Dr Santos on the Evolution of Osimertinib in EGFR Mutated NSCLC

Edgardo S. Santos, MD, FACP, clinical affiliate associate professor, Charles E. Schmidt College of Medicine, Florida Atlantic University, founding partner, Florida Precision Oncology, discusses the evolution of osimertinib (Tagrisso) in the treatment of patients with EGFR-mutated non–small cell lung cancer (NSCLC) and the updated data that reaffirmed its role in the adjuvant setting for this patient population.

In a presentation at an OncLive® State of the Science Summit™ on lung cancer, which he chaired, Santos expanded on the treatment in the adjuvant and metastatic settings for patients with NSCLC harboring EGFRmutations. Specifically, Santos highlighted the role of osimertinib and the data that have supported its use in both settings.

Osimertinib initially received FDA approval in April 2018 for the first-line treatment of patients with metastatic NSCLC whose tumors harbor EGFR exon 19 deletions or exon 21 L858R mutations, based on data from the phase 3 FLAURA trial (NCT02296125).

In December 2020, the FDA approved osimertinib as an adjuvant treatment following tumor resection in patients with NSCLC whose tumors harbor EGFR exon 19 deletions or exon 21 L858R mutations. That regulatory decision was based on data from the phase 3 ADAURA trial (NCT02511106), which included patients with a stage IB, II, or IIIA NSCLC who did or did not receive adjuvant chemotherapy. Patients were randomly assigned to received osimertinib or placebo for up to 3 years, and updated data from the study presented at the 2022 ESMO Congress reinforced adjuvant osimertinib as the standard of care for this patient population, according to Santos.

The long-term data with 2 additional years of follow-up showed that patients treated with osimertinib experienced a median disease-free survival (DFS) of 65.8 months (95% CI, 61.7–not calculable) compared with 28.1 months (95% CI, 22.1-35.0) for those given placebo (HR, 0.27; 95% CI, 0.21-0.34). The DFS benefit was observed across all subgroups, and DFS was improved with osimertinib regardless of whether patients received adjuvant chemotherapy.