Osimertinib Plus Chemotherapy Approved in China as First-Line Treatment for EGFR-Mutated Advanced NSCLC

Osimertinib (Tagrisso) plus pemetrexed and platinum-based chemotherapy has been approved in China as a first-line treatment for adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have exon 19 deletions or exon 21 (L858R) mutations, according to an announcement from AstraZeneca.

The approval by China’s National Medical Products Administration was based on results from the phase 3 FLAURA2 trial that were published in the New England Journal of Medicine, as well as results from a prespecified exploratory subgroup analysis of efficacy and safety in Chinese patients that were presented at the European Society for Medical Oncology Asia Congress 2023, according to the announcement.

“The approval of osimertinib with the addition of chemotherapy in China is critical for the treatment of the largest population of patients with EGFR-mutated lung cancer worldwide,” Ying Cheng, MD, director of the Jilin Lung Cancer Diagnosis and Treatment Centre and principal investigator in China, said in a statement. “These patients will now have a choice of two highly effective osimertinib-based options for first-line treatment, allowing physicians to tailor their approach to their patients. This is especially important for those with a poorer prognosis, such as cancer that has spread to the brain or those who have L858R mutations.”

AstraZeneca officials said that in the overall FLAURA2 trial population, osimertinib plus chemotherapy reduced the risk of disease progression or death by 38%, compared with osimertinib monotherapy, which is “the first-line global standard of care” (hazard ratio [HR], 0.62; 95% CI, 0.49-0.79; P<.0001). The median progression-free survival (PFS) was 25.5 months for patients receiving osimertinib plus chemotherapy, 8.8 months longer than the median PFS of 16.7 months seen in patients receiving osimertinib monotherapy.

Efficacy results from the China cohort of FLAURA2 were “broadly consistent with the overall trial,” according to the announcement, which stated that osimertinib plus chemotherapy reduced the risk of disease progression or death by 44% compared with osimertinib monotherapy (HR, 0.56; 95% CI, 0.34-0.92). The median PFS was 27.4 months for patients receiving osimertinib plus chemotherapy, 5.1 months longer than the median PFS of 22.3 months in those receiving monotherapy.

“Tagrisso with the addition of chemotherapy in FLAURA2 has not only shown unprecedented [PFS] in the overall trial population, but also among Chinese patients, reducing the risk of disease progression by nearly half,” Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca, said in a statement. “This approval reinforces Tagrisso as a backbone therapy in EGFR-mutated lung cancer and acknowledges its important role, as monotherapy or with chemotherapy, in addressing the high prevalence of this disease in Asian countries and China, specifically.”

Osimertinib is approved as monotherapy in more than 100 countries, including the United States, the European Union, China, and Japan. The approved indications include as a first-line treatment for patients with locally advanced or metastatic EGFR-mutated NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of early-stage EGFR-mutated NSCLC. In addition to the new approval in China, osimertinib plus chemotherapy is also approved in the United States and several other countries as a first-line treatment of patients with locally advanced or metastatic EGFR-mutated NSCLC.

Source: AstraZeneca