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    DRUG:

    Herzuma (trastuzumab-pkrb)

    i
    Other names: CT-P6, CT-P06
    Company:
    Celltrion, Mundipharma, Nippon Kayaku, Teva
    Drug class:
    HER2 inhibitor
    Related drugs:
    4d
    To Compare the Pharmacokinetics, Safety, and Immunogenicity of Subcutaneous CT-P6 and Herceptin in Healthy Male Subjects (Trastuzumab) (clinicaltrials.gov)
    P1, N=200, Not yet recruiting, Celltrion
    New P1 trial
    |
    Herzuma (trastuzumab-pkrb) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    5d
    Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) (clinicaltrials.gov)
    P1/2, N=81, Not yet recruiting, Merck Sharp & Dohme LLC
    New P1/2 trial
    |
    Perjeta (pertuzumab) • Tukysa (tucatinib) • patritumab deruxtecan (U3-1402) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    3ms
    Demonstrate Efficacy and Safety of Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=475, Completed, Celltrion | Unknown status --> Completed
    Trial completion
    |
    paclitaxel • Herzuma (trastuzumab-pkrb)
    3ms
    Evaluate Safety, Efficacy and Pharmacokinetics (clinicaltrials.gov)
    P1/2, N=174, Completed, Celltrion | Unknown status --> Completed | Trial completion date: Dec 2020 --> Dec 2023
    Trial completion • Trial completion date • Metastases
    |
    paclitaxel • Herzuma (trastuzumab-pkrb)
    4ms
    Alpha-TEA and Trastuzumab for the Treatment of Refractory HER2+ Metastatic Breast Cancer (clinicaltrials.gov)
    P1, N=24, Suspended, Veana Therapeutics | Trial completion date: Feb 2025 --> Feb 2030 | Recruiting --> Suspended | Trial primary completion date: Feb 2024 --> Feb 2028
    Trial completion date • Trial suspension • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • Vimo (alpha-tocopheroloxyacetic acid)
    5ms
    UCLA l-08: Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=30, Active, not recruiting, Jonsson Comprehensive Cancer Center | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • AXL (AXL Receptor Tyrosine Kinase)
    |
    Tagrisso (osimertinib) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • Portrazza (necitumumab)
    6ms
    MARGetuximab Or Trastuzumab (MARGOT) (clinicaltrials.gov)
    P2, N=174, Active, not recruiting, Dana-Farber Cancer Institute | Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2024 --> Oct 2024
    Enrollment closed • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    paclitaxel • Perjeta (pertuzumab) • Herzuma (trastuzumab-pkrb) • Margenza (margetuximab-cmkb)
    7ms
    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
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • EGFR positive
    |
    Herzuma (trastuzumab-pkrb) • DA 3111 (trastuzumab biosimilar)
    7ms
    DESTINY-Breast11: Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer (clinicaltrials.gov)
    P3, N=912, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • paclitaxel • Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • doxorubicin hydrochloride • cyclophosphamide • Herzuma (trastuzumab-pkrb)
    7ms
    UCLA B-13: Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer (clinicaltrials.gov)
    P1/2, N=18, Recruiting, Jonsson Comprehensive Cancer Center | Phase classification: P1b --> P1/2 | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Apr 2024 --> Apr 2025
    Phase classification • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 amplification
    |
    carboplatin • docetaxel • Perjeta (pertuzumab) • Kisqali (ribociclib) • fulvestrant • Tukysa (tucatinib) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    8ms
    SCHOLAR-2: Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction (clinicaltrials.gov)
    P2, N=130, Recruiting, Population Health Research Institute | Trial completion date: Dec 2025 --> Jun 2025 | Trial primary completion date: Jan 2024 --> Jan 2025
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    9ms
    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
    |
    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)
    10ms
    SMMART Adaptive Clinical Treatment (ACT) Trial (clinicaltrials.gov)
    P1, N=0, Withdrawn, OHSU Knight Cancer Institute | N=25 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation • HR positive • HER-2 negative • EGFR positive
    |
    Avastin (bevacizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • Zelboraf (vemurafenib) • carboplatin • Rozlytrek (entrectinib) • Alecensa (alectinib) • Kadcyla (ado-trastuzumab emtansine) • Cotellic (cobimetinib) • capecitabine • Piqray (alpelisib) • Zejula (niraparib) • albumin-bound paclitaxel • fulvestrant • irinotecan • Halaven (eribulin mesylate) • letrozole • vinorelbine tartrate • Herzuma (trastuzumab-pkrb) • anastrozole • Erivedge (vismodegib) • Trazimera (trastuzumab-qyyp) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    12ms
    UCLA l-08: Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=26, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Dec 2024 --> Dec 2025
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • AXL (AXL Receptor Tyrosine Kinase)
    |
    EGFR mutation • EGFR L858R • HER-2 expression • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • Portrazza (necitumumab)
    almost1year
    Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer (clinicaltrials.gov)
    P2, N=16, Recruiting, University of Washington | Trial primary completion date: Oct 2023 --> Oct 2024
    Trial primary completion date • Surgery
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD4 (CD4 Molecule)
    |
    Herceptin (trastuzumab) • paclitaxel • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • EG1206A (pertuzumab biosimilar)
    1year
    Neratinib and Trastuzumab Biosimilar in Patients With HER2 Mutated Advanced Solid Cancers (clinicaltrials.gov)
    P2, N=42, Active, not recruiting, Korea University Guro Hospital | Recruiting --> Active, not recruiting
    Enrollment closed • Pan tumor • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 mutation
    |
    Nerlynx (neratinib) • Herzuma (trastuzumab-pkrb)
    1year
    Neratinib and Trastuzumab Biosimilar in Patients With HER2 Mutated Advanced Solid Cancers (clinicaltrials.gov)
    P2, N=42, Recruiting, Korea University Guro Hospital
    New P2 trial • Pan tumor • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 mutation
    |
    Nerlynx (neratinib) • Herzuma (trastuzumab-pkrb)
    1year
    Phase II Trial of Anti-HER2 Treatment in HER2-enriched Early Breast Cancer Identified by PAM50 (HER2E-PAM, PAMILIA Study) (clinicaltrials.gov)
    P2; Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative • HER-2 expression
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    Herzuma (trastuzumab-pkrb)
    1year
    KCSG-HB19-14: Trastuzumab-pkrb Combined With Modified FOLFOX-6 in Biliary Tract Cancer Patients Progressed on First Line Therapy (clinicaltrials.gov)
    P2, N=36, Completed, Yonsei University | Recruiting --> Completed | Trial completion date: Mar 2023 --> Jun 2023 | Trial primary completion date: Sep 2022 --> Jun 2023
    Trial completion • Trial completion date • Trial primary completion date • Pan tumor
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 amplification
    |
    5-fluorouracil • oxaliplatin • Herzuma (trastuzumab-pkrb) • leucovorin calcium
    1year
    DESTINY-Breast11: Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer (clinicaltrials.gov)
    P3, N=900, Recruiting, AstraZeneca | Active, not recruiting --> Recruiting | N=654 --> 900 | Trial completion date: Jun 2026 --> Apr 2027 | Trial primary completion date: Dec 2023 --> Dec 2024
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • paclitaxel • Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • doxorubicin hydrochloride • cyclophosphamide • Herzuma (trastuzumab-pkrb)
    1year
    Phase II study of a trastuzumab biosimilar in combination with paclitaxel for HER2-positive recurrent or metastatic urothelial carcinoma: KCSG GU18-18. (PubMed, ESMO Open)
    Trastuzumab-pkrb plus paclitaxel demonstrates promising efficacy with manageable toxicity profiles in patients with HER2-positive recurrent or metastatic UC.
    P2 data • Journal • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    paclitaxel • Herzuma (trastuzumab-pkrb) • SIBP-01 (trastuzumab biosimilar)
    over1year
    SMMART Adaptive Clinical Treatment (ACT) Trial (clinicaltrials.gov)
    P1, N=25, Not yet recruiting, OHSU Knight Cancer Institute | Phase classification: P2 --> P1 | N=131 --> 25
    Phase classification • Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation • HR positive • HER-2 negative • EGFR positive
    |
    Avastin (bevacizumab) • Herceptin (trastuzumab) • Lynparza (olaparib) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • Zelboraf (vemurafenib) • carboplatin • Rozlytrek (entrectinib) • Alecensa (alectinib) • Kadcyla (ado-trastuzumab emtansine) • Cotellic (cobimetinib) • capecitabine • Piqray (alpelisib) • Zejula (niraparib) • albumin-bound paclitaxel • fulvestrant • irinotecan • Halaven (eribulin mesylate) • letrozole • vinorelbine tartrate • Herzuma (trastuzumab-pkrb) • anastrozole • Erivedge (vismodegib) • Trazimera (trastuzumab-qyyp) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • EG1206A (pertuzumab biosimilar)
    over1year
    Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer (clinicaltrials.gov)
    P2, N=16, Recruiting, University of Washington | Trial primary completion date: Jun 2023 --> Oct 2023
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • IL10 (Interleukin 10) • IGFBP2 (Insulin-like growth factor binding protein 2)
    |
    Herceptin (trastuzumab) • paclitaxel • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • EG1206A (pertuzumab biosimilar)
    over1year
    Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer (clinicaltrials.gov)
    P3, N=644, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • paclitaxel • Perjeta (pertuzumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • doxorubicin hydrochloride • cyclophosphamide • Herzuma (trastuzumab-pkrb)
    over1year
    A phase 2 multicenter study of docetaxel-PM and trastuzumab-pkrb combination therapy in recurrent or metastatic salivary gland carcinomas. (PubMed, Cancer)
    Salivary duct carcinoma (SDC) is uncommon but is the most aggressive subtype of salivary gland carcinomas. SDC shares morphological and histological similarities with invasive ductal carcinoma of breast, which led to an investigation of hormonal receptor and human epidermal growth factor receptor 2 (HER2)/neu expression status in SDC. In this study, patients with HER2-positive SDC were enrolled and treated with combination of docetaxel-polymeric micelle and trastuzumab-pkrb. Promising antitumor activities were shown with objective response rate of 69.8%, disease control rate of 93.0%, median progression-free survival of 7.9 months, median duration of response of 6.7 months, and median overall survival of 23.3 months.
    Clinical • P2 data • Journal • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    Herzuma (trastuzumab-pkrb) • Nanoxel M (docetaxel polymeric micelle) • SIBP-01 (trastuzumab biosimilar)
    over1year
    Targeting human EGFR 2 (HER2) in salivary gland carcinoma. (PubMed, Expert Rev Anticancer Ther)
    Conversely, there are prospective trials supporting the use of anti-HER2 therapy in patients with unresectable, recurrent, or metastatic HER2-positive SGC, including trastuzumab plus docetaxel, trastuzumab plus pertuzumab, trastuzumab-pkrb plus nanoxel, trastuzumab emtansine (T-DM1), and trastuzumab deruxtecan (T-Dxd). T-DM1 or T-Dxd can be considered upon disease progression on trastuzumab-combination therapies, although these antibody-drug conjugates can also be used upfront. Future research should investigate predictive biomarkers, the combination of HER2 and androgen blockade, and the application of novel therapies from breast cancer.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification
    |
    docetaxel • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Herzuma (trastuzumab-pkrb)
    over1year
    Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer (clinicaltrials.gov)
    P1, N=39, Suspended, Mayo Clinic | Trial completion date: May 2023 --> May 2026 | Trial primary completion date: Apr 2023 --> Apr 2025
    Trial completion date • Trial primary completion date • FDG PET • Metastases
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • gemcitabine • Rituxan (rituximab) • Gazyva (obinutuzumab) • Aliqopa (copanlisib) • Darzalex (daratumumab) • Herzuma (trastuzumab-pkrb) • carfilzomib • Istodax (romidepsin) • Trazimera (trastuzumab-qyyp) • Beleodaq (belinostat)
    over1year
    Six-Year Survival Outcomes for Patients with HER2-Positive Early Breast Cancer Treated with CT-P6 or Reference Trastuzumab: Observational Follow-Up Study of a Phase 3 Randomised Controlled Trial. (PubMed, BioDrugs)
    Data from this extended follow-up of the CT-P6 3.2 study demonstrate the comparable long-term efficacy of CT-P6 and reference trastuzumab up to 6 years.
    P3 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • EGFR positive
    |
    Herzuma (trastuzumab-pkrb)
    over1year
    UCLA B-13: Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer (clinicaltrials.gov)
    P1b, N=18, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Apr 2023 --> Apr 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    IL6 (Interleukin 6) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C)
    |
    HER-2 amplification • PTPRC expression • IL6 expression
    |
    carboplatin • docetaxel • Perjeta (pertuzumab) • Kisqali (ribociclib) • fulvestrant • Tukysa (tucatinib) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    almost2years
    Necitumumab and Trastuzumab in Combination With Osimertinib for the Treatment of Refractory Epidermal Growth Factor Receptor (EGFR)-Mutated Stage IV Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=26, Recruiting, Jonsson Comprehensive Cancer Center | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2022 --> Dec 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
    |
    Tagrisso (osimertinib) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • Portrazza (necitumumab)
    2years
    Trastuzumab plus FOLFOX for HER2-positive biliary tract cancer refractory to gemcitabine and cisplatin: a multi-institutional phase 2 trial of the Korean Cancer Study Group (KCSG-HB19-14). (PubMed, Lancet Gastroenterol Hepatol)
    For HER2-positive biliary tract cancer, second-line or third-line trastuzumab biosimilar plus FOLFOX exhibited promising activity with acceptable toxicity, warranting further investigation.
    P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification
    |
    cisplatin • gemcitabine • 5-fluorouracil • oxaliplatin • Herzuma (trastuzumab-pkrb) • leucovorin calcium • SIBP-01 (trastuzumab biosimilar)
    2years
    Combined allogeneic NK cell and Herzuma is effective in HER2-low breast cancer preclinical model by enhancing antibody-dependent cellular cytotoxicity (SITC 2022)
    Conclusions The combination of allogeneic NK therapy, Herzuma® and paclitaxel showed synergistic anticancer activity in HER2-low breast cancer preclinical model. This combination merits further clinical investigation in HER2-low breast cancer patients.
    Preclinical
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 underexpression • HER-2-H
    |
    paclitaxel • Herzuma (trastuzumab-pkrb)
    2years
    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
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Herzuma (trastuzumab-pkrb) • DA 3111 (trastuzumab biosimilar) • SIBP-01 (trastuzumab biosimilar)
    over2years
    Genomic analysis of plasma cell-free DNA in patients with heavily pretreated HER-2+ metastatic breast cancer (MBC) (ESMO 2022)
    Funding K-MASTER- This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HI17C2206) KCSG Celltrion for Herzuma...Conclusions ERBB2, TP53 and PIK3CA mutations in ctDNA were associated with worse PFS of trastuzumab biosimilar and cytotoxic chemotherapy in our patients. Enrichment of HRD related gene mutations and newly detected variants in ctDNA may be related with the study drug resistance.
    Clinical • BRCA Biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ATM (ATM serine/threonine kinase) • HRD (Homologous Recombination Deficiency) • RB1 (RB Transcriptional Corepressor 1) • PALB2 (Partner and localizer of BRCA2) • FANCA (FA Complementation Group A) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD50 (RAD50 Double Strand Break Repair Protein)
    |
    TP53 mutation • HER-2 amplification • PIK3CA mutation • HRD • PALB2 mutation • BRIP1 mutation • FANCA mutation • RAD50 mutation
    |
    Herzuma (trastuzumab-pkrb)
    over2years
    SCHOLAR-2: Safety of Continuing HER-2 Directed Therapy in Overt Left Ventricular Dysfunction (clinicaltrials.gov)
    P2, N=130, Recruiting, Population Health Research Institute | Not yet recruiting --> Recruiting | Trial completion date: Jan 2025 --> Dec 2025
    Enrollment open • Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • Kadcyla (ado-trastuzumab emtansine) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    over2years
    Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer (clinicaltrials.gov)
    P1b, N=18, Recruiting, Jonsson Comprehensive Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    IL6 (Interleukin 6) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C)
    |
    HER-2 amplification • PTPRC expression • IL6 expression
    |
    carboplatin • docetaxel • Perjeta (pertuzumab) • Kisqali (ribociclib) • fulvestrant • Tukysa (tucatinib) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    over2years
    Alpha-TEA and Trastuzumab for the Treatment of Refractory HER2+ Metastatic Breast Cancer (clinicaltrials.gov)
    P1; Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2023 --> Feb 2024
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • NCAM1 (Neural cell adhesion molecule 1) • CCR7 (Chemokine (C-C motif) receptor 7) • LAMP1 (Lysosomal Associated Membrane Protein 1) • LAMP2 (Lysosomal Associated Membrane Protein 2)
    |
    HER-2 positive • HER-2 overexpression
    |
    Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • Vimo (alpha-tocopheroloxyacetic acid)
    over2years
    Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer (clinicaltrials.gov)
    P1b, N=18, Not yet recruiting, Jonsson Comprehensive Cancer Center
    New P1 trial
    |
    IL6 (Interleukin 6) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C)
    |
    HER-2 amplification • PTPRC expression • IL6 expression
    |
    carboplatin • docetaxel • Perjeta (pertuzumab) • Kisqali (ribociclib) • fulvestrant • Tukysa (tucatinib) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    over2years
    Efficacy of CT-P6 (trastuzumab biosimilar) versus reference trastuzumab in combination with pertuzumab in HER2-positive early-stage breast cancer: Preclinical and real-life clinical data. (PubMed, Breast)
    Adding paclitaxel to these treatments increased their effectivity to a similar extent. Moreover, the costs of CT-P6-based treatments were reduced by 1474.07 €/patient. All together we provide pre-clinical and clinical evidence of the equivalence of CT-P6 in combination with pertuzumab and chemotherapy and suggest studying these combinations also in HER2 low/negative BC patients.
    Clinical data • Preclinical • Retrospective data • Journal • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    HER-2 positive • HER-2 negative
    |
    Herceptin (trastuzumab) • paclitaxel • Perjeta (pertuzumab) • Herzuma (trastuzumab-pkrb)
    almost3years
    Efficacy and Safety of Trastuzumab Biosimilar (CT-P6) Compared With Reference Trastuzumab in Patients With HER2-positive Advanced Gastric Cancer: A Retrospective Analysis. (PubMed, Am J Clin Oncol)
    Biosimilar trastuzumab showed equivalent outcome to reference trastuzumab, with similar adverse events. Biosimilar trastuzumab can suitably and safely replace trastuzumab as a reference for the treatment of HER2-positive AGC.
    Retrospective data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Herzuma (trastuzumab-pkrb) • SIBP-01 (trastuzumab biosimilar)
    almost3years
    Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer (clinicaltrials.gov)
    P2, N=16, Recruiting, University of Washington | Trial primary completion date: Jun 2022 --> Jun 2023
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • IFNG (Interferon, gamma) • CD4 (CD4 Molecule) • IL10 (Interleukin 10) • IGFBP2 (Insulin-like growth factor binding protein 2)
    |
    ER negative • PGR negative
    |
    Herceptin (trastuzumab) • paclitaxel • Perjeta (pertuzumab) • Herzuma (trastuzumab-pkrb)
    almost3years
    Combination of Nanoxel and Herzuma in Salivary Duct Carcinoma (clinicaltrials.gov)
    P2, N=41, Active, not recruiting, Samsung Medical Center | Trial completion date: Aug 2022 --> Aug 2023 | Trial primary completion date: Aug 2021 --> Sep 2022
    Clinical • Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herzuma (trastuzumab-pkrb)