Tagrisso approved in the EU for the adjuvant treatment
of patients with early-stage EGFR-mutated lung cancer
Approval based on unprecedented results from the ADAURA Phase III trial
where Tagrisso reduced the risk of disease recurrence or death by 80%
AstraZeneca's Tagrisso (osimertinib) has been approved in the European Union (EU) for the adjuvant treatment of adult 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. Tagrisso is indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 (L858R) mutations.
The approval by the European Commission was based on positive results from the ADAURA Phase III trial in which Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the primary analysis population of patients with Stage II and IIIA EGFRm NSCLC. The trial also showed a statistically significant and clinically meaningful improvement in DFS for Tagrisso in the overall trial population, a key secondary endpoint.
While up to 30% of all patients with NSCLC may be diagnosed early enough to have surgery with curative intent, recurrence is still common in early-stage disease. Historically, nearly half of patients diagnosed in Stage IB, and over three quarters of patients diagnosed in Stage IIIA, have experienced disease recurrence within five years.1-3 About a fifth of the world's lung cancer patients are in the EU and among those with NSCLC, approximately 15% have tumours with an EGFR mutation.4-6
Margarita Majem, MD, PhD, Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Spain, said: “In the early stages of lung cancer, where tumour resection is possible but recurrence is far too common, adjuvant Tagrisso has shown an unprecedented disease-free survival benefit for patients with EGFR mutations. I expect this approval will change clinical practice in the EU, as it heightens the critical importance of EGFR mutation testing across all stages of lung cancer to ensure as many patients as possible can benefit from targeted medicines like Tagrisso.”
Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: “We know the earlier a patient's cancer is detected and treated, the greater chance they may have of being cured, which is why this approval is significant. For the first time, patients in the EU with EGFR-mutated lung cancer have a targeted, biomarker-driven treatment option available in the early stages of their disease that can help them live cancer-free longer.”
In the ADAURA trial, adjuvant treatment with Tagrisso reduced the risk of disease recurrence or death by 83% in patients with Stage II and IIIA disease (hazard ratio [HR] 0.17; 99.06% confidence interval [CI] 0.11-0.26; p<0.001) and by 80% in the overall trial population of patients with Stage IB-IIIA disease (HR 0.20; 99.12% CI 0.14-0.30; p<0.001).
Consistent DFS results were seen regardless of prior adjuvant chemotherapy use and across all prespecified subgroups. The safety and tolerability of Tagrisso in this trial was consistent with previous trials in the metastatic setting. The ADAURA results were published in The New England Journal of Medicine .
Tagrisso is now approved to treat early-stage lung cancer in more than fifty countries, including in the US and China , 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 EU, the US, Japan, China and many other countries.