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    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:
    7d
    KEYMAKER-06C: Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06) (clinicaltrials.gov)
    P1/2, N=160, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Apr 2029 --> Sep 2029 | Trial primary completion date: Jan 2027 --> Sep 2029
    Trial completion date • 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) • 5-fluorouracil • capecitabine • oxaliplatin • patritumab deruxtecan (U3-1402) • Jiataile (sacituzumab tirumotecan) • levoleucovorin calcium
    7d
    A combined strategy of EGFR-MET bispecific antibody and HER3 ADC to overcome osimertinib resistance in NSCLC. (PubMed, Cell Oncol (Dordr))
    In conclusion, we have proposed a new therapeutic strategy for NSCLC after osimertinib resistance. The combined strategy of amivantamab and patritumab deruxtecan highlight a promising therapeutic avenue, warranting future clinical trials to validate safety and efficacy.
    Journal
    |
    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    EGFR mutation • MET mutation
    |
    Tagrisso (osimertinib) • patritumab deruxtecan (U3-1402) • simmitinib (SYHA1817)
    11d
    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 completion date: Oct 2028 --> Oct 2030
    Trial 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)
    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, Not yet recruiting, Merck Sharp & Dohme LLC | Trial completion date: Oct 2031 --> Jul 2036
    Trial completion date
    |
    Keytruda (pembrolizumab) • Erbitux (cetuximab) • patritumab deruxtecan (U3-1402) • Jiataile (sacituzumab tirumotecan) • calderasib (MK-1084)
    1m
    ICARUS-BREAST01: Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=139, Recruiting, Gustave Roussy, Cancer Campus, Grand Paris | Active, not recruiting --> Recruiting | N=99 --> 139 | Trial completion date: Apr 2028 --> Apr 2030 | Trial primary completion date: Apr 2025 --> Apr 2027
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    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, Not yet recruiting, Merck Sharp & Dohme LLC
    New P1/2 trial
    |
    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 | N=90 --> 210
    Enrollment change
    |
    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    Keytruda (pembrolizumab) • paclitaxel • Cyramza (ramucirumab) • patritumab deruxtecan (U3-1402) • Jiataile (sacituzumab tirumotecan)
    2ms
    Patritumab deruxtecan in breast cancer treatment: a drug evaluation. (PubMed, Future Oncol)
    This efficacy has been observed across diverse tumor subtypes and varying levels of HER3 expression. In this review, we will analyze the results of clinical trials investigating HER3-DXd in breast cancer and explore its potential role in future clinical applications and treatment algorithms.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    patritumab deruxtecan (U3-1402)
    2ms
    Determinants of long-term response to patritumab deruxtecan in breast cancer patient-derived xenografts. (PubMed, NPJ Precis Oncol)
    Basal-like PAM50 intrinsic subtype, limited prior exposure to chemotherapy and intrinsic sensitivity to the TOP1i irinotecan were associated with long-term response. Long-term responders exhibited persistent DNA damage and lacked early transcriptional activation of the G2/M cell cycle checkpoint that allow for DNA repair and RNA-DNA hybrid (R-loop) resolution, in parallel resulting in immune pathways transcriptional activation. Notably, characteristics linked to long-term response were primarily associated with the TOP1i payload activity.
    Journal • BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    irinotecan • patritumab deruxtecan (U3-1402)
    3ms
    Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02) (clinicaltrials.gov)
    P1/2, N=180, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Jul 2028 --> Dec 2028 | Trial primary completion date: Jul 2028 --> Dec 2028
    Trial completion date • Trial primary completion date • Pan tumor
    |
    patritumab deruxtecan (U3-1402)
    3ms
    Patritumab deruxtecan (HER3-DXd) in patients with active brain metastases of non-small-cell lung cancer (TUXEDO-3): a multicentre, single-arm, phase 2 trial. (PubMed, Lancet Oncol)
    HER3-DXd showed promising clinical activity in patients with advanced NSCLC and active brain metastases, and could represent a novel treatment option in this setting.
    P2 data • Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    patritumab deruxtecan (U3-1402)
    3ms
    Patritumab deruxtecan (HER3-DXd) in patients with active brain metastases of breast cancer (TUXEDO-3): a multicentre, single-arm, phase 2 trial. (PubMed, Lancet Oncol)
    HER3-DXd showed promising clinical activity in patients with metastatic breast cancer and active brain metastases, and could offer a novel therapeutic option in this setting.
    P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    HER-2 positive
    |
    patritumab deruxtecan (U3-1402)