Tagrisso demonstrated strong overall survival benefit in the ADAURA phase III trial for adjuvant treatment of patients with early-stage EGFR-mutated lung cancer.- AstraZeneca

In May 2020, AstraZeneca announced Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in this setting. In September 2022, updated results demonstrated a median DFS of nearly five and a half years.

Per the ADAURA trial protocol, patients on placebo that recurred with metastatic disease had the opportunity to receive open-label Tagrisso.

Roy S. Herbst, MD, PhD, Deputy Director and Chief of Medical Oncology at Yale Cancer Center and Smilow Cancer Hospital, New Haven, Connecticut, and principal investigator in the ADAURA Phase III trial, said: “These new survival data for osimertinib reinforce the unprecedented ADAURA disease-free survival results and confirm its potential to extend patients’ lives in early-stage disease. The ADAURA results provide powerful evidence that osimertinib offers the best possible care for patients with early-stage EGFR-mutated non-small cell lung cancer who historically faced high rates of recurrence and previously had no targeted options after surgery.”

The safety and tolerability of Tagrisso in the ADAURA trial were consistent with its established profile and no new safety concerns were reported.

Each year there are an estimated 2.2 million people diagnosed with lung cancer globally with 80-85% of patients diagnosed with NSCLC, the most common form of lung cancer. Approximately 25-30% of all patients with NSCLC are diagnosed early enough to have surgery with curative intent. Further, 73% of patients with Stage IB and 56-65% of patients with Stage II disease will survive for five years.This decreases to 41% for patients with Stage IIIA and 24% for patients with Stage IIIB disease, reflecting a high unmet medical need.

AstraZeneca has several ongoing registrational trials focused on testing Tagrisso in earlier stages of lung cancer, including in the neoadjuvant resectable setting (NeoADAURA), in the Stage IA2-IA3 adjuvant resectable setting (ADAURA2), and in the Stage III locally advanced unresectable setting (LAURA)

Tagrisso is approved to treat early-stage lung cancer in more than 90 countries, including in the US, EU, China and Japan, and additional global regulatory reviews are ongoing. Tagrisso is also approved for the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC and for the treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC in the US, EU, China, Japan and many other countries.