The US Food and Drug Administration approved osimertinib for adjuvant therapy after tumor resection in patients with non–small-cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations that have been detected by an approved test.
In ADAURA, a randomized, double-blind, placebo-controlled clinical trial, adjuvant therapy with osimertinib demonstrated efficacy in patients with EGFR exon 19 deletions or exon 21 L858R mutation–positive NSCLC who had complete tumor resection, with or without prior adjuvant chemotherapy.
Qualified patients who had resectable tumors (stage IB-IIIA) and predominantly nonsquamous histology as well as EGFR exon 19 deletions or exon 21 L858R mutations were identified prospectively from tumor tissue in a central laboratory using a test for EGFR mutation. Patients (N = 682) were randomized (1:1) to receive either oral once-daily osimertinib (80 mg) or placebo postsurgical procedure and standard adjuvant chemotherapy, if provided.
In patients with stage II to IIIA NSCLC, disease-free survival was the major efficacy outcome measure; this was assessed by investigator determination. Median disease-free survival was not reached in patients in the osimertinib arm, contrasted with patients in the placebo arm (19.6 months).
In the overall study population, disease-free survival was a secondary efficacy outcome measure; the median was not reached in the osimertinib arm, contrasted with 27.5 months in the placebo arm.
For adjuvant treatment of early-stage NSCLC, the recommended once-daily osimertinib dose is 80 mg orally with or without food, until disease recurrence, unacceptable toxicity, or for up to 3 years.1
In patients receiving osimertinib, the most common (>20%) adverse reactions, including laboratory abnormalities, were anemia, cough, diarrhea, dry skin, fatigue, leukopenia, lymphopenia, musculoskeletal pain, nail toxicity, neutropenia, rash, stomatitis, and thrombocytopenia.
US Food and Drug Administration. FDA approves osimertinib as adjuvant therapy for non-small cell lung. www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-osimertinib-adjuvant-therapy-non-small-cell-lung-cancer-egfr-mutations. Published 2021. Accessed March 17, 2021.
- Tagrisso (osimertinib) [package insert]. AstraZeneca. Updated 2020. www.accessdata.fda.gov/drugsatfda_docs/label/2020/208065s021lbl.pdf. Accessed March 17, 2021.