Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024
Phase II Efficacy and Safety of 80 mg Osimertinib in Patients With Leptomeningeal Metastases Associated With Epidermal Growth Factor Receptor Mutation-Positive Non-Small Cell Lung Cancer (BLOSSOM).
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers.
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Who cites it
39 citing papers in PubMed.
- Intrathecal pemetrexed for newly diagnosed leptomeningeal metastases: a multicenter, open-label, phase I/II study.Journal of neuro-oncology · 2025Trial
- Central Nervous System Activity of Lazertinib in EGFR-Mutated NSCLC With Prior EGFR TKI Exposure: A Pooled Analysis of KCSG-LU20-15 and LU21-01.Thoracic cancer · 2026Article
- Increasing incidence and improved survival of leptomeningeal metastasis in advanced lung cancer: a 10-year real-world cohort study.Translational lung cancer research · 2026Article
- Review
- Article
- Clinical predictors of leptomeningeal metastasis from lung adenocarcinoma based on retrospective analysis.Oncology letters · 2026Article
- OB-001 Enhances Osimertinib Brain Penetration: Preclinical Pharmacokinetics and Translational Rationale for EGFR-Mutant NSCLC with CNS Disease.Cancer research communications · 2026Article
- Article
- The Use of Radiotherapy in Leptomeningeal Carcinomatosis: A Systematic Review and Random-Effects Proportions Meta-Analysis.Cancers · 2026Review
- Article
- Therapeutic progress in leptomeningeal metastasis from EGFR mutant non-small cell lung cancer: a clinical medicine review.Journal of cancer research and clinical oncology · 2026Review
- The evolving landscape of leptomeningeal metastases from NSCLC: an international, contemporary, multicenter cohort study.Annals of oncology : official journal of the European Society for Medical Oncology · 2026Article
- Crosstalk in the brain tumor microenvironment: mechanisms, therapeutic strategies, and clinical advances.Military Medical Research · 2026Review
- Palliative Osimertinib Rechallenge Achieving Rapid Improvement in Leptomeningeal Carcinomatosis After Prior Osimertinib-Induced ILD.Respirology case reports · 2026Article
- Leptomeningeal metastatic disease responding to carboplatin, pemetrexed, and amivantamab after progression to osimertinib in EGFR exon 21 L858R-Mutated non-small cell lung cancer: Two case reports.Respiratory medicine case reports · 2026Article
- Brief Report: Safety of Pulse-Dose Osimertinib for Treatment of Leptomeningeal Disease or Refractory Brain Metastases in EGFR-Mutated Nonsmall Cell Lung Cancer.Clinical lung cancer · 2025Article
- Article
- Efficacy of Tyrosine Kinase Inhibitors in ALK and EGFR-Mutated Non-Small Cell Lung Cancer with Brain Metastases.Medical sciences (Basel, Switzerland) · 2025Review
- Clinical Features, Molecular Biology, and the Metastatic Microenvironment in Lung Cancer Brain Metastases: Implications for Treatment Decisions.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025Review
- Advances in the research of leptomeningeal metastases in non-small cell lung cancer: a narrative review.Translational lung cancer research · 2025Review
Corrections and comments
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Authors and funding
18 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeLeptomeningeal metastases (LMs) exhibit a high incidence in patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) post-treatment with first- or second-generation EGFR tyrosine kinase inhibitors (TKIs). This investigation evaluates the efficacy, safety, and pharmacokinetics of 80 mg once daily osimertinib in patients with LMs resistant to prior first- or second-generation EGFR TKIs. MATERIALS AND
methodsIn this phase II multicenter, open-label, single-arm study, 80 mg osimertinib was administered to patients with EGFR-mutated NSCLC who had developed LMs subsequent to treatment with prior EGFR TKIs. The primary end point was overall survival (OS), assessed alongside objective response rate by the blinded independent central review (BICR) and a pharmacokinetic analysis of plasma and cerebrospinal fluid (CSF) on the first day of cycles 3 and 6.
resultsA total of 73 patients diagnosed with LM were treated with osimertinib, including 64 patients evaluable for the LM efficacy set-T790M negative (n = 62) and T790M positive (n = 2). The median OS in the full-analysis set was 15.6 months (95% CI, 11.5 to 20.2). The objective response rate for LM was 51.6%, including a 15.6% complete response, and the disease control rate was 81.3% by BICR in the LM efficacy evaluable set. The median LM progression-free survival by BICR was 11.2 months (95% CI, 7.7 to 15.3), the duration of response was 12.6 months (95% CI, 7.6 to 17.7), and OS was 15.0 months (95% CI, 11.3 to 18.7). Pharmacokinetic analysis showed that the CSF to free plasma osimertinib ratio was 22%. Most safety profiles were grade 1 and 2.
conclusionThe study demonstrates significant intracranial efficacy and survival benefits of 80 mg once daily osimertinib in NSCLC patients with LMs. The data support considering daily 80 mg of osimertinib as a treatment option for EGFR-mutated NSCLC patients with LMs, irrespective of T790M mutation status.
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