2023 World Conference on Lung Cancer (Posters)-P2.09. OSTARA: A Phase II Study of First-line Osimertinib Combined with Amivantamab in EGFRm Advanced Non-Small Cell Lung Cancer

P2.09. OSTARA: A Phase II Study of First-line Osimertinib Combined with Amivantamab in EGFRm Advanced Non-Small Cell Lung Cancer - PDF(Abstract)

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OSTARA is a Phase II study evaluating the combination of osimertinib and amivantamab as a first-line treatment for advanced non-small cell lung cancer (NSCLC) with EGFR mutations. Osimertinib is a third-generation EGFR-tyrosine kinase inhibitor (TKI) that has shown efficacy in EGFR mutation-positive NSCLC. However, patients eventually develop resistance, with MET alterations being a common mechanism. Amivantamab is a bispecific monoclonal antibody targeting EGFR and MET, with promising results in combination with other EGFR-TKIs.<br /><br />The study aims to assess the safety and efficacy of the osimertinib-amivantamab combination in patients with EGFR mutation-positive advanced NSCLC. Approximately 80 patients will receive the combination therapy until disease progression. The primary endpoints are safety, assessed through adverse events and dose modifications, and efficacy, measured by progression-free survival. Secondary endpoints include objective response rate, duration of response, and overall survival. Other exploratory endpoints include CNS efficacy and biomarker analyses.<br /><br />The study will enroll its first patient in July 2023, with an expected data cut-off for interim safety analysis in February 2024. If successful, this combination therapy has the potential to improve outcomes by blocking MET-driven mechanisms of resistance to osimertinib.<br /><br />In conclusion, OSTARA is a Phase II study investigating the combination of osimertinib and amivantamab as a first-line treatment for EGFR mutation-positive advanced NSCLC. The study aims to determine the safety and efficacy of this combination therapy in improving outcomes for patients with this type of lung cancer.

Asset Subtitle

Daniel Tan

Meta Tag

Speaker Daniel Tan

Topic Metastatic NSCLC: Targeted Therapy - EGFR/HER2

Keywords

OSTARA

Phase II study

osimertinib

amivantamab

first-line treatment

advanced non-small cell lung cancer

NSCLC

EGFR mutations

EGFR-tyrosine kinase inhibitor

MET alterations