AstraZeneca PLC announced Positive high-level results from the ADAURA Phase III trial showed AstraZeneca's Tagrisso (osimertinib) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS), a key secondary endpoint, compared to placebo 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. The safety and tolerability of Tagrisso in the ADAURA trial were consistent with its established profile and no new safety concerns were reported. These new ADAURA OS results in the early-stage resectable setting add to the extensive body of evidence for Tagrisso in EGFRm NSCLC which has now shown a statistically significant and clinically meaningful OS benefit in both the early adjuvant and late-stage metastatic settings.

The data will be presented at a forthcoming medical meeting. 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.1-3 Approximately 25-30% of all patients with NSCLC are diagnosed early enough to have surgery with curative intent.4-5 Further, 73% of patients with Stage IB and 56-65% of patients with Stage II disease will survive for five years.6 This decreases to 41% for patients with Stage IIIA and 24% for patients with Stage IIIB disease, reflecting a high unmet medical need.6 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. AstraZeneca has a comprehensive portfolio of approved and potential new medicines in development for patients with lung cancer. In addition to these results, the Company has also announced positive results from the AEGEAN Phase III trial of Imfinzi (durvalumab) in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery in Stage IIA-IIIB resectable NSCLC.