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AstraZeneca Sees New Lung Cancer Indication for Tagrisso, Chemo in FLAURA2 Data

NEW YORK – AstraZeneca on Wednesday said it will share results from the FLAURA2 Phase III trial demonstrating first-line treatment with Tagrisso (osimertinib) and chemotherapy significantly improved progression-free survival compared to Tagrisso alone in patients with advanced or metastatic EGFR-mutated non-small cell lung cancer.

The US Food and Drug Administration approved Tagrisso in 2018 as a first-line single-agent therapy for patients with metastatic EGFR-mutated NSCLC, and in 2020, as an adjuvant therapy for patients with early-stage EGFR-mutated NSCLC.

In FLAURA2, AstraZeneca sought to establish whether adding chemotherapy to Tagrisso would boost its efficacy over giving it alone in patients with stage IIIB-C or stage IV EGFR-mutated NSCLC. Following an initial safety assessment in 30 patients, more than 550 patients were randomized to receive either the combination or just the EGFR inhibitor.

The company reported at a high level that the study met its primary efficacy endpoint by showing that Tagrisso-chemotherapy significantly improved investigator-assessed progression-free survival compared to Tagrisso monotherapy. The trial's secondary endpoints include overall survival, objective response rate, and duration of response. The company said overall survival data were not mature at the time of the analysis, and safety results were consistent with what has previously been seen with each therapy.

"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," Susan Galbraith, AstraZeneca executive VP of oncology R&D, said in a statement. "This meaningfully builds on successive trials, which have demonstrated improved clinical benefit with Tagrisso in patients with EGFR-mutated lung cancer."

The company said it will present the data from FLAURA2 at a forthcoming medical meeting. AstraZeneca is also conducting LAURA, a randomized Phase III trial comparing Tagrisso or placebo in patients with stage III uresectable EGFR-mutated NSCLC following chemoradiation.