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]

NCT06822543

/ Not yet recruitingPhase 2IIT

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.

Start Date24 Feb 2025

Sponsor / Collaborator

Merck Sharp & Dohme Corp.

[+1]

CTR20244119

/ RecruitingPhase 3

一项在既往奥希替尼治疗过程中出现疾病进展的EGFR 突变阳性局部晚期或转移性非小细胞肺癌参与者中评估Dato-DXd 联合或不联合奥希替尼治疗对比含铂化疗的III 期、开放性、申办者盲态、随机研究（TROPION-Lung15）

[Translation] A phase III, open-label, sponsor-blinded, randomized study evaluating Dato-DXd with or without osimertinib versus platinum-based chemotherapy in participants with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer who have progressed on prior osimertinib (TROPION-Lung15)

本研究旨在评估 Dato-DXd 联合或不联合奥希替尼对比含铂化疗在既往奥希替尼治疗出现疾病进展的EGFRm 局部晚期或转移性 NSCLC 参与者中的疗效。拟定双主要研究终点旨在证明 Dato-DXd 联合和不联合奥希替尼在盲态独立中心审查（BICR）评估的 PFS 方面相较于化疗的优效性。关键次要有效性终点是OS和CNS PFS。还将评估 Dato-DXd 联合或不联合奥希替尼相较于化疗的安全性和耐受性特征。

[Translation]

This study is designed to evaluate Dato-DXd with or without osimertinib versus platinum-based chemotherapy in participants with EGFRm locally advanced or metastatic NSCLC who have progressed on prior osimertinib therapy. The proposed dual primary endpoints are to demonstrate the superiority of Dato-DXd with or without osimertinib versus chemotherapy with respect to PFS assessed by blinded independent central review (BICR). Key secondary efficacy endpoints are OS and CNS PFS. The safety and tolerability profile of Dato-DXd with or without osimertinib versus chemotherapy will also be evaluated.

Start Date05 Feb 2025

Sponsor / Collaborator

AstraZeneca AB

[+2]

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.

01 Mar 2025·Breast Cancer

Management of nausea and vomiting induced by antibody–drug conjugates

Review

Author: Sakai, Hitomi ; Tsurutani, Junji ; Farhat, Jawhara

Abstract:

Antibody–drug conjugates (ADCs) are an emerging class of anticancer therapy that combines the specificity and long circulation half-life of monoclonal antibodies with the cytotoxic potency of the payload connected through a chemical linker. The optimal management of toxicities is crucial for improving quality of life in patients undergoing ADCs and for avoiding improper dose reductions or discontinuations. This article focuses on the characteristics and management of nausea and vomiting (NV) induced by three ADCs: trastuzumab deruxtecan (T-DXd), sacituzumab govitecan (SG), and datopotamab deruxtecan (Dato-DXd). We summarize the proposed mechanism of NV, clinical study data on NV, and recommendations from clinical guidelines. We also discuss three prospective studies evaluating prophylactic antiemetic therapy in patients receiving T-DXd, along with future perspectives.

354

News (Medical) associated with Datopotamab Deruxtecan

19 Mar 2025

·www.fiercepharma.com

AstraZeneca offers early look at Datroway-Tagrisso combo in EGFR lung cancer as phase 3 trial rolls on

AstraZeneca recently launched the phase 3 Tropion-Lung15 trial—testing Datroway either by itself or with Tagrisso—in post-Tagrisso EGFR-mutated non-small cell lung cancer. As AstraZeneca awaits an FDA decision for its Daiichi Sankyo-partnered Datroway in EGFR-mutated non-small cell lung cancer (NSCLC), the British pharma has rolled out early data from a trial combining the antibody-drug conjugate (ADC) with its old blockbuster Tagrisso.A combination of Datroway and Tagrisso induced a response in 36% of patients with EGFR-mutant NSCLC who had progressed on first-line Tagrisso, new data show.The data come from module 10 of the phase 2 Orchard trial, a platform study of novel combinations in the post-Tagrisso setting. The findings are part of an abstract set to be presented at the European Lung Cancer Congress (ELCC) next week.The 36% objective response rate (ORR) was recorded among 33 evaluable patients who received Datroway at 6 milligrams per kilogram of body weight, which is the recommended dose for the TROP2-directed ADC’s FDA-approved indication in third-line HR-positive, HER2-negative breast cancer.Among 35 patients who received Datroway at a lower 4 mg/kg dose, investigators recorded a 43% ORR for the combination. The two patient groups had similar follow-up times at about 13 months.Considering the overall benefit-risk profiles of the two doses, investigators recommended the 6 mg/kg option, according to the abstract.In October, AZ and Daiichi launched the phase 3 Tropion-Lung15 trial testing Datroway 6 mg/kg—either by itself or with Tagrisso—in post-Tagrisso EGFR-mutant NSCLC. The study bears an estimated primary completion date in June 2026.Cancer that becomes resistant to Tagrisso may still have tumor cells that harbor EGFR mutations, an AstraZeneca spokesperson explained in offering the company’s rationale for adding Tagrisso to Datroway in second-line treatment.“Continuing Tagrisso ensures ongoing inhibition against those EGFRm-driven tumor cells, while also receiving treatment to suppress the resistance and, ultimately, prolong patients’ responses to treatment,” the spokesperson said in a statement. Besides the ORR measure, the higher dose of Datroway can trigger a response faster and keep tumors at bay longer, investigators found. The median time to onset of response was 1.4 months versus 2.7 months, respectively, for the two doses. Investigators estimated that only 15% of patients who received the lower dose would remain in response at nine months, whereas 64% on the preferred dose could enjoy that status.Patients on the higher Datroway dose went a median 11.7 months without disease progression, compared with 9.5 months among recipients of the lower dose, the data show.As expected, the combination with the higher dose was linked to more adverse events, although no new safety signals emerged.Overall, 56% and 34% of patients given the high and low doses, respectively, experienced grade 3 or above treatment-related adverse events. Adverse events leading to Datroway dose reductions were recorded in 59% and 23% of patients in the two groups, respectively.Interstitial lung disease or pneumonitis, a side effect that experts are watching closely for all ADCs based on Daiichi’s DXd platform, was seen in 15% of patients on the high dose, including 6% at grade 3 or above.Before the latest Datroway-Tagrisso combo readout, AZ and Daiichi have applied for FDA approval of Datroway as a monotherapy in previously treated EGFR-mutated NSCLC. A decision from the agency is expected by July 12, 2025.That submission was based on a pooled analysis of certain patients from the phase 3 Tropion-Lung01 and the phase 2 Tropion-Lung05 trials. Among 117 patients with EGFR-mutated NSCLC who had tried a median of three prior lines of therapy, Datroway alone achieved an ORR of 43% in the analysis, with the responses lasting for a median of seven months. For years, Tagrisso has been the standard first-line treatment for EGFR-mutated NSCLC. But that status has recently come under attack from Johnson & Johnson’s combination of Rybrevant and Lazcluze. Rybrevant, an EGFRxMET bispecific antibody, is also approved in combination with chemotherapy following treatment with an EGFR inhibitor such as Tagrisso.In the phase 3 Mariposa-2 trial conducted in post-Tagrisso patients, the Rybrevant-chemo regimen registered a 53% ORR, with a 6.9-month duration of response. The combo significantly reduced the risk of progression or death by 52% versus chemo alone. The median progression-free survival for the combo was 6.3 months.The latest Orchard data for AZ’s Datroway-Tagrisso cocktail look competitive, with the inherent drawbacks of cross-trial comparisons in mind. Other data at ELCCBesides Orchard, AZ also shared the primary analysis of the phase 2 Savannah trial, which evaluated Tagrisso in tandem with Hutchmed-partnered MET inhibitor savolitinib, which is approved in China under the brand name Orpathys. The analyzed patients had EGFR-mutant NSCLC with high MET overexpression or amplification following treatment with first-line Tagrisso.The combo logged a 56% ORR by investigator assessment or 55% by blinded central review among 80 patients who met a high MET expression criterion. The median duration of response was 7.1 months and 9.9 months, respectively, based on the separate types of review. And the median progression-free survival was 7.4 months and 7.5 months, respectively. The primary efficacy analysis focused on a cohort of patients who received Orpathys doses more frequently than the regimen studied as part of a 2022 readout, in which AZ reported a 49% ORR.Phase 3 results from the Saffron trial utilizing the more frequent, twice-a-day Orpathys regimen together with Tagrisso are expected in the second half of 2025. The trial includes patients who have progressed on either first- or second-line treatment with Tagrisso.Editor's Note: The story has an updated statement from AstraZeneca.

Clinical ResultPhase 3Phase 2Drug ApprovalADC

17 Mar 2025

·pipelinereview.com

Imfinzi approved in the EU as first and only immunotherapy for limited-stage small cell lung cancer

Approval based on ADRIATIC Phase III trial results which showed a 27% reduction in the risk of death versus placebo LONDON, UK I March 17, 2025 I AstraZeneca’s Imfinzi (durvalumab) has been approved in the European Union (EU) as monotherapy for the treatment of adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy (CRT). The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the ADRIATIC Phase III trial, which were published in The New England Journal of Medicine . SCLC is a highly aggressive form of lung cancer, with an estimated 8,000 people treated for LS-SCLC across the five major European countries each year. 1-2 LS-SCLC typically recurs and progresses rapidly, despite initial response to standard-of-care chemotherapy and radiotherapy. 3-4 The prognosis for LS-SCLC is particularly poor, as only 15-30% of patients survive for five years after diagnosis. 5 Suresh Senan, PhD, radiation oncologist at the Amsterdam University Medical Centers, The Netherlands, and principal investigator in the trial, said: “This approval marks a turning point for patients with limited-stage small cell lung cancer in Europe, bringing them an immunotherapy option for the first time. An unprecedented 57% of patients treated with durvalumab were still alive at three years in the ADRIATIC trial. This significant advance establishes a new benchmark in a setting where the standard of care has remained unchanged for decades.” Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “Imfinzi has the potential to transform how limited-stage small cell lung cancer is treated as the first immunotherapy approved in Europe in this setting. As the only immunotherapy approved for both early and late-stage disease, Imfinzi is poised to become the foundation for transforming outcomes for people with small cell lung cancer.” In the trial, results showed Imfinzi reduced the risk of death by 27% versus placebo (based on an overall survival [OS] hazard ratio [HR] of 0.73; 95% confidence interval [CI] 0.57-0.93; p=0.0104). Estimated median OS was 55.9 months for Imfinzi versus 33.4 months for placebo. An estimated 57% of patients treated with Imfinzi were alive at three years compared to 48% for placebo. Imfinzi also reduced the risk of disease progression or death by 24% (based on a progression-free survival [PFS] HR of 0.76; 95% CI 0.61-0.95; p=0.0161) versus placebo. Median PFS was 16.6 months for Imfinzi versus 9.2 months for placebo. An estimated 46% of patients treated with Imfinzi had not experienced disease progression at two years compared to 34% for placebo. The safety profile for Imfinzi was generally manageable and consistent with the known profile of this medicine. No new safety signals were observed. Imfinzi is approved in the US and several other countries in this setting based on the ADRIATIC results. Regulatory applications are currently under review in Japan and several other countries for this indication. Imfinzi is also approved in combination with chemotherapy for the treatment of extensive-stage SCLC based on the CASPIAN Phase III trial. Notes Small cell lung cancer Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths. 6-7 Lung cancer is broadly split into non-small cell lung cancer (NSCLC) and SCLC, with about 15% of cases classified as SCLC. 8 LS-SCLC (Stage I-III) accounts for approximately 30% of SCLC diagnoses and is classified when the disease is generally only in one lung or one side of the chest. 9 The prognosis for patients with LS-SCLC remains poor despite curative-intent treatment with standard-of-care concurrent CRT (cCRT). 10 ADRIATIC The ADRIATIC trial is a randomised, double-blind, placebo-controlled, multi-centre global Phase III trial evaluating Imfinzi monotherapy and Imfinzi plus Imjudo (tremelimumab) versus placebo in the treatment of 730 patients with LS-SCLC who had not progressed following cCRT. In the experimental arms, patients were randomised to receive a 1500mg fixed dose of Imfinzi with or without Imjudo 75mg every four weeks for up to four doses/cycles each, followed by Imfinzi every four weeks for up to 24 months. The dual primary endpoints were PFS and OS for Imfinzi monotherapy versus placebo. Key secondary endpoints included OS and PFS for Imfinzi plus Imjudo versus placebo, safety and quality of life measures. The trial included 164 centres in 19 countries across North and South America, Europe and Asia. Imfinzi Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune response s. In addition to its indications in SCLC, Imfinzi is also the global standard of care based on OS in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after CRT. Additionally, Imfinzi is approved as a perioperative treatment in combination with neoadjuvant chemotherapy in resectable NSCLC; and in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC. Imfinzi is also approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU. In March 2025, perioperative Imfinzi added to standard-of-care chemotherapy met the primary endpoint of event-free survival in the MATTERHORN Phase III trial in resectable gastric and gastroesophageal junction cancers. Imfinzi in combination with chemotherapy followed by Imfinzi monotherapy is approved as a 1 st -line treatment for primary advanced or recurrent endometrial cancer (mismatch repair deficient disease only in US and EU). Imfinzi in combination with chemotherapy followed by Lynparza (olaparib) and Imfinzi is approved for patients with mismatch repair proficient advanced or recurrent endometrial cancer in EU and Japan. Since the first approval in May 2017, more than 374,000 patients have been treated with Imfinzi . As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer, several gastrointestinal and gynaecologic cancers, and other solid tumours. AstraZeneca in lung cancer AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating innovative approaches, the Company aims to match medicines to the patients who can benefit most. The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso (osimertinib) and Iressa (gefitinib); Imfinzi and Imjudo ; Enhertu (trastuzumab deruxtecan) and Datroway (datopotamab deruxtecan) in collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action. AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment. AstraZeneca in immuno-oncology (IO) AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumour immune response and stimulate the body’s immune system to attack tumours. AstraZeneca strives to redefine cancer care and help transform outcomes for patients with Imfinzi as a monotherapy and in combination with Imjudo as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers. AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical programme, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca . References 1. National Cancer Institute. NCI Dictionary – Small Cell Lung Cancer. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer . Accessed March 2025. 2. AstraZeneca PLC. Investor Relations Epidemiology Spreadsheet. Available at: https://www.astrazeneca.com/investor-relations.html . Accessed March 2025. 3. Qin A, Kalemkerian GP. Treatment Options for Relapsed Small-Cell Lung Cancer: What Progress Have We Made? J Oncol Pract . 2018;14(6):369-370. 4. Cheng Y, et al. Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer. N Engl J Med . 2024;391(14):1313-1327. 5. Bebb DG, et al. Symptoms and Experiences with Small Cell Lung Cancer: A Mixed Methods Study of Patients and Caregivers. Pulm Ther . 2023;9:435-450. 6. World Health Organization. International Agency for Research on Cancer. Lung Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf . Accessed March 2025. 7. World Health Organization. International Agency for Research on Cancer. World Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf . Accessed March 2025. 8. LUNGevity Foundation. Types of Lung Cancer. Available at: https://www.lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer . Accessed March 2025. 9. American Cancer Society. Small Cell Lung Cancer Stages. Available at: https://www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/staging-sclc.html . Accessed March 2025. 10. Senan S, et al. ADRIATIC: A phase III trial of durvalumab ± tremelimumab after concurrent chemoradiation for patients with limited stage small cell lung cancer. Ann Oncol . 2019;30(suppl. 2):ii25. SOURCE: AstraZeneca

ImmunotherapyPhase 3Clinical ResultDrug Approval

17 Mar 2025

·www.biopharmadive.com

Taiho buys Swiss biotech and its ADC tech for $400M

Japan-based Taiho Pharmaceuticals on Monday said it will acquire Switzerlands Araris Biotech and its antibody-drug conjugate technology for $400 million upfront.The two companies have worked together since 2023, when they agreed to use Araris technology to explore and develop new drug candidates aimed at targets chosen by Taiho. The deal announced Monday, which they expect to close in the first half of this year, could hand Araris up to $740 million more if certain milestones are met.Antibody-drug conjugates, or ADCs, pair tumor-killing toxins with a targeting molecule via a linker. Improvements in this linking technology have helped buoy the field, yielding new treatments and sparking greater investment. Many large pharmaceutical companies, among them AstraZeneca, Pfizer and Merck & Co, have inked multibillion-dollar deals to pad their pipelines with ADC prospects. AstraZeneca, together with its partner Daiichi Sankyo, have arguably had the most success recently with their ADC drugs Enhertu and Datroway.Spun off from the Paul Scherrer Institute six years ago, Araris was funded by 4BIO Capital in 2020 and again in 2022. The biotech touts its AraLinQ technology, which it claims can provide more stable and more potent ADCs. It is developing three candidates for blood and solid tumors, and expects to advance these prospects into clinical testing this year and next.Araris unique ADC technology represents a quantum leap for the ADC field, potentially offering precise payload delivery of multiple mechanisms of action simultaneously to the tumor, with less toxicity, Dragan Grabulovski, CEO and co-founder of Araris, said in a statement.Taiho, a subsidiary of Japans Otsuka, sells several cancer drugs in the U.S: Lytgobi for bile duct cancer, Lonsurf for colorectal cancer and the myelodysplastic syndromes treatment Inqovi. It also markets other anticancer medicines in Japan. '

ADC

100 Deals associated with Datopotamab Deruxtecan

External Link

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	Japan	Daiichi Sankyo Co., Ltd.	27 Dec 2024

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	United States	Daiichi Sankyo Co., Ltd.	12 Nov 2024
EGFR-mutated non-small Cell Lung Cancer	NDA/BLA	United States	AstraZeneca PLC	12 Nov 2024
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	NDA/BLA	United States	Daiichi Sankyo, Inc.	19 Feb 2024
Locally Advanced Lung Non-Squamous Non-Small Cell Carcinoma	NDA/BLA	United States	AstraZeneca PLC	19 Feb 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	NDA/BLA	United States	AstraZeneca PLC	19 Feb 2024
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma	NDA/BLA	United States	Daiichi Sankyo, Inc.	19 Feb 2024
Adenocarcinoma of Lung	Phase 3	United States	AstraZeneca PLC	15 Oct 2024
Adenocarcinoma of Lung	Phase 3	Japan	AstraZeneca PLC	15 Oct 2024
Adenocarcinoma of Lung	Phase 3	Belgium	AstraZeneca PLC	15 Oct 2024
Adenocarcinoma of Lung	Phase 3	Brazil	AstraZeneca PLC	15 Oct 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04612751 (TROPION-Lung04, ESMO_TAT2025) Manual	Phase 1	Non-Small Cell Lung Cancer First line	52	Dato-DXd + Durvalumab	klxwggjivk(sokqwkkrop) = ptpthclkfu qvqkueyilu (zhainltegv ) View more	Positive	03 Mar 2025
				Dato-DXd + Durvalumab + Carboplatin	klxwggjivk(sokqwkkrop) = gqlekgexjn qvqkueyilu (zhainltegv ) View more
NCT03401385 (TROPION-PanTumor01, ASCO_GU2025) Manual	Phase 1	Transitional Cell Carcinoma	40	Dato-DXd 6mg/kg	xyjicagnka(rpxlbyfteg) = ikoziagysh uezomdlboo (rkvccvzmwq, 12.7 41.2) View more	Positive	13 Feb 2025
NCT05104866 (TROPION-Breast01, FDA_CDER) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer Second line \| Third line	732	DATROWAY 6 mg/kgDATROWAY 6 mg/kg	vlcsoorsax(usknjucuqg) = gdnuvgaivv lhmwproxiq (ekqhqpkidy, 5.7 - 7.4) View more	Positive	17 Jan 2025
				Chemotherapy	vlcsoorsax(usknjucuqg) = vmtlzkqstj lhmwproxiq (ekqhqpkidy, 4.2 - 5.5) View more
NCT04484142 (TROPION-Lung05, Pubmed) Manual	Phase 2	metastatic non-small cell lung cancer Last line ALK Rearrangement \| EGFR Mutation	137	Datopotamab deruxtecan 6 mg/kg	bvxewrfqum(pffqmshkxi) = vzhjxvyfpr cqjxigiusx (ofejczaosg, 27.8 - 44.4) View more	Positive	06 Jan 2025
				Datopotamab deruxtecan 6 mg/kg (EGFR mutations)	bvxewrfqum(pffqmshkxi) = wtplbazqyy cqjxigiusx (ofejczaosg, 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)	zpcrvgnjvd(pqnouvjeap) = yemlcicerk gyiwunicag (ivyhvjhizn ) View more	Positive	07 Dec 2024
				Chemotherapy (capecitabine/eribulin/gemcitabine/vinorelbine) (China cohort)	zpcrvgnjvd(pqnouvjeap) = ejdqcssgvy gyiwunicag (ivyhvjhizn ) View more
NCT04484142 \| NCT04656652 (TROPION-Lung01, ESMO_ASIA2024) Manual	Not Applicable	EGFR-mutated non-small Cell Lung Cancer EGFR Mutation	117	Dato-DXd	vjpjrybnpz(tekpunvybc) = ngyxjnscyc gojoraxury (dvgujiiofp, 34 - 52) View more	Positive	06 Dec 2024
				Dato-DXd (TROPION-Lung05)	vjpjrybnpz(tekpunvybc) = jsvloipzrb gojoraxury (dvgujiiofp, 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）	qsnjgevtyr(jogosnriof): 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)	gufgbqyaam(ivnduikshw) = xneibbibrl pkcjkdqeio (dztlsohrpg )	-	16 Sep 2024
NCT05489211 (ESMO2024) Manual	Phase 2	Ovarian Cancer \| Endometrial Carcinoma	75	Dato-DXd 6 mg/kg IV Q3W	qvfvfuorvo(tlqkstgwvw) = nksjpwosgf geevhzjkkn (fxulyvztku ) View more	Positive	15 Sep 2024
				Dato-DXd (Ovarian)	qvfvfuorvo(tlqkstgwvw) = aeesywxjpp geevhzjkkn (fxulyvztku ) 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	vzjzlppyqn(hjfprlxpqc) = cclpkmhiwo vfvbmwiszu (rqmbebneqm, 2.9 - 5.9) View more	Positive	14 Sep 2024
				Docetaxel (DTX) 75 mg/m2	vzjzlppyqn(hjfprlxpqc) = cpjahzlgax vfvbmwiszu (rqmbebneqm, 1.5 - 4.6) View more

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