A plain language summary of results from the NeoADAURA study: treatment with osimertinib before surgery for patients with EGFR-mutated non-small cell lung cancer that can be surgically removed

Plain Language SummaryWhat is this summary about?Osimertinib is an oral (by mouth) medicine that blocks the mutated form of a protein called EGFR on cancer cells, reducing their growth and spread.Osimertinib is recommended for EGFR-mutated non-small cell lung cancer (NSCLC) after surgery, but its benefit before surgery was unclear.The Phase 3 NeoADAURA study examined whether osimertinib alone, or with chemotherapy, before surgery improved outcomes for patients with EGFR-mutated stage 2–3B non-small cell lung cancer.What were the results?358 patients were randomly assigned to receive either osimertinib plus chemotherapy, osimertinib alone, or placebo plus chemotherapy. Most patients underwent surgery: more than 90% of those who had surgery had all the cancer removed.The main result that this study looked at was major pathological response, which is defined as when 10% or fewer live cancer cells can be seen in tissue that is removed during surgery. Among all randomized patients, the proportion of patients achieving a major pathological response was: 26% with osimertinib plus chemotherapy25% with osimertinib alone2% with placebo plus chemotherapy.After 1 year, among all randomized patients, 93% who received osimertinib plus chemotherapy, 95% of those receiving osimertinib alone, and 83% receiving placebo plus chemotherapy did not experience cancer worsening or the disease coming back and remained alive. No unexpected safety issues were found.What do the results of the study mean?In people living with stage 2–3B, EGFR-mutated non-small cell lung cancer that can be surgically removed, osimertinib treatment with or without chemotherapy before surgery, worked better than placebo plus chemotherapy at reducing the amount of cancer at the time of surgery.Clinical trial number: NCT04351555