WILMINGTON, Del. — AstraZeneca announced that its targeted therapy TAGRISSO® (osimertinib), when combined with pemetrexed and platinum-based chemotherapy, significantly extends overall survival in patients with previously untreated, advanced EGFR-mutated non-small cell lung cancer (NSCLC), according to final results from the Phase III FLAURA2 trial.
The combination demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared to TAGRISSO alone, reinforcing the drug’s role as a foundational treatment for EGFR-mutated lung cancer across disease stages.
“These positive results support osimertinib, either as monotherapy or in combination with chemotherapy, as standard of care for patients with 1st-line advanced EGFR-mutated lung cancer,” said Dr. Pasi A. Jänne, senior vice president of translational medicine at Dana-Farber Cancer Institute and lead investigator of the FLAURA2 trial. “The observed survival benefit is particularly impressive given that the study allowed any subsequent treatments after disease progression.”
The findings build on previously reported interim OS results and primary endpoint data showing that TAGRISSO combined with chemotherapy offers the longest median progression-free survival seen to date in this patient group.
“TAGRISSO plus chemotherapy can significantly extend survival in the 1st-line advanced setting,” said Susan Galbraith, executive vice president of Oncology R&D at AstraZeneca. “These results add to the extensive evidence supporting TAGRISSO as the backbone therapy in EGFR-mutated lung cancer and show that patients can live longer while maintaining quality of life.”
The safety profile of the combination remained manageable with longer-term follow-up. While adverse events were more common in the combination arm due to known chemotherapy-related effects, discontinuation rates for treatment-related toxicity were low across both groups.
AstraZeneca plans to present the full findings at an upcoming medical meeting and submit the data to global regulatory authorities for potential label expansion.
