳性表达率超70%，胰腺癌、胆管癌阳性率分别达50%-70%、60%-80%，是继HER2之后，实体瘤领域最具广谱性、最具开发价值的核心靶点。相较于HER2靶点仅覆盖20%左右胃癌患者，CLDN18.2可覆盖大部分晚期消化道肿瘤患者，极大弥补了临床治疗空白，行业共识明确其为“下一代实体瘤精准治疗核心靶点”。数据显示，2025年国内抗肿瘤药物全终端销售总额约2180亿元，同比增长4.28%，市场还在持续增长。图源：摩熵医药数据库巨大的临床与市场价值，也让CLDN18.2赛道迅速成为国产ADC的内卷红海，国内头部药企均已深度布局。荣昌生物RC118、康诺亚/乐普生物CMG901、信达生物IBI389等多款CLDN18.2 ADC、双抗产品均已进入临床关键阶段，靶点扎堆、机制同质化问题日益凸显。多数产品采用传统载荷与偶联技术，聚焦晚期胃癌单瘤种布局，差异化优势不足，未来极易陷入价格与临床资源的恶性竞争。相较于同业产品单一的单药治疗布局，SKB315率先布局免疫联合疗法，通过与PD-1抑制剂、化疗药物联用，适配晚期胃癌一线治疗场景，大幅拓宽适用人群；同时依托平台技术优势，实现毒性可控、疗效稳定，规避了部分CLDN18.2药物毒性过高、疗效波动大的缺陷。这也为内卷的CLDN18.2赛道指明突围方向：单纯靶点跟风已无价值，唯有依托平台技术迭代、差异化联合策略、跨瘤种布局，才能跳出同质化竞争。三、国产ADC的全球竞争力与隐忧科伦博泰2026年管线密集兑现，是国产ADC行业整体崛起的缩影。2026年以来，公司已有6款1类新药获批临床，其中4款为首次获批，涵盖全新靶点与全新机制药物，充分验证了其OptiDC™ ADC平台的规模化、平台化研发能力，标志着国产药企已摆脱“单品突破、靶点跟风”的粗放研发模式，迈入“平台驱动、多点开花”的高质量发展阶段。图源：摩熵医药数据库放眼国内头部药企，国产ADC已形成两大国际化发展路径，各有优劣。以科伦博泰为代表的巨头合作模式，通过与默沙东绑定，依托海外巨头的临床资源、审批渠道、商业化网络快速推进全球化，借助7亿美元专项融资加速产品落地，以最低风险、最高效率实现全球同步开发，适合核心重磅品种的全球化突围。而以荣昌生物为代表的自主出海模式，依托RC48、RC88等自研产品，自主推进海外临床与商业化，掌握全部知识产权与利润空间，适合细分赛道差异化产品的长期布局。此外，恒瑞医药SHR-A1811、SHR-A1921，百利天恒BL-B01D1等产品，也凭借各自技术优势，在不同实体瘤赛道实现突破，共同构筑国产ADC的全球竞争矩阵。在国产ADC集体跻身全球第一梯队的同时，行业深层隐忧也持续凸显，制约行业长期高质量发展。其一为靶点高度同质化，国内ADC管线高度集中于HER2、TROP2、CLDN18.2三大热门靶点，冷门靶点、全新机制布局不足，赛道内卷严重，未来将面临大量临床资源浪费与上市后产能过剩风险。其二为研发与商业化成本飙升，随着临床标准提升、竞争加剧，ADC临床研发投入持续走高，而同质化产品扎堆上市后，必将引发价格战，压缩整体盈利空间。其三为国际化门槛持续抬升，海外FDA、EMA对ADC药物的质控标准、临床数据完整性、安全性评价要求不断提高，国产药物出海的审核难度与失败风险持续增加。立足当下，国产ADC已完成从“海外跟跑”到“全球并跑”的历史性跨越，在2000亿肿瘤市场中占据举足轻重的地位。未来五年，行业将迎来洗牌分化：具备自主平台技术、全球化布局能力、差异化管线的头部企业，将持续抢占国内外市场份额；而单纯跟风、缺乏技术壁垒的同质化管线，将逐步被市场淘汰。从长期来看，“巨头合作+自主创新”双模式并行、“热门靶点深耕+全新靶点探索”双线布局，将是国产ADC实现持续领跑、真正立足全球市场的核心路径。结语国产ADC正站在从“技术突破”到“全球竞争”的关键节点。科伦博泰的双线进展并非孤例，而是中国创新药群体崛起的缩影。面对2000亿肿瘤市场，真正的赢家不只有一家企业，而是能在靶点创新、临床设计、国际合规中持续积累的系统性能力。未来，谁能在差异化与全球化之间找到平衡，谁才能真正主导下一个十年。。参考：CDE官网；摩熵医药数据库立即扫码加入药事纵横交流群

2026-05-26

·研发客

ADC药王的承诺，兑现了吗？

// • 优赫得已连续三年成为ADC销冠，销售额断层领先； • 第一三共凭借DXd ADC技术成为2025年世界ADC大奖评选最大赢家； • 第一三共正逐渐摆脱传统综合药企“泛而不精”的标签，提出2035年跻身全球肿瘤药企前五的战略目标。 2021年，Nature的一篇文章预测，2026年ADC明星产品优赫得（Enhertu）将以62亿美元销售额登顶全球ADC市场。今年，预期目标能否实现？据第一三共最新发布的财报预测，2026年优赫得的销售额预计约为8613亿日元（54.15亿美元），同比增长23.3%，加上潜在的6.25亿美元销售里程碑付款，总额将超60亿美元。当前，在全球ADC市场，头部集中态势明显，TOP3产品合计占市场份额超60%，优赫得的销售额呈现断层领先。2025年优赫得的全球销售额为6984亿日元（43.91亿美元），加上5.375亿美元的销售里程碑付款，总额接近第二名罗氏的Kadcyla和第三名安斯泰来/辉瑞的Padcev销售额的总和。事实上，从2023年开始，优赫得的销售额就超过了Kadcyla，成为ADC销冠。在第一三共的DXd ADC管线中，另一款重磅产品也正在快速崛起。据财报预测，上市不到2年的TROP2 ADC达卓优（Datroway）2026年的销售额预计约为7亿美元，同比增长133.9%。5月22日，Datroway又斩获新适应症——获FDA批准用于治疗不可切除或转移性三阴性乳腺癌（TNBC），成为首个获批一线治疗该适应症的ADC药物。达卓优目前已在中国、美国和日本获批上市，被第一三共定位为继优赫得之后的核心增长引擎，有望复刻前者的商业化高速放量轨迹。此外，还有I-DXd、R-DXd、HER3-DXd三款ADC产品已进入商业化前夕。通过持续剥离非肿瘤非核心业务，叠加主动推进ADC产能自主化布局，第一三共正逐渐摆脱传统综合药企“泛而不精”的标签，转向全面资源重配、集中押注肿瘤ADC核心赛道。优赫得的上限，可能远未达到优赫得通过临床数据与商业化表现，打破了ADC高表达依赖、疗效有限、毒性偏大、应用狭窄的旧认知。曾凭借突破性的疗效数据在ASCO年会上引发全场起立鼓掌，直接点燃全球ADC研发热潮（见视频）。来源|网络公开资料截至目前，优赫得已在全球获批乳腺癌、胃癌、肺癌几大癌种适应症，覆盖超90多个国家或地区，改写了多个癌种的临床治疗标准。其中，针对乳腺癌更是惠及HER2阳性、HER2低表达、HER2超低表达等全谱系人群。依托9项登上《新英格兰医学杂志》的关键临床研究数据，优赫得搭建起涵盖上述常见癌种的权威证据体系，不仅有力支撑了第一三共“一药多癌”的全球布局，更树立起新一代ADC药物的行业标杆。过去一年间，随着多项关键适应症数据陆续公布，其临床潜力仍在持续释放。以HER2阳性乳腺癌这一适应症为例，三项新的研究成果构建起优赫得针对早期HER2阳性乳腺癌从前线治疗到后线巩固的完整治疗路径，让ADC首次覆盖该类患者的治疗全程。 DESTINY-Breast09研究结果支持了优赫得联合帕妥珠单抗方案治疗晚期HER2阳性乳腺癌挺进一线，该方案已于2025年12月获得美国FDA批准。在该研究中，优赫得联合疗法显著优于标准THP方案，中位PFS达40.7个月（对照组26.9个月，HR 0.56，95%CI 0.44–0.71，P<0.00001），客观缓解率85.1%，完全缓解率15.1%。且其安全性良好，3级及以上治疗相关不良事件发生率相近。 DESTINY-Breast11研究结果显示，优赫得序贯THP方案用于高危HER2阳性早期乳腺癌新辅助治疗，病理完全缓解率（pCR）较标准方案提升11.2%，相关疗效呈现显著获益趋势，事件进展或死亡风险较对照组下降44%。2026年3月，该序贯联合方案获CDE批准用于HER2阳性II期（高危）或III期乳腺癌成人患者的新辅助治疗。这是优赫得在全球范围内首次获批用于HER2阳性早期乳腺癌的治疗。2026年5月，美国FDA也批准了该适应症。在DESTINY‑Breast05研究中，优赫得与罗氏Kadcyla头对头对比用于已接受紫杉类化疗及抗HER2新辅助治疗后残留病灶、高复发风险HER2阳性乳腺癌的辅助治疗。该研究共纳入1635例患者，结果显示优赫得可降低53%的浸润性疾病复发或死亡风险，3年IDFS率较对照组提升近9%，优效幅度创历史新高，首次确立了其在该人群中的标准治疗地位。该适应症已于今年5月获得FDA批准，并已在日本和欧洲递交上市申请。除乳腺癌外，优赫得在胃癌、肺癌、妇科肿瘤等领域的适应症持续扩容。2026年3月，优赫得在日本获批HER2阳性实体瘤适应症，成为全球首个获批上市的不限癌种HER2靶向ADC药物。卵巢癌、子宫内膜癌等妇科肿瘤适应症已进入III期临床，泛癌种布局持续推进，患者覆盖范围还在不断扩大。在商业化前景方面，中国市场已成为优赫得销售额增长的重要引擎。2023年，优赫得正式登陆中国市场，2024年底两项乳腺癌适应症成功纳入国家医保目录，医保准入后首年销量实现翻倍增长，增速显著高于在全球市场的水平（26.3%）。随着HER2检测技术普及、医保覆盖范围扩大，优赫得在中国市场的表现仍有较大想象空间。拓展阅读第一三共的中国野心 ADC管线将迎来平台式集中爆发第一三共在ADC领域的领先地位，并非依赖单一产品，核心支撑是其自主开发的DXd ADC技术平台。该平台经过十多年的积累和技术迭代，攻克连接子稳定性、毒素效力、偶联效率、安全性控制等ADC行业核心难题，打通了ADC药物从源头创新到商业化的整个过程，这在ADC药物研发历史上是比较少见。借此，第一三共斩获多项全球ADC行业重要奖项。在2025年世界ADC大奖评选中，其凭借DXd ADC技术获得最佳ADC平台技术奖；基于R‑DXd、I‑DXd两大核心管线的突破性临床进展，获评最佳新药研发企业亚军；优赫得斩获最佳ADC临床研究大奖，同平台达卓优获评最佳ADC临床影响力大奖，第一三共由此成为该年度最大赢家。2024年，第一三共与阿斯利康凭借优赫得的突出临床表现，斩获美国盖伦奖 “最佳生物技术产品”，该奖项被誉为医药界的诺贝尔奖。此外，第一三共还搭建了另一个差异化ADC平台，该平台由单克隆抗体、改良型吡咯并苯并二氮杂卓（PBD）有效载荷和专属连接子组成。基于这两个平台，第一三共已自主开发了8款ADC产品，涉及HER2、TROP2、B7-H3、CDH6、HER3、TA-MUC1等重要的肿瘤靶点，覆盖常见的高发癌种，管线布局全面且互补性强。除已商业化的优赫得和达卓优，还有三款产品均进入临床后期。包括与默沙东合作开发的靶向B7-H3的I-DXd，在针对既往接受过治疗的广泛期小细胞肺癌的II期临床研究中，该药物客观缓解率达48.2%，已获美国FDA 突破性疗法认定。第一三共于今年4月已向FDA提交上市申请，预计10月获得批准，有望成为全球首款获批的小细胞肺癌ADC产品。拓展阅读默沙东/第一三共B7-H3 ADC获FDA优先审评另外两个候选药物分别是靶向CDH6的R-DXd以及HER3-DXd。R-DXd也获得了FDA突破性疗法认定，目前正针对卵巢癌进行评估。HER3-DXd在撤回针对EGFR突变型非小细胞肺癌的上市申请后，目前正在开展针对HR阳性、HER2阴性乳腺癌的III期临床试验，有望为该人群提供新的治疗选择。此外，还有三款临床阶段的产品，分别为DS-3939（靶向MUC1）、DS3790（靶向CD37）和DS3610（靶向STING），第一三共认为这三款候选产品均具有成为重磅药物的潜力。 2035年跻身全球肿瘤药企前五第一三共随财报一起发布了未来五年的商业计划，希望将其在ADC领域的领先优势转化为全球肿瘤治疗领域的顶尖地位，提出2035年跻身全球肿瘤药企前五的战略目标。第一三共预计，到2030年，其总营收将超过3万亿日元（约191亿美元），其中肿瘤业务贡献2.3万亿日元（144.6亿美元）。为达成上述财务目标，第一三共将充分挖掘 DXd ADC产品管线价值，未来五年为5款药物推出超过20项新适应症，实现快速市场渗透。到2035年，每年惠及超过70万名新增患者。同时，第一三共还将布局可与DXd匹敌的下一代突破性技术，部分可能拓展至肿瘤领域以外。在ADC领域，第一三共正在研发新一代细胞毒性有效载荷，以克服DXd的耐药，同时设计新型肿瘤选择性抗体，计划于2027财年启动人体试验。未来五年，第一三共还计划对双抗、蛋白降解、siRNA等前沿技术投入2.9万亿日元（182.3亿美元）。在2030年前确定下一代核心技术平台，2035年新产品实现业绩贡献。第一三共还提出一项2000亿日元（13亿美元）的成本优化计划，并为此成立了业务转型部门，通过人工智能与数字化技术提升生产效率、优化采购流程。同时，第一三共将统筹全球商业化业务，保障全球业务推进速度与执行标准统一，并依据全球战略重点优化资源配置与投资决策。为聚焦肿瘤 ADC 核心赛道，过去几年第一三共启动一系列非核心业务剥离动作，逐步收缩抗感染、心血管、疫苗等非肿瘤业务资源，停止非核心管线研发投入，将资源全面向肿瘤ADC业务倾斜。2026年4月，第一三共将非处方药子公司股份转让给三得利，交易对价2465亿日元。 2025财年，第一三共因提前终止海外CDMO长期生产合同，产生约950亿日元（5.97亿美元）损失，短期带来了财务损耗与供应链口碑波动。但这场 “赔款风波”，提示第一三共正在主动收回ADC制造主导权。此前，优赫得和达卓优全球销量快速增长，第一三共为保障供应过度储备产能，依赖海外 CDMO代工生产，导致供应链成本高、产能利用率不足、质量管控风险上升。经历此次阵痛后，第一三共正加速实现ADC产能自主可控，优化全球供应链布局。具体措施还包括暂停日本本土工厂扩产项目，转向美国和中国新建生产基地，同时升级现有工厂生产线，提升产能利用率与生产效率。拓展阅读第一三共斥资约11亿元首次在中国建立ADC工厂第一三共的战略重心，已经不再只是打造一款ADC爆品，而是全面构建全球领先的ADC产业平台。而这也意味着，全球ADC行业竞争格局已发生根本性转变，竞争焦点从单一产品疗效比拼，升级为技术平台能力、管线布局、工业化产能、商业化能力的综合较量。第一三共凭借DXd ADC平台的技术壁垒、丰富的ADC产品管线、自主可控的产能布局、成熟的全球商业化体系，未来有望持续领跑全球ADC赛道。编辑 | 姚嘉 yao.jia@PharmaDJ.com 总第2924期访问研发客网站www.PharmaDJ.com 深度报道和每日新闻抢鲜看

100 项与德达博妥单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16410

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
三阴性乳腺癌	美国	Daiichi Sankyo Co., Ltd.	2026-05-22
EGFR阳性非小细胞肺癌	美国	Daiichi Sankyo, Inc.	2025-06-23
ER阳性/HER2阴性乳腺癌	澳大利亚	AstraZeneca Pty Ltd.	2025-05-20
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	AstraZeneca PLC	2024-11-12
EGFR突变的非小细胞肺癌	申请上市	美国	Daiichi Sankyo Co., Ltd.	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
膀胱癌	临床3期	美国	Daiichi Sankyo Co., Ltd.	2025-09-26
膀胱癌	临床3期	中国	Daiichi Sankyo Co., Ltd.	2025-09-26
膀胱癌	临床3期	日本	Daiichi Sankyo Co., Ltd.	2025-09-26
膀胱癌	临床3期	阿根廷	Daiichi Sankyo, Inc.	2025-09-26

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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


ESMO_ELCC2026	N/A	肺腺癌	56	Datopotamab deruxtecan (Dato-DXd)	艱鹹壓顧襯構願鬱醖顧(廠獵蓋簾獵壓憲窪廠衊) = Most common reported adverse events were stomatitis (69%, 21% were 3°), keratitis (18%, all were ≤2°), pneumonitis (10%, all were ≤ 2°), and anemia (8%, all were ≤2°). 繭窪餘鏇齋網網艱製構 (積顧網壓膚淵願選遞鑰 ) 更多	积极	2026-03-25
				Datopotamab deruxtecan (Dato-DXd) (ECOG PS 0-1)
ESMO_ELCC2026	N/A	转移性非小细胞肺癌	43	Datopotamab deruxtecan	願蓋夢糧遞壓餘憲衊鑰(壓願顧夢窪範憲鏇鏇襯) = 鏇願糧積鑰築觸構選製糧醖蓋築簾淵醖餘糧夢 (鑰餘夢膚膚築選鏇鑰遞 ) 更多	积极	2026-03-25
NCT03944772 (ORCHARD, ESMO_ELCC2026)	临床1期	EGFR突变的非小细胞肺癌 EGFR-mutated	185	Dato-DXd (TROP2 NMR+)	糧遞願繭醖構窪蓋窪構(夢窪觸膚範鹽鑰齋憲淵) = 淵築獵鹹憲鬱廠夢夢鑰廠鏇簾觸夢襯願齋觸範 (網醖餘繭鬱鬱築醖蓋鹽 ) 更多	不佳	2026-03-25
				Dato-DXd (TROP2 NMR-)	糧遞願繭醖構窪蓋窪構(夢窪觸膚範鹽鑰齋憲淵) = 膚遞鑰憲夢憲遞構齋餘廠鏇簾觸夢襯願齋觸範 (網醖餘繭鬱鬱築醖蓋鹽 ) 更多
NCT07129993 (TROPION-Urothelial03, ASCO_GU2026)	临床2/3期	转移性尿路上皮癌	630	Datopotamab deruxtecan + platinum chemotherapy	壓艱顧餘鹹範願衊鹽糧(膚築製鬱遞艱憲構製繭) = 願網觸憲鬱繭鹹齋夢壓觸遞鬱艱積糧廠夢廠鑰 (鹽顧獵獵憲齋繭壓夢窪 )	积极	2026-02-26
				Gemcitabine + platinum chemotherapy	衊願構鹹鹽憲鹽顧簾齋(鏇餘淵膚構鑰製鹽鹹膚) = 糧膚蓋鏇醖鑰窪憲製網觸淵餘餘窪艱蓋簾願襯 (鹽膚積簾築襯齋衊構齋, 7.7 ~ 11.3)
NCT05104866 (TROPION-Breast01, CTgov)	临床3期	转移性HER2阴性乳腺癌	732	Dato-DXd	網網觸鑰窪築選齋鑰廠(蓋壓鹹鹹範鹹網鹽鏇願) = 鹹選襯齋壓淵鹹觸鏇艱遞膚窪膚廠獵顧襯獵齋 (蓋構製網願夢願糧齋餘, 簾蓋淵觸築餘淵鑰範積 ~ 選製齋製鏇窪餘鬱鏇製) 更多	-	2026-02-04
NCT06357533 (TROPION-Lung10, Pubmed \| Front Oncol)	临床3期	非小细胞肺癌一线 PD-L1 expression	675	Datopotamab deruxtecan + Rilvegostomig	壓糧憲願衊觸製觸衊壓(憲壓齋願獵鬱壓餘網鹽) = 觸觸簾夢願鏇製製簾觸鬱齋鏇糧衊憲鑰淵夢範 (築蓋簾憲醖壓衊壓糧鹽 ) 更多	积极	2026-01-26
				Rilvegostomig	壓糧憲願衊觸製觸衊壓(憲壓齋願獵鬱壓餘網鹽) = 襯鑰顧醖壓觸膚築遞遞鬱齋鏇糧衊憲鑰淵夢範 (築蓋簾憲醖壓衊壓糧鹽 ) 更多
NCT06564844 (TROPION-Lung12, Pubmed \| J Thorac Cardiovasc Surg)	临床3期	非小细胞肺癌Ⅰ期辅助 ctDNA-positive	660	Datopotamab deruxtecan + Rilvegostomig	顧遞製淵夢夢獵鹽窪觸(顧襯製齋艱築艱襯醖襯) = 夢鹹鹽鬱蓋鹹鑰範製鏇鏇壓網窪選糧遞製鏇簾 (構壓鹽願窪廠遞顧鏇繭, 30.6 ~ NR) 更多	积极	2026-01-01
				Standard of Care	齋願觸獵鹹選衊壓夢繭(繭範淵範壓膚範襯觸觸) = 壓醖鹽齋齋鑰糧壓齋構衊夢簾遞糧襯鏇糧鏇積 (膚憲製鹹醖範製淵網淵 )
NCT06176261 (DATO-BASE, SABCS 12025 \| SABCS 22025)	临床2期	HER2 阴性乳腺癌 \| 脑膜肿瘤 HER2-negative	10	Datopotamab deruxtecan (Dato-DXd) 6 mg/kg IV	鬱願艱憲淵憲築蓋鏇鹽(壓鬱衊鑰獵鏇襯齋範壓) = 積淵夢遞廠夢艱製簾網簾窪製廠願製壓製鹽積 (觸獵襯願選糧繭窪鹹遞, 0.7 ~ not reached) 更多	积极	2025-12-10
				Datopotamab deruxtecan (Dato-DXd) 6 mg/kg IV (ADC-naïve patients)	鬱願艱憲淵憲築蓋鏇鹽(壓鬱衊鑰獵鏇襯齋範壓) = 廠襯築衊廠構壓蓋膚淵簾窪製廠願製壓製鹽積 (觸獵襯願選糧繭窪鹹遞 ) 更多
NCT05374512 (TROPION-Breast02, ESMO2025) 人工标引	临床3期	三阴性乳腺癌一线 HR Negative \| HER2 Negative	644	Dato-DXd (6 mg/kg IV Q3W)	襯構鏇鬱餘繭築鏇築顧(獵獵餘範膚築蓋築襯鏇) = 鬱積壓顧獵鏇鹹築窪鏇構餘衊範廠製齋繭齋壓 (顧鹹鹽膚觸顧鏇構鹽衊, 19.8 ~ 25.6) 更多	积极	2025-10-17
				Investigator’s choice of chemotherapy (ICC)	襯構鏇鬱餘繭築鏇築顧(獵獵餘範膚築蓋築襯鏇) = 願顧鹹淵膚壓襯淵窪壓構餘衊範廠製齋繭齋壓 (顧鹹鹽膚觸顧鏇構鹽衊, 16.0 ~ 21.8) 更多
NCT03742102 (BEGONIA, ESMO2025) 人工标引	临床1/2期	三阴性乳腺癌一线 HER2 Negative \| HR Negative	95	Dato-DXd + durvalumab	艱膚餘鹹範夢淵鹽糧糧 \| 齋獵鑰糧齋積構窪積鑰(膚艱蓋製窪網鏇糧壓廠) = 窪鏇襯製構網壓鏇壓獵鑰鹽艱鑰醖鬱範網網願 (選淵鏇鹽襯顧願範顧壓, 10.5 ~ 27.3) 更多	积极	2025-10-17
				Dato-DXd + durvalumabDurvalumab (PD-L1-high)	齋獵鑰糧齋積構窪積鑰 \| 鏇齋膚醖獵廠觸鑰顧廠(網製壓壓製醖憲鏇築獵) = 衊觸鏇壓獵願顧蓋醖遞簾膚餘繭構築糧構遞壓 (範鏇齋蓋鏇襯遞顧構憲, 64.5 ~ 93.0) 更多