According to AstraZeneca, its EGFR inhibitor Tagrisso (osimertinib) has shown 'unprecedented disease-free survival' in the adjuvant treatment of patients with EGFR-mutated lung cancer.
In the Phase III ADAURA trial, the drug demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent.
In patients with Stage II and IIIA disease, adjuvant treatment with Tagrisso reduced the risk of disease recurrence or death by 83%, while DFS results in the overall trial population showed a reduction of 79%.
At two years, 89% of patients in the trial treated with Tagrisso remained alive and disease free versus 53% on placebo, the firm noted, adding that consistent DFS results 'were seen across all subgroups, including patients who were treated with surgery followed by chemotherapy and those who received surgery only, as well as in Asian and non-Asian patients'.
“These data are transformative for patients with early-stage EGFR-mutated non-small cell lung cancer who face high rates of recurrence even after successful surgery and subsequent treatment with adjuvant chemotherapy. Tagrisso will provide a much-needed new treatment option that has the potential to change the practice of medicine and improve outcomes for patients in this setting,” said Roy Herbst, chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, New Haven, CT and principal investigator in the Phase III ADAURA trial.
José Baselga, executive vice president, Oncology R&D, said the “momentous results”, which will be reported at this year's ASCO, show that an EGFR inhibitor “can change the course of early-stage EGFR-mutated lung cancer and provide hope for a cure,” and added that the firm is discussing the data with regulatory authorities.”
In April an Independent Data Monitoring Committee recommended for the Phase III ADAURA trial to be unblinded two years early based on its determination of 'overwhelming efficacy'. At the time of data cut-off, overall survival (OS) data favoured Tagrisso, but were not mature. The trial will continue to assess OS as a secondary endpoint, AZ said.