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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:
    2ms
    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)
    4ms
    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)
    9ms
    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)
    over1year
    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)
    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 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)
    almost2years
    A historical controlled study of domestic trastuzumab and pertuzumab in combination with docetaxel for the neoadjuvant treatment of early HER2-positive breast cancer. (PubMed, Front Oncol)
    In this study, we investigated the efficacy and safety of a neoadjuvant Chinese THP regimen (docetaxel, trastuzumab biosimilar TQB211 plus the pertuzumab biosimilar TQB2440 or pertuzumab) for ER/PR-negative and HER2-positive breast cancer in China. Domestic dual-target HP has a more satisfactory efficacy and safety in the neoadjuvant phase of treatment. https://clinicaltrials.gov/study/NCT05985187, NCT05985187.
    Journal • Combination therapy
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive • ER negative • PGR negative
    |
    docetaxel • Perjeta (pertuzumab) • Paletan (pertuzumab biosimilar)
    almost2years
    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: Mar 2024 --> Jun 2024 | Trial primary completion date: Mar 2024 --> Jun 2024
    Trial completion date • Trial primary completion date
    |
    Trazimera (trastuzumab-qyyp) • Paletan (pertuzumab biosimilar) • Pertuvia (pertuzumab biosimilar)
    2years
    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)
    New P2 trial
    |
    Trazimera (trastuzumab-qyyp) • Paletan (pertuzumab biosimilar) • EG1206A (pertuzumab biosimilar) • Pertuvia (pertuzumab biosimilar)
    2years
    Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer (clinicaltrials.gov)
    P1/2, N=2, Terminated, National Cancer Institute (NCI) | N=12 --> 2 | Recruiting --> Terminated; Inadequate accrual rate
    Enrollment change • Trial termination • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog)
    |
    HR positive • PIK3CA mutation • PTEN mutation
    |
    Herceptin (trastuzumab) • Aliqopa (copanlisib) • Trazimera (trastuzumab-qyyp) • Paletan (pertuzumab biosimilar) • EG1206A (pertuzumab biosimilar) • Pertuvia (pertuzumab biosimilar)
    2years
    Comparing the Efficacy and Safety of TQB2440 versus the Reference Pertuzumab for the Treatment of HER2-Positive Early or Locally Advanced Breast Cancer: A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase 3 Trial (SABCS 2023)
    This study aimed to compare the efficacy and safety of TQB2440 and the reference pertuzumab combined with trastuzumab and docetaxel in pts with HER2-positive early or locally advanced breast cancer...The pts then underwent surgery followed by adjuvant treatment with FEC regimens (fluorouracil 600 mg/m², epirubicin 90 mg/m², cyclophosphamide 600 mg/m², cycle 5-7, q3w), then TQB2440 (840 mg on day 1, cycle 8, followed by 420 mg on cycle 9-20, q3w) + trastuzumab (8 mg/kg on day 1, cycle 8, followed by 6 mg/kg for cycles 9-20, q3w) or until disease progression or intolerable toxicity... In patients with HER2-positive early or locally advanced breast cancer, TQB2440 demonstrated equivalent efficacy and similar safety to the reference pertuzumab.
    Clinical • P3 data • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • docetaxel • 5-fluorouracil • Perjeta (pertuzumab) • cyclophosphamide • epirubicin • Paletan (pertuzumab biosimilar)
    over2years
    Clinical Study to Evaluate the Efficacy and Safety of TQB2440 Injection/Perjeta® Combined With Trastuzumab and Docetaxel in the Treatment of Patients With Early or Locally Advanced Breast Cancer. (clinicaltrials.gov)
    P3, N=412, Active, not recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    New P3 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • cyclophosphamide • epirubicin • Paletan (pertuzumab biosimilar)