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    DRUG:

    Hetronifly (serplulimab)

    i
    Other names: HLX10, HLX 10, HLX-10
    Company:
    Fosun Pharma, Intas, Lotus Pharmaceutical, PT Kalbe Farma
    Drug class:
    PD1 inhibitor
    Related drugs:
    1d
    PD-1 + FOLFOXIRI vs CAPOX as Total Neoadjuvant Therapy for pMMR Low Rectal Cancer (clinicaltrials.gov)
    P3, N=382, Not yet recruiting, Sun Yat-sen University
    New P3 trial • pMMR
    |
    5-fluorouracil • capecitabine • oxaliplatin • irinotecan • leucovorin calcium • Hetronifly (serplulimab)
    3d
    Comparative effectiveness and safety of systemic therapies for treatment-naïve, PD-L1 expression <1% advanced NSCLC: a systematic review and network meta-analysis. (PubMed, Transl Lung Cancer Res)
    In terms of OS, pembrolizumab + chemotherapy + canakinumab (Pembro-chemo-canakinumab) (SUCRA =0.90) showed great potential in improving outcomes, although its long-term efficacy still needed to be validated...For squamous patients, nivolumab + ipilimumab ± chemotherapy (Nivo-ipi-chemo) led in OS, while serplulimab + chemotherapy in PFS. First-line personalized treatment for PD-L1 <1%, advanced NSCLC should be histology-based, balancing efficacy and toxicity. Pembro-chemo and nivolumab + chemotherapy + bevacizumab combinations are recommended as the optimal first-line options for non-squamous patients, and Nivo-ipi-chemo for squamous patients.
    Retrospective data • Journal • HEOR • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Avastin (bevacizumab) • Yervoy (ipilimumab) • Hetronifly (serplulimab) • Ilaris (canakinumab)
    3d
    ASTRUM-005: A Phase III Study to Investigate Efficacy and Safety of HLX10 + Chemotherapy in Patients With ES-SCLC (clinicaltrials.gov)
    P3, N=585, Completed, Shanghai Henlius Biotech | Active, not recruiting --> Completed
    Trial completion • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    carboplatin • etoposide IV • Hetronifly (serplulimab)
    4d
    A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Combination With Serplulimab as Neoadjuvant Therapy in Subjects With NSCLC (clinicaltrials.gov)
    P2, N=60, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial
    |
    Hetronifly (serplulimab) • HLX43
    5d
    First-line serplulimab plus chemotherapy with or without HLX04 versus chemotherapy in locally advanced or metastatic non-squamous non-small-cell lung cancer (ASTRUM-002): a randomised, double-blind, multicentre phase 3 trial. (PubMed, Lancet Respir Med)
    The addition of serplulimab to chemotherapy led to significantly longer progression-free survival in patients with locally advanced or metastatic non-squamous NSCLC compared with chemotherapy alone and represents an alternative first-line treatment option for this patient population. HLX04 plus serplulimab and chemotherapy did not confer further statistical benefit compared with serplulimab plus chemotherapy.
    P3 data • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 expression • ALK rearrangement • ROS1 rearrangement
    |
    carboplatin • pemetrexed • Hetronifly (serplulimab) • Hanbeitai (bevacizumab biosimilar)
    7d
    A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=340, Recruiting, Shanghai Henlius Biotech | N=174 --> 340
    Enrollment change
    |
    DDX5 (DEAD-Box Helicase 5)
    |
    PD-L1 expression
    |
    docetaxel • Hetronifly (serplulimab) • HLX43
    9d
    Safety and Efficacy of Serplulimab Combined with Neoadjuvant Chemoradiotherapy in High-Risk Locally Advanced Rectal Cancer: A Retrospective Study. (PubMed, Cancer Manag Res)
    All enrolled patients received conventional radiotherapy combined with CapeOX or capecitabine monotherapy, along with serplulimab, followed by TME 8-12 weeks post-nCRT. The combination of serplulimab with nCRT demonstrated safety and efficacy in patients with high-risk pMMR LARC. However, further verification through longer follow-up periods and large-scale prospective studies is warranted.
    Retrospective data • Journal
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    capecitabine • Hetronifly (serplulimab)
    10d
    Serplulimab Combined With Chemotherapy in Patients With Resectable Non-small-cell Lung Cancer (clinicaltrials.gov)
    P2, N=36, Active, not recruiting, Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting --> Active, not recruiting | Trial completion date: May 2030 --> Dec 2030 | Trial primary completion date: May 2025 --> Dec 2025
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    carboplatin • albumin-bound paclitaxel • Hetronifly (serplulimab)
    11d
    SCRT-CAPEOX-Serplulimab for MSS/pMMR Rectal Cancer With Oligometastases (clinicaltrials.gov)
    P2, N=102, Recruiting, First Affiliated Hospital of Zhejiang University | Not yet recruiting --> Recruiting
    Enrollment open • Mismatch repair • pMMR
    |
    capecitabine • oxaliplatin • Hetronifly (serplulimab)
    14d
    A Phase II Clinical Study to Evaluate HLX43 in Combination With Serplulimab in Subjects With Advanced Lung Cancer (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Shanghai Henlius Biotech
    New P2 trial
    |
    Hetronifly (serplulimab) • HLX43
    23d
    Firstline Sequential AG and mFOLFOX Combined With Serplulimab and Bevacizumab Versus AG Chemotherapy Alone in Advanced Pancreatic Cancer (clinicaltrials.gov)
    P3, N=292, Recruiting, Zhejiang Cancer Hospital
    New P3 trial
    |
    Avastin (bevacizumab) • gemcitabine • albumin-bound paclitaxel • oxaliplatin • Hetronifly (serplulimab)
    25d
    Study of ZG006 in Combination With PD-1/PD-L1 Immune Checkpoint Inhibitors as First-Line Standard Therapy in Participants With Extensive Stage Small-Cell Lung Cancer (clinicaltrials.gov)
    P1, N=100, Not yet recruiting, Suzhou Zelgen Biopharmaceuticals Co.,Ltd
    New P1 trial • Checkpoint inhibition
    |
    Hetronifly (serplulimab) • alveltamig (ZG006)