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China Approves Tagrisso Combined with Chemotherapy as First-Line Treatment for Advanced EGFR-Mutated Lung Cancer | 2024 | iPharmaCenter

Tagrisso approved in China for NGFRm NSCLC
Tagrisso approved in China for NGFRm NSCLC

China’s National Medical Products Administration (NMPA) has granted approval for AstraZeneca’s Tagrisso (osimertinib), combined with pemetrexed and platinum-based chemotherapy, as a first-line treatment for adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with exon 19 deletions or exon 21 (L858R) mutations.

This approval is founded on the results from the Phase III FLAURA2 trial, published in The New England Journal of Medicine, and the findings from a prespecified exploratory subgroup analysis of efficacy and safety in Chinese patients, presented at the European Society for Medical Oncology (ESMO) Asia Congress 2023.

FLAURA2 Trial Details

FLAURA2 is a randomized, open-label, multi-center, global Phase III trial evaluating first-line treatment of patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC. Participants received Tagrisso 80mg once daily with added chemotherapy (pemetrexed 500mg/m2 plus cisplatin 75mg/m2 or carboplatin AUC5) every three weeks for four cycles, followed by Tagrisso with pemetrexed maintenance every three weeks.

The trial enrolled 557 patients across more than 150 centers in over 20 countries, including the US, Europe, South America, and Asia. The primary endpoint is PFS, with ongoing assessment of OS as a secondary endpoint.

In the overall trial population, Tagrisso combined with chemotherapy significantly reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy, which is the current global standard of care for first-line treatment. This was reflected in a hazard ratio of 0.62. Patients treated with the combination therapy had a median progression-free survival (PFS) of 25.5 months, an improvement of 8.8 months over Tagrisso alone (16.7 months).

By blinded independent central review (BICR), the PFS results were consistent, showing a median PFS of 29.4 months with the combination therapy, a 9.5-month improvement over monotherapy (19.9 months).

Although overall survival (OS) data is still immature at the second interim analysis (41% maturity), there is a promising trend towards an OS benefit with the combination therapy versus monotherapy. The trial continues to evaluate OS as a key secondary endpoint.

For the Chinese cohort within the FLAURA2 trial, the efficacy results aligned broadly with the overall trial findings.

China sees over a million new lung cancer cases annually, representing more than a third of the global lung cancer population. Among those with NSCLC, about 40% of patients in China have tumors with an EGFR mutation.

The safety profile of Tagrisso combined with chemotherapy was generally manageable and consistent with the known profiles of the individual medications. Adverse event (AE) rates were higher in the combination therapy group, primarily due to well-characterized chemotherapy-related AEs. Discontinuation rates due to AEs were 11% for the combination therapy and 6% for monotherapy.

Tagrisso is approved as monotherapy in over 100 countries, including the US, EU, China, and Japan. Approved indications include first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage EGFRm NSCLC. This new approval in China also includes the combination with chemotherapy for first-line treatment of locally advanced or metastatic EGFRm NSCLC, already approved in the US and several other countries.


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