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.

Start Date01 Apr 2025

Sponsor / Collaborator

Medica Scientia Innovation Research SL

[+1]

NCT06533826

/ Not yet recruitingPhase 2IIT

A Phase II Non-comparative Trial of Datopotamab Deruxtecan (Dato-DXd) or Trastuzumab Deruxtecan (T-DXd) in Patients With Metastatic HER2-low Breast Cancer After Progression on Prior Antibody Drug Conjugate Therapy

The purpose of this study is to test the safety and effectiveness of the sequence of two investigational drugs (trastuzumab deruxtecan followed by datopotamab deruxtecan, or datopotamab deruxtecan followed by trastuzumab deruxtecan) to learn whether the treatment works in treating HER2-low metastatic breast cancer.
The names of the study drugs involved in this study are:
* Datopotamab deruxtecan (a type of antibody drug conjugate)
* Trastuzumab deruxtecan (a type of antibody drug conjugate)

Start Date01 Jan 2025

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06564844

/ RecruitingPhase 3

A Phase III, Randomised, Open-label, Global Study of Adjuvant Datopotamab Deruxtecan (Dato-DXd) in Combination With Rilvegostomig or Rilvegostomig Monotherapy Versus Standard of Care, Following Complete Tumour Resection, in Participants With Stage I Adenocarcinoma Non-small Cell Lung Cancer Who Are ctDNA-positive or Have High-risk Pathological Features (TROPION-Lung12)

This is a Phase III, randomised, open-label, multicentre, global study assessing the efficacy and safety of adjuvant Dato-DXd in combination with rilvegostomig compared with SoC, after complete surgical resection (R0) in participants with Stage I adenocarcinoma NSCLC who are ctDNA-positive, as determined by the Sponsor-designated ctDNA assay, or have at least one high-risk pathological feature.

Start Date15 Oct 2024

Sponsor / Collaborator

AstraZeneca PLC

[+1]

100 Clinical Results associated with Datopotamab Deruxtecan

100 Translational Medicine associated with Datopotamab Deruxtecan

100 Patents (Medical) associated with Datopotamab Deruxtecan

Literatures (Medical) associated with Datopotamab Deruxtecan

31 Dec 2025·mAbs

Antibodies to watch in 2025

Review

Author: Kapoor, Vaishali ; Kaplon, Hélène ; Crescioli, Silvia ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; 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.

01 Dec 2025·Current Neurology and Neuroscience Reports

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

Review

Author: 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.

20 Jan 2025·JOURNAL OF CLINICAL ONCOLOGY

Datopotamab Deruxtecan Versus Docetaxel for Previously Treated Advanced or Metastatic Non–Small Cell Lung Cancer: The Randomized, Open-Label Phase III TROPION-Lung01 Study

Article

PURPOSE:

The randomized, open-label, global phase III TROPION-Lung01 study compared the efficacy and safety of datopotamab deruxtecan (Dato-DXd) versus docetaxel in patients with pretreated advanced/metastatic non–small cell lung cancer (NSCLC).

METHODS:

Patients received Dato-DXd 6 mg/kg or docetaxel 75 mg/m 2 once every 3 weeks. Dual primary end points were progression-free survival (PFS) and overall survival (OS). Objective response rate, duration of response, and safety were secondary end points.

RESULTS:

In total, 299 and 305 patients were randomly assigned to receive Dato-DXd or docetaxel, respectively. The median PFS was 4.4 months (95% CI, 4.2 to 5.6) with Dato-DXd and 3.7 months (95% CI, 2.9 to 4.2) with docetaxel (hazard ratio [HR], 0.75 [95% CI, 0.62 to 0.91]; P = .004). The median OS was 12.9 months (95% CI, 11.0 to 13.9) and 11.8 months (95% CI, 10.1 to 12.8), respectively (HR, 0.94 [95% CI, 0.78 to 1.14]; P = .530). In the prespecified nonsquamous histology subgroup, the median PFS was 5.5 versus 3.6 months (HR, 0.63 [95% CI, 0.51 to 0.79]) and the median OS was 14.6 versus 12.3 months (HR, 0.84 [95% CI, 0.68 to 1.05]). In the squamous histology subgroup, the median PFS was 2.8 versus 3.9 months (HR, 1.41 [95% CI, 0.95 to 2.08]) and the median OS was 7.6 versus 9.4 months (HR, 1.32 [95% CI, 0.91 to 1.92]). Grade ≥3 treatment-related adverse events occurred in 25.6% and 42.1% of patients, and any-grade adjudicated drug-related interstitial lung disease/pneumonitis occurred in 8.8% and 4.1% of patients, in the Dato-DXd and docetaxel groups, respectively.

CONCLUSION:

Dato-DXd significantly improved PFS versus docetaxel in patients with advanced/metastatic NSCLC, driven by patients with nonsquamous histology. OS showed a numerical benefit but did not reach statistical significance. No unexpected safety signals were observed.

238

News (Medical) associated with Datopotamab Deruxtecan

20 Jan 2025

·medcitynews.com

AstraZeneca, Daiichi Sankyo ADC Lands FDA Approval in Advanced Breast Cancer - MedCity News

A targeted cancer therapy from AstraZeneca’s alliance with Daiichi Sankyo is now FDA approved to treat certain cases of advanced breast cancer, giving the British pharmaceutical giant another product to fill out an oncology portfolio that’s a key part of its revenue growth strategy. The regulatory decision announced late Friday covers the treatment of adults with advanced cases of breast cancer that is HR positive and HER2 negative and cannot be removed by surgery. Also, these cancers must have advanced or spread following treatment with an endocrine-based therapy and chemotherapy. The drug, known in development as datopotamab deruxtecan, or Dato-DXd, will be marketed under the brand name Datroway. Datroway is part of a class of therapies called antibody drug conjugates (ADCs), which are made by linking a toxic chemotherapy payload to a targeting antibody. The target of Datroway is TROP2, a protein abundant on the surface of many types of cancer cells, including breast cancer cells. Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech The AstraZeneca/Daiichi Sankyo drug was evaluated in an open-label Phase 3 study that enrolled 732 patients with advanced breast cancer. Study participants were randomly assigned to receive the study drug or chemotherapy. The main goals were measuring progression-free survival and overall survival. Results showed median progression-free survival of 6.9 months in the Datroway arm compared with 4.9 months in the chemotherapy arm, which was enough to be statistically significant. But Datroway fell short of statistical significance on the measure of overall survival, with a median 18.6 months in the study drug arm compared with 18.3 months for those treated with chemo. AstraZeneca already markets an ADC for breast cancer. Enhertu was initially approved in 2019 as a treatment for HER2-positive breast cancer. The ADC’s approval later expanded to include HER2-low metastatic breast cancer and HER2-positive non-small cell lung cancer. Last year, the FDA approved Enhertu for treating solid tumors regardless of where they’re found in the body as long as they express HER2. AstraZeneca has set a goal bringing to market at least 20 new drugs by 2030, growing annual revenue to $80 billion. The company said Datroway is now the eighth new medicine for its 2030 goal. “With this first approval of Datroway in the U.S., we continue to deliver on our ambition for antibody drug conjugates to improve upon and replace conventional chemotherapy for the treatment of multiple cancers,” Dave Fredrickson, executive vice president, oncology hematology business unit, AstraZeneca, said in a prepared statement. Biopharma information services firm Citeline included Datroway in its report on key potential drug launches for 2025. The drug’s Phase 3 results are comparable to those of Trodelvy, a TROP2-targeting ADC marketed by Gilead Sciences as a second-line treatment for HR positive, HER2 negative breast cancer, the report said. But Datroway’s results come up short compared with Enhertu. Healthcare Using Data to Help Healthcare Practices Succeed A new report from Relatient, A Data-Driven Guide to Patient Access Succes, highlights how focusing on data accuracy and relevance can enhance the performance of healthcare practices. By Relatient The Citeline report also noted one treatment-related death in the Datroway trial. Given that patients with advanced breast cancer have other treatment options, the potential safety risks could place the drug lower on a physicians’ lists of available therapies, Citeline said. For those reasons, Datroway is unlikely to stand out as a leader in this setting and is expected to get a small piece of market share, the report said. AstraZeneca said Datroway submissions in breast cancer are still under regulatory review in Europe and China, among other markets. The company is also seeking to expand use of the drug to other cancers. Last week, the FDA accepted an application seeking approval of the ADC for EGFR-mutated non-small cell lung cancer. A regulatory decision in this indication is expected in the third quarter of this year. Public domain image by the National Cancer Institute

Phase 3ADCClinical ResultDrug Approval

20 Jan 2025

·pmlive.com

AstraZeneca/Daiichi Sankyo’s Datroway granted FDA approval in breast cancer

AstraZeneca (AZ) and Daiichi Sankyo’s Datroway (datopotamab deruxtecan-dlnk) has been approved by the US Food and Drug Administration (FDA) to treat a subset of breast cancer patients. The TROP2-targeting antibody drug conjugate (ADC) has been authorised for use in adults with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy. The FDA’s decision was based on positive results from the late-stage TROPION-Breast01 trial, in which intravenous Datroway reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy. The safety profile of Datroway was also shown to be consistent with the known profile of the drug, with no new safety concerns identified. More than 300,000 people are diagnosed with breast cancer in the US every year, and HR-positive, HER2-negative breast cancer accounts for approximately 70% of cases. Endocrine therapies, which work by either lowering the amount of hormones in the body or blocking them from getting to breast cancer cells, are widely given in the early lines of treatment for those with HR-positive metastatic disease. However, further efficacy from endocrine therapy is often limited following initial treatment, and the current standard of care at this point is chemotherapy, which is associated with poor response rates and outcomes. Datroway belongs to a relatively new class of cancer drugs that combine the selectivity of antibodies with the potent cell-killing power of chemotherapy or other anti-cancer agents. Unlike chemotherapy, which works by attacking lots of different cells as well as the cancer, ADCs are designed to target and kill tumour cells while sparing healthy ones. Additional regulatory submissions for Datroway in breast cancer are under review in the EU, China and other markets, the companies said. Global principal investigator for TROPION-Breast01 Aditya Bardia, UCLA Health Jonsson Comprehensive Cancer Center, said: “Despite considerable progress in the HR-positive, HER2-negative metastatic breast cancer treatment landscape, new therapies are still needed to tackle the frequent and complex challenge of disease progression after endocrine and initial chemotherapy. “The approval of [Datroway], a novel TROP2-directed ADC, marks a major therapeutic milestone and provides patients with metastatic breast cancer a new treatment alternative to conventional chemotherapy.”

Drug ApprovalADCImmunotherapyClinical Result

18 Jan 2025

·pipelinereview.com

DATROWAY® Approved in the U.S. for Patients with Previously Treated Metastatic HR Positive, HER2 Negative Breast Cancer

TOKYO, Japan & BASKING RIDGE, NJ, USA I January 17, 2055 I DATROWAY ® (datopotamab deruxtecan-dlnk) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN). DATROWAY is the second DXd ADC approved in the U.S. based on Daiichi Sankyo’s DXd ADC Technology. The approval by the U.S. Food and Drug Administration (FDA) was based on results from the TROPION-Breast01 phase 3 trial. In the trial, DATROWAY significantly reduced the risk of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio [HR]=0.63; 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative metastatic breast cancer as assessed by blinded independent central review (BICR). Median progression-free survival (PFS) was 6.9 months in patients treated with DATROWAY versus 4.9 months with chemotherapy. A confirmed objective response rate (ORR) of 36% was observed in the DATROWAY arm compared to an ORR of 23% observed in the chemotherapy arm. Two (0.5%) complete responses (CR) and 131 (36%) partial responses (PR) were observed in the DATROWAY arm compared to zero CR and 84 PR (23%) in the chemotherapy arm. The median duration of response (DoR) was 6.7 months (95% CI: 5.6-9.8) in the DATROWAY arm compared to 5.7 (95% CI: 4.9-6.8) in the chemotherapy arm. “Despite considerable progress in the HR positive, HER2 negative metastatic breast cancer treatment landscape, new therapies are still needed to tackle the frequent and complex challenge of disease progression after endocrine and initial chemotherapy,” said Aditya Bardia, MD, MPH, Program Director of Breast Oncology and Director of Translational Research Integration at the UCLA Health Jonsson Comprehensive Cancer Center and Global Principal Investigator for TROPION-Breast01. “The approval of datopotamab deruxtecan, a novel TROP2 directed antibody drug conjugate, marks a major therapeutic milestone and provides patients with metastatic breast cancer a new treatment alternative to conventional chemotherapy.” “Only one in three patients with metastatic HR positive, HER2 negative breast cancer live more than five years following diagnosis, highlighting the urgent need for additional effective therapies,” said Caitlin Lewis, Senior Vice President of Strategy & Mission, Living Beyond Breast Cancer. “The approval of DATROWAY is a significant advance, offering patients with metastatic HR positive breast cancer a new and much needed treatment option.” In TROPION-Breast01, the safety of DATROWAY (6 mg/kg) was evaluated in 360 patients. The most common (>20%) adverse reactions, including laboratory abnormalities, were stomatitis, nausea, fatigue, decreased leukocytes, decreased calcium, alopecia, decreased lymphocytes, decreased hemoglobin, constipation, decreased neutrophils, dry eye, increased alanine transaminase, vomiting, increased aspartate aminotransferase, increased alkaline phosphatase, and keratitis. Serious adverse reactions among patients who received DATROWAY included urinary tract infection (1.9%), COVID-19 infection (1.7%), interstitial lung disease (ILD)/pneumonitis (1.1%), acute kidney injury (0.6%), pulmonary embolism (0.6%), vomiting (0.6%), diarrhea (0.6%), hemiparesis (0.6%), and anemia (0.6%). One patient fatality (0.3%) was attributed to an adverse reaction (ILD/pneumonitis). “The approval of DATROWAY provides patients with HR positive, HER2 negative breast cancer previously treated with endocrine-based therapy and traditional chemotherapy with the opportunity to be treated with a new TROP2 directed antibody drug conjugate earlier in the metastatic setting,” said Ken Keller, Global Head of Oncology Business, and President and CEO, Daiichi Sankyo, Inc. “DATROWAY is the latest addition to our portfolio of innovative cancer treatments and marks the fourth medicine from our oncology pipeline to receive approval in the U.S.” “With this first approval of DATROWAY in the U.S., we continue to deliver on our ambition for antibody drug conjugates to improve upon and replace conventional chemotherapy for the treatment of multiple cancers,” said Dave Fredrickson, Executive Vice President, Oncology Hematology Business Unit, AstraZeneca. “We are proud to bring DATROWAY to people living with metastatic HR positive, HER2 negative breast cancer, and this approval marks the eighth new medicine of the 20 we have set out to deliver across AstraZeneca by 2030.” DATROWAY will be available by prescription in the U.S. in approximately two weeks. Daiichi Sankyo and AstraZeneca are committed to ensuring that patients in the U.S. who are prescribed DATROWAY can access the medication and receive necessary financial support. Provider and patient support, reimbursement and distribution for DATROWAY in the U.S. will be accessible by visiting Datroway4u.com or calling 1-855-DAT-RO4U (1-855-328-7648). Additional regulatory submissions for DATROWAY in breast cancer are under review in the EU, China and other regions. Please visit www.DATROWAY.com for full Prescribing Information , including the Medication Guide . About TROPION-Breast01 TROPION-Breast01 is a global, randomized, multicenter, open-label phase 3 trial evaluating the efficacy and safety of intravenous DATROWAY (6 mg/kg) once per 21-day cycle versus investigator’s choice of single-agent chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy per investigator assessment and have received at least one prior line of chemotherapy for unresectable or metastatic disease. Following disease progression or discontinuation of DATROWAY or chemotherapy, patients had the option to receive a subsequent treatment at the discretion of their physician. Crossover between trial arms was not permitted. The dual primary endpoints of TROPION-Breast01 are PFS as assessed by BICR and OS. Key secondary endpoints include ORR, duration of response, investigator-assessed PFS, disease control rate, time to first subsequent therapy and safety. The PFS data and additional results for key secondary endpoints of TROPION-Breast01 were published in the Journal of Clinical Oncology . TROPION-Breast01 enrolled 732 patients in Africa, Asia, Europe, North America and South America. For more information visit ClinicalTrials.gov . About Hormone Receptor Positive, HER2 Negative Breast Cancer In the U.S., more than 300,000 cases of breast cancer are diagnosed annually. 1 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis. 2 Approximately 70% of diagnosed cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-). 2 Endocrine therapies are widely given consecutively in the early lines of treatment for HR positive metastatic breast cancer. 3 However, after initial treatment, further efficacy from endocrine therapy is often limited. 3 The current standard of care following endocrine therapy is chemotherapy, which is associated with poor response rates and outcomes. 3,4,5,6 About DATROWAY DATROWAY (datopotamab deruxtecan-dlnk) is a TROP2 directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca’s ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. DATROWAY (6 mg/kg) is approved in the U.S. and Japan for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial. About the DATROWAY Clinical Development Program A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including non-small cell lung cancer, triple negative breast cancer and HR positive, HER2 negative breast cancer. The program includes seven phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other anticancer treatments in various settings. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU ® in March 2019 and DATROWAY in July 2020 , except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. DATROWAY U.S. Important Safety Information Indication DATROWAY ® is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH−) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. Please see accompanying full Prescribing Information , including the Medication Guide . About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit www.daiichisankyo.com . References 1 American Cancer Society. Key Statistics for Breast Cancer. Accessed January 2025. 2 National Cancer Institute. SEER Cancer Stat Facts: Female Breast Cancer Subtypes. Accessed January 2025. 3 Manohar P, et al. Cancer Biol Med. 2022 Feb 15; 19(2):202–212. 4 Cortes J, et al. Lancet. 2011;377:914-923. 5 Yuan P, et al. Eur J Cancer. 2019;112:57-65. 6 Jerusalem G, et al. JAMA Oncol. 2018;4(10):1367–1374. SOURCE: Daiichi Sankyo

Phase 3ADCLicense out/inDrug ApprovalClinical Result

100 Deals associated with Datopotamab Deruxtecan

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KEGG	Wiki	ATC	Drug Bank
-	-	-	DB16410

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hormone receptor positive HER2 negative breast cancer	JP	Daiichi Sankyo Co., Ltd.	27 Dec 2024

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	US	AstraZeneca PLC	12 Nov 2024
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	US	Daiichi Sankyo Co., Ltd.	12 Nov 2024
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	NDA/BLA	US	Daiichi Sankyo, Inc.	19 Feb 2024
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	NDA/BLA	US	AstraZeneca PLC	19 Feb 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	NDA/BLA	US	AstraZeneca PLC	19 Feb 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	NDA/BLA	US	Daiichi Sankyo, Inc.	19 Feb 2024
Non-small cell lung cancer stage I	Phase 3	US	AstraZeneca PLC	15 Oct 2024
Non-small cell lung cancer stage I	Phase 3	JP	AstraZeneca PLC	15 Oct 2024
Non-small cell lung cancer stage I	Phase 3	BE	AstraZeneca PLC	15 Oct 2024
Non-small cell lung cancer stage I	Phase 3	BR	AstraZeneca PLC	15 Oct 2024

Clinical Result

Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05104866 (TROPION-Breast01, FDA_CDER) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer Second line \| Third line	732	DATROWAY 6 mg/kg	dethxsyyvx(zcagwlgoix) = ytpgfwvltx jmzqtkdayr (yhdtmwiqhw, 5.7 - 7.4) View more	Positive	17 Jan 2025
				Chemotherapy	dethxsyyvx(zcagwlgoix) = iqqyzokzag jmzqtkdayr (yhdtmwiqhw, 4.2 - 5.5) View more
NCT04484142 (TROPION-Lung05, Pubchem) Manual	Phase 2	metastatic non-small cell lung cancer Last line ALK Rearrangement \| EGFR Mutation	137	Datopotamab deruxtecan 6 mg/kg	qfkvtngfeu(rziywjfgva) = izkmbbiehb gdstwzndic (sdnhhxjlwh, 27.8 - 44.4) View more	Positive	06 Jan 2025
				Datopotamab deruxtecan 6 mg/kg (EGFR mutations)	qfkvtngfeu(rziywjfgva) = fgjejkqmgu gdstwzndic (sdnhhxjlwh, 32.4 - 55.3)
NCT05104866 (TROPION-Breast01, ESMO_ASIA2024) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer Hormone Receptor Positive \| HER2 Negative	83	Datopotamab deruxtecan (Dato-DXd) (China cohort)	cmxhuwdbjh(ekwseshfpo) = feepicslnq qvtvdrwewj (weaumauosu ) View more	Positive	07 Dec 2024
				Chemotherapy (capecitabine/eribulin/gemcitabine/vinorelbine) (China cohort)	cmxhuwdbjh(ekwseshfpo) = mthkkurgtr qvtvdrwewj (weaumauosu ) View more
NCT04484142 \| NCT04656652 (TROPION-Lung01, ESMO_ASIA2024) Manual	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	117	Dato-DXd	fphdyzubfh(pizctjfbhn) = lzttidzmvm yksryffrpj (vfsebqlijc, 34 - 52) View more	Positive	06 Dec 2024
				Dato-DXd (TROPION-Lung05)	fphdyzubfh(pizctjfbhn) = tsijxdwxsa yksryffrpj (vfsebqlijc, 32 - 55) View more
NCT05104866 (TROPION-Breast01, NEWS) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer HER2 Negative \| Hormone Receptor Positive	700	Dato-DXd （6.0mg/kg）	zmfivdmveu(hlxydyypcb): HR = 0.84 (95% CI, 0.62 - 1.14) Not Met	Negative	23 Sep 2024
				研究者选择的单药化疗
NCT05104866 (ESMO2024)	Phase 3	Hormone receptor positive HER2 negative breast cancer	-	Investigator’s choice of chemotherapy (ICC)	eaepzchqck(ueroskktem) = zkyyhmtyuq rjyxhuzfpw (ywpbnzsucw )	-	16 Sep 2024
NCT05489211 (ESMO2024) Manual	Phase 2	Ovarian Cancer \| Endometrial Carcinoma	75	Dato-DXd 6 mg/kg IV Q3W	lftwddattp(aiznanyica) = arznlduuyl ehhhexszrp (yontklhwhf ) View more	Positive	15 Sep 2024
				Dato-DXd (Ovarian)	lftwddattp(aiznanyica) = jzrsnxxynp ehhhexszrp (yontklhwhf ) View more
NCT04656652 (TROPION-LUNG01, ESMO2024) Manual	Phase 3	Advanced Lung Non-Squamous Non-Small Cell Carcinoma Second line \| Third line	468	Datopotamab deruxtecan (Dato-DXd) 6 mg/kg	tzsjjwpeid(yyvnknpxmf) = sqhrejeaph tsajlnxtbc (akamswihhz, 2.9 - 5.9) View more	Positive	14 Sep 2024
				Docetaxel (DTX) 75 mg/m2	tzsjjwpeid(yyvnknpxmf) = nsmtiyhrpd tsajlnxtbc (akamswihhz, 1.5 - 4.6) View more
NCT05104866 (TROPION-Breast01, Pubmed \| J Clin Oncol) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer Second line \| Third line Hormone Receptor Positive \| HER2 Negative	732	Datopotamab deruxtecan (Dato-DXd)	fhjwqorjhy(mchtynjfjy): HR = 0.84 (95% CI, 0.62 - 1.14) View more	Positive	12 Sep 2024
				Investigator's choice of chemotherapy (ICC)
NCT04656652 (TROPION-Lung01, Pubmed \| J Clin Oncol) Manual	Phase 3	Non-Small Cell Lung Cancer Second line	604	Datopotamab deruxtecan 6 mg/kg	xccvpaoauo(bcaxftsvwo) = emdogsmmyx eyswsdokab (avtxlbhbkb, 11.0 - 13.9) View more	Positive	09 Sep 2024
				Docetaxel 75 mg/m2	xccvpaoauo(bcaxftsvwo) = alikergfry eyswsdokab (avtxlbhbkb, 10.1 - 12.8) View more

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