AstraZeneca Plc AZN has reported topline data from the Phase 3 FLAURA2 trial of Tagrisso (osimertinib) in combination with chemotherapy for locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
The results showed that Tagrisso plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to Tagrisso alone.
Related: AstraZenceca's Tagrisso Shows Survival Benefit In Early-Stage Lung Cancer Settings.
Safety results and discontinuation rates due to adverse events were consistent with the established profiles of each medicine.
At the time of this analysis, the overall survival (OS) data were immature and will be formally assessed at a subsequent analysis.
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "These significant FLAURA2 results show Tagrisso has the potential to offer patients in the first-line setting a new treatment option that can extend the time they live without their disease progressing."
The data will be presented at a forthcoming medical meeting and shared with global health authorities.
Tagrisso is also being investigated in unresectable NSCLC in the pivotal LAURA Phase 3 trial, with results expected later this year.
Price Action: AZN shares closed at $75.28 on Tuesday.
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