AstraZeneca’s Tagrisso (osimertinib) has received U.S. approval for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC), whose disease has not progressed during or after concurrent or sequential platinum-based chemoradiation therapy (CRT). The drug is indicated specifically for patients with exon 19 deletions or exon 21 (L858R) mutations, as confirmed by an FDA-approved test.
This approval follows a Priority Review by the U.S. Food and Drug Administration (FDA), based on data from the Phase III LAURA trial. Results were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine.
In the trial, Tagrisso significantly reduced the risk of disease progression or death by 84% compared to placebo (hazard ratio 0.16; 95% confidence interval 0.10-0.24; p<0.001), as evaluated by blinded independent central review. Patients treated with Tagrisso experienced a median progression-free survival (PFS) of 39.1 months, compared to just 5.6 months for those on placebo.
Overall survival (OS) data remain immature at this time, and the trial continues to assess OS as a secondary endpoint.
Each year, over 200,000 people in the U.S. are diagnosed with lung cancer, with 80-85% of cases classified as NSCLC, the most prevalent type of lung cancer. About 15% of NSCLC patients in the U.S. have EGFR mutations, and nearly 20% of NSCLC patients have unresectable tumors.
Dr. Suresh Ramalingam, Executive Director of Winship Cancer Institute at Emory University and principal investigator of the LAURA trial, called the approval “a major breakthrough” for Stage III, EGFR-mutated lung cancer patients, noting that patients treated with Tagrisso remained free from disease progression for over three years in the trial. He emphasized the importance of early diagnosis and testing for lung cancer.
Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, highlighted the significance of this approval for patients who previously lacked targeted therapy options for Stage III unresectable EGFR-mutated NSCLC. He also underscored the potential of Tagrisso as a cornerstone treatment for this disease, stating that patients across all stages of EGFR-mutated NSCLC can now benefit from the drug.
The safety and tolerability of Tagrisso in the LAURA trial were consistent with its established safety profile, with no new concerns identified.
Tagrisso is already approved for patients with EGFR mutations as a first-line metastatic treatment, both as monotherapy and in combination with chemotherapy, and as adjuvant therapy for early-stage disease. The drug is also under regulatory review in other countries for this new indication.
