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2022 World Conference on Lung Cancer (ePosters)
EP08.01-044. A Phase 2 Multi-Cohort Study of Tirag ...
EP08.01-044. A Phase 2 Multi-Cohort Study of Tiragolumab, Atezolizumab and Bevacizumab in Advanced Non-Squamous Non-Small Cell Lung Cancer
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A phase 2 multi-cohort study is being conducted to evaluate the efficacy of tiragolumab, atezolizumab, and bevacizumab in patients with advanced non-squamous non-small cell lung cancer (NSCLC) who have shown resistance to checkpoint inhibitor immunotherapy (CPI). This study aims to address two unmet needs in NSCLC treatment: patients with EGFR-mutated NSCLC and those with driver mutation-negative NSCLC who have primary or acquired resistance to CPI.<br /><br />VEGF has been found to promote CPI resistance by creating an immunosuppressive tumor microenvironment. Previous research has shown promise in combining the anti-VEGF antibody bevacizumab with the anti-PD-L1 CPI atezolizumab in both EGFR-mutated and EGFR-wild type NSCLC. TIGIT, an inhibitory checkpoint, has also been associated with chemotherapy and CPI resistance.<br /><br />The trial design includes two cohorts of patients: those with EGFR-wild type NSCLC who are refractory to CPI and those with EGFR-mutated NSCLC who are resistant to targeted therapy and have not received CPI. The patients will receive tiragolumab, atezolizumab, and bevacizumab every three weeks until disease progression or unacceptable toxicity. The study will utilize a Simon 2-stage design to test the objective response rate (ORR) and assess the contribution of tiragolumab to the overall treatment effect.<br /><br />The primary endpoint is the ORR as assessed by RECIST v1.1. Secondary endpoints include duration of response, progression-free survival (PFS), 6-month PFS, and overall survival. The study also includes planned correlative analyses to investigate tumor multiplex imaging, whole blood cytometry, whole exome sequencing, and T-cell receptor sequencing.<br /><br />Enrollment for the study is ongoing at Georgetown Lombardi Comprehensive Cancer Center, with plans to activate enrollment at John Theurer Cancer Center, Hackensack University Medical Center. The study is funded by Georgetown Lombardi Comprehensive Cancer Center, with drug support provided by Genentech/Roche.
Asset Subtitle
Joshua Reuss
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Speaker
Joshua Reuss
Topic
Metastatic Non-small Cell Lung Cancer - Immunotherapy
Keywords
phase 2 multi-cohort study
tiragolumab
atezolizumab
bevacizumab
advanced non-squamous non-small cell lung cancer
checkpoint inhibitor immunotherapy
EGFR-mutated NSCLC
driver mutation-negative NSCLC
refractory to CPI
RECIST v1.1
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