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    DRUG CLASS:

    HER3-targeted antibody-drug conjugate

    Related drugs:
    3d
    Study on the Efficacy and Safety of JSKN016 as Neoadjuvant Therapy in Resectable Stage II-III Non-small Cell Lung Cancer Patients (clinicaltrials.gov)
    P2, N=54, Not yet recruiting, Shanghai Pulmonary Hospital, Shanghai, China
    New P2 trial
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    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
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    EGFR L858R • EGFR exon 19 deletion • ALK fusion
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    carboplatin • Loqtorzi (toripalimab-tpzi)
    3d
    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
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
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    EGFR mutation • EGFR expression • ERBB3 positive
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    erlotinib • patritumab deruxtecan (U3-1402)
    10d
    A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=280, Not yet recruiting, Shanghai Junshi Bioscience Co., Ltd.
    New P2 trial
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    5-fluorouracil • Loqtorzi (toripalimab-tpzi)
    10d
    A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P3, N=498, Active, not recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
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    cisplatin • carboplatin • ruzaltatug rezetecan (SHR-A2009)
    12d
    A Phase II Clinical Study Evaluating the Safety, Tolerability,Pharmacokinetics, and Preliminary Efficacy of JS212 andJS213 as Monotherapy and in Combination in Patients Withadvanced Malignant Solid Tumors (clinicaltrials.gov)
    P2, N=480, Not yet recruiting, Shanghai Junshi Bioscience Co., Ltd.
    New P2 trial
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    Loqtorzi (toripalimab-tpzi) • AWT020
    20d
    YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P3, N=376, Not yet recruiting, MediLink Therapeutics (Suzhou) Co., Ltd.
    New P3 trial
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 negative
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    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • Trodelvy (sacituzumab govitecan-hziy) • BNT326
    21d
    A Study of YL202 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P2, N=100, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
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    BNT326
    25d
    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
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    KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    KRAS mutation • KRAS G12C • EGFR L858R • EGFR exon 19 deletion • ALK fusion • EGFR L861Q • ROS1 fusion • EGFR G719X • KRAS G12
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    patritumab deruxtecan (U3-1402)
    26d
    Izalontamab Brengitecan in Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Actionable Genomic Alterations Outside of Classical EGFR Mutations: A Phase Ib Study. (PubMed, J Clin Oncol)
    iza-bren demonstrated encouraging antitumor activity and a manageable safety profile in pretreated NSCLC patients with diverse GAs outside of classical EGFR mutations, especially in EGFR exon20ins/nonclassical and HER2 mutations.
    P1 data • Journal
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
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    KRAS mutation • EGFR mutation • BRAF mutation • RET fusion • EGFR exon 20 insertion • RET mutation • ROS1 fusion • MET mutation • EGFR exon 20 mutation • NTRK fusion
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    izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    1m
    The Impact of HER3 Dynamics Altered by HER3-DXd Alone and in Combination with Driver Oncogene Inhibitors on HER3-DXd Efficacy. (PubMed, Int J Mol Sci)
    The increase in HER3 expression induced by osimertinib treatment was associated with increased payload release in PC-9 cells. Our results indicate that HER3 dynamics, as well as baseline HER3 expression, modulate payload release from HER3-DXd and support combination strategies to potentiate the antitumor activity of HER3-DXd.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    EGFR mutation • ALK fusion • ROS1 fusion • ERBB3 positive
    |
    Tagrisso (osimertinib) • patritumab deruxtecan (U3-1402)
    1m
    Pivotal Study to Evaluate YL202 Versus Docetaxel in Patients With Locally Advanced or Metastatic EGFR Sensitive Mutation Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=440, Not yet recruiting, MediLink Therapeutics (Suzhou) Co., Ltd.
    New P3 trial
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    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
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    docetaxel • BNT326
    1m
    A clinical study of patritumab deruxtecan (HER3-DXd) in children with cancer (MK-9999-01C) (2024-518771-66-00)
    P1/2, N=31, Recruiting, Merck Sharp & Dohme LLC
    New P1/2 trial
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    patritumab deruxtecan (U3-1402) • dexamethasone