2023 World Conference on Lung Cancer (Posters)-P2.08. STAR-121: Phase 3 Study of DOM and ZIM plus Chemo vs Pembro plus Chemo in 1L mNSCLC with No Actionable Gene Alterations

P2.08. STAR-121: Phase 3 Study of DOM and ZIM plus Chemo vs Pembro plus Chemo in 1L mNSCLC with No Actionable Gene Alterations - PDF(Abstract)

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A Phase 3 study called STAR-121 is being conducted to evaluate the effectiveness of a combination therapy using domvanalimab (DOM) and zimberelimab (ZIM) with chemotherapy compared to pembrolizumab (pembro) with chemotherapy as a first-line treatment for metastatic non-small cell lung cancer (mNSCLC) patients without EGFR or ALK gene alterations. The study aims to address the need for more effective treatment options for mNSCLC patients who experience progression and shorter survival despite immune checkpoint inhibitor therapy. DOM is an anti-T-cell immunoreceptor with immunoglobulin and ITIM domains (TIGIT) Fc-silent IgG1 monoclonal antibody that inhibits the interaction between TIGIT and CD155, reducing immunosuppression and promoting antitumor activity. ZIM is an anti-PD-1 IgG4 monoclonal antibody which has shown antitumor activity in various tumor types. Previous studies have shown that dual blockade of TIGIT and PD-(L)1 has increased antitumor activity compared to PD-(L)1 inhibition alone. In ARC-7, a phase 2 study, the combination of DOM and ZIM demonstrated higher response rates and longer progression-free survival than ZIM monotherapy in PD-L1-high, first-line NSCLC. The hypothesis is that adding DOM and ZIM to chemotherapy will improve outcomes in untreated mNSCLC patients without EGFR or ALK aberrations, regardless of PD-L1 expression. The study is being conducted globally and is currently enrolling participants in various regions. The primary endpoints of the study are progression-free survival and overall survival, with secondary endpoints including response rates, duration of response, safety, and quality of life. Clinical Trials in Progress.

Asset Subtitle

Delvys Rodriguez-Abreu

Meta Tag

Speaker Delvys Rodriguez-Abreu

Topic Metastatic NSCLC: Immunotherapy - TIPs

Keywords

Phase 3 study

combination therapy

domvanalimab

zimberelimab

chemotherapy

metastatic non-small cell lung cancer

mNSCLC

TIGIT

PD-L1 expression

progression-free survival