^
    7ms
    EON: A Single-arm Phase II Study of Etigilimab (OMP-313M32) in Combination With Checkpoint Inhibition (Nivolumab) in Patients With Platinum-resistant, Recurrent Epithelial Ovarian Cancer (clinicaltrials.gov)
    P2, N=20, Recruiting, M.D. Anderson Cancer Center | Completed --> Recruiting | N=10 --> 20 | Trial completion date: Apr 2024 --> Apr 2025 | Trial primary completion date: Apr 2024 --> Apr 2025
    Enrollment open • Enrollment change • Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition
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    Opdivo (nivolumab) • etigilimab (MPH-313)
    8ms
    EON: A Single-arm Phase II Study of Etigilimab (OMP-313M32) in Combination With Checkpoint Inhibition (Nivolumab) in Patients With Platinum-resistant, Recurrent Epithelial Ovarian Cancer (clinicaltrials.gov)
    P2, N=10, Completed, M.D. Anderson Cancer Center | Recruiting --> Completed | N=20 --> 10 | Trial completion date: Dec 2025 --> Apr 2024
    Trial completion • Enrollment change • Trial completion date • Combination therapy • Checkpoint inhibition
    |
    Opdivo (nivolumab) • etigilimab (MPH-313)
    10ms
    ACTIVATE: A Study of Etigilimab and Nivolumab in Subjects With Locally Advanced or Metastatic Tumors. (clinicaltrials.gov)
    P1/2, N=76, Completed, Mereo BioPharma | Active, not recruiting --> Completed | Phase classification: P1b/2 --> P1/2 | N=125 --> 76 | Trial completion date: Dec 2023 --> Sep 2023
    Trial completion • Phase classification • Enrollment change • Trial completion date
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    Opdivo (nivolumab) • etigilimab (MPH-313)
    1year
    EON: A Single-arm Phase II Study of Etigilimab (OMP-313M32) in Combination With Checkpoint Inhibition (Nivolumab) in Patients With Platinum-resistant, Recurrent Epithelial Ovarian Cancer (clinicaltrials.gov)
    P2, N=20, Recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Dec 2023 --> Jun 2024
    Trial primary completion date • Combination therapy • Checkpoint inhibition
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    Opdivo (nivolumab) • etigilimab (MPH-313)
    over1year
    Safety and efficacy of etigilimab (anti-TIGIT) with nivolumab (anti-PD1) in recurrent/advanced solid tumors (ESMO 2023)
    Table: 1021MO Best Observed Response (BOR)1 - Days on study Cohorts -n Complete Response (CR) Partial response (PR) Stable disease (SD) Progressive disease (PD) CPI-n Cervical Cancer - 8 CPS>1% 3 pts – 163, 365, 386 2 pts – 174, 241 3 pts CPI-n Uveal Melanoma - 8 2 pts – 228, 608 2 pts – 175, 294 4 pts Dedifferentiated Liposarcoma - 10 1 pt – 512 4 pts – 162, 167, 191, 216 5 pts EC – CPI-n - 10 3 pts – 168, 2882, 394 3 pts – 120, 131, 378 4 pts GCT - 4 1 pt – 3722 3 pts Total = 40 (%) 3 pts (7.5) 7 pts (17.5) 11 pts (27.5) 19 pts (47.5) Conclusions Etig in combination with nivo is safe and well tolerated. Preliminary efficacy data of prolonged on study duration with clinical benefit in immune resistant tumors supports continued evaluation in tumor types not typically responsive to anti-PD(L)1 monotherapy.
    Clinical • Metastases
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    TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
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    Opdivo (nivolumab) • etigilimab (MPH-313)
    over1year
    Etigilimab and Nivolumab for the Treatment of Platinum-Resistant Recurrent Clear Cell Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (clinicaltrials.gov)
    P2, N=20, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: May 2023 --> Dec 2023 | Trial primary completion date: May 2023 --> Dec 2023
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition
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    Opdivo (nivolumab) • etigilimab (MPH-313)
    over1year
    Anti-TIGIT therapies for solid tumors: a systematic review. (PubMed, ESMO Open)
    Vibostolimab was evaluated in a phase I alone or in combination with pembrolizumab...Etigilimab was tested in a phase I alone or in combination with nivolumab, but the study was stopped due to business reasons. In the phase II CITYSCAPE trial, tiragolumab demonstrated higher objective response rate and progression-free survival in combination with atezolizumab than atezolizumab alone in advanced PD-L1-high NSCLC...Anti-TIGIT antibodies are under development as a novel immunotherapy approach. A promising research area includes the combination with anti-PD-1 therapies in advanced NSCLCs.
    Review • Journal
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    LAG3 (Lymphocyte Activating 3) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
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    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • tiragolumab (RG6058) • vibostolimab (MK-7684) • etigilimab (MPH-313)
    over2years
    Interim biomarker analysis of a phase Ib/II study of anti-TIGIT etigilimab (MPH313) and nivolumab in subjects with select locally advanced or metastatic solid tumors (ACTIVATE) (ESMO 2022)
    Additionally, reduction in ctDNA levels were noted in some subjects between Days 36 – Days 78. Conclusions These interim biomarker data from Etig+nivo combination therapy demonstrated robust target engagement and evidence of dual TIGIT/PD-1 blockade as seen by decreases in TIGIT hi cells (e.g., Tregs) and an associated increase in proliferating and cytokine producing T-cells in circulation.
    Clinical • P1/2 data • PD(L)-1 Biomarker • IO biomarker
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    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • FCGR2A (Fc fragment of IgG receptor IIa)
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    Opdivo (nivolumab) • etigilimab (MPH-313)
    3years
    A Phase 1a/b Open‑Label, Dose‑Escalation Study of Etigilimab Alone or in Combination with Nivolumab in Patients with Locally Advanced or Metastatic Solid Tumors. (PubMed, Clin Cancer Res)
    Etigilimab had an acceptable safety profile with preliminary evidence of clinical benefit alone and in combination with nivolumab and warrants further investigation in clinical trials.
    Clinical • P1 data • Journal • Combination therapy • PD(L)-1 Biomarker • IO biomarker
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    TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
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    Opdivo (nivolumab) • etigilimab (MPH-313)