- |||||||||| Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon, Kanjinti (trastuzumab-anns) / Amgen, Daiichi Sankyo, AbbVie, Herceptin (trastuzumab) / Roche
Trastuzumab biosimilars interchangeability: Preliminary real-world data in neoadjuvant breast cancer setting. () - Apr 24, 2024 - Abstract #ASCO2024ASCO_4543;
Brazilian Ministry of Health, as the only provider, has a policy based on lowest cost for trastuzumab compound, causing constant changes along pts treatments. Furthermore, it is expected that Brazil has the potential to evaluate the IC in thousands of pts prospectively next years.
- |||||||||| Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon
Trial completion date, Trial primary completion date, Combination therapy, Metastases: A Study of Trastuzumab in Combination With Capecitabine and Cisplatin in Patients With Tissue HER2- But Serum HER2+ AGC (clinicaltrials.gov) - Mar 2, 2024
P2, N=28, Recruiting,
TB was TRAZIMERA Trial completion date: Mar 2023 --> Dec 2024 | Trial primary completion date: Mar 2023 --> Dec 2024
- |||||||||| Review, Journal: Biosimilar in Breast Cancer: A Narrative Review. (Pubmed Central) - Feb 26, 2024
Trial completion date: Mar 2023 --> Dec 2024 | Trial primary completion date: Mar 2023 --> Dec 2024 Trastuzumab biosimilars, such as CT-P6, Ontruzant
- |||||||||| Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon, SIBP-01 (trastuzumab biosimilar) / Sinopharm
P2 data, Clinical Trial,Phase II, Journal, Pan tumor, Circulating tumor DNA: Safety and efficacy of trastuzumab biosimilar plus irinotecan or gemcitabine in patients with previously treated HER2 (ERBB2)-positive non-breast/non-gastric solid tumors: a phase II basket trial with circulating tumor DNA analysis. (Pubmed Central) - Jul 3, 2023
Trastuzumab biosimilars, such as CT-P6, Ontruzant Trastuzumab plus irinotecan or gemcitabine was safe and feasible for patients with previously treated HER2-positive advanced solid tumors with modest efficacy outcomes, and ctDNA analysis was useful for detecting HER2 amplification.
- |||||||||| Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon
Trial completion date, Trial primary completion date: Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON) (clinicaltrials.gov) - Apr 18, 2023
P4, N=108, Recruiting,
Trastuzumab plus irinotecan or gemcitabine was safe and feasible for patients with previously treated HER2-positive advanced solid tumors with modest efficacy outcomes, and ctDNA analysis was useful for detecting HER2 amplification. Trial completion date: Jan 2023 --> Jul 2023 | Trial primary completion date: Jan 2022 --> Apr 2023
- |||||||||| Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon
Trial completion date, Trial primary completion date, Combination therapy, Metastases: A Study of Trastuzumab in Combination With Capecitabine and Cisplatin in Patients With Tissue HER2- But Serum HER2+ AGC (clinicaltrials.gov) - Jan 3, 2023
P2, N=28, Recruiting,
This study shows that MC2000 with dual camera appears to increase the detection rate of SB lesions compared with the PC3 in the diagnosis of patient with suspected SB bleeding. Trial completion date: Sep 2022 --> Mar 2023 | Trial primary completion date: Dec 2021 --> Mar 2023
- |||||||||| Ontruzant (trastuzumab biosimilar) / Merck (MSD), Samsung, AffaMed Therap, Mundipharma, Onbevzi (bevacizumab biosimilar) / Samsung
Quality-based biosimilar development: Samfenet & Onbevzi (Room C,D) - Jun 28, 2022 - Abstract #KSMO2022KSMO_102;
Sponsored by Boryung Sponsored by Boryung
- |||||||||| Retrospective data, Review, Journal: Trastuzumab biosimilars vs trastuzumab originator in the treatment of HER2-positive breast cancer: a systematic review and network meta-analysis. (Pubmed Central) - Jun 22, 2022
The cumulative ranking curve (SUCRA) probability indicated that the ORR from best to worst was CT-P6, Herceptin, HLX02, PF-05280014, R-TPR-016, BCD-022, MYL-1401O, SB3, and the pCR from best to worst was PF-05280014, CT-P6, Herceptin, ABP-980, SB3...Both CT-P6 and PF-05280014 are better in the overall curative effect, but CT-P6 had the highest serious adverse reactions when compared with others. The PF-05280014 might be a better trastuzumab biosimilar in the treatment of HER2-positive breast cancer patients.
- |||||||||| Ontruzant (trastuzumab biosimilar) / Merck (MSD), Samsung, AffaMed Therap, Mundipharma, SIBP-01 (trastuzumab biosimilar) / Sinopharm, Perjeta (pertuzumab) / Roche
Journal: Safety and Clinical Evaluation of Dual Inhibition with Pertuzumab and Trastuzumab Biosimilar SB3 in HER2-Positive Breast Cancer Patients. (Pubmed Central) - Jan 28, 2022
The safety and the efficacy in this setting was comparable to the trastuzumab plus pertuzumab combination in neoadjuvantly treated matched samples. In this series of HER2-positive breast cancer patients, the combination of SB3 plus pertuzumab was consistent with the known safety and efficacy profile of trastuzumab and pertuzumab combination.
- |||||||||| Ontruzant (trastuzumab biosimilar) / Merck (MSD), Samsung, AffaMed Therap, Mundipharma
Preclinical, Journal: Employing defined bioconjugates to generate chemically functionalised gold nanoparticles for in vitro diagnostic applications. (Pubmed Central) - Jul 21, 2021
The utility of this approach is further demonstrated through the conjugation of the monoclonal antibody Ontruzant to f-BSA-AuNPs using inverse electron-demand Diels-Alder (iEDDA) click chemistry, a hitherto unexplored chemistry for AuNP-IgG conjugation. Finally, we show that the AuNP-Ontruzant particles generated via f-BSA-AuNPs have a greater affinity for their target in a lateral flow format when compared to conventional physisorption, highlighting the potential of this technology for producing sensitive diagnostic tests.
- |||||||||| Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon
Trial completion date, Trial primary completion date, Combination therapy, Metastases: A Study of Trastuzumab in Combination With Capecitabine and Cisplatin in Patients With Tissue HER2- But Serum HER2+ AGC (clinicaltrials.gov) - Jun 24, 2021
P2, N=28, Recruiting,
Finally, we show that the AuNP-Ontruzant particles generated via f-BSA-AuNPs have a greater affinity for their target in a lateral flow format when compared to conventional physisorption, highlighting the potential of this technology for producing sensitive diagnostic tests. Trial completion date: Sep 2021 --> Sep 2022 | Trial primary completion date: Mar 2021 --> Dec 2021
- |||||||||| Avastin (bevacizumab) / Roche, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Journal: Understanding the discrimination and quantification of monoclonal antibodies preparations using Raman spectroscopy. (Pubmed Central) - Jun 22, 2021
Multivariate analysis (partial least square regression and partial least square discriminant analysis) further demonstrates that the signatures of the mAbs themselves are not prominent in mathematical models and that those of the excipients are solely responsible for the differentiation of formulation and accurate determination of concentrations. While Raman spectroscopy can successfully validate the conformity of mAbs intravenous infusion solutions, the basis for the analysis should be considered, and special caution should be given to excipient compositions in commercial formulations to ensure reliability and reproducibility of the analysis.
- |||||||||| Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon
Trial completion date, Trial termination, Trial primary completion date, Metastases: SB3-G31-BC-E: A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC (clinicaltrials.gov) - Jan 7, 2021
P=N/A, N=549, Terminated,
While Raman spectroscopy can successfully validate the conformity of mAbs intravenous infusion solutions, the basis for the analysis should be considered, and special caution should be given to excipient compositions in commercial formulations to ensure reliability and reproducibility of the analysis. Trial completion date: Dec 2021 --> Dec 2020 | Enrolling by invitation --> Terminated | Trial primary completion date: Dec 2021 --> Dec 2020; Considering the life-threatening risk posed by COVID-19 disease to a fragile population, the Sponsor concluded that the benefit of continuing the study does not outweigh the risk to the safety of patients & site staffs.
- |||||||||| Ontruzant (trastuzumab biosimilar) / Merck (MSD), Samsung, AffaMed Therap, Mundipharma
[VIRTUAL] Budget impact of Ontruzant for the treatment of breast cancer and gastric cancer in the United States (OnDemand) - Oct 2, 2020 - Abstract #SABCS2020SABCS_680;
The cost saving was mainly driven by the lower drug acquisition cost of Ontruzant compared to originator trastuzumab, as well as potential reduction of vial wastage due to the availability of Ontruzant multi-dose vials. CONCLUSIONS : Adding Ontruzant to the formulary for treatment of HER2+ breast cancer and gastric cancer and creating mechanisms to encourage providers to utilize Ontruzant instead of the reference branded agent, could lead to substantial cost-savings for the US healthcare payers; and consequently, improve access to treatments for the patients.
- |||||||||| Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon
Enrollment open, Combination therapy, Metastases: A Study of Trastuzumab in Combination With Capecitabine and Cisplatin in Patients With Tissue HER2- But Serum HER2+ AGC (clinicaltrials.gov) - Jun 3, 2020
P2, N=28, Recruiting,
CONCLUSIONS : Adding Ontruzant to the formulary for treatment of HER2+ breast cancer and gastric cancer and creating mechanisms to encourage providers to utilize Ontruzant instead of the reference branded agent, could lead to substantial cost-savings for the US healthcare payers; and consequently, improve access to treatments for the patients. Not yet recruiting --> Recruiting
- |||||||||| Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon
New P2 trial, Metastases: BIOs-Her: Trastuzumab Biosimilar (Samfenet (clinicaltrials.gov) - Jan 2, 2020
P2, N=42, Not yet recruiting,
- |||||||||| Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon
Enrollment open, Phase classification, Enrollment change, Metastases: SB3-G31-BC-E: A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC (clinicaltrials.gov) - Jul 1, 2019
P=N/A, N=612, Recruiting,
Recruiting --> Enrolling by invitation Active, not recruiting --> Recruiting | Phase classification: P3 --> PN/A | N=367 --> 612
- |||||||||| Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon
Trial primary completion date, Metastases: SB3-G31-BC-E: A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC (clinicaltrials.gov) - Feb 14, 2018
P3, N=367, Active, not recruiting,
Active, not recruiting --> Recruiting | Phase classification: P3 --> PN/A | N=367 --> 612 Trial primary completion date: Dec 2017 --> Dec 2021
- |||||||||| Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon
Enrollment closed, Enrollment change, Metastases: SB3-G31-BC-E: A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC (clinicaltrials.gov) - Sep 5, 2017
P3, N=367, Active, not recruiting,
Trial primary completion date: Dec 2017 --> Dec 2021 Enrolling by invitation --> Active, not recruiting | N=570 --> 367
- |||||||||| Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon
Trial completion, Metastases: A Study to Compare the Effect of SB3 and Herceptin (clinicaltrials.gov) - Apr 13, 2017
P3, N=806, Completed,
Enrolling by invitation --> Active, not recruiting | N=570 --> 367 Active, not recruiting --> Completed
- |||||||||| Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon
Enrollment closed, Metastases: A Study to Compare the Effect of SB3 and Herceptin (clinicaltrials.gov) - Sep 24, 2015
P3, N=806, Active, not recruiting,
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- |||||||||| Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon
Trial completion: Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects (clinicaltrials.gov) - May 18, 2014
P1, N=109, Completed,
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- |||||||||| Ontruzant (trastuzumab-dttb) / Samsung, AffaMed Therap, Mundipharma, Organon
New P1 trial: Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB3 in Healthy Male Subjects (clinicaltrials.gov) - Feb 27, 2014
P1, N=108, Active, not recruiting,
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