2023 North America Conference on Lung Cancer (NACLC) - Posters and Abstracts-PP01.50 (Poster) SAFFRON: Savolitinib + Osimertinib vs Chemotherapy in EGFRm NSCLC with MET Overexpression and / or Amplification Post-Osimertinib

PP01.50 (Poster) SAFFRON: Savolitinib + Osimertinib vs Chemotherapy in EGFRm NSCLC with MET Overexpression and / or Amplification Post-Osimertinib

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The SAFFRON study is a global, multicenter, randomized phase III study that aims to evaluate the efficacy and safety of the combination of savolitinib and osimertinib compared to platinum doublet chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) who have a mutation in the epidermal growth factor receptor (EGFR) gene and MET overexpression and/or amplification. <br /><br />The study includes adults aged 18 years or older with locally advanced or metastatic NSCLC who are not eligible for curative therapy and have documented EGFR mutations (Ex19del/L858R) and/or T790M, and MET overexpression and/or amplification. The patients must have experienced disease progression on 1st or 2nd line treatment with osimertinib as the most recent anti-cancer therapy and have an Eastern Cooperative Oncology Group performance status of 0-1.<br /><br />Patients with spinal cord compression or brain metastases, active gastrointestinal disease, selected cardiac diseases, severe or uncontrolled systemic disease, active hepatitis B or C infection, serious active infections (such as HIV or tuberculosis), and liver disease are excluded from the study.  <br /><br />The study is planned to enroll approximately 324 patients from 30 countries and is sponsored and funded by AstraZeneca, the manufacturer of savolitinib. Patients will receive either savolitinib plus osimertinib or standard chemotherapy, and tumor assessments will be conducted regularly. The primary endpoint of the study is progression-free survival, with overall survival, objective response rate, duration of response, and safety as secondary endpoints. The analysis of the primary endpoint is expected to be conducted in mid-2025.<br /><br />The study is being conducted because patients with advanced lung cancer who have EGFR mutations are often treated with EGFR-tyrosine kinase inhibitors (TKIs) like osimertinib. However, resistance to osimertinib can develop through MET overexpression and/or amplification. Preclinical studies suggest that combining osimertinib with savolitinib, a MET inhibitor, may be effective in reducing tumor growth and spread in these patients. The SAFFRON study aims to investigate the efficacy and safety of this combination compared to chemotherapy in patients with MET-driven resistance to osimertinib.

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Zofia Piotrowska

Keywords

SAFFRON study

savolitinib

osimertinib

platinum doublet chemotherapy

non-small cell lung cancer

NSCLC

epidermal growth factor receptor

EGFR gene

MET overexpression

MET amplification