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    DRUG:

    Irene (pyrotinib)

    i
    Other names: SHR-1258, HTI-1001, HTI1001, SHR1258, HTI 1001, SHR 1258
    Company:
    HLB Bio Group, Jiangsu Hengrui Pharma
    Drug class:
    EGFR inhibitor, HER2 inhibitor, HER4 inhibitor
    Related drugs:
    1d
    SHR-A1811-II-203: A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=324, Recruiting, Jiangsu HengRui Medicine Co., Ltd. | Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Nov 2023 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811) • AiRuiLi (adebrelimab)
    7d
    Association between diarrhea and survival in patients with HER2-positive advanced breast cancer treated with pyrotinib-based therapy: A landmark analysis from the real-world PRETTY study. (PubMed, Breast)
    For patients with HER2-positive advanced breast cancer, diarrhea that occurs during pyrotinib-based therapy maybe a prognostic marker of longer OS.
    Journal • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Irene (pyrotinib)
    8d
    Artificial Intelligence Model-Guided Neoadjuvant Anti-HER2 Targeted Therapy (clinicaltrials.gov)
    P3, N=280, Not yet recruiting, Fudan University
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Irene (pyrotinib)
    20d
    Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing (clinicaltrials.gov)
    P2, N=39, Recruiting, Peking Union Medical College | Trial primary completion date: Jul 2026 --> Jul 2028
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    carboplatin • Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Lenvima (lenvatinib) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Piqray (alpelisib) • Irene (pyrotinib) • albumin-bound paclitaxel • abiraterone acetate • fulvestrant • Aidixi (disitamab vedotin) • exemestane • Padcev (enfortumab vedotin-ejfv) • bicalutamide • Kaitanni (cadonilimab) • goserelin acetate • Qibeian (iparomlimab/tuvonralimab) • Yidafan (ivonescimab) • iparomlimab (QL1604) • leuprolide acetate for depot suspension • Entyvio (vedolizumab)
    21d
    REIN: Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases (clinicaltrials.gov)
    P2, N=150, Recruiting, Henan Cancer Hospital | Trial completion date: Apr 2026 --> Jun 2029 | Trial primary completion date: Oct 2025 --> Dec 2028
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Avastin (bevacizumab) • Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811)
    21d
    Exploring tyrosine kinase inhibitors for HER2-positive breast cancer: comprehensive review on a complete pharmacology-molecular mechanisms, safety profiles, and insights from preclinical and clinical studies. (PubMed, Clin Transl Oncol)
    They have demonstrated substantial improvements in survival-free and life expectancy of patients, establishing them as a standard treatment modality. The ongoing development of novel tyrosine kinase inhibitors and their strategic integration into personalized treatment regimens will shape the evolving landscape of breast cancer therapy.
    Preclinical • Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    lapatinib • Nerlynx (neratinib) • Irene (pyrotinib)
    1m
    Pyrotinib or placebo in combination with trastuzumab and docetaxel for HER2 positive metastatic breast cancer: long term survival results from randomised phase 3 PHILA trial. (PubMed, BMJ)
    The updated analysis of the phase 3 PHILA trial confirmed the superiority of pyrotinib in combination with trastuzumab and docetaxel over placebo in combination with trastuzumab and docetaxel in sustaining longer progression-free survival and improving overall survival for initial treatment of HER2 positive metastatic breast cancer. The safety profile remained consistent with interim findings, with no new safety signals identified during extended follow-up. This analysis reinforces the efficacy of this dual anti-HER2 (pyrotinib plus trastuzumab) regimen as an effective treatment strategy for this patient population.
    Clinical • P3 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • EGFR positive
    |
    Herceptin (trastuzumab) • docetaxel • Irene (pyrotinib)
    1m
    Final Efficacy and Safety Results of Pyrotinib Combined With Trastuzumab and Chemotherapy in Pre-Treated Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer. (PubMed, Cancer Med)
    Updated analyses pertaining to PFS and safety were generally aligned with data obtained from initial assessments. The OS outcomes further substantiated that the combination of pyrotinib, trastuzumab, and chemotherapy is an alternative therapeutic regimen for managing HER2-positive MBC with heavy pre-treatment in certain situations, particularly among those with non-visceral metastases.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • EGFR positive
    |
    Herceptin (trastuzumab) • lapatinib • Perjeta (pertuzumab) • Irene (pyrotinib)
    1m
    Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer (clinicaltrials.gov)
    P=N/A, N=42, Not yet recruiting, Peking University Cancer Hospital & Institute
    New trial • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Irene (pyrotinib)
    1m
    Genomic profiling and HER2-targeted therapy: a case series of Chinese salivary duct carcinoma patients and its clinical implications. (PubMed, Front Oncol)
    Two metastatic SDC patients with HER2 amplification responded to HER2 tyrosine kinase inhibitor (TKI) pyrotinib and the combination of trastuzumab and pertuzumab, respectively. Our work underscores the potential of genomic profiling to guide precision therapy in SDC, with HER2-targeted treatments offering promising therapeutic avenues.
    Journal
    |
    TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • HRAS (Harvey rat sarcoma viral oncogene homolog) • NF1 (Neurofibromin 1)
    |
    TP53 mutation • HER-2 amplification • PIK3CA mutation
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Irene (pyrotinib)
    2ms
    Advances in the study of pyrotinib for the treatment of HER2-positive breast cancer. (PubMed, Breast Cancer Res)
    Moreover, its ability to traverse the blood-brain barrier confers potential therapeutic advantages in patients with brain metastases. This comprehensive review provides a systematic overview of the pharmacological profile and mechanism of action of pyrotinib, with emphasis on recent clinical trials assessing pyrotinib-based regimens in HER2-positive breast cancer.
    Review • Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ERBB4 (erb-b2 receptor tyrosine kinase 4)
    |
    HER-2 positive
    |
    Irene (pyrotinib)
    2ms
    SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, Peking University Cancer Hospital & Institute
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811)