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DRUG:

DA 3111 (trastuzumab biosimilar)

i
Other names: DA 3111, DA-3111, DMB-3111
Associations
Trials
Company:
Dong-A, Meiji Seika
Drug class:
HER2 inhibitor
Related drugs:
Associations
Trials
2ms
Cystic-Like HER2-Positive Breast Cancer with Low Tumor-Infiltrating Lymphocytes and High Programmed Death-Ligand 1 Expression in a Young Woman: A Case Report. (PubMed, Case Rep Oncol)
Adjuvant therapy with the TCbHP regimen (docetaxel, carboplatin, pertuzumab, and trastuzumab) was initiated, with a total of six cycles planned, followed by maintenance therapy with trastuzumab and pertuzumab (HP) for 1 year. To date, the patient has tolerated the treatment well without evidence of distant recurrence or metastasis. This case underscores the discordance between radiological and pathological findings in breast cancer, highlighting the clinical significance of low TILs and high PD-L1 expression in HER2-positive tumors, and emphasizes the importance of individualized surgical and adjuvant treatment strategies.
Journal • Tumor-infiltrating lymphocyte • PD(L)-1 Biomarker • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1)
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PD-L1 expression • HER-2 positive • PD-L1 overexpression • HER-2 expression • PD-L1 expression + HER-2 overexpression
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Herceptin (trastuzumab) • carboplatin • docetaxel • Perjeta (pertuzumab) • DA 3111 (trastuzumab biosimilar)
over1year
Targeting neutrophil elastase is a promising direction for future cancer treatment. (PubMed, Discov Oncol)
In addition, the combination of sivelestat and trastuzumab can enhance the efficacy of human epidermal growth factor receptor 2(HER 2) positive breast cancer patients. Additionally, we discuss the challenges associated with the clinical application of sivelestat. By shedding light on the promising potential of NE, this review contributes to the advancement of cancer treatment strategies.
Review • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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EGFR positive
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Herceptin (trastuzumab) • DA 3111 (trastuzumab biosimilar)
over1year
Efficacy and safety of biosimilar trastuzumab (CT-P6) in routine clinical practice in the Republic of Korea: a real-world post-marketing surveillance study. (PubMed, Expert Opin Biol Ther)
Among trastuzumab-naïve patients, 34/106 (32.1%) with EBC achieved pathological complete response; 30/74 (40.5%) MBC and 24/49 (49.0%) MGC patients achieved complete or partial response. In a real-world setting, CT-P6 demonstrated safety and efficacy findings consistent with previous CT-P6 studies.
P4 data • Journal • Real-world evidence • Real-world
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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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Herzuma (trastuzumab-pkrb) • DA 3111 (trastuzumab biosimilar)
over1year
BCAR4 facilitates trastuzumab resistance and EMT in breast cancer via sponging miR-665 and interacting with YAP1. (PubMed, FASEB J)
Reciprocally, YAP1 could occupy the BCAR4 promoter to enhance its transcription, suggesting that there exists a positive feedback regulation between YAP1 and BCAR4. Targeting the BCAR4/miR-665/YAP1 axis may provide a novel insight of therapeutic approaches for TR in BC.
Journal
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YAP1 (Yes associated protein 1) • TGFB1 (Transforming Growth Factor Beta 1) • BCAR4 (Breast Cancer Anti-Estrogen Resistance 4)
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Herceptin (trastuzumab) • DA 3111 (trastuzumab biosimilar)
almost2years
Cuproptosis-related genes predict prognosis and trastuzumab therapeutic response in HER2-positive breast cancer. (PubMed, Sci Rep)
There was a negative correlation between TIDE and DLAT expression (r = - 0.292, p < 0.001), which means high DLAT expression is an indicator of sensitivity to immunotherapy. In conclusion, our study constructed a four CRGs signature prognostic prediction model and identified DLAT as an independent prognostic factor and associated with resistant to HER2-targeted therapy for HER2-positive breast cancer patients.
Journal • IO biomarker
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • DLAT (Dihydrolipoamide S-Acetyltransferase)
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HER-2 positive • DLAT overexpression
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Herceptin (trastuzumab) • DA 3111 (trastuzumab biosimilar)
almost2years
Real-world data of triplet combination of pyrotinib, trastuzumab, and chemotherapy in HER2-positive metastatic breast cancer: a multicenter, retrospective study. (PubMed, Ther Adv Med Oncol)
The most prevalent chemotherapies paired with PyroH were capecitabine (36.3%)...Longer previous trastuzumab (⩾6.37 months) or lapatinib (⩾10.05 months) therapies could indicate improved PFS, while prior pyrotinib exposure negatively influenced PFS...PyroHC shows promising efficacy and a satisfactory safety profile for treating HER2+ MBC, both as a first-line option and for heavily treated patients, including those with brain metastasis. Our findings suggest the duration and history of anti-HER2 therapy as potential predictors for PyroHC efficacy in advanced settings.
Retrospective data • Journal • Real-world evidence • Real-world • Metastases
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive
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Herceptin (trastuzumab) • lapatinib • capecitabine • Irene (pyrotinib) • DA 3111 (trastuzumab biosimilar)
almost2years
Identification of a novel potent CDK inhibitor degrading cyclinK with a superb activity to reverse trastuzumab-resistance in HER2-positive breast cancer in vivo. (PubMed, Eur J Med Chem)
Compound 32e potently inhibited CDK12/cyclinK with IC = 3 nM, and suppressed the growth of the both trastuzumab-sensitive and trastuzumab-resistant HER2-positive breast cancer cell lines (GI's = 9-21 nM), which is superior to a potent, clinical pan-CDK inhibitor dinaciclib. Compound 32e could be developed as a drug for intractable trastuzumab-resistant HER2-positive breast cancers. Our current study would provide a useful insight in designing potent cyclinK degraders.
Preclinical • Journal
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HER-2 (Human epidermal growth factor receptor 2) • CDK12 (Cyclin dependent kinase 12)
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HER-2 positive • HER-2 overexpression
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Herceptin (trastuzumab) • dinaciclib (MK-7965) • DA 3111 (trastuzumab biosimilar)
over2years
Pyrotinib plus capecitabine for trastuzumab-resistant, HER2-positive advanced breast cancer (PICTURE): a single-arm, multicenter phase 2 trial. (PubMed, BMC Med)
Pyrotinib plus capecitabine can be considered to be a treatment option in HER2-positive advanced breast cancer patients who have shown primary resistance to trastuzumab. Even in the era of modern anti-HER2 treatments, this clinical setting warrants more investigations to meet unmet needs.
P2 data • Journal • Metastases
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HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive • EGFR positive
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Herceptin (trastuzumab) • Perjeta (pertuzumab) • capecitabine • Irene (pyrotinib) • DA 3111 (trastuzumab biosimilar)
over2years
Genomic analysis of plasma circulating tumor DNA in patients with heavily pretreated HER2 + metastatic breast cancer. (PubMed, Sci Rep)
In conclusion, TP53 and PIK3CA mutations, as well as a higher ctDNA fraction, were associated with worse PFS with trastuzumab and cytotoxic chemotherapy. The enrichment of HRD-related gene mutations and newly detected variants in ctDNA may be related to resistance to treatment.
Journal • BRCA Biomarker • Circulating tumor DNA • Metastases
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HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • RB1 (RB Transcriptional Corepressor 1) • FANCA (FA Complementation Group A) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD50 (RAD50 Double Strand Break Repair Protein)
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TP53 mutation • PIK3CA mutation • HRD • BRIP1 mutation • ERBB3 mutation • FANCA mutation • RAD50 mutation
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Herceptin (trastuzumab) • DA 3111 (trastuzumab biosimilar)
almost3years
Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): a double-blind, randomized phase 3 trial. (PubMed, BMC Med)
The primary endpoint of the study was met. Neoadjuvant pyrotinib, trastuzumab, and docetaxel significantly improved the tpCR rate compared with placebo, trastuzumab, and docetaxel, with manageable toxicity, providing a new option for HER2-positive early or locally advanced breast cancer.
P3 data • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 positive
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Herceptin (trastuzumab) • docetaxel • capecitabine • Irene (pyrotinib) • DA 3111 (trastuzumab biosimilar)
over3years
Phase II study to investigate the efficacy of trastuzumab biosimilar (Herzuma®) plus treatment of physician's choice (TPC) in patients with heavily pretreated HER-2+ metastatic breast cancer (KCSG BR 18-14/KM10B). (PubMed, Breast)
We investigated the efficacy and safety of a trastuzumab biosimilar, Herzuma®, in combination with treatment of physician's choice (TPC) in patients with HER2+ metastatic breast cancer (MBC) who had failed at least two HER2 directed chemotherapies.
P2 data • Journal
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HER-2 (Human epidermal growth factor receptor 2)
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Herzuma (trastuzumab-pkrb) • DA 3111 (trastuzumab biosimilar) • SIBP-01 (trastuzumab biosimilar)
over3years
Identification of Genes Predicting Poor Response of Trastuzumab in Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer. (PubMed, J Immunol Res)
Further survival analysis of hub genes showed that DLD overexpression was significantly associated with an unfavorable prognosis in HER2+ breast cancer patients. Ten novel trastuzumab resistance-related genes were discovered, of which DLD could be used for trastuzumab response prediction and prognostic prediction in HER2+ breast cancer.
Journal
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HER-2 (Human epidermal growth factor receptor 2) • NQO1 (NAD(P)H dehydrogenase, quinone 1) • ASCL1 (Achaete-Scute Family BHLH Transcription Factor 1)
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HER-2 expression • EGFR positive
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Herceptin (trastuzumab) • DA 3111 (trastuzumab biosimilar)