Positive results from the final overall survival (OS) analysis of the FLAURA2 Phase III trial showed AstraZeneca’s TAGRISSO^® (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of OS compared to TAGRISSO monotherapy in the 1st-line treatment of patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).

In the final OS analysis, TAGRISSO plus chemotherapy demonstrated a median OS of nearly four years (47.5 months) compared to approximately three years (37.6 months) for TAGRISSO monotherapy. At 57% data maturity, results showed TAGRISSO plus chemotherapy reduced the risk of death by 23% compared to TAGRISSO monotherapy (based on a hazard ratio [HR] of 0.77; 95% confidence interval [CI] 0.61-0.96; p=0.0202). An estimated 63.1% of patients treated with the combination were alive at three years and 49.1% of patients were alive at four years compared to 50.9% and 40.8%, respectively, in the monotherapy arm. Importantly, the observed OS benefit for TAGRISSO plus chemotherapy versus TAGRISSO monotherapy was consistent across all prespecified subgroups. Patients in the control arm received standard of care, including chemotherapy, upon progression, supporting the relevance of the OS results.

David Planchard, MD, PhD, Thoracic Oncologist at Gustave Roussy Institute of Oncology, Villejuif, France, and principal investigator for the trial, said: “The fundamental goals of lung cancer treatment are to extend survival while preserving patients' quality of life. These compelling results, which demonstrated unprecedented median overall survival, show this combination can achieve both of these goals and support osimertinib, with or without the addition of chemotherapy, as the standard of care for patients with 1st-line advanced EGFR-mutated lung cancer. With two highly effective osimertinib-based options for these patients, physicians can better tailor treatment to individual needs and help ensure the best possible outcome for each patient.”

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “The latest FLAURA2 trial results set a new survival standard for patients, with TAGRISSO plus chemotherapy demonstrating a median overall survival of nearly four years in 1st-line advanced EGFR-mutated lung cancer—surpassing the three-year benchmark established in the FLAURA trial. Over the past decade, TAGRISSO has consistently delivered strong survival benefits and tolerable safety across all stages of non-small cell lung cancer, cementing its role as the backbone therapy in EGFR-mutated lung cancer.”

Summary of OS results: FLAURA2

1. OS data cut-off date was 12 June 2025
2. Median follow-up duration for OS in censored patients at data cut-off: 51.2 (0.2-60.4) months for TAGRISSO plus chemotherapy and 51.3 (0.1-60.1) months for TAGRISSO monotherapy
3. Calculated by Kaplan–Meier method
4. Not calculable
5. For statistical significance, a 2-sided p-value of less than 0.04953, as determined by the O’Brien and Fleming spending rule, was required

With longer follow-up, the safety profile of TAGRISSO plus chemotherapy continued to be manageable and consistent with the established profiles of the individual medicines. Grade 3 or higher adverse events (AEs) from all causes occurred in 70% of patients in the TAGRISSO plus chemotherapy arm, driven by well-characterized chemotherapy-related AEs, versus 34% in the TAGRISSO monotherapy arm, similar to the rates reported at the primary analysis presented at the IASLC 2023 WCLC (64% versus 27%, respectively). Discontinuation rates due to AEs and on-target toxicities were low in both trial arms (12% versus 7%).