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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:
2d
Assessment of the efficacy of various neoadjuvant anti-HER2 targeted therapies combined with chemotherapy for HER2-positive breast cancer in the real-world setting and development of a predictive model for pathological complete response. (PubMed, Front Oncol)
The efficacy of NAT regimens containing trastuzumab plus pertuzumab (HP) and trastuzumab plus pyrotinib (HPy) was compared. Both HP and HPy combined with chemotherapy can be considered as optional NAT regimens for HER2-positive BC. The nomogram incorporating common clinical indicators provides a basis for clinicians to predict NAT efficacy at an earlier stage.
Journal • Real-world evidence
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • EGFR positive
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Herceptin (trastuzumab) • Perjeta (pertuzumab) • Irene (pyrotinib)
2d
Phase II Clinical Study of Pyrotinib in First-line Treatment of Primary HER2-amplified/Mutated Advanced Non-small Cell Lung Cancer (clinicaltrials.gov)
P2, N=18, Recruiting, Peking Union Medical College Hospital | N=45 --> 18 | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2026
Enrollment change • Trial completion date • Trial primary completion date
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 amplification
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Irene (pyrotinib)
8d
Pyrotinib Plus Trastuzumab as an Effective Later-Line Therapeutic Strategy for HER2-Positive Metastatic Colorectal Cancer: Results from a Phase II Study. (PubMed, Drug Des Devel Ther)
Pyrotinib plus trastuzumab demonstrates clinically meaningful efficacy and a manageable safety profile in heavily pretreated HER2-positive metastatic colorectal cancer. These findings support advancing this regimen as a potential alternative in refractory HER2-positive mCRC, particularly in the RAS/BRAF wild-type subgroup.
Clinical • P2 data • Journal
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HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene)
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HER-2 positive • KRAS mutation • BRAF wild-type • HER-2 positive + RAS wild-type
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Herceptin (trastuzumab) • Irene (pyrotinib)
9d
HER2-targeted therapy combined with multidisciplinary management in advanced gallbladder cancer: a case report with 90-month survival. (PubMed, Front Oncol)
The patient achieved a prolonged period of disease stability, who was treated with various anti-HER2 targeted therapy, such as trastuzumab combined with pyrotinib and HER2-targeted antibody-drug conjugate (ADC). Dynamic CA199 levels paralleled the treatment efficacy. This report underscores the significance of molecular profiling-guided personalized therapy and integrated multidisciplinary management in the treatment of biliary tract cancers.
Journal
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CA 19-9 (Cancer antigen 19-9)
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HER-2 positive
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Herceptin (trastuzumab) • Irene (pyrotinib)
24d
Combined treatment of inetetamab plus pyrotinib and vinorelbine in managing advanced HER2-positive breast cancer patients (ILLUMINE): a multicenter, retrospective, real-world study. (PubMed, Transl Breast Cancer Res)
No severe TAAEs were observed during the investigation. The triple regimen of inetetamab plus pyrotinib and vinorelbine exhibited promising therapeutic effects and was tolerable for participants with HER2-positive ABC.
Retrospective data • Journal • Real-world evidence
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HR positive • EGFR positive
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Irene (pyrotinib) • vinorelbine tartrate • Cipterbin (inetetamab)
1m
An LC-MS/MS method for simultaneous quantification of pyrotinib, docetaxel and paclitaxel in human plasma and its application to therapeutic drug monitoring. (PubMed, J Chromatogr B Analyt Technol Biomed Life Sci)
With imatinib as internal standard, one-step deproteinization approach with acetonitrile was applied to extract analytes and purify specimens. The therapeutic drug monitoring results showed that the plasma concentration of pyrotinib, docetaxel and paclitaxel varied significantly among individuals. Therapeutic drug monitoring for pyrotinib, docetaxel and paclitaxel is essential for individualized treatment to ensure efficacy and safety.
Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive
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paclitaxel • imatinib • docetaxel • Irene (pyrotinib)
1m
Treatment beyond progression and rechallenge with pyrotinib in HER2-positive metastatic breast cancer and brain metastases: a multicenter real-world study. (PubMed, Ther Adv Med Oncol)
Among patients with BMs before pyrotinib re-treatment, the median PFS for pyrotinib re-treatment was 7.2 months, and the median OS was 25.2 months. Pyrotinib TBP and pyrotinib rechallenge both demonstrate potential benefits for patients with HER2-positive MBC, including those with BM.
Journal • Real-world evidence
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • EGFR positive
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Irene (pyrotinib)
1m
New P4 trial
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive • HER-2 expression
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Perjeta (pertuzumab) • Irene (pyrotinib) • trastuzumab rezetecan (SHR-A1811)
1m
Advances in Targeted Therapy for Advanced Non-small Cell Lung Cancer with HER2 Mutation (PubMed, Zhongguo Fei Ai Za Zhi)
Currently, Pyrotinib and Trastuzumab deruxtecan have been approved for the treatment of advanced NSCLC with HER2 mutations, suitable for patients who have failed standard therapy, which is far from meeting the clinical demands. Future exploration trends are gradually shifting from single drugs to combination strategies, and are exploring more precise selection strategies as well as research on resistance mechanisms. These studies will provide a theoretical basis for clinical treatment strategies for advanced NSCLC with HER2 mutations, promoting the development of personalized therapy..
Review • Journal • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2)
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EGFR mutation • HER-2 mutation
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Enhertu (fam-trastuzumab deruxtecan-nxki) • Irene (pyrotinib)