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• W3205871812 abstract "Leptomeningeal metastases (LM) are severe, an aggressive complication of cancer, characterized by tumor cell spread to the cerebrospinal fluid (CSF) and leptomeninges. The higher incidence of LM in EGFR mutated non-small cell lung cancer (NSCLC) has been observed, especially after treated with 1st or 2nd generation EGFR TKI. The Osimertinib, the third generation irreversible EGFR TKI, has been developed to target T790M mutation. Unlike other EGFR TKIs, Osimertinib showed homogenous distribution to the brain suggesting high penetration of blood-brain barrier, and clinical efficacy in intracranial lesions has been demonstrated from the retrospective analyses. In addition, from prospective study, double dosage (160mg) of osimertinib demonstrated meaningful clinical efficacy in LM by extending progression-free (PFS) and overall survivals (OS). However, despite the approval of Osimertinib as 1st line treatment option by the FDA in EGFR mutated NSCLC, many other countries are still in use of Osimertinib as a subsequent treatment option in selected patients. This study is designed to evaluate the clinical efficacy and safety of Osimertinib in patients with LM who failed from the previous first- or second-generation EGFR TKI. This study (BLOSSOM) is a Phase II, open-label, single-arm, multicenter study to evaluate the clinical efficacy of 80mg Osimertinib in patients with LM in EGFR mutated, either exon 19 deletion or L858R, NSCLC. From the 5 sites across South Korea and first or second-generation EGFR TKI pre-treated patients will be recruited. A total of 80 patients, 40 patients with T790M positive and 40 patients with T790M negative, will be recruited and treated with 80mg of Osimertinib until disease progression or intolerable adverse event. All the patients will be required to have at least one site of LM as identified by the radiologists from the central site that can be assessed by MRI which is suitable for repeat assessment. If the patient has no T790M mutation, the extracranial lesion must be stable following previous EGFR TKI treatment. The primary endpoint is OS. The secondary endpoints are blind independent committee review assessed RANO-LM criteria to evaluate the LM-objective response rate, LM-duration of response, LM-disease control rate, LM- PFS and this will be assessed based on the T790M mutation status. The RECIST 1.1 response assessed by investigator, CSF cytology clearance rates, disease-related symptom, and pharmacokinetics in plasma and CSF will be evaluated. The first patient received treatment in Dec. 2020, and the expected timeline for the final analyses is Q3, 2023. This study is conducted under an applicable regulatory requirement and supervision of the institutional review board (NCT04563871). ▪▪▪ ▪▪▪" @default.
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• W3205871812 date "2021-10-01" @default.
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• W3205871812 title "P47.08 A Phase II, Single-arm, Multicenter, Efficacy of 80 mg Osimertinib in Patients With Leptomeningeal Metastases Associated With EGFR Mutated NSCLC" @default.
• W3205871812 doi "https://doi.org/10.1016/j.jtho.2021.08.501" @default.
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