Lung cancer is the foremost cause of cancer death among both men and women, which is responsible for approximately one-fifth of all cancer deaths. Lung cancer is generally split into non-small cell lung cancer (NSCLC) and small cell lung cancer, with 80-85% classified as NSCLC. The majority of all NSCLC patients are diagnosed with advanced disease, while approximately 20% in the US and EU and about 35% in Japan present with EGFRm at diagnosis.
ADAURA is a randomized, double-blinded, global, placebo-controlled phase III trial in the adjuvant treatment of 682 patients with stage IB, II, IIIA EGFRm NSCLC resulting in the complete tumor resection and adjuvant chemotherapy as indicated. Patients were treated with Tagrisso 80mg once-daily oral tablets or placebo for three years or until disease recurrence.
The primary endpoint is DFS in Stage II, and IIIA patients, and a key secondary endpoint is DFS in Stage IB, II, and IIIA patients. The data readout was originally anticipated in 2022. The trial will continue to assess overall survival.
Results from a prespecified exploratory analysis of the positive ADAURA phase III trial of Tagrisso (osimertinib) established a clinically meaningful improvement with an 82% reduction in risk of central nervous system (CNS) disease-free survival (DFS) in the adjuvant treatment of patients with early-stage (IB, II, and IIIA) EGFRm NSCLC, after complete tumor resection. Overall, 682 patients were randomized out of which 339 were with osimertinib and 343 with placebo (PBO). Patients treated with osimertinib had fewer recurrence events vs PBO 45 patients had CNS DFS events (osimertinib: 6; PBO: 39; median follow-up 22 months [mo]). Conditional probability of CNS recurrence at 12 mo (95% CI): <1% (0%, 2%) with osimertinib vs 7% (4%, 10%) with PBO. Median CNS DFS: not reached (95% CI 39.0 mo, not calculable [NC]) with osimertinib vs 48.2 (NC, NC) mo with PBO. CNS DFS HR: 0.18 (95% CI 0.10, 0.33); p<0.0001.
These exceptional results establish Tagrisso expanding on its proven efficacy in treating progression in the brain in the metastatic setting as a result of its ability to cross the blood-brain barrier. Tagrisso is not currently approved for the adjuvant setting in any country. Tagrisso received Breakthrough Therapy Designation in July 2020 for the adjuvant treatment of patients with early-stage EGFRm NSCLC after complete tumor resection with curative intent. Tagrisso is approved for the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC and the treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC in the US, Japan, China, the EU, and many other countries around the world.
Also, as per Delveinsight estimates in the report titled “Non-small cell lung cancer (NSCLC) -Market Insights, Epidemiology, and Market Forecast-2030” Tagrisso (osimertinib) will remain the standard of care in the future and is also expected to dominate the market in future with the major market share in EGFRm NSCLC market.