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    DRUG:

    Ontruzant (trastuzumab-dttb)

    i
    Other names: SB3, AMT901
    Company:
    AffaMed Therap, Mundipharma, Organon, Samsung
    Drug class:
    HER2 inhibitor
    Related drugs:
    6d
    Pulmonary Hypertension Following the Use of Trastuzumab Biosimilars. (PubMed, Case Rep Pulmonol)
    She previously completed five cycles of trastuzumab biosimilars (trastuzumab-anns or trastuzumab-dttb), Perjeta (pertuzumab), and Taxotere (docetaxel) and then transitioned to maintenance therapy with just trastuzumab-anns and pertuzumab for one cycle due to neuropathy. Early recognition and monitoring of right-sided pressures in high-risk patients may improve outcomes. This case adds to emerging evidence on trastuzumab's pulmonary risks.
    Journal
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    ACVRL1 (Activin A Receptor Like Type 1)
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    HER-2 positive
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    docetaxel • Perjeta (pertuzumab) • Ontruzant (trastuzumab-dttb) • Kanjinti (trastuzumab-anns)
    1m
    A Study of Trastuzumab in Combination With Capecitabine and Cisplatin in Patients With Tissue HER2- But Serum HER2+ AGC (clinicaltrials.gov)
    P2, N=28, Completed, Asan Medical Center | Recruiting --> Completed
    Trial completion
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    cisplatin • capecitabine • Ontruzant (trastuzumab-dttb)
    6ms
    ESPERO: Eribulin With or Without Trastuzumab-biosimilar in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer (clinicaltrials.gov)
    P2, N=180, Recruiting, Seoul National University Hospital | Trial completion date: Dec 2026 --> Jun 2028 | Trial primary completion date: Dec 2026 --> Jun 2028
    Trial completion date • Trial primary completion date
    |
    HER-2 positive • HER-2 expression
    |
    Halaven (eribulin mesylate) • Ontruzant (trastuzumab-dttb)
    1year
    ESPERO: Eribulin With or Without Trastuzumab-biosimilar in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer (clinicaltrials.gov)
    P2, N=180, Recruiting, Seoul National University Hospital | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Feb 2024 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 positive • HER-2 expression
    |
    Halaven (eribulin mesylate) • Ontruzant (trastuzumab-dttb)
    2years
    A Study of Trastuzumab in Combination With Capecitabine and Cisplatin in Patients With Tissue HER2- But Serum HER2+ AGC (clinicaltrials.gov)
    P2, N=28, Recruiting, Asan Medical Center | Trial completion date: Mar 2023 --> Dec 2024 | Trial primary completion date: Mar 2023 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    cisplatin • capecitabine • Ontruzant (trastuzumab-dttb)
    2years
    Biosimilar in Breast Cancer: A Narrative Review. (PubMed, Cureus)
    Trastuzumab biosimilars, such as CT-P6, Ontruzant®, ABP 980, and PF-05280014, have shown efficacy in treating HER2-positive metastatic BCs, presenting a viable alternative to the reference product. Monoclonal biosimilars present a promising avenue in BC therapy, demonstrating efficacy, safety, and potential cost savings. The integration of biosimilars into cancer treatment strategies offers a means to improve accessibility to effective care while addressing economic considerations in healthcare.
    Review • Journal
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Herzuma (trastuzumab-pkrb) • Ontruzant (trastuzumab-dttb) • Kanjinti (trastuzumab-anns) • Trazimera (trastuzumab-qyyp)
    almost3years
    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, ESMO Open)
    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.
    P2 data • Clinical Trial,Phase II • Journal • Pan tumor • Circulating tumor DNA
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification
    |
    gemcitabine • irinotecan • Ontruzant (trastuzumab-dttb) • SIBP-01 (trastuzumab biosimilar)
    3years
    Neoadjuvant Ontruzant (SB3) in Patients With HER2-positive Early Breast Cancer: An Open-Label (NeoON) (clinicaltrials.gov)
    P4, N=108, Recruiting, Institut fuer Frauengesundheit | Trial completion date: Jan 2023 --> Jul 2023 | Trial primary completion date: Jan 2022 --> Apr 2023
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Perjeta (pertuzumab) • Ontruzant (trastuzumab-dttb)
    3years
    Cardiac Safety and Efficacy of SB3 Trastuzumab Biosimilar for ERBB2-Positive Early Breast Cancer: Secondary Analysis of a Randomized Clinical Trial. (PubMed, JAMA Netw Open)
    In the original trial, patients were randomized to either SB3 or TRZ with concomitant neoadjuvant chemotherapy for 8 cycles (4 cycles of docetaxel followed by 4 cycles of fluorouracil, epirubicin, and cyclophosphamide)...In this secondary analysis of a randomized clinical trial, SB3 demonstrated cardiac safety and survival comparable to those of TRZ after up to 6 years of follow-up in patients with ERBB2-positive early or locally advanced breast cancer. ClinicalTrials.gov Identifier: NCT02771795.
    Clinical • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • docetaxel • 5-fluorouracil • cyclophosphamide • epirubicin • Ontruzant (trastuzumab-dttb) • SIBP-01 (trastuzumab biosimilar)
    over3years
    A Study of Trastuzumab in Combination With Capecitabine and Cisplatin in Patients With Tissue HER2- But Serum HER2+ AGC (clinicaltrials.gov)
    P2, N=28, Recruiting, Asan Medical Center | Trial completion date: Sep 2022 --> Mar 2023 | Trial primary completion date: Dec 2021 --> Mar 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    cisplatin • capecitabine • Ontruzant (trastuzumab-dttb)
    over3years
    ESPERO: Eribulin With or Without Trastuzumab-biosimilar in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer (clinicaltrials.gov)
    P2, N=180, Recruiting, Seoul National University Hospital
    New P2 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    Halaven (eribulin mesylate) • Ontruzant (trastuzumab-dttb)
    4years
    First-Line Treatment of HER2-Positive Metastatic Breast Cancer With Dual Blockade Including Biosimilar Trastuzumab (SB3): Population-Based Real-World Data From the DBCG. (PubMed, Breast Cancer (Auckl))
    Median time on treatment was 8.7 months (95% CI, 7.6-11.4); 36 patients (31%) were still on treatment at end of study. This retrospective real-world, nationwide study demonstrated comparable median PFS to the historical data of using reference trastuzumab and pertuzumab as first-line dual blockade.
    Journal • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • EGFR positive
    |
    Herceptin (trastuzumab) • Perjeta (pertuzumab) • Ontruzant (trastuzumab-dttb) • SIBP-01 (trastuzumab biosimilar)