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    DRUG:

    Paletan (pertuzumab biosimilar)

    i
    Other names: TQB2440, TQB-2440, TQB 2440
    Company:
    Sino Biopharm
    Drug class:
    HER2 inhibitor
    Related drugs:
    2d
    Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial (clinicaltrials.gov)
    P2, N=120, Recruiting, M.D. Anderson Cancer Center | Active, not recruiting --> Recruiting
    Enrollment open • Minimal residual disease
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 positive
    |
    Keytruda (pembrolizumab) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • Paletan (pertuzumab biosimilar) • Pertuvia (pertuzumab biosimilar) • Poherdy (pertuzumab-dpzb)
    28d
    NRG-BR004: Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=190, Terminated, National Cancer Institute (NCI) | Completed --> Terminated; Inadequate accrual rate
    Trial termination
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor) • IL2 (Interleukin 2)
    |
    HER-2 positive
    |
    Tecentriq (atezolizumab) • paclitaxel • docetaxel • Trazimera (trastuzumab-qyyp) • Paletan (pertuzumab biosimilar) • Pertuvia (pertuzumab biosimilar)
    2ms
    Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis (clinicaltrials.gov)
    P3, N=562, Not yet recruiting, SWOG Cancer Research Network
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Trazimera (trastuzumab-qyyp) • Paletan (pertuzumab biosimilar) • Pertuvia (pertuzumab biosimilar) • Poherdy (pertuzumab-dpzb)
    4ms
    EAY131-J: Testing Trastuzumab and Pertuzumab in Patients With Higher Than Normal Copies of the HER2 Gene Found in Their Tumors (MATCH - Subprotocol J) (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Jan 2027
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 amplification
    |
    Trazimera (trastuzumab-qyyp) • Paletan (pertuzumab biosimilar) • Pertuvia (pertuzumab biosimilar) • Poherdy (pertuzumab-dpzb)
    4ms
    Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial (clinicaltrials.gov)
    P2, N=120, Active, not recruiting, M.D. Anderson Cancer Center
    New P2 trial • Minimal residual disease
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 positive
    |
    Keytruda (pembrolizumab) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp) • Paletan (pertuzumab biosimilar) • Pertuvia (pertuzumab biosimilar) • Poherdy (pertuzumab-dpzb)
    6ms
    NRG-BR004: Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=190, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed
    Trial completion
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor) • IL2 (Interleukin 2)
    |
    HER-2 positive
    |
    Tecentriq (atezolizumab) • paclitaxel • docetaxel • Trazimera (trastuzumab-qyyp) • Paletan (pertuzumab biosimilar) • Pertuvia (pertuzumab biosimilar)
    6ms
    TQB2440 compared with reference pertuzumab for HER2-positive, ER/PgR-negative, early or locally advanced breast cancer: a multicenter, randomized, double-blind, parallel-controlled, phase III equivalence trial. (PubMed, ESMO Open)
    TQB2440 showed equivalent efficacy, comparable safety, PK, and immunogenicity profiles to reference pertuzumab in the neoadjuvant treatment of patients with HER2-positive early or locally advanced breast cancer.
    Clinical • P3 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
    |
    HER-2 positive • EGFR positive
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • Ansaizhu (pertuzumab biosimilar) • Paletan (pertuzumab biosimilar)
    9ms
    NCI-MATCH: Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (clinicaltrials.gov)
    P2, N=6452, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    MSI (Microsatellite instability) • CD4 (CD4 Molecule)
    |
    Opdivo (nivolumab) • Herceptin (trastuzumab) • Mekinist (trametinib) • Xalkori (crizotinib) • Tagrisso (osimertinib) • Gilotrif (afatinib) • Ibrance (palbociclib) • dasatinib • Tafinlar (dabrafenib) • Vitrakvi (larotrectinib) • sunitinib • Kadcyla (ado-trastuzumab emtansine) • Balversa (erdafitinib) • Mektovi (binimetinib) • adavosertib (AZD1775) • Truqap (capivasertib) • Aliqopa (copanlisib) • fexagratinib (ABSK091) • sapanisertib (CB-228) • ipatasertib (RG7440) • taselisib (GDC-0032) • omipalisib (GSK2126458) • ulixertinib (BVD-523) • Erivedge (vismodegib) • Trazimera (trastuzumab-qyyp) • Fakzynja (defactinib) • GSK2636771 • Paletan (pertuzumab biosimilar) • relatlimab (BMS-986016) • ABP 206 (nivolumab biosimilar) • Pertuvia (pertuzumab biosimilar)
    11ms
    Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=315, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    carboplatin • docetaxel • Trazimera (trastuzumab-qyyp) • goserelin acetate • Paletan (pertuzumab biosimilar) • Pertuvia (pertuzumab biosimilar)
    over1year
    Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=315, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Dec 2025
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    carboplatin • docetaxel • Trazimera (trastuzumab-qyyp) • goserelin acetate • Paletan (pertuzumab biosimilar) • Pertuvia (pertuzumab biosimilar)
    2years
    NRG-BR004: Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=190, Active, not recruiting, National Cancer Institute (NCI) | N=600 --> 190 | Trial completion date: Apr 2024 --> May 2025
    Enrollment change • Trial completion date • Metastases
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor) • IL2 (Interleukin 2)
    |
    HER-2 positive
    |
    Tecentriq (atezolizumab) • paclitaxel • docetaxel • Trazimera (trastuzumab-qyyp) • Paletan (pertuzumab biosimilar) • Pertuvia (pertuzumab biosimilar)
    over2years
    Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=315, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Dec 2024
    Trial completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    carboplatin • docetaxel • Trazimera (trastuzumab-qyyp) • goserelin acetate • Paletan (pertuzumab biosimilar) • Pertuvia (pertuzumab biosimilar)