Topline Findings
- Tagrisso plus chemotherapy survival benefit: Median overall survival (OS) of nearly four years in first-line EGFR-mutated non-small cell lung cancer (NSCLC) is the longest reported in a global Phase III trial.
- Efficacy and risk reduction: Combination therapy reduced the risk of death by 23% versus Tagrisso monotherapy (HR 0.77; 95% CI 0.61–0.96; p=0.0202), with consistent benefits across all patient subgroups.
- Manageable safety profile: Grade ≥3 adverse events (AEs) occurred in 70% of patients administered the combination, largely chemotherapy-related, with discontinuation rates of 12% compared to 7% for monotherapy.
Results from the Phase III FLAURA2 trial (NCT04035486) showed that AstraZeneca’s Tagrisso (osimertinib) combined with chemotherapy demonstrated a median overall survival (OS) of nearly four years in the first-line treatment of patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC), marking the longest overall survival benefit reported in a global Phase III trial for this population.1
How Could Tagrisso plus Chemotherapy Change Treatment Strategies for Advanced EGFR-Mutated NSCLC?
“The fundamental goals of lung cancer treatment are to extend survival while preserving patients' quality of life,” said FLAUR2 trial principal investigator David Planchard, MD, PhD, thoracic oncologist, Gustave Roussy Institute of Oncology, Villejuif, France, in the press release. “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 first-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.”
FLAUR2 Trial Design and Key Results
- The randomized, open-label, multi-center FLAUR2 trial evaluated Tagrisso as a first-line treatment for locally advanced or metastatic EGFR-mutated NSCLC in combination with pemetrexed and platinum-based chemotherapy.
- During the trial, 557 patients received the combination every three weeks for four cycles, followed by Tagrisso with pemetrexed maintenance every three weeks.
- The primary endpoints of the trial were adverse events (AEs) graded by common terminology criteria for AEs, progression-free survival, and sensitivity analysis for PFS by blinded independent central review.
- Key secondary endpoints included OS, duration of response, objective response rate, disease control rate, and depth of response.1,2
- Results showed that the combination reduced the risk of death by 23% versus Tagrisso monotherapy (HR 0.77; 95% CI 0.61–0.96; p=0.0202), with OS benefits consistent across all prespecified subgroups, despite patients in the control arm receiving standard-of-care therapies upon progression.
- Survival rates at three and four years were 63.1% and 49.1% with the combination, versus 50.9% and 40.8% with monotherapy, respectively.
- The safety profile of Tagrisso plus chemotherapy was reported to be manageable and consistent with the established profiles of the individual medicines.
- Grade 3 or higher AEs were reported in 70% of patients in the combination arm compared to 34% in the monotherapy arm.
- Twelve percent of patients in the combination arm discontinued treatment due to AEs compared to 7% in the monotherapy arm.1
Lung Cancer Context
- According to the American Cancer Society, lung cancer is the most commonly diagnosed form of cancer and the leading cause of cancer death worldwide.
- In 2022, approximately one out of every eight cancers diagnosed globally were lung cancer, representing 12% of all cancers.
- In men, the prevalence was the highest in Hungary, Serbia, Bulgaria, and Turkey. In women, the prevalence was the highest in China and North Korea.3
“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 first-line advanced EGFR-mutated lung cancer—surpassing the three-year benchmark established in the FLAURA trial,” said Susan Galbraith, EVP, oncology hematology R&D, AstraZeneca, in the press release. “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.”
References
- Tagrisso plus chemotherapy demonstrated a median overall survival of nearly four years, the longest benefit ever reported in a global Phase III trial in EGFR-mutated advanced lung cancer. AstraZeneca. September 7, 2025. Accessed September 8, 2025. https://www.astrazeneca.com/media-centre/press-releases/2025/tagrisso-plus-chemotherapy-demonstrated-a-median-overall-survival-of-nearly-four-years.html
- A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2) (FLAURA2)/ Clinicaltrials.gov. Accessed September 8, 2025. https://clinicaltrials.gov/study/NCT04035486?term=NCT04035486&rank=1
- Lung Cancer Kills More People Worldwide Than Other Cancer Types. American Cancer Society. Accessed September 8, 2025. https://www.cancer.org/research/acs-research-news/lung-cancer-kills-more-people-worldwide-than-other-cancers.html
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