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- || DA 3111 (trastuzumab biosimilar) - Meiji Seika, Dong / A, Herzuma (trastuzumab-pkrb) / Nippon Kayaku, Mundipharma, Celltrion, Teva
P4 data, Journal, Real-world evidence, Real-world: 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 Central) - Apr 30, 2024
Among trastuzumab-na
- | DA 3111 (trastuzumab biosimilar) - Meiji Seika, Dong / A, Herceptin (trastuzumab) / Roche
Journal: BCAR4 facilitates trastuzumab resistance and EMT in (Pubmed Central) - Apr 8, 2024
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.
- | DA 3111 (trastuzumab biosimilar) - Meiji Seika, Dong / A, Herceptin (trastuzumab) / Roche
Preclinical, Journal: 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 Central) - Jan 2, 2024
Targeting the BCAR4/miR-665/YAP1 axis may provide a novel insight of therapeutic approaches for TR in BC. Compound 32e potently inhibited CDK12/cyclinK with IC
- | Irene (pyrotinib) / Jiangsu Hengrui Pharma, DA 3111 (trastuzumab biosimilar) - Meiji Seika, Dong / A, Herceptin (trastuzumab) / Roche
Retrospective data, Journal, Real-world evidence, Real-world, Metastases: Real-world data of triplet combination of pyrotinib, trastuzumab, and chemotherapy in HER2-positive metastatic breast cancer: a multicenter, retrospective study. (Pubmed Central) - Dec 25, 2023
P
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.
- | DA 3111 (trastuzumab biosimilar) - Meiji Seika, Dong / A, Herceptin (trastuzumab) / Roche
Journal, BRCA Biomarker, Circulating tumor DNA, Metastases: Genomic analysis of plasma circulating tumor DNA in patients with heavily pretreated HER2?+?metastatic breast cancer. (Pubmed Central) - Jun 20, 2023
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.
- || DA 3111 (trastuzumab biosimilar) - Meiji Seika, Dong / A, Herceptin (trastuzumab) / Roche
Clinical, Journal, Metastases: Treatment outcomes of advanced/metastatic extramammary Paget's disease in Korean patients: KCSG-RC20-06. (Pubmed Central) - Jun 2, 2023
Due to its rarity, advanced or metastatic EMPD still has no established standard treatment. Results of our study indicate that the combination of trastuzumab with taxane has longer survival than trastuzumab monotherapy or conventional platinum- or taxane-based chemotherapy.
- ||| Irene (pyrotinib) / Jiangsu Hengrui Pharma, DA 3111 (trastuzumab biosimilar) - Meiji Seika, Dong / A, Herceptin (trastuzumab) / Roche
P3 data, Journal: Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): a double-blind, randomized phase 3 trial. (Pubmed Central) - Dec 28, 2022
P3
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.
- | Kadcyla (ado-trastuzumab emtansine) / Roche, DA 3111 (trastuzumab biosimilar) - Meiji Seika, Dong / A, Cyramza (ramucirumab) / Eli Lilly
Journal, Real-world evidence: Data collection framework for electronic medical record-based real-world data to evaluate the effectiveness and safety of cancer drugs: a nationwide real-world study of the Korean Cancer Study Group. (Pubmed Central) - Nov 8, 2022
Mean missing values of the RAM/PTX and T-DM1 cohorts at the time of simulation of fictional cases and final data analysis decreased from 20.7% to 0.46% and from 18.5% to 0.76%, respectively. This real-world study provides a framework that ensures relevance and reliability of EMR-based RWD for evaluating the effectiveness and safety of cancer drugs.
- || DA 3111 (trastuzumab biosimilar) - Meiji Seika, Dong / A, SIBP-01 (trastuzumab biosimilar) / Sinopharm, Herzuma (trastuzumab-pkrb) / Nippon Kayaku, Mundipharma, Celltrion, Teva
P2 data, Journal: 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 Central) - Aug 28, 2022
This real-world study provides a framework that ensures relevance and reliability of EMR-based RWD for evaluating the effectiveness and safety of cancer drugs. 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.
- | DA 3111 (trastuzumab biosimilar) - Meiji Seika, Dong / A, Herceptin (trastuzumab) / Roche
Journal: Identification of Genes Predicting Poor Response of Trastuzumab in Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer. (Pubmed Central) - Aug 10, 2022
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.
- | Herceptin (trastuzumab) / Roche
Journal: Large-scale genomic sequencing reveals adaptive opportunity of targeting mutated-PI3Kα in early and advanced HER2-positive breast cancer. (Pubmed Central) - Mar 4, 2022
We proposed adaptive treatment strategies that the mutated PIK3CA and amplified ERBB2 should be concomitantly inhibited when exposing to continuous anti-HER2 therapy, while the combination of anti-HER2 and anti-PI3Kα treatment was not essential for anti-HER2 treatment-naïve patients. These findings improve the understanding of genomics-guided treatment in the different progressions of HER2+ breast cancer.
- | DA 3111 (trastuzumab biosimilar) - Meiji Seika, Dong / A, Herceptin (trastuzumab) / Roche
Journal, Tumor Mutational Burden: The Impact of Tumor Mutation Burden on the Effect of Frontline Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2-Positive Advanced Gastric Cancers. (Pubmed Central) - Dec 21, 2021
The median progression-free survival (PFS) was not reached in the TMB-high group but was 8.0 months (95% CI, 7.6-8.5) in the TMB-low group (P=0.019). The status of TMB could be a novel biomarker in predicting the efficacy of trastuzumab plus chemotherapy in HER2-positive AGCs.
- | DA 3111 (trastuzumab biosimilar) - Meiji Seika, Dong / A, Herceptin (trastuzumab) / Roche
Journal: Tamoxifen overcomes the trastuzumab-resistance of SK-BR-3 tumorspheres by targeting crosstalk between cytoplasmic estrogen receptor α and the EGFR/HER2 signaling pathway. (Pubmed Central) - Nov 21, 2021
Taken together, our findings indicate that crosstalk between cytoplasmic ERα and the HER2/EGFR signaling pathway be considered a novel therapeutic target for quiescent cell populations within HER2-positive breast cancer and that simultaneous inhibition of ER and the EGFR/HER2 pathway may prevent trastuzumab resistance. We hope that these results provide a basis for the use of combinations of tamoxifen and trastuzumab in HER2-positive breast cancer patients.
- || Herceptin (trastuzumab) / Roche
Biomarker, Clinical, Retrospective data, Journal: Axillary response according to neoadjuvant single or dual human epidermal growth factor receptor 2 (HER2) blockade in clinically node-positive, HER2-positive breast cancer. (Pubmed Central) - Sep 8, 2021
In conclusion, adding trastuzumab to chemotherapy increased the axillary pCR rate in patients with clinically node-positive, HER2-positive breast cancer; furthermore, dual HER2-blockade with trastuzumab and pertuzumab did not elevate the axillary response compared with trastuzumab alone. Breast pCR could be a strong predictor for axillary pCR in clinically node-positive patients treated with HER2-targeting therapy.
- || Herceptin (trastuzumab) / Roche
Clinical data, Reimbursement, Retrospective data, Journal: How government health insurance coverage of novel anti-cancer medicines benefited patients in China - a retrospective analysis of hospital clinical data. (Pubmed Central) - Aug 24, 2021
However, rural patients, patients enrolled in the "resident program", and patients from low-income residential areas and non-local patients benefited less from this policy. Improving the benefits package of the low-income patients and the "resident program" beneficiary would be of considerable significance for a more inclusive and equal health insurance coverage of novel anti-cancer medicines.
- ||| Kadcyla (ado-trastuzumab emtansine) / Roche, DA 3111 (trastuzumab biosimilar) - Meiji Seika, Dong / A
Clinical, P3 data, Journal: Trastuzumab emtansine (T-DM1) versus trastuzumab in Chinese patients with residual invasive disease after neoadjuvant chemotherapy and HER2-targeted therapy for HER2-positive breast cancer in the phase 3 KATHERINE study. (Pubmed Central) - Jun 24, 2021
P3
In the KATHERINE study, T-DM1 demonstrated increased efficacy compared to trastuzumab in Chinese patients. Consistent with previous data in Asian patients, T-DM1 was associated with more grade ≥ 3 AEs, and AEs leading to discontinuation, which was driven by an increase in thrombocytopenia.
- | Herceptin (trastuzumab) / Roche
Journal: The Prognostic Impact of HER2 Genetic and Protein Expression in Pancreatic Carcinoma-HER2 Protein and Gene in Pancreatic Cancer. (Pubmed Central) - May 1, 2021
These findings support the hypothesis that low-level HER2 expression and heterogeneity have significant clinical implications in PDAC. HER2 heterogeneity might indicate the best strategies of combination therapies to prevent the development of subdominant clones with resistance potential.
- ||| DA 3111 (trastuzumab biosimilar) - Meiji Seika, Dong / A
Trial completion: Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults (clinicaltrials.gov) - Feb 10, 2015
P1, N=70, Completed, Sponsor: Meiji Seika Pharma Co., Ltd.
HER2 heterogeneity might indicate the best strategies of combination therapies to prevent the development of subdominant clones with resistance potential. Active, not recruiting --> Completed
- || DA 3111 (trastuzumab biosimilar) - Meiji Seika, Dong / A
Enrollment closed: Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults (clinicaltrials.gov) - Jul 4, 2014
P1, N=70, Active, not recruiting, Sponsor: Meiji Seika Pharma Co., Ltd.
Active, not recruiting --> Completed Enrolling by invitation --> Active, not recruiting
- ||| DA 3111 (trastuzumab biosimilar) - Meiji Seika, Dong / A
New P1 trial: Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults (clinicaltrials.gov) - Mar 30, 2014
P1, N=70, Enrolling by invitation, Sponsor: Meiji Seika Pharma Co., Ltd.