Tagrisso with the addition of chemotherapy approved in the EU as new 1st-line treatment for patients with EGFR-mutated advanced lung cancer.- AstraZeneca

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the FLAURA2 Phase III trial published in The New England Journal of Medicine (previously cited).

In the trial, Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death by 38% by investigator assessment compared to Tagrisso monotherapy, which is the 1st-line global standard of care (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.49-0.79; p<0.0001). median progression-free survival (pfs) was 25.5 months for patients treated with tagrisso plus chemotherapy, an 8.8-month improvement versus tagrisso monotherapy (16.7 months). pfs results from blinded independent central review (bicr) were consistent with the results by investigator assessment, showing 29.4 months median pfs with tagrisso plus chemotherapy, a 9.5-month improvement over tagrisso monotherapy (19.9 months) (hr 0.62; 95% ci 0.48-0.80; nominal p="0.0002).">

Results from a prespecified exploratory analysis of patients in the FLAURA2 trial with brain metastases at baseline showed Tagrisso plus chemotherapy reduced the risk of central nervous system (CNS) disease progression or death by 42% compared to Tagrisso monotherapy (HR 0.58; 95% CI 0.33-1.01) as assessed by BICR. With two years of follow up, 74% of patients treated with Tagrisso plus chemotherapy had not experienced CNS disease progression or death versus 54% of patients treated with Tagrisso monotherapy.

While the overall survival (OS) results remained immature at the second interim analysis (41% maturity), a trend towards an OS benefit was observed with Tagrisso plus chemotherapy versus Tagrisso alone (HR 0.75; 95% CI 0.57-0.97), as presented at the 2024 European Lung Cancer Congress. The trial continues to assess OS as a key secondary endpoint.

David Planchard, MD, PhD, Thoracic Oncologist at Gustave Roussy Institute of Oncology and principal investigator for the trial, said: “Today’s news marks a significant advance for patients with EGFR-mutated lung cancer in Europe, providing a new 1st-line treatment option with osimertinib now in combination with chemotherapy. The FLAURA2 results build on the established efficacy of osimertinib monotherapy, showing a meaningful nine-month improvement in progression-free survival and offering physicians the option to tailor treatment to a patient’s specific needs.”