AstraZeneca's Osimertinib Gains New Approval in China for Unresectable Stage III EGFR-Mutated NSCLC

On January 2, the NMPA official website showed that a new indication of Osimertinib applied by AstraZeneca was approved for marketing in China.Used for treating patients who have not experienced disease progression during or after receiving platinum-based chemoradiotherapy and have epidermal growth factor receptor（EGFR）Exon 19 deletion or Exon 21（L858R）Locally advanced, unresectable substitution mutation(Phase III)Non-Small Cell Lung Cancer（NSCLC）Adult patients(Application No.: JXHS2400041/2)。

Screenshot source: NMPA official website

At the 2024 ASCO Annual Meeting, AstraZeneca presented a Phase III, randomized, double-blind, placebo-controlled, global multicenter study.（LAURA）TheCritical Clinical Evidence. This study aims to evaluate the efficacy and safety of osimertinib as maintenance therapy in patients with stage III unresectable EGFR-mutated NSCLC after chemoradiotherapy.

Blinded Independent Review Center（BICR）Evaluation, compared with the placebo group, patients receiving Osimertinib treatmentReduced the risk of disease progression or death by 84%。The median PFS for patients treated with osimertinib was 39.1 months, compared to 5.6 months in the placebo group.。PFS Rate at 12 Months for Patients Receiving Osimertinib（74% vs 22%）At 24 months（65% vs 13%）Significantly ImproveOS data were not yet mature at the time of this assessment, but compared with placebo, osimertinib still demonstratedOS Benefit TrendMomentum。

In terms of safety, the incidence of ≥G3 adverse reactions in patients treated with Osimertinib was 35% (vs 12%), the incidence of serious adverse reactions was 38% (vs 15%), the incidence of radiation pneumonitis toxicity was 48% (vs 38%), and the incidence of adverse reactions leading to discontinuation was 13% (vs 5%).

Screenshot source: Insight database

At the 2024 ESMO Congress, AstraZeneca presented in an oral report LAURA China SubgroupClinical data. The study results show,Clinical benefits and safety of osimertinib treatment in Chinese patients are consistent with the global population, SupportOsimertinib as Maintenance Therapy After Chemoradiotherapy in Patients with Stage III Unresectable EGFR-Mutated NSCLC as a New Treatment Standard.

Osimertinib is AstraZenecaSelf-developedAn irreversibleThird-generation EGFR-TKI, in the treatment of non-small cell lung cancer(Including with central nervous system metastasis)There is confirmed clinical activity in the patients.

Osimertinib since 2015First FDA ApprovalAfter being launched, it becameThe World's First Third-Generation EGFR-TKI Targeted Lung Cancer Drug, and was subsequently approved in the European Union, Japan, and other regions and countries. Previously,Osimertinib has been approved for 4 indications in China：

• In March 2017, it was approved for the first time in China, for patients with locally advanced or metastatic NSCLC who have progressed after prior EGFR-TKI treatment and are positive for the EGFR T790M mutation;

• In September 2019, it was approved for use in EGFR exon 19 deletions or exon 21.（L858R）First-line treatment for adult patients with locally advanced or metastatic NSCLC harboring substitution mutations;

• In April 2021, it was approved for adjuvant treatment in adult patients with NSCLC who have EGFR-sensitive mutations after tumor resection.

• In June 2024, combined with pemetrexed and platinum-based chemotherapy drugs for EGFR exon 19 deletion or exon 21（L858R）First-line treatment for adult patients with locally advanced or metastatic NSCLC harboring substitution mutations.

Since its first approval, the sales of Osimertinib have been on the rise. In 2023, global sales reached 5.799 billion US dollars. In the first 9 months of 2024, global sales amounted to 4.877 billion US dollars,The Second-Highest Revenue in AstraZeneca's Product PipelineThe flagship product.

Insight database shows that, apart from Osimertinib,Currently, there are 5 third-generation EGFR-TKIs approved in China.City, all produced in China, respectivelyHansoh PharmaAmeitinib,AstralisFurmonertinib,Betta PharmaceuticalsBeftinib,Beirun PharmaRuiqiti andShenghe PharmaceuticalDuiruotinib.

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