AstraZeneca declares positive results from trial of Tagrisso plus chemotherapy to treat EGFR-mutated advanced lung cancer
Cambridge: AstraZeneca has announced positive results from FLAURA2 phase III trial of Tagrisso (osimertinib) in combination with chemotherapy for the treatment of EGFR-mutated advanced lung cancer.
Tagrisso (osimertinib) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS), compared to Tagrisso alone for patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
These results were presented in a Presidential Symposium at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (WCLC) (abstract #PL03).
Results showed Tagrisso plus chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso alone (based on a hazard ratio [HR] of 0.62; 95% confidence interval [CI] 0.49-0.79; p<0.0001). By investigator assessment, the combination extended median PFS by 8.8 months versus Tagrisso alone. PFS results from blinded independent central review (BICR) were consistent, showing Tagrisso plus chemotherapy extended median PFS by 9.5 months (based on HR of 0.62; 95% CI 0.48-0.80; p=0.0002). Importantly, a clinically meaningful PFS benefit was observed across all prespecified subgroups, including sex, race, type of EGFR mutation, age at time of diagnosis, smoking history and central nervous system (CNS) metastases status at baseline.
At the time of this analysis, the overall survival (OS) data were immature however, a favourable trend was observed for Tagrisso plus chemotherapy.
Pasi A. Jänne, MD, PhD, medical oncologist at Dana-Farber Cancer Institute and principal investigator for the FLAURA2 trial, said, “Patients received nearly nine additional months before their EGFR-mutated non-small cell lung cancer progressed as a result of the addition of chemotherapy to standard-of-care osimertinib, building on the strong efficacy we have already seen with osimertinib monotherapy. With these convincing data, patients may soon have a choice of two highly effective osimertinib-based treatment options in this advanced disease setting.”
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said, “The compelling FLAURA2 results add to the extensive evidence supporting Tagrisso as the backbone therapy in EGFR-mutated non-small cell lung cancer and establish a new benchmark for progression-free survival in this setting. We look forward to bringing this potential treatment regimen to patients with advanced lung cancer to further delay disease progression, especially for patients with the greatest unmet need including those with central nervous system metastasis at diagnosis."
Safety results and discontinuation rates due to adverse events (AEs) were consistent with the established profiles of each medicine and no new safety concerns were reported. Grade 3 or higher AEs from all causes occurred in 64% of patients in the Tagrisso plus chemotherapy arm versus 27% in the Tagrisso monotherapy arm.
