^
    11d
    VELOCITY-HNSCC: Study of Novel Treatment Combination Therapies in Participants with Head and Neck Squamous Cell Carcinoma. (clinicaltrials.gov)
    P2, N=100, Not yet recruiting, Gilead Sciences
    New P2 trial • Combination therapy
    |
    carboplatin • paclitaxel • Yutuo (zimberelimab) • domvanalimab (AB154)
    1m
    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 • 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)
    2ms
    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)
    3ms
    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)
    4ms
    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)
    4ms
    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)
    5ms
    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)
    6ms
    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)
    7ms
    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)
    7ms
    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)
    8ms
    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)
    8ms
    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)
    9ms
    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)
    9ms
    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)
    9ms
    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)
    9ms
    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)
    9ms
    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)
    10ms
    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)
    10ms
    PACIFIC-8: A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC (clinicaltrials.gov)
    P3, N=860, Recruiting, AstraZeneca | Trial completion date: Sep 2029 --> Aug 2030 | Trial primary completion date: Jun 2027 --> Jun 2028
    Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)
    |
    EGFR wild-type • ALK wild-type • EGFR wild-type + ALK wild-type
    |
    Imfinzi (durvalumab) • domvanalimab (AB154)
    10ms
    Peri-operative Zimberelimab (Anti-PD-1) vs Zimberelimab in Combination With Domvanalimab (Anti-TIGIT) in Resectable Mismatch Repair Deficient/Micro-satellite Unstable Gastric and Gastro-oesophageal Junctional Adenocarcinoma (ZODIAC) (clinicaltrials.gov)
    P2, N=50, Not yet recruiting, Royal Marsden NHS Foundation Trust
    New P2 trial • Combination therapy • Mismatch repair
    |
    MSI (Microsatellite instability)
    |
    MSI-H/dMMR
    |
    Yutuo (zimberelimab) • domvanalimab (AB154)
    11ms
    STAR-121: A Phase III Randomized Study of Domvanalimab and Zimberelimab in Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy in Untreated Metastatic Non-Small Cell Lung Cancer With No Actionable Gene Alterations. (PubMed, Clin Lung Cancer)
    Enrollment in the STAR-121 study commenced on October 12, 2022, and is currently ongoing with completion planned by September 2024. The study completion is expected by December 2027.
    P3 data • Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    PD-L1 expression • EGFR mutation • ALK mutation • EGFR mutation + ALK mutation
    |
    Keytruda (pembrolizumab) • Yutuo (zimberelimab) • domvanalimab (AB154)
    11ms
    Domvanalimab and Zimberelimab in Advanced Liver Cancers (clinicaltrials.gov)
    P2, N=58, Recruiting, University of Texas Southwestern Medical Center | Trial primary completion date: Jul 2025 --> Jul 2026
    Trial primary completion date • Pan tumor • Metastases
    |
    Yutuo (zimberelimab) • domvanalimab (AB154)
    1year
    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=970, Recruiting, Arcus Biosciences, Inc.
    Trial completion date • Trial primary completion date • Surgery • Metastases
    |
    Opdivo (nivolumab) • 5-fluorouracil • capecitabine • oxaliplatin • Yutuo (zimberelimab) • leucovorin calcium • domvanalimab (AB154)
    1year
    TROPHY-U-01: Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread (clinicaltrials.gov)
    P2, N=643, Recruiting, Gilead Sciences
    Trial completion date • Trial primary completion date • Metastases
    |
    Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • Bavencio (avelumab) • Yutuo (zimberelimab) • Trodelvy (sacituzumab govitecan-hziy) • domvanalimab (AB154)
    1year
    ARC-7: Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=151, Active, not recruiting, Arcus Biosciences, Inc. | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • PD-L1 overexpression
    |
    Yutuo (zimberelimab) • domvanalimab (AB154) • etrumadenant (AB928)
    over1year
    EDGE-Lung: A Phase 2 Open-Label Platform Study to Evaluate Immunotherapy-Based Combinations in Patients with Metastatic NSCLC (IASLC-WCLC 2023)
    Quemliclustat (quemli) is a potent, selective, small molecule inhibitor of CD73...Domvanalimab (dom) is an Fc-silent humanized IgG1 monoclonal antibody (mAb) that blocks T cell Immunoglobulin and ITIM domain (TIGIT), reducing immunosuppression of T/natural killer (NK) cells and promoting antitumor activity. Zimberelimab (zim) is a mAb that binds PD-1 on T/NK cells, preventing PD-L1-mediated immunosuppressive effects and resulting in increased immune-mediated tumor cell death...In substudy C, patients with metastatic NSCLC who have progressed after prior platinum-based chemotherapy and anti-PD-L1 therapy will receive docetaxel (75 mg/m2 IV Q3W) in combination with either quemli (300 mg IV Q3W) or dom (1200 mg IV Q3W) in combination with zim (360 mg IV Q3W)...Other endpoints include disease control rate, progression-free survival, duration of response, overall survival, and pharmacokinetics. EDGE-Lung is currently enrolling patients in Asia-Pacific, Europe, and North America.
    Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • PD-1 (Programmed cell death 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
    |
    EGFR mutation • ALK mutation
    |
    docetaxel • Yutuo (zimberelimab) • domvanalimab (AB154) • quemliclustat (AB680)
    over1year
    STAR-121: Phase 3 Study of DOM and ZIM plus Chemo vs Pembro plus Chemo in 1L mNSCLC with No Actionable Gene Alterations (IASLC-WCLC 2023)
    Domvanalimab (DOM) is an anti-T-cell immunoreceptor with immunoglobulin and ITIM domains (TIGIT) Fc-silent IgG1 monoclonal antibody designed to inhibit the interaction between TIGIT and its ligand, CD155, thereby reducing immunosuppression of T cells and natural killer cells and promoting antitumor activity. Zimberelimab (ZIM) is an anti-PD-1 IgG4 monoclonal antibody with demonstrated antitumor activity in vivo and preliminary clinical activity in multiple tumor types...PT will be chosen by investigators based on tumor histology and administered for the first 4 cycles, after which, pemetrexed can be continued for patients with nonsquamous histology until PD or intolerable toxicities...Key secondary endpoints are ORR and duration of response by BICR, safety, and quality of life. As of April 10, 2023, the study has 239 planned sites and is currently enrolling globally in North America, South America, Europe, and Asia.
    P3 data • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • PVR (PVR Cell Adhesion Molecule)
    |
    PD-L1 expression
    |
    Keytruda (pembrolizumab) • pemetrexed • Yutuo (zimberelimab) • domvanalimab (AB154)
    over1year
    Domvanalimab and Zimberelimab in Advanced Liver Cancers (clinicaltrials.gov)
    P2, N=58, Recruiting, University of Texas Southwestern Medical Center | Not yet recruiting --> Recruiting
    Enrollment open • Pan tumor • Metastases
    |
    Yutuo (zimberelimab) • domvanalimab (AB154)
    over1year
    ARC-10: A phase 3 study to evaluate zimberelimab + domvanalimab versus pembrolizumab in front-line, PD-L1-high, locally advanced or metastatic non–small-cell lung cancer. (ASCO 2023)
    Study recruitment is planned in Asia, North and South America, Africa, and Europe. Clinical trial information: NCT04736173.
    P3 data • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    PD-L1 overexpression
    |
    Keytruda (pembrolizumab) • Yutuo (zimberelimab) • domvanalimab (AB154)
    over1year
    Phase 3 trial of durvalumab combined with domvanalimab following concurrent chemoradiotherapy (cCRT) in patients with unresectable stage III NSCLC (PACIFIC-8). (ASCO 2023)
    Previously presented at the European Society for Medical Oncology (ESMO) Congress 2022, FPN (Final Publication Number): 971TiP, Mustafa Özgüroğlu et al. – Reused with permission.Clinical trial information: NCT05211895.
    P3 data • Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • PVR (PVR Cell Adhesion Molecule) • NECTIN2 (Nectin Cell Adhesion Molecule 2)
    |
    PD-L1 expression • PD-L1 overexpression • EGFR wild-type • ALK wild-type
    |
    VENTANA PD-L1 (SP263) Assay
    |
    Imfinzi (durvalumab) • domvanalimab (AB154)
    over1year
    VELOCITY-Lung: Study of Novel Treatment Combinations in Patients With Lung Cancer (clinicaltrials.gov)
    P2, N=335, Recruiting, Gilead Sciences | Not yet recruiting --> Recruiting | Initiation date: Dec 2022 --> Mar 2023
    Enrollment open • Trial initiation date
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    cisplatin • carboplatin • docetaxel • albumin-bound paclitaxel • pemetrexed • Yutuo (zimberelimab) • Trodelvy (sacituzumab govitecan-hziy) • domvanalimab (AB154) • etrumadenant (AB928)
    almost2years
    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; Trial completion date: Jun 2026 --> Jul 2027 | Trial primary completion date: Dec 2025 --> Aug 2024
    Trial completion date • Trial primary completion date • 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)
    almost2years
    Updates on Abstract 397600: ARC-7: Randomized phase 2 study of domvanalimab + zimberelimab ± etrumadenant versus zimberelimab in first-line, metastatic, PD-L1-high non-small cell lung cancer (NSCLC) (ASCO 2023)
    No abstract available
    Clinical • P2 data • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    Yutuo (zimberelimab) • domvanalimab (AB154) • etrumadenant (AB928)
    almost2years
    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=200, Recruiting, Arcus Biosciences, Inc. | N=120 --> 200 | Trial completion date: May 2024 --> Nov 2025 | Trial primary completion date: Mar 2024 --> Sep 2025
    Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    5-fluorouracil • oxaliplatin • Yutuo (zimberelimab) • leucovorin calcium • domvanalimab (AB154) • quemliclustat (AB680)
    2years
    AB154 Combined With AB122 for Recurrent Glioblastoma (clinicaltrials.gov)
    P1, N=46, Recruiting, Yale University | Trial completion date: Jul 2023 --> Dec 2025 | Trial primary completion date: Dec 2022 --> Feb 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    CD8 (cluster of differentiation 8) • FOXP3 (Forkhead Box P3)
    |
    Yutuo (zimberelimab) • domvanalimab (AB154)
    2years
    ARC-7: Randomized phase 2 study of domvanalimab + zimberelimab ± etrumadenant versus zimberelimab in first-line, metastatic, PD-L1-high non-small cell lung cancer (NSCLC). (ASCO Plenary Dec 2022)
    NCT04262856
    Clinical • P2 data
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1-H
    |
    Yutuo (zimberelimab) • domvanalimab (AB154) • etrumadenant (AB928)
    2years
    VELOCITY-Lung: A Study of Novel Treatment Combinations in Patients With Lung Cancer (clinicaltrials.gov)
    P2, N=335, Not yet recruiting, Gilead Sciences
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
    |
    cisplatin • carboplatin • docetaxel • albumin-bound paclitaxel • pemetrexed • Yutuo (zimberelimab) • Trodelvy (sacituzumab govitecan-hziy) • domvanalimab (AB154) • etrumadenant (AB928)
    2years
    ARC-7: Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=150, Active, not recruiting, Arcus Biosciences, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Feb 2023 --> Feb 2024 | Trial primary completion date: Nov 2022 --> Feb 2024
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression • PD-L1 overexpression
    |
    Yutuo (zimberelimab) • domvanalimab (AB154) • etrumadenant (AB928)
    2years
    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 | Not yet recruiting --> Recruiting
    Enrollment open • 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)
    over2years
    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, Not yet recruiting, Gilead Sciences
    New P3 trial • Combination therapy
    |
    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)
    over2years
    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; Trial completion date: Feb 2028 --> Feb 2029 | Trial primary completion date: Nov 2023 --> Nov 2024
    Combination therapy • Trial completion date • Trial primary completion date
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Yutuo (zimberelimab) • domvanalimab (AB154) • etrumadenant (AB928)
    over2years
    Phase III trial of durvalumab combined with domvanalimab following concurrent chemoradiotherapy (cCRT) in patients with unresectable stage III NSCLC (PACIFIC-8) (ESMO 2022)
    Secondary endpoints include PFS (RECIST v1.1; BICR) in pts with PD-L1 TC ≥1%, overall survival, objective response rate and duration of response (RECIST v1.1; BICR), safety/tolerability, and pt-reported outcomes. Enrolment is ongoing.
    P3 data • Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • PVR (PVR Cell Adhesion Molecule) • NECTIN2 (Nectin Cell Adhesion Molecule 2)
    |
    PD-L1 expression • EGFR wild-type • ALK wild-type
    |
    VENTANA PD-L1 (SP263) Assay
    |
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