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(Slides)

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The poster presents the rationale and design for the OSTARA study, a phase II trial evaluating the combination of osimertinib (an EGFR-tyrosine kinase inhibitor) and amivantamab (a bispecific monoclonal antibody targeting EGFR and MET) as first-line treatment for advanced non-small cell lung cancer (NSCLC) with EGFR mutations. The study aims to assess the safety and efficacy of this combination therapy.<br /><br />Osimertinib is a recommended first-line treatment for NSCLC with EGFR mutations, but resistance to this drug can develop, often due to MET gene amplification. Amivantamab has been approved for use in NSCLC with EGFR Exon 20 insertions. By combining these two drugs, it is hoped that they will work together to enhance treatment efficacy and prevent the development of resistance.<br /><br />The OSTARA study will enroll around 80 patients with newly diagnosed locally advanced/metastatic or recurrent non-squamous NSCLC with EGFR mutations. Patients will receive osimertinib and amivantamab until disease progression or discontinuation for other reasons. The primary endpoints of the study are safety and progression-free survival. Secondary endpoints include objective response rate, duration of response, and overall survival.<br /><br />The first patient was enrolled in July 2023, and recruitment is ongoing at multiple study locations. Interim safety and efficacy analyses are planned, with final completion of the study expected in February 2028.<br /><br />In summary, the OSTARA study aims to evaluate the combination therapy of osimertinib and amivantamab as a first-line treatment for advanced NSCLC with EGFR mutations. This study will provide important insights into the safety and efficacy of this treatment approach and may offer new options for patients with EGFR-mutated lung cancer.

Asset Subtitle

Daniel Tan

Meta Tag

Speaker Daniel Tan

Topic Metastatic NSCLC: Targeted Therapy - EGFR/HER2

Keywords

OSTARA study

phase II trial

osimertinib

EGFR-tyrosine kinase inhibitor

amivantamab

bispecific monoclonal antibody

EGFR

MET

non-small cell lung cancer

NSCLC