marked.bio

Company

Daiichi Sankyo

16 active trials that select patients by a biomarker on marked.bio, across 7 biomarkers; 3 in phase 3.

Counts only trials this company leads as sponsor, not partnered or academic trials of its drugs.

Biomarkers

Drugs in these trials

Targeted, immune and antibody-drug-conjugate therapies named in the company's active biomarker-selected trials (including other companies' drugs used in combination).

trastuzumab deruxtecan 5patritumab deruxtecan 5datopotamab deruxtecan 3quizartinib 2trastuzumab 1safusidenib 1osimertinib 1pembrolizumab 1

Upcoming readouts

Active phase 2 and 3 trials whose primary completion date falls in the next 12 months, according to the sponsor.

Trials

16 of 35 trials shown

  1. Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer

    Recruiting Phase 3 Daiichi Sankyo Started 2023Primary completion 2027-10 NCT05950945

    trastuzumab deruxtecan FDA EUtrastuzumab

    In participants with hormone receptor-positive HER2-low metastatic BC (Cohort 3):

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

  2. HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

    Active, not recruiting Phase 3 Daiichi Sankyo Started 2022Primary completion 2024-05 NCT05338970

    patritumab deruxtecanPlatinum-based chemotherapy

    … documentation of an EGFR-activating mutation detected from tumor tissue or blood sample: exon 19 deletion or L858R at diagnosis or thereafter.

    EGFR exon 19 deletion / L858RNonsquamous Non-small Cell Lung Cancer, EGFR L858R, EGFR Exon 19 Deletion

  3. 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

  4. A Study of Patritumab Deruxtecan (HER3-DXd) in Combination With Trastuzumab Deruxtecan (T-DXd) in Participants With HR-Positive, HER2-Low or HER2-Ultralow Unresectable or Metastatic Breast Cancer

    Recruiting Phase 1/2 Daiichi Sankyo Started 2026Primary completion 2031-01 NCT07701941

    patritumab deruxtecantrastuzumab deruxtecan FDA EU

    Assessed as HER2-low (defined as Immunohistochemistry (IHC)2+/In-situ hybridization (ISH)- or IHC1+) or HER2-u…

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Hormone Receptor Positive, HER2-low or HER2-ultralow, Unresectable or Metastatic Breast Cancer

  5. Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission

    Recruiting Phase 2 Daiichi Sankyo Started 2025Primary completion 2028-06 NCT06824168

    quizartinib FDA EU

    Participant has confirmed FLT3-ITD-positive (≥0.05 SR or ≥5% VAF) activating mutation from initial diagnosis in bone marrow …

    FLT3 mutation (ITD/TKD)Acute Myeloid Leukemia, Leukemia

  6. A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)

    Recruiting Phase 1/2 Daiichi Sankyo Started 2024Primary completion 2028-07 NCT06330064

    Ifinatamab deruxtecan

    for HER2-Low BC Participants

    HER2-low / ultralow (IHC 1+ or 2+/ISH-)Recurrent or Metastatic Solid Tumors

  7. HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

    Active, not recruiting Phase 2 Daiichi Sankyo Started 2021Primary completion 2022-11 NCT04619004

    patritumab deruxtecan

    Documentation of an EGFR-activating mutation detected from tumor tissue or blood sample: exon 19 deletion or L858R.

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer Metastatic, Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor

  8. Valemetostat Tosylate (DS-3201b), an Enhancer of Zeste Homolog (EZH) 1/2 Dual Inhibitor, for Relapsed/Refractory Peripheral T-Cell Lymphoma (VALENTINE-PTCL01)

    Active, not recruiting Phase 2 Daiichi Sankyo Started 2021Primary completion 2023-05 NCT04703192

    Valemetostat Tosylate

    Anaplastic large cell lymphoma, ALK positive

    ALK fusionRelapsed/Refractory Peripheral T-Cell Lymphoma, Adult T Cell Leukemia/Lymphoma

  9. A Study of DS-1001b in Patients With Chemotherapy- and Radiotherapy-Naive IDH1 Mutated WHO Grade II Glioma

    Active, not recruiting Phase 2 Daiichi Sankyo Started 2020Primary completion 2023-03 NCT04458272

    safusidenib

    Has a histopathologically documented IDH1 mutated WHO grade II glioma according to the 2016 WHO classification.

    IDH1/2 mutationWHO Grade II Glioma

  10. Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood

    Active, not recruiting Phase 1/2 Daiichi Sankyo Started 2018Primary completion 2027-05 NCT03793478

    quizartinib FDA EUfludarabinecytarabineIntrathecal (IT) triple chemotherapy prophylaxisetoposide

    Has presence of the FLT3-ITD activating mutation in bone marrow or peripheral blood as defined in the protocol

    FLT3 mutation (ITD/TKD)Acute Myeloid Leukemia

  11. A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors

    Recruiting Phase 1 Daiichi Sankyo Started 2025Primary completion 2028-12 NCT07015697

    trastuzumab deruxtecan FDA EU

    NSCLC, HER2 mut: adults with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) m…

    HER2 (ERBB2) activating mutationHER2-low / ultralow (IHC 1+ or 2+/ISH-)Recurrent or Metastatic Solid Tumors

  12. 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

  13. HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer

    Active, not recruiting Phase 1 Daiichi Sankyo Started 2021Primary completion 2025-01 NCT04676477

    patritumab deruxtecanosimertinib FDA EU

    Documentation of EGFR exon 19 deletion or L858R mutation detected from tumor tissue

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer (NSCLC)

  14. DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer

    Active, not recruiting Phase 1 Daiichi Sankyo Started 2020Primary completion 2025-07 NCT04042701

    trastuzumab deruxtecan FDA EUpembrolizumab

    Pathologically documented, locally advanced/metastatic HER2-mutant NSCLC

    HER2 (ERBB2) activating mutationHER2-low / ultralow (IHC 1+ or 2+/ISH-)Breast Cancer, Non-small Cell Lung Carcinoma

  15. 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

  16. U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer

    Active, not recruiting Phase 1 Daiichi Sankyo Started 2017Primary completion 2025-12 NCT03260491

    patritumab deruxtecan

    …with EGFR tyrosine kinase inhibitor (TKI) sensitivity (including G719X, exon 19 deletion, L858R, L861Q)

    EGFR exon 19 deletion / L858RKRAS G12CNon-Small Cell Lung Cancer (NSCLC)