Tagrisso (osimertinib) with the addition of chemotherapy showed favourable trend in overall survival in EGFR-mutated advanced lung cancer with further follow up in FLAURA2 phase III trial. - AstraZeneca

Tagrisso with the addition of chemotherapy also demonstrated a favourable trend toward overall survival (OS) improvement at two years of follow up. These results were presented at the 2024 European Lung Cancer Congress (ELCC) in Prague, Czech Republic (abstract #4O).

This follows primary endpoint data presented at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (WCLC) and published in The New England Journal of Medicine (previously cited), which showed Tagrisso with the addition of chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS). In February 2024, Tagrisso with the addition of chemotherapy was approved in the US following a Priority Review by the FDA based on these results.

At 41% data maturity, the OS interim results showed a favourable trend with the Tagrisso plus chemotherapy arm (hazard ratio [HR] 0.75; 95% confidence interval [CI] 0.57-0.97), with consistent results across prespecified subgroups, including sex, race, type of EGFR mutation, age at time of diagnosis, smoking history, performance status and central nervous system (CNS) metastases status at baseline. The OS data were not statistically significant at this interim analysis and will continue to be assessed as a key secondary endpoint at final analysis.

Tagrisso with the addition of chemotherapy also showed a consistent benefit across prespecified post-progression endpoints of time to first subsequent treatment (TFST; HR 0.73; 95% CI 0.56-0.94), time to progression on 2nd-line therapy (PFS2; HR 0.70; 95% CI 0.52-0.93) and time to second subsequent treatment (TSST; HR 0.69; 95% CI 0.51-0.93).

Pasi A. Jänne, MD, PhD, medical oncologist at Dana-Farber Cancer Institute and principal investigator for the trial, said: “The improvement in post-progression outcomes with chemotherapy added to standard-of-care osimertinib is encouraging for patients with advanced EGFR-mutated lung cancer, particularly the encouraging trend toward overall survival. These results further validate the importance of this additional treatment option, especially for those patients whose cancer has spread to the brain, those with L858R mutations, or other cause for poorer prognosis.”