marked.bio

TROP2 ADC · ADC

datopotamab deruxtecan

13 active trials across 6 of our biomarkers, targeting TROP2. 1 active approval for a biomarker on marked.bio.

Also known as Dato-DXd, DS-1062a, DS-1062, Datroway.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
datopotamab deruxtecan
FDA, 2025
locally advanced or metastatic EGFR-mutated, after EGFR-directed therapy and platinum chemotherapy AA 23/06/2025; still accelerated (FDA Ongoing list, label 1.1). Label says 'EGFR-mutated' (broader than ex19del/L858R). Source
EU (EMA)
(no EU lung indication) No EU lung indication. A separate MAA (Datopotamab deruxtecan Daiichi Sankyo, non-squamous NSCLC, not EGFR-restricted) was withdrawn by the company on 20/12/2024; EMA's provisional view was that it could not be authorised. Datroway's EU indication is HR+/HER2- breast cancer only (MA 04/04/2025). Source
Datopotamab deruxtecan Daiichi Sankyo, DatrowayBroader label 		EGFR exon 19 deletion / L858R NSCLC Approved 2025 accelerated Not approved

TROPION-Lung05 and TROPION-Lung01 (pooled) single-arm, 114 patients
Response 45% (35-54)Lasting 6.5 months

Serious side effects 26%Stopped for side effects 8%Fatal 1.6%

Trial details and side effects
Patients
EGFR-mutated NSCLC after EGFR-directed therapy and platinum chemotherapy (NCT04484142)
Most common side effects
stomatitis 71%, nausea 50%, alopecia 49%, fatigue 42%, constipation 31% (125 patients)
Notes
Accelerated approval. Efficacy from the FDA approval notice; side effects from the US label rev. 05/2026.
Source
FDA approval summary

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
EGFR exon 19 deletion / L858R 6 6 Phase 4
HER2-low / ultralow (IHC 1+ or 2+/ISH-) 5 5 Phase 2
MET exon 14 skipping 2 4 Phase 3
BRCA1/2 mutation 1 1 Phase 1/2
IDH1/2 mutation 1 1 Phase 1/2
BRAF V600E 0 1 –

Sponsors

Industry sponsors leading active biomarker-selected trials of datopotamab deruxtecan.

  1. AstraZeneca 7
  2. Daiichi Sankyo 3
  3. Cullinan Therapeutics 1

Trials

13 of 15 trials shown

  1. An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (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 Non-small Cell Lung Cancer.

    Recruiting Phase 4 AstraZeneca Started 2026Primary completion 2028-01 NCT07357597

    dexamethasonedatopotamab deruxtecan FDA

    Patients with locally advanced or metastatic EGFRm NSCLC who have received prior EGFR-directed therapy and platinum-based chemotherapy.

    EGFR exon 19 deletion / L858RStomatitis

  2. A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

    Active, not recruiting Phase 3 AstraZeneca Started 2024Primary completion 2027-01 NCT06417814

    datopotamab deruxtecan FDAosimertinib FDA EUpemetrexedcarboplatincisplatin

    …pidermal growth factor receptor \[EGFR\] tyrosine kinase inhibitor \[TKis\] sensitivity \[Ex19del, L858R, G719X, S768I, or L861Q\], either alone or in combination with other EGFR mutation…

    EGFR exon 19 deletion / L858RMetastatic Non-small Cell Lung Cancer

  3. Phase III, Open-label Study of First-line Osimertinib With or Without Datopotamab Deruxtecan for EGFRm Locally Advanced or Metastatic Non-small Cell Lung Cancer

    Recruiting Phase 3 AstraZeneca Started 2024Primary completion 2028-03 NCT06350097

    osimertinib FDA EUdatopotamab deruxtecan FDA

    … least 1 of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del or L858R), either alone or in combination with other genomic alterations, which may inclu…

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer

  4. Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)

    Active, not recruiting Phase 3 Daiichi Sankyo Started 2020Primary completion 2024-05 NCT04656652

    datopotamab deruxtecandocetaxel

    …ave one or more documented actionable genomic alteration(s): EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET.

    MET exon 14 skippingNon-small Cell Lung Cancer

  5. A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer

    Recruiting Phase 1/2 Memorial Sloan Kettering Cancer Center Started 2026Primary completion 2028-04 NCT07535437

    ivonescimabdatopotamab deruxtecan FDAosimertinib FDA EU

    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

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

  6. A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced/Metastatic Solid Tumors

    Recruiting Phase 1/2 AstraZeneca Started 2024Primary completion 2028-12 NCT06130553

    AZD3470datopotamab deruxtecan FDA

    …defined criteria) and the participant has received prior systemic therapy appropriate for EGFR-altered advanced/metastatic NSCLC (per protocol), OR Tumor is negative for EGFR alterations eligi…

    EGFR exon 19 deletion / L858RAdvanced Solid Tumors That Are MTAP Deficient

  7. TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd

    Recruiting Phase 2 Ana C Garrido-Castro, MD Started 2024Primary completion 2028-01 NCT06533826

    trastuzumab deruxtecan FDA EUdatopotamab deruxtecan

    Participants must have history of HER2-low or HER2-0 breast cancer per local testing, and no known history of HER2-positive breast c…

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Breast Cancer, HER2-low Breast Cancer, Metastatic Breast Cancer, HER2-negative Breast Cancer

  8. Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies

    Recruiting Phase 1/2 AstraZeneca Started 2022Primary completion 2028-02 NCT05417594

    AZD9574temozolomide[11C]AZ1419 3391trastuzumab deruxtecandatopotamab deruxtecan

    …ced or metastatic disease and evidence of a predicted loss of function germline or tumour mutation in BRCA1, BRCA2, PALB2, RAD51C, or RAD51D,

    BRCA1/2 mutationIDH1/2 mutationHER2-low / ultralow (IHC 1+ or 2+/ISH-)Advanced Solid Malignancies

  9. A Study of Dato-DXd in Chinese Patients With Advanced Non-Small Cell Lung Cancer, Triple-negative Breast Cancer and Other Solid Tumors (TROPION-PanTumor02)

    Active, not recruiting Phase 1/2 AstraZeneca Started 2022Primary completion 2023-11 NCT05460273

    datopotamab deruxtecan

    …ted positive test results for one or more actionable genomic alteration: EGFR, ALK, ROS1, METex14 skipping, RET or other AGAs with approved therapies

    MET exon 14 skippingCarcinoma, Non-Small-Cell Lung, Triple Negative Breast Cancer

  10. A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

    Active, not recruiting Phase 1/2 AstraZeneca Started 2018Primary completion 2024-11 NCT03742102

    durvalumabcapivasertiboleclumabpaclitaxeltrastuzumab deruxtecan FDA EUdatopotamab deruxtecan

    …provide documentation of locally determined advanced/unresectable or metastatic TNBC with HER2 low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested)

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Triple Negative Breast Neoplasms

  11. A Study of Valemetostat Tosylate in Combination With DXd ADCs in Subjects With Solid Tumors

    Active, not recruiting Phase 1 Daiichi Sankyo Started 2024Primary completion 2028-11 NCT06244485

    Valemetostat tosylatetrastuzumab deruxtecan FDA EUdatopotamab deruxtecan

    Has a history of low HER2 expression, defined as immunohistochemistry (IHC) 2+ /in situ hybridization (ISH)-negative or IHC 1+…

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Advanced Solid Tumor

  12. A Study of CLN-619 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors

    Active, not recruiting Phase 1 Cullinan Therapeutics Started 2021Primary completion 2026-03 NCT05117476

    CLN-619pembrolizumabpaclitaxelcarboplatinpemetrexeddatopotamab deruxtecan FDA

    …1: Histologically or cytologically confirmed metastatic or locally advanced, unresectable EGFRm NSCLC.

    EGFR exon 19 deletion / L858RAdvanced Solid Tumor, NSCLC

  13. First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)

    Active, not recruiting Phase 1 Daiichi Sankyo Started 2018Primary completion 2028-01 NCT03401385

    datopotamab deruxtecanSteroid Containing Mouthwash

    DS-7300\]. (Note: Participants in the new HR-positive HER2-low breast cancer cohort is required to have prior treatment with T-DXd and must not have bee…

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Hormone Receptor Positive Breast Cancer, Triple Negative Breast Cancer, Non-small Cell Lung Cancer