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    DRUG:

    Yutuo (zimberelimab)

    i
    Other names: AB 122, GLS010, WBP 3055, AB122, WBP3055, GLS 010, GLS-010 , AB-122, WBP-3055
    Company:
    Arcus Biosci, Gilead, Gloria Pharma, Ligand, Otsuka, WuXi AppTec
    Drug class:
    PD1 inhibitor
    Related drugs:
    4d
    ARIAN: Study of Treatment With Sacituzumab and Zimberelimab for Patients With Lung Cancer Confined to the Chest and Previously Operated on Who Were Not Disease-free. (clinicaltrials.gov)
    P2, N=129, Not yet recruiting, Fundación GECP | Trial completion date: Jun 2031 --> Nov 2031 | Trial primary completion date: Jun 2031 --> Nov 2031
    Trial completion date • Trial primary completion date
    |
    cisplatin • carboplatin • Yutuo (zimberelimab) • Trodelvy (sacituzumab govitecan-hziy)
    5d
    ARC-10: Study Evaluating Effectiveness and Safety of Zimberelimab and Domvanalimab in Lung Cancer (clinicaltrials.gov)
    P2, N=169, Active, not recruiting, Arcus Biosciences, Inc. | Phase classification: P3 --> P2 | Trial primary completion date: Aug 2024 --> May 2027
    Phase classification • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • PD-L1 overexpression
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • Yutuo (zimberelimab) • domvanalimab (AB154)
    19d
    Phase 2 randomized study of domvanalimab combined with zimberelimab in front-line, PD-(L)1 high, locally advanced or metastatic non-small cell lung cancer (NSCLC): results from ARC-10 part 1 (SITC 2024)
    Ethics Approval At each site, the study was conducted in full accordance with the 21 Code of Federal Regulations, International Council for Harmonisation guidelines, institutional review board and independent ethics committee guidelines, and all other applicable local or regional regulations. All patients provided written informed consent before enrollment.View this table:View inline View popup Download powerpoint Abstract 1461 Table 1 ARC-10 study efficacy endpointsDownload figure Open in new tab Download powerpoint Abstract 1461 Figure 1 Kaplan-Meier estimate of progression-free survivalDownload figure Open in new tab Download powerpoint Abstract 1461 Figure 2 Kaplan-Meier estimate of overall survival
    Clinical • P2 data • Late-breaking abstract • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Yutuo (zimberelimab) • domvanalimab (AB154)
    1m
    ELEVATE HNSCC: Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=193, Terminated, Gilead Sciences | Trial completion date: Jul 2025 --> Oct 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Jul 2025 --> Oct 2024; Sponsor decision to terminate study
    Trial completion date • Trial termination • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • docetaxel • 5-fluorouracil • Yutuo (zimberelimab) • magrolimab (ONO-7913)
    2ms
    PANTHER: A Phase I-II Study to Test the Safety and Efficacy of PD1 (AB122) and Adenosine Receptor (AB928) Antagonists With Chemotherapy After Short-Course Radiation for Rectal Cancer. (clinicaltrials.gov)
    P2, N=43, Recruiting, Weill Medical College of Cornell University | Trial completion date: Dec 2027 --> Dec 2030
    Trial completion date
    |
    5-fluorouracil • Yutuo (zimberelimab) • leucovorin calcium • etrumadenant (AB928)
    2ms
    Zimberelimab and Quemliclustat in Combination with Chemotherapy for the Treatment of Patients with Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=56, Recruiting, Jonsson Comprehensive Cancer Center | Suspended --> Recruiting
    Enrollment open
    |
    oxaliplatin • irinotecan • Yutuo (zimberelimab) • leucovorin calcium • fluorouracil topical • quemliclustat (AB680)
    2ms
    EDGE-Lung: Study With Immunotherapy Combinations in Participants With Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=320, Recruiting, Gilead Sciences | Trial completion date: Sep 2026 --> Dec 2027 | Trial primary completion date: Sep 2026 --> Dec 2027
    Trial completion date • Trial primary completion date • Metastases
    |
    docetaxel • Yutuo (zimberelimab) • domvanalimab (AB154) • quemliclustat (AB680)
    2ms
    ARC-6: Adenosine Receptor Antagonist Combination Therapy for Metastatic Castrate Resistant Prostate Cancer (clinicaltrials.gov)
    P1/2, N=173, Completed, Arcus Biosciences, Inc. | Active, not recruiting --> Completed
    Trial completion • Combination therapy • Metastases
    |
    docetaxel • Xtandi (enzalutamide capsule) • Yutuo (zimberelimab) • Trodelvy (sacituzumab govitecan-hziy) • etrumadenant (AB928) • quemliclustat (AB680)
    2ms
    Study of GS-4528 in Adults With Solid Tumors (clinicaltrials.gov)
    P1, N=182, Recruiting, Gilead Sciences | N=132 --> 182
    Enrollment change • Combination therapy • Metastases
    |
    Yutuo (zimberelimab) • GS-4528
    3ms
    TROPHY-U-01: Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread (clinicaltrials.gov)
    P2, N=827, Recruiting, Gilead Sciences | Trial completion date: Jul 2026 --> Jun 2030 | Trial primary completion date: Jul 2024 --> Jun 2030
    Trial completion date • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • Bavencio (avelumab) • Yutuo (zimberelimab) • Trodelvy (sacituzumab govitecan-hziy) • Padcev (enfortumab vedotin-ejfv) • domvanalimab (AB154)
    3ms
    MCC-21676: Sacituzumab Govitecan and Zimberelimab w/SRS in the Management of Metastatic Triple Negative Breast Cancer With Brain Metastases (clinicaltrials.gov)
    P1/2, N=31, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Yutuo (zimberelimab) • Trodelvy (sacituzumab govitecan-hziy)
    3ms
    Study to Assess the Effects of GS-3583 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=13, Terminated, Gilead Sciences | Phase classification: P1b --> P1
    Phase classification • Metastases
    |
    cisplatin • carboplatin • docetaxel • 5-fluorouracil • Yutuo (zimberelimab) • GS-3583
    3ms
    Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=154, Recruiting, Gilead Sciences | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Yutuo (zimberelimab)
    3ms
    Study to Evaluate Safety and Clinical Activity of AB122 in Biomarker Selected Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=18, Completed, Arcus Biosciences, Inc. | Active, not recruiting --> Completed
    Trial completion • IO biomarker • Metastases
    |
    TMB (Tumor Mutational Burden)
    |
    Yutuo (zimberelimab)
    3ms
    ARIAN: Study of Treatment With Sacituzumab and Zimberelimab for Patients With Lung Cancer Confined to the Chest and Previously Operated on Who Were Not Disease-free. (clinicaltrials.gov)
    P2, N=129, Not yet recruiting, Fundación GECP | Initiation date: Jun 2024 --> Oct 2024
    Trial initiation date
    |
    cisplatin • carboplatin • Yutuo (zimberelimab) • Trodelvy (sacituzumab govitecan-hziy)
    3ms
    STAR-121: Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=792, Active, not recruiting, Gilead Sciences | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • Yutuo (zimberelimab) • domvanalimab (AB154)
    4ms
    ARC-4: A Study to Evaluate Immunotherapy Combinations in Participants With Lung Cancer (clinicaltrials.gov)
    P1, N=77, Active, not recruiting, Arcus Biosciences, Inc. | Trial completion date: Aug 2024 --> Nov 2024 | Trial primary completion date: Aug 2024 --> Nov 2024
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    Keytruda (pembrolizumab) • carboplatin • pemetrexed • Yutuo (zimberelimab) • etrumadenant (AB928)
    4ms
    ARC-9: An Open Label Study Evaluating the Efficacy and Safety of Etrumadenant (AB928) Based Treatment Combinations in Participants With Metastatic Colorectal Cancer. (clinicaltrials.gov)
    P1/2, N=227, Active, not recruiting, Arcus Biosciences, Inc. | Trial completion date: Jul 2024 --> Oct 2024 | Trial primary completion date: Jul 2024 --> Oct 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    Avastin (bevacizumab) • 5-fluorouracil • Stivarga (regorafenib) • Yutuo (zimberelimab) • leucovorin calcium • etrumadenant (AB928) • quemliclustat (AB680)
    4ms
    Study of GS-2121 Given Alone or in Combination in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=154, Not yet recruiting, Gilead Sciences
    New P1 trial • Metastases
    |
    Yutuo (zimberelimab)
    4ms
    preSAVE: Bladder Preservation With Sacituzumab Govitecan + Zimberelimab for Muscle-Invasive Bladder Cancer (clinicaltrials.gov)
    P2, N=63, Not yet recruiting, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
    New P2 trial
    |
    cisplatin • Yutuo (zimberelimab) • Trodelvy (sacituzumab govitecan-hziy)
    4ms
    VELOCITY-Lung: Study of Novel Treatment Combinations in Patients With Lung Cancer (clinicaltrials.gov)
    P2, N=593, Recruiting, Gilead Sciences | N=397 --> 593
    Enrollment change
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    Opdivo (nivolumab) • cisplatin • carboplatin • docetaxel • albumin-bound paclitaxel • pemetrexed • Yutuo (zimberelimab) • Trodelvy (sacituzumab govitecan-hziy) • domvanalimab (AB154) • etrumadenant (AB928)
    5ms
    STAR-221: A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body (clinicaltrials.gov)
    P3, N=1040, Active, not recruiting, Arcus Biosciences, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Jan 2027 --> May 2026 | Trial primary completion date: Sep 2026 --> May 2026
    Enrollment closed • Trial completion date • Trial primary completion date • Surgery • Metastases
    |
    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • Yutuo (zimberelimab) • leucovorin calcium • domvanalimab (AB154)
    6ms
    Combinational zimberelimab plus lenvatinib and chemotherapy for alpha-fetoprotein elevated, advanced gastric cancer patients (AFPGC): a phase 1 dose-escalation study. (PubMed, Cancer Immunol Immunother)
    GLS-010 plus lenvatinib and XELOX demonstrated a manageable safety profile with promising efficacy for AFPGC. With RP2D of lenvatinib determined as 16 mg, further expansion cohort is now ongoing. Translational investigation suggested that serum AFP can be indictive for therapeutic responses and certain microbiota species indicating favorable responses to immunotherapy was elevated after the combinational treatment.
    P1 data • Clinical Trial,Phase I • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • AFP (Alpha-fetoprotein)
    |
    Lenvima (lenvatinib) • capecitabine • oxaliplatin • Yutuo (zimberelimab)
    6ms
    A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies (clinicaltrials.gov)
    P1, N=94, Active, not recruiting, Arcus Biosciences, Inc. | Trial completion date: Jan 2025 --> Sep 2025 | Trial primary completion date: Jan 2025 --> Sep 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Yutuo (zimberelimab) • ralzapastotug (AB308)
    6ms
    ARC-8: A Study to Evaluate the Safety and Tolerability of AB680 in Participants With Gastrointestinal Malignancies (clinicaltrials.gov)
    P1, N=195, Recruiting, Arcus Biosciences, Inc. | Active, not recruiting --> Recruiting
    Enrollment open
    |
    gemcitabine • albumin-bound paclitaxel • Yutuo (zimberelimab) • quemliclustat (AB680)
    6ms
    AB154 Combined With AB122 for Recurrent Glioblastoma (clinicaltrials.gov)
    P1, N=46, Recruiting, Yale University | Trial primary completion date: Jul 2025 --> Feb 2025
    Trial primary completion date • Combination therapy
    |
    Yutuo (zimberelimab) • domvanalimab (AB154)
    6ms
    Study of SRF617 With AB928 (Etrumadenant) and AB122 (Zimberelimab) in Patients With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=16, Terminated, Coherus Biosciences, Inc. | Completed --> Terminated; The study was terminated for strategic reasons, not due to any safety concerns.
    Trial termination • Combination therapy • Metastases
    |
    Yutuo (zimberelimab) • etrumadenant (AB928) • perenostobart (SRF617)
    6ms
    AB154 Combined With AB122 for Recurrent Glioblastoma (clinicaltrials.gov)
    P1, N=46, Recruiting, Yale University | Trial completion date: Feb 2025 --> Dec 2025 | Trial primary completion date: Feb 2025 --> Jul 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    Yutuo (zimberelimab) • domvanalimab (AB154)
    7ms
    SBRT-AMICO: Adenosine Signaling Modulation and Immune Checkpoint Inhibition With Hormone Sensitive Oligometastatic Prostate Cancer (clinicaltrials.gov)
    P2, N=23, Recruiting, Catherine Spina | Trial primary completion date: Apr 2024 --> Dec 2025
    Trial primary completion date • Checkpoint inhibition • Metastases
    |
    Yutuo (zimberelimab) • etrumadenant (AB928) • quemliclustat (AB680)
    7ms
    Zimberelimab (AB122) With TIGIT Inhibitor Domvanalimab (AB154) in PD-1 Relapsed/Refractory Melanoma (clinicaltrials.gov)
    P2, N=26, Recruiting, Diwakar Davar | Trial completion date: Jan 2028 --> Jan 2030 | Trial primary completion date: Jan 2025 --> Jan 2027
    Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4)
    |
    BRAF mutation
    |
    Yutuo (zimberelimab) • domvanalimab (AB154)
    7ms
    AB154 Combined With AB122 for Recurrent Glioblastoma (clinicaltrials.gov)
    P1, N=46, Recruiting, Yale University | Trial completion date: Dec 2025 --> Feb 2025
    Trial completion date • Combination therapy
    |
    Yutuo (zimberelimab) • domvanalimab (AB154)
    7ms
    Safety and Efficacy of Zimberelimab (AB122) in Combination With Domvanalimab (AB154) and Etrumadenant (AB928) in Patients With Previously Treated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2; Recruiting --> Active, not recruiting
    Combination therapy • Enrollment closed
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Yutuo (zimberelimab) • domvanalimab (AB154) • etrumadenant (AB928)
    7ms
    STAR-121: Zimberelimab and Domvanalimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=720, Recruiting, Gilead Sciences | Trial completion date: Dec 2027 --> Sep 2027 | Trial primary completion date: Dec 2027 --> Sep 2027
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    BRAF mutation • ALK mutation • RET mutation
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • albumin-bound paclitaxel • pemetrexed • Yutuo (zimberelimab) • domvanalimab (AB154)
    7ms
    ARC-8: A Study to Evaluate the Safety and Tolerability of AB680 in Participants With Gastrointestinal Malignancies (clinicaltrials.gov)
    P1, N=165, Active, not recruiting, Arcus Biosciences, Inc. | Trial completion date: Jun 2024 --> May 2027 | Trial primary completion date: Jun 2024 --> May 2027
    Trial completion date • Trial primary completion date • Combination therapy
    |
    CD73 (5'-Nucleotidase Ecto)
    |
    gemcitabine • albumin-bound paclitaxel • Yutuo (zimberelimab) • quemliclustat (AB680)
    8ms
    Study of GS-1811 Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=376, Recruiting, Gilead Sciences | N=216 --> 376 | Trial completion date: Feb 2027 --> Dec 2027 | Trial primary completion date: Jun 2026 --> Dec 2027
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Yutuo (zimberelimab) • GS-1811
    8ms
    EDGE-Gastric: A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants With Advanced Upper Gastrointestinal Tract Malignancies (clinicaltrials.gov)
    P2, N=360, Recruiting, Arcus Biosciences, Inc. | N=200 --> 360 | Trial completion date: Nov 2025 --> Jun 2027 | Trial primary completion date: Sep 2025 --> Sep 2026
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    5-fluorouracil • oxaliplatin • Yutuo (zimberelimab) • leucovorin calcium • domvanalimab (AB154) • quemliclustat (AB680)
    8ms
    VELOCITY-Lung: Study of Novel Treatment Combinations in Patients With Lung Cancer (clinicaltrials.gov)
    P2, N=397, Recruiting, Gilead Sciences | Trial completion date: Jan 2028 --> Jan 2027
    Trial completion date
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
    |
    Opdivo (nivolumab) • cisplatin • carboplatin • docetaxel • albumin-bound paclitaxel • pemetrexed • Yutuo (zimberelimab) • Trodelvy (sacituzumab govitecan-hziy) • domvanalimab (AB154) • etrumadenant (AB928)
    8ms
    Study Comparing the Combination Domvanalimab and Zimberelimab With Pembrolizumab in Untreated Locally Advanced or Metastatic PD-L1-High Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3; Recruiting --> Active, not recruiting | N=750 --> 169
    Enrollment change • Enrollment closed • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • PD-L1 overexpression
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Keytruda (pembrolizumab) • carboplatin • paclitaxel • pemetrexed • Yutuo (zimberelimab) • domvanalimab (AB154)
    8ms
    Study to Evaluate Safety and Clinical Activity of AB122 in Biomarker Selected Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, Arcus Biosciences, Inc. | Phase classification: P1b --> P1
    Phase classification • IO biomarker • Metastases
    |
    TMB (Tumor Mutational Burden)
    |
    TMB-H
    |
    Yutuo (zimberelimab)
    8ms
    ELEVATE HNSCC: Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=230, Active, not recruiting, Gilead Sciences | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • docetaxel • 5-fluorouracil • Yutuo (zimberelimab) • magrolimab (ONO-7913)
    9ms
    AIRPanc: Combination Therapy in Patients With Localized Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov)
    P2, N=60, Recruiting, Gulam Manji | Initiation date: Oct 2023 --> Jun 2024
    Trial initiation date • Combination therapy • Checkpoint inhibition • Checkpoint block • Metastases
    |
    5-fluorouracil • oxaliplatin • irinotecan • Yutuo (zimberelimab) • leucovorin calcium • etrumadenant (AB928) • quemliclustat (AB680)
    9ms
    A Study to Evaluate the Safety and Tolerability of AB154 in Participants With Advanced Malignancies (clinicaltrials.gov)
    P1, N=75, Active, not recruiting, Arcus Biosciences, Inc. | Trial completion date: Feb 2024 --> Nov 2024 | Trial primary completion date: Feb 2024 --> Nov 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Yutuo (zimberelimab) • domvanalimab (AB154)