AstraZeneca announced that the US Food and Drug Administration (FDA) has granted approval for Tagrisso (osimertinib) as a treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR mutations. Simultaneously, the company reported positive outcomes from the LAURA Phase III trial, where Tagrisso exhibited promise compared to a placebo in treating stage III EGFR-mutated NSCLC post-chemoradiotherapy.
The FDA’s decision was rooted in data from the FLAURA2 Phase III trial, revealing that combining Tagrisso with chemotherapy resulted in a 38 percent reduction in the risk of disease progression or death compared to Tagrisso alone. Median progression-free survival for the Tagrisso-chemotherapy group was 25.5 months, surpassing the 16.7 months observed with Tagrisso monotherapy.
An exploratory analysis within FLAURA2 focused on patients with brain metastases at baseline, demonstrating a 42 percent risk reduction in central nervous system disease progression or death with Tagrisso-chemotherapy versus Tagrisso monotherapy. After two years, 74 percent of the combination-treated patients were alive without CNS disease progression, compared to 54 percent in the Tagrisso monotherapy group.
While overall survival results were still pending a mature analysis at the second interim review, AstraZeneca expressed confidence in the positive trend observed in the data. Dave Fredrickson, Executive VP of AstraZeneca’s oncology business unit, emphasized the significance of this approval, positioning Tagrisso as a crucial component in the treatment of EGFR-mutated lung cancer, either alone or in conjunction with chemotherapy.
Tagrisso had previously gained approval as a first-line treatment for EGFR-mutated NSCLC, including T790M mutation-positive cases, and as an adjuvant treatment for early-stage EGFR-mutated NSCLC. The recent FDA approval further solidifies Tagrisso’s role in managing EGFR-mutated lung cancer, particularly for patients with challenging prognoses, including those with brain metastases and specific mutations like L858R.
AstraZeneca plans to share these promising findings from the FLAURA2 trial with global regulatory authorities, while international partners in Australia, Canada, and Switzerland are currently reviewing Tagrisso plus chemotherapy for the treatment of EGFR-mutated NSCLC under Project Orbis.