AstraZeneca's Osimertinib Receives NMPA Approval for Adjuvant Treatment of EGFR-Mutated NSCLC Post-Surgery

Today, the official website of the National Medical Products Administration (NMPA) showed that the approval status of AstraZeneca’s new indication application for osimertinib mesylate tablets (Acceptance Numbers: JXHS2000150/JXHS2000151) has been updated to “Approval Completed – Pending Certificate Issuance.” This means that the indication for osimertinib tablets as adjuvant treatment in adult patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations after tumor resection has been approved by the NMPA. This is the third indication for osimertinib approved in China.

Osimertinib is an irreversible third-generation EGFR tyrosine kinase inhibitor that can simultaneously inhibit EGFR sensitizing mutations and the EGFR T790M resistance mutation. Compared with first- and second-generation EGFR-TKIs, it has a greater ability to penetrate the blood-brain barrier and demonstrates significant efficacy in patients with central nervous system metastases.

Osimertinib was first approved in China in March 2017 for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who experienced disease progression during or after prior treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) and whose tumors tested positive for the EGFR T790M mutation. On September 3, 2019, osimertinib mesylate tablets were approved for first-line treatment of NSCLC patients with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. In December 2020, osimertinib was renewed and included in the updated National Reimbursement Drug List (Class B), with both first- and second-line indications fully covered.

Results from the phase III ADAURA study demonstrated that osimertinib provided a statistically significant and clinically meaningful benefit in disease-free survival (DFS) both in the primary analysis population of patients with stage II–IIIA EGFR-mutated non-small cell lung cancer (NSCLC) and in the overall study population of patients with stage IB–IIIA disease, assessed at the key secondary endpoint.

Adjuvant osimertinib therapy reduced the risk of disease recurrence or death, the primary endpoint, by 83% in patients with stage II and IIIA disease (hazard ratio [HR] 0.17; 95% CI: 0.12–0.23; p<0.0001). In the overall trial population of patients with stage IB–IIIA disease, DFS results demonstrated that osimertinib reduced the risk of disease recurrence or death by 80% (HR 0.20; 95% CI: 0.15–0.27; p<0.0001). At two years, the DFS rate was 89% among patients receiving osimertinib, compared with 52% in the postoperative placebo group, which represents the current standard of care. The safety and tolerability profile of osimertinib in this study was consistent with findings from previous studies in metastatic non-small cell lung cancer.