AstraZeneca Reports Positive Trial Results Of Tagrisso Plus Chemotherapy In FLAURA2 Phase III Trial

AstraZeneca PLC (AZN.L,AZN) announced Wednesday positive high-level results from the FLAURA2 Phase III trial of Tagrisso (osimertinib) plus chemotherapy in patients with epidermal growth factor receptor-mutated or EGFR-mutated advanced lung cancer.

The company noted that Tagrisso in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival or PFS compared to Tagrisso alone for patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm non-small cell lung cancer or NSCLC.

In the trial, 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 or 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. This meaningfully builds on successive trials which have demonstrated improved clinical benefit with Tagrisso in patients with EGFR-mutated lung cancer.”

The company plans to present the data at a forthcoming medical meeting and to share with global health authorities.

Tagrisso is also being investigated in unresectable NSCLC in the pivotal LAURA Phase III trial, with results expected later this year.

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