Newly released results from the Phase III ADAURA trial reveal that osimertinib yielded a 5.5-year median disease-free survival in the post-surgical treatment of patients with EGFR-mutated lung cancer, and nearly three in four patients treated with adjuvant osimertinib were disease-free at four years.

The new results also indicated that the use of osimertinib reduced the risk of disease recurrence in the brain and spinal cord.

The results from the study were presented today at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris.

“An additional two years out from the presentation of the 2020 data, with all patients completing three years of adjuvant treatment, the results are even more dramatic. We were able to show that adjuvant osimertinib not only continues to prolong disease free survival after surgery, but also continues to reduce the risk of recurrence in the central nervous system,” said senior author of the study, Roy S. Herbst, MD, PhD, Deputy Director for Clinical Affairs and Chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital; Ensign Professor of Medicine (Medical Oncology) and Professor of Pharmacology, and Assistant Dean for Translational Research at Yale School of Medicine.

“Prior to this, there were no targeted therapies for these patients following surgery,” said Dr. Herbst.

“While up to thirty percent of patients with non-small cell lung cancer may be diagnosed early enough to have curative surgery, recurrence is still common in early-stage disease. We will continue to monitor the patients on study, and review additional data, but these recent results are remarkable and may indicate a role for adjuvant osimertinib in even earlier stages of disease.”

The ADAURA trial assessed osimertinib as a post-surgical or adjuvant treatment for patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).

Osimertinib reduced the risk of disease recurrence or death by 77% in patients with stages II-IIIA disease and by 73% in patients with stages IB-IIIA disease.

Disease recurrence in the central nervous system, a common occurrence for patients with EGFRm NSCLC, was reduced by 76% in patients with stage II-IIIA disease.

At four years, 90% of patients were disease-free in the brain and spinal cord compared to 75% of patients who received the placebo.

Funding for the ADAURA study was provided by AstraZeneca.

Source: Yale Cancer Center