China Expands Use of AstraZeneca's Tagrisso for Lung Cancer

AstraZeneca has achieved an important regulatory milestone in China with the approval of Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy. This combination is now authorized as a first-line treatment for adult patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) that has mutations in the EGFR gene, specifically exon 19 deletions or exon 21 mutations. This approval is based on the successful results from the Phase III FLAURA2 trial and represents a significant expansion of Tagrisso's usage in a strategically crucial market for AstraZeneca. Recently, the company has designated Shanghai as a global strategic hub to further underline its commitment.

Dave Fredrickson, head of AstraZeneca's oncology business unit, stated that this approval solidifies Tagrisso's role as a fundamental therapy in treating EGFR-mutated lung cancer. Whether used as a monotherapy or in combination with chemotherapy, Tagrisso addresses the high prevalence of this disease, especially in Asian countries and China. The third-generation EGFR TKI was already approved in China, as well as in the US, Europe, and Japan, for use as a monotherapy.

The pivotal 557-patient FLAURA2 study demonstrated that adding chemotherapy to Tagrisso significantly reduced the risk of disease progression or death by 38% compared to standard care with Tagrisso alone. Patients who received the combination therapy had a median progression-free survival (PFS) of 25.5 months, which is an improvement of 8.8 months over the PFS of Tagrisso monotherapy. These results were mirrored in the Chinese cohort of the study. For Chinese patients, the combination therapy reduced the risk of disease progression or death by 44%, and the median PFS was 27.4 months, 5.1 months longer than for those who received Tagrisso alone.

While overall survival (OS) data from the FLAURA2 trial is still maturing, AstraZeneca noted an "encouraging trend" in the overall population, with a hazard ratio (HR) for OS of 0.75. In the Chinese cohort, the HR was 0.97. The trial continues to monitor OS as a key secondary endpoint.

Ying Cheng, the principal investigator in China, emphasized the significance of this new approval for the treatment of the largest population of patients with EGFR-mutated lung cancer worldwide. These patients now have two highly effective first-line treatment options based on Tagrisso. The company estimates that approximately 40% of NSCLC patients in China have tumors with an EGFR mutation, and most of them are diagnosed at an advanced stage.

Earlier this year, the FDA also approved the combination of Tagrisso with pemetrexed and platinum-based chemotherapy for first-line patients with locally advanced or metastatic EGFR-mutated NSCLC, further validating the combination's efficacy and broadening its global reach.