^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    Puyouheng (pucotenlimab)

    i
    Other names: HX008, HX 008, HX-008, LP001, AK103
    Company:
    HanX Biopharma, Lepu Med, Taizhou Hanzhong Biopharma
    Drug class:
    PD1 inhibitor
    Related drugs:
    5d
    Results and Exploratory Biomarker Analyses of a Phase II Study CHANGEABLE: Combination of PD-1 Inhibitor and Niraparib in GErm-Line-mutAted Metastatic Breast Cancer. (PubMed, MedComm (2020))
    This phase II trial evaluated the efficacy and safety of combining niraparib with the PD-1 inhibitor HX008 in patients with metastatic breast cancer who had germline DNA damage response (DDR) mutations. Somatic TP53 mutations significantly correlated with shorter PFS, while ASXL1 mutations correlated with longer PFS. This chemotherapy-free regimen demonstrates promising efficacy and a tolerable safety profile in patients with metastatic breast cancer and germline DDR mutations, providing a novel therapeutic option for this patient population, even those with brain metastases.
    P2 data • Journal • BRCA Biomarker • PARP Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ASXL1 (ASXL Transcriptional Regulator 1) • PALB2 (Partner and localizer of BRCA2) • XPO1 (Exportin 1)
    |
    HER-2 positive • TP53 mutation • HER-2 negative • PALB2 mutation • ASXL1 mutation
    |
    Zejula (niraparib) • Puyouheng (pucotenlimab)
    8d
    TRIUMPH-AM: Neoadjuvant Pucotenlimab Combined With Lenvatinib and Temozolomide in Resectable Stage IIB/III Acral Melanoma (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Shanghai Zhongshan Hospital
    New P2 trial
    |
    temozolomide • Lenvima (lenvatinib) • Puyouheng (pucotenlimab)
    10d
    A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Fudan University
    New P2 trial • IO biomarker
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR expression
    |
    Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin) • becotarug (JMT101)
    20d
    MRG006A Combination Therapy for Advanced Hepatocellular Carcinoma (Phase I/II) (clinicaltrials.gov)
    P1/2, N=160, Not yet recruiting, Lepu Biopharma Co., Ltd.
    New P1/2 trial • Checkpoint inhibition
    |
    GPC3 (Glypican 3)
    |
    Avastin (bevacizumab) • Puyouheng (pucotenlimab)
    1m
    Low-Dose Radiotherapy to Sensitize Pucotenlimab Plus CAPEOX for pMMR Locally Advanced Rectal Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, Sun Yat-sen University
    New P2 trial • pMMR
    |
    capecitabine • oxaliplatin • Puyouheng (pucotenlimab)
    2ms
    Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=38, Not yet recruiting, Fudan University
    New P2 trial
    |
    Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin) • becotarug (JMT101)
    2ms
    Neoadjuvant Becotatug Vedotin Plus Pucotenlimab and Cisplatin for Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Sir Run Run Shaw Hospital
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    cisplatin • Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin) • becotarug (JMT101)
    2ms
    Pucotenlimab Combination With Vorolanib as Neoadjuvant Therapy for ccRCC (clinicaltrials.gov)
    P2, N=21, Recruiting, Sun Yat-sen University
    New P2 trial
    |
    Puyouheng (pucotenlimab) • Fumena (vorolanib)
    2ms
    MRG003 Combined With Immunotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, West China Hospital
    New P2 trial
    |
    Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin)
    2ms
    Clinical Efficacy of Pucotenlimab Combined with Lenvatinib and SOX Versus SOX Alone in Patients with HER2-Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: A Single-Center Randomized Controlled Trial (ChiCTR2600116583)
    P=N/A, N=100, Not yet recruiting, Department of Gastric Surgery, Fujian Medical University Union Hospital; Fujian Medical University Union Hospital
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    Lenvima (lenvatinib) • oxaliplatin • Puyouheng (pucotenlimab)
    2ms
    Efficacy and Safety of Becotatug Vedotin (EGFR ADC) plus Pucotenlimab and Cisplatin as Neoadjuvant Therapy for LA-HNSCC (ChiCTR2600115972)
    P=N/A, N=30, Not yet recruiting, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
    New trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    cisplatin • Puyouheng (pucotenlimab) • Meiyouheng (becotatug vedotin) • becotarug (JMT101)
    2ms
    Pucotenlimab Combined with Lenvatinib and eribulin in Patients with Advanced Melanoma Failed in First-Line Therapy, a Single-Arm, Open-Label, Multicenter, Phase II Clinical Study (ChiCTR2500114916)
    P=N/A, N=35, Not yet recruiting, Shanghai Sixth People's Hospital; Shanghai Sixth People's Hospital
    New trial
    |
    Lenvima (lenvatinib) • irinotecan • Halaven (eribulin mesylate) • Puyouheng (pucotenlimab)