AstraZeneca Announces LAURA Phase III Trial Results: Tagrisso Reduces Risk of Disease Progression or Death by 84% in Unresectable Stage III EGFR-Mutated NSCLC

China Finance Network June 4th — At the plenary session of the "2024 American Society of Clinical Oncology (ASCO)" held today, the positive results of the LAURA Phase III clinical study were announced. These results were simultaneously published in The New England Journal of Medicine.

Results show that, compared with placebo after chemoradiotherapy, AstraZeneca's Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with stage III unresectable non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.

Results from the Blinded Independent Central Review (BICR) showed that, compared with placebo, osimertinib reduced the risk of disease progression or death by 84% ([HR] 0.16; 95% [CI] 0.10-0.24; p<0.001). The median PFS for patients treated with osimertinib was 39.1 months, while the median PFS for those in the placebo group was 5.6 months. More importantly, clinically meaningful PFS benefits were observed across all predefined subgroups, including gender, race, EGFR mutation type, age, smoking history, and prior response to CRT treatment.

The overall survival (OS) data for Osimertinib showed a positive trend, although the data were not yet mature at the time of this analysis. The trial will continue to evaluate the secondary endpoint of OS.

Suresh Ramalingam, MD, Executive Director of the Winship Cancer Institute at Emory University in Atlanta, USA, and principal investigator of the LAURA clinical trial, stated that the progression-free survival results of the LAURA Phase III clinical trial were astonishing, marking a significant breakthrough for patients with Stage III EGFR-mutated lung cancer who currently have no targeted treatment options. "Osimertinib has unprecedentedly delayed the risk of disease progression or death by 84%. Based on these data, osimertinib should become the new standard of care for these patients."

AstraZeneca's Global Executive Vice President and Head of Oncology R&D, Susan Galbraith, stated that osimertinib can extend the progression-free survival period by more than three years for these potentially curable lung cancer patients, underscoring the necessity of early detection and diagnosis for patients. These practice-changing data highlight the powerful impact of osimertinib as a cornerstone therapy for EGFR-mutated lung cancer, especially for early-stage patients who have progressed after chemoradiotherapy.

The safety and discontinuation rate due to adverse events (AEs) were consistent with expectations, and no new safety issues were identified. In the osimertinib group, 35% of patients experienced grade 3 or higher adverse events from any cause, compared to 12% in the placebo group.

Osimertinib has been approved as a monotherapy in more than 100 countries and regions, including the United States, the European Union, China, and Japan. The approved indications include first-line treatment for locally advanced or metastatic EGFRm NSCLC, treatment for patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment for patients with early-stage EGFRm NSCLC post-surgery. Osimertinib in combination with chemotherapy has also been approved in the United States and other countries for the first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC.