Tagrisso Approved in the EU and China for Adjuvant Treatment of Early-Stage EGFR-Mutated NSCLC, Transforming Clinical Practice

May 28, 2021 /BioonBIOON/ --AstraZeneca(AstraZeneca) recently announced that the European Commission (EC) has approved the targeted anticancer drug Tagrisso (Chinese trade name: Tai Ruisha, generic name: osimertinib) as an adjuvant (post-operative) therapy for the treatment of adult patients with early-stage (Stage IB/II/IIIA) epidermal growth factor receptor mutation-positive (EGFRm) non-small cell lung cancer (NSCLC) who have undergone complete tumor resection with curative intent. Tagrisso is indicated forTumorpatients with EGFRm NSCLC harboring EGFR exon 19 deletion (EGFR Ex19Del) or exon 21 substitution mutation (EGFR L858R) are present in.

To date, Tagrisso has been approved in more than 50 countries worldwide for the treatment of early-stage lung cancer. In China, Tagrisso received approval from the National Medical Products Administration (NMPA) in April 2021: as an adjuvant (postoperative) therapy, with or without adjuvant chemotherapy at the physician's discretion, for the treatment of adult patients with early-stage (Stage IB/II/IIIA) EGFR-mutant (EGFRm) non-small cell lung cancer (NSCLC) who have undergone complete tumor resection with curative intent. The drug is indicated forTumorpatients with EGFRm NSCLC harboring EGFR exon 19 deletion (EGFR Ex19Del) or exon 21 substitution mutation (EGFR L858R).

It is worth noting that,Tagrisso is the only targeted therapy to demonstrate efficacy in treating early-stage lung cancer in a global clinical trial, and the first of its kind approved in China.In China, this indication was approved through the priority review program."Unprecedented" results from the ADAURA Phase III trial show that adjuvant Tagrisso reduces the risk of disease recurrence or death by 80%.

This approval will change clinical practice in early EGFR-mutant lung cancer., as it underscores the critical importance of EGFR mutation testing across all stages of lung cancer, to ensure that as many patients as possible can benefit from targeted therapies.

Lung Cancer

Lung cancer is a devastating disease, although up to 30% of patients with non-small cell lung cancer (NSCLC) mayDiagnosisdiagnosed early enough to undergo curative surgery, disease recurrence remains common in early-stage disease. Based on historical data, nearly half of patients diagnosed at stage IB and more than three-quarters of those diagnosed at stage IIIA will experience recurrence within 5 years. Among the global lung cancer patient population, approximately one-fifth are in the European Union and more than one-third are in China. In the European Union, approximately 15% of NSCLC patients have tumors with EGFR mutations; whereas in China, approximately 40% of NSCLC patientsTumorEGFR mutation is present.

AstraZeneca Executive Vice President, Global, andTumorDave Fredrickson, Head of the Business Unit, said: “We know that the earlier a patient’s cancer is detected and treated, the greater the chance of a cure, which is why this approval is so significant. For the first time in the EU, patients with EGFR-mutated lung cancer have a targeted, biomarker-driven treatment option in the early stages of the disease, which can help extend their disease-free survival.”

This approval is based on the positive results from the global Phase III registrational clinical trial ADAURA. The data demonstrated that Tagrisso showed a statistically significant and clinically meaningful disease-free survival (DFS) benefit in both the primary study population of patients with stage II and IIIA EGFRm NSCLC and the stage IB–IIIA patient population for the secondary endpoint.

The specific data are: (1)In patients with stage II and IIIA disease, DFS results showed that Tagrisso reduced the risk of disease recurrence or death by 83%.（HR=0.17；99.06%CI:0.11-0.26；p<0.001 ）；（2）In the overall study population of patients with stage IB–IIIA disease, DFS results showed that Tagrisso reduced the risk of disease recurrence or death by 80%.（HR=0.20；99.12%CI:0.14-0.30；p<0.001）。Consistent DFS benefit was observed across all prespecified subgroups, including Asian and non-Asian patients, regardless of prior adjuvant chemotherapy use.. The safety and tolerability profile of Tagrisso in this study was consistent with that observed in prior studies of metastatic NSCLC. The relevant study results have been published in 《The New England Journal of Medicine》 (NEJM).

Tagrisso is an oral, small-molecule, third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that has previously been approved in multiple countries and regions worldwide (including the United States, Japan, China, and the European Union): (1) as first-line treatment for patients with locally advanced or metastatic EGFRm NSCLC; (2) as second-line treatment for patients with locally advanced or metastatic NSCLC positive for the EGFR T790M mutation. Additionally, Tagrisso has been approved in more than ten countries, including the United States, for the treatment of early-stage lung cancer.

In China, Tagrisso for the treatment of early-stage EGFRm NSCL followsSecond-line treatment of EGFR T790M-mutated NSCLC, first-line treatment of EGFR-mutated NSCLCthe third indication subsequently approved,The first two indications have both been included in the National Reimbursement Drug List.。

Tagrisso is a third-generation irreversible EGFR-TKI with clinical activity against central nervous system metastases. Globally, Tagrisso has treated approximately 250,000 patients.

Currently, AstraZeneca is developing Tagrisso for the treatment of patients with EGFRm NSCLC across multiple disease stages, including: treatment of stage III locally advanced unresectable disease (LAURA trial), neoadjuvant treatment for resectable disease (NeoADAURA), in combination with chemotherapy for metastatic disease (FLAURA2), and in combination with potential novel agents to overcome resistance to EGFR TKIs (SAVANNAH trial, ORCHARD trial). (Bioon.com)

Source: Tagrissoapproved in the EU for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer