Evaluating osimertinib for EGFR positive non-small-cell lung cancer that was surgically removed.

This trial was carried out to assess the effectiveness and safety of osimertinib (Tagrisso) after surgery for EGFR-positive advanced non-small cell lung cancer (NSCLC). The trial found that this treatment improved the outcomes of patients with stage IB to IIIA EGFR-positive NSCLC that was surgically removed.

NSCLC is the most common form of lung cancer. NSCLC is responsible for around 85% of all lung cancer diagnoses. Treatment for NSCLC is usually chemotherapy, radiotherapy, and surgical removal of tumors. Despite this, NSCLC can be difficult to treat. EGFR mutation is a gene abnormality that causes excess growth of cancer cells, in particular lung cancer cells. 

Osimertinib is standard-of-care therapy for patients with previously untreated EGFR-positive NSCLC. However, the effectiveness and safety of osimertinib after tumor removal are currently unknown. 

There were a total of 682 patients with EGFR-positive NSCLC in this trial. All patients underwent a complete surgical removal of lung tumors. After surgery, 339 patients were randomly assigned to receive osimertinib daily for 3 years. The other 343 patients received a placebo. 

89% of all patients in the osimertinib group were alive and disease free at 24-months compared to 52% of those in the placebo group. Osimertinib was associated with a 80% lower risk of disease recurrence or deah compared to placebo.

In patients with stage II to IIIA disease, the average survival disease-free in the osimertinib group was 22.1 months. The average disease-free survival in the placebo group was 14.9 months. 90% of patients in the osimertinib group were alive and disease-free at 24-months. 44% of patients in the placebo group were alive and disease-free at 24-months. Osimertinib was associated with a 83% reduction in the risk of disease recurrence or death compared to placebo. 

There were no new safety concerns noted in the osimertinib group. 98% in the osimertinib group and 89% in the placebo group reported side effects. Common side effects experienced by patients in the osimertinib group were diarrhea, nail and skin infections, and skin itching. 

The authors concluded that in patients with EGFR-positive NSCLC that was surgically removed, osimertinib resulted in a significantly longer disease-free survival compared to placebo.

This study was funded by AstraZeneca, the manufacturer of osimertinib.