Osimertinib Significantly Improves Disease-Free Survival in EGFR-Mutated Lung Cancer

AstraZeneca reported that adjuvant treatment with osimertinib (Tagrisso) had a clinically meaningful improvement in disease-free survival (DFS) among patients with early-stage (1B, 2 and 3A) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) compared to placebo. These findings were presented at the at the European Society for Medical Oncology Congress 2022.

After 4 years, nearly 75% of patients treated with osimertinib were alive and disease-free, which met the primary endpoint of DFS for stage 2 and 3A patients. The key secondary endpoint was DFS for patients with stage 1B, 2, and 3A NSCLC, and its safety and tolerability aligned with the established profile.

“The updated ADAURA results show us that adjuvant osimertinib not only continues to strikingly prolong the time patients with early-stage EGFR-mutated lung cancer are living cancer-free after surgery, but also continues to reduce the risk of tumours recurring in the central nervous system over time,” said lead investigator Masahiro Tsuboi, MD, PhD, chief and director, Department of Thoracic Surgery & Oncology, National Cancer Center Hospital East, Japan, in a press release.

Osimertinib was found to reduce the risk of disease recurrence and death by 77% in stage 2-3A patients. It reduced these same risks by 73% among all the stage populations (1B-3A).

ADAURA was a global, randomized, double-blind, placebo-controlled phase 3 trial evaluating the safety and efficacy of osimertinib vs placebo for patients with stage 1B, 2, and 3A EGFRm NSCLC.

After identifying 682 patients with stage 1B, 2, and 3A EGFRm NSCLC who had tumor resection—some of whom also received adjuvant chemotherapy—the researchers administered a once-daily 80 mg oral tablet of osimertinib or placebo for 3 years or until disease recurrence.

Among the primary population, osimertinib increased the median DFS to 5.5 years, which was more than 3-times higher than the placebo group. It also decreased the risk of central nervous system disease, or tumor recurrence in the brain and spinal cord, in 76% of stage 2-3A patients.

“It is remarkable that just two years ago, patients with early-stage EGFR-mutated lung cancer had no targeted treatment options after surgery. Now, around the world, patients have access to Tagrisso and its added benefit of protecting the brain and spinal cord,” said Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, in a press release.

Nearly 50% of patients who are diagnosed with stages I-II NSCLC have recurrent cancer within 5 years of resection, which increases to 75% among stage 3 patients. Until osimertinib, patients with lung cancer did not have post-surgery target treatment options, lead investigator Tsuboi explained in the press release. Without target treatment, rates of disease recurrence increase.

“We look forward to mature overall survival results for ADAURA in due time,” Galbraith said in the press release.

Reference

AstraZeneca. Tagrisso demonstrated 5.5-year median disease-free survival in the adjuvant treatment of patients with EGFR-mutated lung cancer. AstraZeneca website. September 11, 2022. Accessed on September 12, 2022. https://www.astrazeneca.com/media-centre/press-releases/2022/tagrisso-demonstrated-5-year-median-disease-free-survival-in-the-adjuvant-treatment-of-patients-with-egfr-mutated-lung-cancer.html#