^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    patritumab deruxtecan (U3-1402)

    i
    Other names: U3-1402, U3 1402, U3-1402a, U31402, Patritumab-DX-8951 conjugate, HER3-DXd, MK-1022, HER3DXd, U31402a, U3 1402a, HER3 DXd, MK1022, MK 1022
    Company:
    Daiichi Sankyo, Merck (MSD)
    Drug class:
    Topoisomerase I inhibitor, HER3-targeted antibody-drug conjugate
    Related drugs:
    5d
    Non-small cell lung cancer research: advances and persistent challenges. (PubMed, Front Oncol)
    Recent innovations include antibody-drug conjugates (ADCs) such as TROP-2-targeting agents and HER3-DXd, which show promising efficacy in refractory disease. Next-generation tyrosine kinase inhibitors (TKIs), including lorlatinib, tepotinib, and glecirasib, have shown improved outcomes for patients with oncogene-driven NSCLC...Future efforts must prioritize overcoming resistance through combination strategies and ADCs, validating biomarkers using AI and ctDNA, streamlining CGP implementation, and addressing the unique needs of special populations. Bridging these biological and systemic challenges is essential for improving survival outcomes and ensuring equitable benefits for all NSCLC patients.
    Review • Journal • IO biomarker
    |
    STK11 (Serine/threonine kinase 11) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • KEAP1 (Kelch Like ECH Associated Protein 1)
    |
    Lorbrena (lorlatinib) • patritumab deruxtecan (U3-1402) • Tepmetko (tepotinib) • Airuikai (glecirasib)
    7d
    ATR inhibition potentiates the antitumor efficacy of HER3-DXd in HER3-positive/HR-positive breast cancer by increasing DNA damage. (PubMed, Br J Cancer)
    Combining HER3-DXd with an ATR inhibitor could benefit HER3+/HR+ BC patients with both endocrine-sensitive and -resistant diseases.
    Journal
    |
    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • CHEK1 (Checkpoint kinase 1)
    |
    HR positive • ERBB3 positive
    |
    tamoxifen • patritumab deruxtecan (U3-1402)
    10d
    TUXEDO-3: HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease (clinicaltrials.gov)
    P2, N=63, Completed, MedSIR | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    HER-2 positive • EGFR mutation • HER-2 expression • EGFR T790M
    |
    patritumab deruxtecan (U3-1402)
    15d
    HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=277, Active, not recruiting, Daiichi Sankyo | Trial completion date: Jan 2026 --> Jul 2026
    Trial completion date
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • ROS1 fusion
    |
    patritumab deruxtecan (U3-1402)
    25d
    The Effect of HER3 Expression on Prognosis in EGFR-Mutant Non-Small Cell Lung Cancer: A Retrospective Real-World Study. (PubMed, Medicina (Kaunas))
    Of 52 patients (55.8% female; mean age 64.5 years), 59.6% received chemotherapy and 40.4% received an EGFR TKI as first-line treatment; erlotinib constituted 71.2% of targeted therapies. These results suggest that HER3 expression may warrant further investigation as a candidate biomarker for treatment sequencing decisions and as a potential therapeutic target in EGFR-mutant NSCLC. Prospective studies evaluating chemotherapy-TKI sequencing and HER3-directed agents such as patritumab deruxtecan (HER3-DXd) in HER3-positive patients are needed to confirm these preliminary observations.
    Retrospective data • Journal • Real-world evidence
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    EGFR mutation • EGFR expression • ERBB3 positive
    |
    erlotinib • patritumab deruxtecan (U3-1402)
    1m
    A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F) (clinicaltrials.gov)
    P1/2, N=190, Recruiting, Merck Sharp & Dohme LLC | N=57 --> 190
    Enrollment change • Trial initiation date
    |
    PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • patritumab deruxtecan (U3-1402) • Jiataile (sacituzumab tirumotecan) • calderasib (MK-1084)
    1m
    A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F) (clinicaltrials.gov)
    P1/2, N=57, Recruiting, Merck Sharp & Dohme LLC | N=32 --> 57
    Enrollment change
    |
    PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • patritumab deruxtecan (U3-1402) • Jiataile (sacituzumab tirumotecan) • calderasib (MK-1084)
    1m
    A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F) (clinicaltrials.gov)
    P1/2, N=190, Recruiting, Merck Sharp & Dohme LLC | N=32 --> 190
    Enrollment change • Trial initiation date
    |
    PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • patritumab deruxtecan (U3-1402) • Jiataile (sacituzumab tirumotecan) • calderasib (MK-1084)
    1m
    A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F) (clinicaltrials.gov)
    P1/2, N=32, Recruiting, Merck Sharp & Dohme LLC
    New P1/2 trial
    |
    PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • patritumab deruxtecan (U3-1402) • Jiataile (sacituzumab tirumotecan) • calderasib (MK-1084)
    2ms
    Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06) (clinicaltrials.gov)
    P1/2, N=210, Recruiting, Merck Sharp & Dohme LLC | Trial primary completion date: Dec 2026 --> May 2028
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    HER-2 expression
    |
    Keytruda (pembrolizumab) • paclitaxel • Cyramza (ramucirumab) • patritumab deruxtecan (U3-1402) • Jiataile (sacituzumab tirumotecan)
    2ms
    U31402-A-U102: U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=312, Active, not recruiting, Daiichi Sankyo | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    KRAS mutation • KRAS G12C • EGFR L858R • EGFR exon 19 deletion • ALK fusion • EGFR L861Q • ROS1 fusion • EGFR G719X • KRAS G12
    |
    patritumab deruxtecan (U3-1402)
    2ms
    A Clinical Study of MK-1084 With Other Treatments for Non-small Cell Lung Cancer (MK-3475-01F) (clinicaltrials.gov)
    P1/2, N=190, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting | Trial completion date: Jul 2036 --> May 2037
    Enrollment open • Trial completion date
    |
    PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • patritumab deruxtecan (U3-1402) • Jiataile (sacituzumab tirumotecan) • calderasib (MK-1084)