Osimertinib Plus Chemo Significantly Extends Survival for Patients With Lung Cancer
A recent phase 3 study reveals osimertinib combined with chemotherapy offers unprecedented survival rates for patients with advanced EGFR-mutated lung cancer.
Patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) demonstrated the longest-ever survival rate in results of a phase 3 study of osimertinib (Tagrisso) as an EGFRm NSCLC treatment when combined with chemotherapy, according to drug manufacturer AstraZeneca.
Results of the FLAURA2 phase 3 were presented at the International Association for the Study of Lung Cancer's 2025 World Conference on Lung Cancer in Barcelona, Spain, on September 7.
What are the Existing Challenges for EGFRm NSCLC?
The general stereotype of lung cancer patients is older adults with a history of smoking, but EGFRm lung cancers present more in atypical populations, such as nonsmokers, light smokers, and young adults. Women and people of Asian or East Asian descent also show mutations in this protein.
While immunotherapies have helped patients with other types of lung cancers, the immune systems in EGFRm NSCLC patients tend to function well at the start of treatment, so immunotherapies are not as effective.2 Patients whose cancers are detected at stage 1 may expect a 5-year survival rate of up to 98%, but survival rates of the same cancer in late stages or those whose cancer has metastasized may be as low as 11%.3,4
What Were the Results of the FLAURA2 Phase 3 Study?
The study showed that patients who took osimertinib and had chemotherapy (n = 279) had an average overall survival (OS) rate of 47.5 months, compared to those who took the drug as a monotherapy (n = 278). The patients in the combination therapy arm also showed a reduced risk of death (23%; hazard ratio [HR] 0.77%). OS was consistent across all the study's prespecified subgroups for both the combination and monotherapy groups.
Patients received 80 mg of osimertinib daily. The chemotherapy was pemetrexed (500 mg/m2) plus either cisplatin (75 mg/m2) or carboplatin (AUC5) every 3 weeks for 4 cycles, followed by osimertinib with pemetrexed maintenance every 3 weeks.
The control group received standard of care, including chemotherapy.
What Do Pharmacists Need to Know?
Patients in the combination group experienced serious adverse events (AEs) at more than double the rate of the monotherapy group (70% vs 34%), but these were typical of those experienced by chemotherapy patients. Discontinuation rates in both arms were low (12% and 7%, respectively).1
Pharmacists should counsel patients on the importance of adhering to their medication schedules and the importance of reporting their symptoms as soon as possible.
Overall, the study reinforces the importance of osimertinib as a treatment for advanced EGFRm lung cancer.
David Planchard, MD, PhD, a thoracic oncologist at the Gustave Roussy Institute of Oncology in Villejuif, France, and principal investigator for the trial, called the results "compelling" and said the study reinforces osimertinib's importance as "the standard of care for patients with first-line advanced EGFR-mutated lung cancer."1
REFERENCES
1. AstraZeneca. 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. Published Sept. 7, 2025. Accessed Sept. 12, 2025. https://www.astrazeneca.com/media-centre/press-releases/2025/tagrisso-plus-chemotherapy-demonstrated-a-median-overall-survival-of-nearly-four-years.html
2. Lung Cancer Foundation of America. EGFR. Lung Cancer Foundation of America. Accessed Sept. 12, 2025. https://lcfamerica.org/about-lung-cancer/diagnosis/biomarkers/egfr/
3. Izar B, Sequist L, Lee M, et al. The impact of EGFR mutation status on outcomes in patients with resected stage I non-small cell lung cancers. The Annals of Thoracic Surgery. 2013;96(3):962-968. https://www.annalsthoracicsurgery.org/article/S0003-4975(13)01252-6/fulltext
4. Sabari JK, Yu HA, Mahadevia PJ, et al. Overall survival in EGFR‑mutant advanced NSCLC treated with first‑line osimertinib: a cohort study integrating clinical and biomarker data in the United States. Journal of Thoracic Oncology. 2025;20(9):1268‑1278. https://www.jto.org/article/S1556-0864(25)00699-9/fulltext
Newsletter
Stay informed on drug updates, treatment guidelines, and pharmacy practice trends—subscribe to Pharmacy Times for weekly clinical insights.
