Tagrisso plus chemotherapy achieves nearly four-year median overall survival in EGFR-mutated advanced lung cancer, setting new global standard in phase III trial
AstraZeneca announced positive final overall survival (OS) results from the Phase III FLAURA2 trial, demonstrating that Tagrisso (osimertinib) in combination with pemetrexed and platinum-based chemotherapy achieved the longest survival benefit ever reported in a global Phase III study for patients with advanced epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
The data, presented during the Presidential Symposium at the IASLC 2025 World Conference on Lung Cancer (WCLC) in Barcelona, showed that the combination delivered a median OS of 47.5 months—nearly four years—compared with 37.6 months for Tagrisso monotherapy.
David Planchard, MD, PhD, Thoracic Oncologist at Gustave Roussy Institute of Oncology in Villejuif, France, and principal investigator of the trial, said: “The fundamental goals of lung cancer treatment are to extend survival while preserving patients’ quality of life. These compelling results, which demonstrate unprecedented median overall survival, show that this combination can achieve both. They firmly establish osimertinib—with or without chemotherapy—as the standard of care for 1st-line advanced EGFR-mutated lung cancer. With two highly effective options, physicians can better tailor treatment to individual patient needs and maximize outcomes.”
Susan Galbraith, Executive Vice President, Oncology R&D at AstraZeneca, said:
“The FLAURA2 final analysis sets a new survival benchmark in EGFR-mutated advanced lung cancer, with Tagrisso plus chemotherapy extending median overall survival to nearly four years, surpassing the three-year standard established in the landmark FLAURA trial. For nearly a decade, Tagrisso has consistently delivered strong survival outcomes with a well-characterized safety profile across stages of non-small cell lung cancer. These results reinforce Tagrisso’s role as the backbone of treatment in EGFR-mutated lung cancer.”
With the FLAURA2 results, Tagrisso strengthens its position as the global standard of care in 1st-line advanced EGFR-mutated NSCLC and as the foundation for future therapeutic strategies in this patient population.
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