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    DRUG:

    Yidafan (ivonescimab)

    i
    Other names: SMT-112, SMT 112, AK112, AK 112, AK-112, SMT112
    Company:
    Akesobio, Summit Therapeutics
    Drug class:
    PD1 inhibitor, VEGF inhibitor
    Related drugs:
    3d
    AK112-US-01: Ivocizumab in the Treatment of Multiple Advanced Tumors (clinicaltrials.gov)
    P2, N=100, Recruiting, Fudan University | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Yidafan (ivonescimab)
    7d
    Ivonescimab Plus Chemotherapy in Patients With EGFR Variant Non-Small Cell Lung Cancer-Reply. (PubMed, JAMA)
    No abstract available
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    Yidafan (ivonescimab)
    7d
    Ivonescimab Plus Chemotherapy in Patients With EGFR Variant Non-Small Cell Lung Cancer. (PubMed, JAMA)
    No abstract available
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    Yidafan (ivonescimab)
    7d
    Ivonescimab Plus Chemotherapy in Patients With EGFR Variant Non-Small Cell Lung Cancer. (PubMed, JAMA)
    No abstract available
    Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    Yidafan (ivonescimab)
    17d
    SBRT, Chemotherapy, and AK112 Neoadjuvant Therapy for Luminal-type Breast Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, Hubei Cancer Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    doxorubicin hydrochloride • albumin-bound paclitaxel • cyclophosphamide • Yidafan (ivonescimab)
    1m
    A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (clinicaltrials.gov)
    P3, N=510, Recruiting, Akeso | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • Yidafan (ivonescimab) • ligufalimab (AK117)
    1m
    An Exploratory, Multi-cohort Phase II Study of Combination Therapy of AK112 With Chemotherapy and/or Olaparib in Platinum-sensitive Ovarian Cancer (clinicaltrials.gov)
    P2, N=150, Not yet recruiting, Akeso
    New P2 trial
    |
    Lynparza (olaparib) • Yidafan (ivonescimab)
    1m
    A Multicenter, Single-arm, Open-label Study Evaluating the Safety and Efficacy of AK112 Combined With Chemotherapy as First-line Treatment for Non-squamous NSCLC Patients With BRAIN Metastases and Negative Driver Genes (IVO BRAIN) (clinicaltrials.gov)
    P2, N=55, Not yet recruiting, Sun Yat-sen University
    New P2 trial
    |
    Yidafan (ivonescimab)
    1m
    A Prospective, Multicenter Clinical Study of the Efficacy and Safety of First-Line Treatment with Ivonescimab in Combination with XELOX for Unresectable Advanced Gastric/Gastroesophageal Junction Adenocarcinoma (ChiCTR2400089954)
    P2, N=30, Not yet recruiting, Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine; Renji Hospital affiliated to Shanghai Jiaotong University School of Medi
    New P2 trial • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    capecitabine • oxaliplatin • Yidafan (ivonescimab)
    1m
    AK104 in combination with AK112 in an exploratory, multi-cohort stage II treatment of recurrent ovarian cancer study (ChiCTR2400090899)
    P2, N=172, Not yet recruiting, Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center
    New P2 trial • Combination therapy • IO biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Kaitanni (cadonilimab) • Yidafan (ivonescimab)
    1m
    A Single-Arm, Single-Center, Phase II Clinical Study of Neoadjuvant Treatment of Resectable EGFR-Sensitive Mutant Non-Small Cell Lung Cancer with Ivonescimab (Anti-PD-1 and VEGF Bispecific Antibody) Combination with Chemotherapy (ChiCTR2400089410)
    P2, N=25, Recruiting, Cancer Hospital Affiliated of Shandong First Medical University; Cancer Hospital Affiliated of Shandong First Medical University
    New P2 trial • IO biomarker
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    Yidafan (ivonescimab)
    1m
    Ivonescimab (AK112) plus paclitaxel and carboplatin in frontline neoadjuvant therapy of advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer: a phase II trial (ChiCTR2400090496)
    P2, N=132, Recruiting, Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center
    New P2 trial • Metastases
    |
    carboplatin • paclitaxel • Yidafan (ivonescimab)
    1m
    ICONIC trial: Ivonescimab (AK112) combination with radiochemotherapy in the first-line treatment of small cell lung cancer patients, a single arm, multicenter, phase Ib clinical study. (ChiCTR2400089992)
    P1, N=48, Not yet recruiting, Taizhou People's Hospital; Taizhou People's Hospital
    New P1 trial
    |
    Yidafan (ivonescimab)
    1m
    A Phase I/II Study of IVONESCIMAB in Recurrent Glioblastoma (clinicaltrials.gov)
    P1/2, N=45, Not yet recruiting, M.D. Anderson Cancer Center
    New P1/2 trial
    |
    Yidafan (ivonescimab)
    2ms
    AK112-102: A Study of AK112, a PD-1/VEGF Bispecific Antibody, for Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=59, Completed, Akeso | Active, not recruiting --> Completed | Trial completion date: May 2023 --> Jul 2024
    Trial completion • Trial completion date • Metastases
    |
    Yidafan (ivonescimab)
    2ms
    AK112 and Cadonilimab Combined With Chemotherapy for 1L Treatment of Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=110, Not yet recruiting, Akeso
    New P1/2 trial • Metastases
    |
    gemcitabine • albumin-bound paclitaxel • Kaitanni (cadonilimab) • Yidafan (ivonescimab)
    2ms
    Phase II Clinical Trial of Chidamide Combined With AK112 for Second-line and Advanced Bone and Soft Tissue Sarcoma (clinicaltrials.gov)
    P2, N=30, Recruiting, Shanxi Province Cancer Hospital
    New P2 trial • Metastases
    |
    Epidaza (chidamide) • Yidafan (ivonescimab)
    3ms
    A Phase II Study of Ivonescimab Combined with Cadonilimab and Chemotherapy in Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=70, Not yet recruiting, Shanghai Pulmonary Hospital, Shanghai, China
    New P2 trial
    |
    carboplatin • paclitaxel • Kaitanni (cadonilimab) • Yidafan (ivonescimab)
    3ms
    Phase II Clinical Study of Anti-PD-1 and VEGF Bispecific Antibody AK112 in Combination With Etoposide and Carboplatin for the First-line Treatment of Patients With Extensive Stage Small Cell Lung Cancer (ChiCTR2400087910)
    P2, N=12, Not yet recruiting, Jilin Cancer Hospital; Jilin Cancer Hospital
    New P2 trial • Combination therapy
    |
    carboplatin • etoposide IV • Yidafan (ivonescimab)
    3ms
    Single-arm, open, exploratory study of ivonescimab combined with chemotherapy and SBRT in patients with advanced cholangiocarcinoma (ChiCTR2400088480)
    P2, N=35, Recruiting, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; Union Hospital, Tongji Medical College, Huazhong University o
    New P2 trial • Metastases
    |
    Yidafan (ivonescimab)
    3ms
    A Phase 3 Study of AK112 Plus AK117 Versus Pembrolizumab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (clinicaltrials.gov)
    P3, N=510, Not yet recruiting, Akeso
    New P3 trial • Combination therapy • Metastases
    |
    Keytruda (pembrolizumab) • Yidafan (ivonescimab) • ligufalimab (AK117)
    3ms
    AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P3, N=682, Not yet recruiting, Akeso
    New P3 trial • Metastases
    |
    cisplatin • Imfinzi (durvalumab) • gemcitabine • Yidafan (ivonescimab)
    3ms
    Phase III Study of AK112 for NSCLC Patients (clinicaltrials.gov)
    P3, N=420, Active, not recruiting, Summit Therapeutics | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    carboplatin • pemetrexed • Yidafan (ivonescimab)
    3ms
    Miracle-03: Lvosidenib (AK112) Combined With CapeOX and Radiotherapy in Patients With Unresectable Metastatic MSS-type Colorectal Cancer (clinicaltrials.gov)
    P2, N=36, Not yet recruiting, Fudan University
    New P2 trial • Metastases
    |
    Tibsovo (ivosidenib) • Yidafan (ivonescimab)
    3ms
    EGFR-mutated NSCLC: A roadmap to treatment sequences. (PubMed, Med)
    Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are the standard of care for the management of EGFR-mutated non-small cell lung cancer. Recent results from the HARMONi-A trial lead to considering ivonescimab-a first-in-class, bispecific antibody targeting PD-1 and VEGF-plus chemotherapy as a new second-line option following third-generation TKIs.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR mutation
    |
    Yidafan (ivonescimab)
    4ms
    Phase 2 Study of Ivonescimab in Patients With Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=24, Not yet recruiting, M.D. Anderson Cancer Center
    New P2 trial
    |
    Yidafan (ivonescimab)
    4ms
    An Exploratory, Multi-cohort Phase II Study of Combination Therapy With AK104 and AK112 for Recurrent Ovarian Cancer (clinicaltrials.gov)
    P2, N=172, Not yet recruiting, Akeso
    New P2 trial • Combination therapy
    |
    Kaitanni (cadonilimab) • Yidafan (ivonescimab)
    5ms
    AK112 Plus AP Regimen for Operable Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=36, Not yet recruiting, Wuhan Union Hospital, China
    New P2 trial • Metastases
    |
    Yidafan (ivonescimab)
    5ms
    A Phase Ib/II Study of AK112 (PD-1/VEGF Bispecific Antibody) in Combination Therapy for Patients With Advanced Hepatocellular Carcinoma (HCC). (clinicaltrials.gov)
    P1/2, N=280, Not yet recruiting, Akeso
    New P1/2 trial • Combination therapy • Metastases
    |
    Avastin (bevacizumab) • Tyvyt (sintilimab) • Kaitanni (cadonilimab) • Yidafan (ivonescimab) • lancastotug (AK127)
    5ms
    SEVILLA: Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients (clinicaltrials.gov)
    P2, N=72, Not yet recruiting, UNICANCER
    New P2 trial • Metastases
    |
    5-fluorouracil • oxaliplatin • leucovorin calcium • Yidafan (ivonescimab)
    5ms
    Ivonescimab: First Approval. (PubMed, Drugs)
    In May 2024, ivonescimab, in combination with pemetrexed and carboplatin, received its first approval in China for the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed after tyrosine kinase inhibitor (TKI) therapy. Clinical studies of ivonescimab are underway in multiple countries worldwide. This article summarizes the milestones in the development of ivonescimab leading to this first approval for EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed after TKI therapy.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor)
    |
    carboplatin • pemetrexed • Yidafan (ivonescimab)
    5ms
    A single arm, open phase II clinical study of AK112 combined with GC regimen in the treatment of patients with potentially resectable biliary malignancies (ChiCTR2400085953)
    P2, N=20, Not yet recruiting, Harbin Medical University Cancer Hospital; Harbin Medical University Cancer Hospital
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • PD-L2 (Programmed Cell Death 1 Ligand 2)
    |
    cisplatin • gemcitabine • Yidafan (ivonescimab)
    5ms
    Ivonescimab(AK112/SMT112) in Combination With Stereotactic Body Radiation Therapy and Chemotherapy in Patients With Pancreatic Cancer (clinicaltrials.gov)
    P2, N=36, Recruiting, Wuhan Union Hospital, China
    New P2 trial • Combination therapy
    |
    gemcitabine • albumin-bound paclitaxel • Yidafan (ivonescimab)
    6ms
    AK112 Combined With Chemotherapy as the First-line Treatment in Advanced Esophageal Squamous Cell Carcinoma Patients (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial • Metastases
    |
    cisplatin • albumin-bound paclitaxel • Yidafan (ivonescimab)
    6ms
    HARMONi: Phase 3 Clinical Study of AK112 for NSCLC Patients (clinicaltrials.gov)
    P3, N=322, Active, not recruiting, Akeso | Recruiting --> Active, not recruiting | N=470 --> 322 | Trial primary completion date: Jan 2025 --> Jun 2024
    Enrollment closed • Enrollment change • Trial primary completion date • Metastases
    |
    carboplatin • pemetrexed • Yidafan (ivonescimab)
    6ms
    AK104 in Combination With AK112 Plus Chemotherapy(SOX/XELOX) as First-line Treatment for Advanced G/GEJ Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, Harbin Medical University | Not yet recruiting --> Recruiting | Initiation date: Jan 2024 --> Apr 2024
    Enrollment open • Trial initiation date • Combination therapy • Metastases
    |
    capecitabine • oxaliplatin • Kaitanni (cadonilimab) • Yidafan (ivonescimab)
    6ms
    A Study to Investigate the Efficacy and Safety of Ivonescimab Combined With Irinotecan Liposome as Second-line Regimen for ES-SCLC (clinicaltrials.gov)
    P2, N=54, Not yet recruiting, Zhejiang Cancer Hospital
    New P2 trial • Checkpoint inhibition
    |
    Yidafan (ivonescimab)
    6ms
    A Study of AK112 Monotherapy in Advanced/Metastatic Renal Cell Carcinoma (clinicaltrials.gov)
    P1/2, N=30, Not yet recruiting, Peking University Cancer Hospital & Institute
    New P1/2 trial • Metastases
    |
    Yidafan (ivonescimab)
    7ms
    Ivonescimab Plus Chemotherapy in Non-Small Cell Lung Cancer With EGFR Variant: A Randomized Clinical Trial. (PubMed, JAMA)
    Participants received ivonescimab (n = 161) or placebo (n = 161) plus pemetrexed and carboplatin once every 3 weeks for 4 cycles, followed by maintenance therapy of ivonescimab plus pemetrexed or placebo plus pemetrexed. Ivonescimab plus chemotherapy significantly improved progression-free survival with tolerable safety profile in TKI-treated non-small cell lung cancer. ClinicalTrials.gov Identifier: NCT05184712.
    Clinical • Journal
    |
    EGFR (Epidermal growth factor receptor)
    |
    carboplatin • pemetrexed • Yidafan (ivonescimab)
    7ms
    AK112-103: Anti-PD-1 and VEGF Bispecific Antibody AK112 in Combination With Chemotherapy in Patients With ES-SCLC (clinicaltrials.gov)
    P1, N=35, Completed, Akeso | Active, not recruiting --> Completed | Trial completion date: Apr 2024 --> Dec 2023
    Trial completion • Trial completion date • Combination therapy
    |
    carboplatin • etoposide IV • Yidafan (ivonescimab)
    7ms
    A Trial of AK104 or AK112 in Combination With Axitinib in Patients With Metastatic Mucosal Melanoma (clinicaltrials.gov)
    P1, N=60, Not yet recruiting, Peking University Cancer Hospital & Institute
    New P1 trial
    |
    Inlyta (axitinib) • Kaitanni (cadonilimab) • Yidafan (ivonescimab)
    8ms
    Phase III Study of AK112 for NSCLC Patients (clinicaltrials.gov)
    P3, N=420, Recruiting, Summit Therapeutics
    New P3 trial • Metastases
    |
    carboplatin • pemetrexed • Yidafan (ivonescimab)