▎WuXi AppTec Content Team Report

AstraZeneca（AstraZeneca）It was announced recently, at the just-concludedDuring the 2024 European Society for Medical Oncology (ESMO) Annual Meeting,Shanghai Chest Hospital Affiliated to Shanghai Jiao Tong UniversityProfessor Lu ShunAn oral report was given on the reduction of the risk of central nervous system (CNS) and distant progression in the LAURA study.According to the evaluation results from the Blinded Independent Central Review (BICR), compared with the placebo,Osimertinib Reduces the Risk of CNS Progression or Death by 83%。In addition, osimertinib treatmentMedian Time to Distant Metastasis (TTDM) also showed clinically meaningful improvement,The cumulative incidence of TTDM at 12 months was 11% in patients treated with osimertinib and 37% in those receiving placebo.

Osimertinib is an irreversible third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI).LAURA StudyThe targeted indication isStage III unresectableEGFRMutant Non-Small Cell Lung Cancer.For this indication,The marketing application for Osimertinib has been accepted by China's NMPA in June this year.Priority Review。

Unlike Stage IV advanced lung cancer, in Stage IIINon-Small Cell Lung CancerThis phase,Cancer cells are still confined to a single lung area, or have just spread to the lymph nodes of the lung, and can still be treated with a radical treatment plan.. However, for inoperablePhase IIIPatients with non-small cell lung cancer,Although a large number of studies have established concurrent chemoradiotherapy as the standard treatment, it has not been able to further improve patient survival rates, especiallyEGFRPatients with mutant NSCLC also experience CNS progression more frequently, representing a significant unmet need in clinical treatment.

LAURA is a randomized, double-blind, placebo-controlled, global multi-center Phase III clinical study, with participants beingStage III UnresectableEGFRMutant Non-Small Cell Lung CancerThese patients did not experience disease progression after receiving platinum-based chemoradiotherapy.Patients received oral tablets of 80 mg osimertinib once daily until disease progression, intolerable toxicity, or meeting the discontinuation criteria.After disease progression, patients in the placebo group may continue to receive osimertinib treatment.The trial was conducted at 145 centers across more than 15 countries in the United States, Europe, South America, and Asia, enrolling a total of 216 patients.The study'sThe primary endpoint was progression-free survival (PFS）。

AstraZeneca's previously published LAURA Phase 3 study results show that, compared with placebo after chemoradiotherapy, in patients withEGFRExon 19 deletion or exon 21 (L858R) In III stage unresectable NSCLC patients with substitution mutations, osimertinib demonstrated statistically significant and clinically meaningful PFS improvement.Extended PFS by more than three years and reduced the risk of disease progression or death by 84%.。These results were presented at the 2024 ASCO Plenary Session and simultaneously published in The New England Journal of Medicine.

According to the introduction in AstraZeneca's press release,The results announced at this year's ESMO annual meeting are a follow-up toAfter the primary endpoint PFS was achieved,OsimertinibAnother significant achievement has been added.Compared with placebo after concurrent chemoradiotherapy, osimertinib asEGFRConsolidation Therapy for Positive Stage III Unresectable Non-Small Cell Lung Cancer, the improvement in CNS progression and median time to distant metastasis is clinically significant., further confirming that osimertinib is expected to become a new standard treatment option for such patients.The study will also continue to evaluate the secondary endpoint of overall survival (OS).

References:

[1] AstraZeneca Press Release.