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    DRUG:

    Hetronifly (serplulimab)

    i
    Other names: HLX10, HLX 10, HLX-10
    Company:
    Eisai, Fosun Pharma, Shanghai Henlius Biotech, Intas, Lotus Pharmaceutical, PT Kalbe Farma
    Drug class:
    PD1 inhibitor
    Related drugs:
    6d
    Serplulimab Plus Chemotherapy, with or without HLX04, versus Chemotherapy as First-Line Treatment for Nonsquamous NSCLC: Final Survival Analysis of the Phase III ASTRUM-002 Study. (PubMed, Cancer Commun (Lond))
    Serplulimab plus chemotherapy significantly prolonged OS and maintained PFS benefit compared to chemotherapy; however, the addition of bevacizumab biosimilar HLX04 did not yield further improvement for the first-line treatment of nsq-NSCLC without EGFR or ALK/ROS1 genetic alterations. Trial registration: This trial was registered at ClinicalTrials.gov (NCT03952403, date of registration: 2019 May 14).
    P3 data • Journal
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Hetronifly (serplulimab) • Hanbeitai (bevacizumab biosimilar)
    9d
    Clinical Study of Taurine Combined With Neoadjuvant Chemo-Immunotherapy for Treatment of Locally Advanced Gastric Cancer (clinicaltrials.gov)
    P=N/A, N=96, Recruiting, Tang-Du Hospital | Trial completion date: Jun 2026 --> Jun 2027 | Trial primary completion date: Jun 2026 --> Jun 2027
    Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    capecitabine • oxaliplatin • Hetronifly (serplulimab)
    15d
    Primary large cell neuroendocrine carcinoma of pulmonary artery: a case report and literature review (PubMed, Zhonghua Jie He He Hu Xi Za Zhi)
    The patient subsequently received etoposide plus cisplatin (EP), irinotecan, and third-line combination therapy of serplulimab, anlotinib, and temozolomide. Radical surgery combined with platinum-based chemotherapy constitutes the mainstay of treatment. Molecular testing can provide a basis for personalized therapy, and multiline comprehensive treatment may offer prolonged survival benefits for patients.
    Journal
    |
    NRAS (Neuroblastoma RAS viral oncogene homolog)
    |
    NRAS mutation • NRAS exon 3 mutation
    |
    cisplatin • Focus V (anlotinib) • temozolomide • etoposide IV • irinotecan • Hetronifly (serplulimab)
    16d
    A Single-arm, Multicenter Clinical Study of Fruquintinib Combined With Serplulimab and Chemotherapy as First-line Treatment for Patients With RAS/BRAF-mutated Advanced Colorectal Cance (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, Jiangsu Cancer Institute & Hospital
    New P2 trial
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • RAS mutation
    |
    capecitabine • oxaliplatin • Fruzaqla (fruquintinib) • Hetronifly (serplulimab)
    16d
    HIPEC Priming Followed by Serplulimab Plus SOX/XELOX in Locally Advanced Gastric Cancer (clinicaltrials.gov)
    P2, N=48, Not yet recruiting, Shanghai Changzheng Hospital
    New P2 trial
    |
    docetaxel • capecitabine • oxaliplatin • Hetronifly (serplulimab) • Teysuno (gimeracil/oteracil/tegafur)
    17d
    Perioperative serplulimab with neoadjuvant chemotherapy versus perioperative chemotherapy in PD-L1-positive gastric cancer (ASTRUM-006): a randomised, double-blind, multicentre, phase 3 study. (PubMed, Lancet)
    Neoadjuvant serplulimab plus SOX followed by adjuvant serplulimab significantly improved event-free survival and demonstrated a better safety profile compared with neoadjuvant and adjuvant SOX in PD-L1-positive, resectable gastric or gastro-oesophageal junction adenocarcinoma. Extended follow-up for the overall survival data is warranted to confirm a survival advantage of this perioperative strategy with a chemotherapy-sparing adjuvant component for this indication.
    P3 data • Journal
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    oxaliplatin • Hetronifly (serplulimab) • Teysuno (gimeracil/oteracil/tegafur)
    20d
    HLX43-FIH101: A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=367, Enrolling by invitation, Shanghai Henlius Biotech | Recruiting --> Enrolling by invitation
    Enrollment status • First-in-human
    |
    PD-L1 expression
    |
    docetaxel • Hetronifly (serplulimab) • HLX43
    23d
    Second-line Treatment With Serplulimab, Lenvatinib, and Paclitaxel in Advanced Gastric Cancer After Prior Immunotherapy (clinicaltrials.gov)
    P2, N=59, Active, not recruiting, Qilu Hospital of Shandong University | Recruiting --> Active, not recruiting | Trial primary completion date: Nov 2025 --> Apr 2026
    Enrollment closed • Trial primary completion date
    |
    PD-L1 expression
    |
    Lenvima (lenvatinib) • albumin-bound paclitaxel • Hetronifly (serplulimab)
    27d
    A Phase II Randomized Trial of Serplulimab With Second-Line Chemo/Targeted Therapy for Early Relapse Colorectal Cancer After Adjuvant Chemotherapy (clinicaltrials.gov)
    P2, N=40, Recruiting, Fudan University
    New P2 trial • Tumor mutational burden
    |
    PD-L1 (Programmed death ligand 1) • MSI (Microsatellite instability)
    |
    Avastin (bevacizumab) • Erbitux (cetuximab) • 5-fluorouracil • irinotecan • Hetronifly (serplulimab)
    29d
    A Single-arm, Open-label, Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of HLX10 + Chemotherapy in Patients With ES-SCLC (clinicaltrials.gov)
    P2, N=26, Active, not recruiting, Shanghai Henlius Biotech | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    carboplatin • etoposide IV • Hetronifly (serplulimab)
    1m
    Serplulimab Monotherapy in Elderly Patients With NSCLC and PD-L1 TPS ≥ 50% (clinicaltrials.gov)
    P2, N=60, Recruiting, Tang-Du Hospital
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    ALK fusion • ROS1 fusion
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    Hetronifly (serplulimab)
    1m
    Neoadjuvant Serplulimab Plus Weekly Paclitaxel and Carboplatin in TNBC (Neo-SERPENT) (clinicaltrials.gov)
    P2, N=46, Recruiting, RenJi Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    carboplatin • paclitaxel • Hetronifly (serplulimab)