On Monday, AstraZeneca Plc (NASDAQ:AZN) released high-level results from the final overall survival (OS) analysis of the FLAURA2 Phase 3 trial of Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy.
The study demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of OS compared to Tagrisso monotherapy for patients with 1st-line locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
The final OS analysis demonstrates consistent survival benefit, as reported in the interim OS results.
It builds on the previously presented primary endpoint data, demonstrating the longest-reported median progression-free survival (PFS) in this setting.
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In September 2023, AstraZeneca released data from the FLAURA2 Phase 3 trial showing Tagrisso (osimertinib) in combination with chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso alone in patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
According to the investigator’s assessment, the combination extended median progression-free survival by 8.8 months compared to Tagrisso alone.
In March 2024, results from the FLAURA2 Phase 3 trial showed Tagrisso, with the addition of chemotherapy, provided a clinically meaningful and consistent benefit in subsequent outcomes after disease progression in patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer.
Tagrisso, with the addition of chemotherapy, also demonstrated a favorable trend toward overall survival improvement at two years of follow-up.
With longer follow-up, the safety profile of Tagrisso plus chemotherapy continues to be manageable and consistent with the established profiles of the individual medicines.
Adverse event (AE) rates were higher in the Tagrisso plus chemotherapy arm, driven by well-characterised chemotherapy-related AEs. Discontinuation rates due to AEs and on-target toxicities were low in both arms of the trial.
Based on the FLAURA2 Phase 3 trial, Tagrisso plus chemotherapy is approved in over 80 countries, including the U.S., EU, China, and Japan.
Price Action: AZN stock closed lower by 0.10% at $68.72 on Monday.
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