Osimertinib improved progression-free survival in patients with unresectable stage III EGFR-mutated non–small cell lung cancer (NSCLC) that has been treated with chemoradiotherapy—and may be a new standard of care for this population, according to research presented by Suresh Ramalingam, MD, FACP, FASCO, and colleagues at the 2024 ASCO Annual Meeting (Abstract LBA4).
Suresh Ramalingam, MD, FACP, FASCO
About the LAURA Study
The international phase III LAURA trial enrolled patients with unresectable stage III NSCLC with EGFR mutations without any disease progression during/after definitive platinum-based chemoradiotherapy. People were randomly assigned 2:1 to receive osimertinib (n = 143) or placebo (n = 73).
The median patient age was 62 years in the osimertinib arm and 64 years in the placebo arm. The majority of the trial participants were female (63% in the osimertinib arm, 58% in the placebo arm), Asian (81% in the osimertinib arm, 85% in the placebo arm), and had never smoked (63% in the osimertinib arm, 67% in the placebo arm).
Key Findings
Osimertinib significantly improved progression-free survival when compared with placebo. The median progression-free survival was 39 months in the osimertinib group compared to 6 months with the placebo group.
In the osimertinib group, 74% of participants did not have any cancer growth after 12 months and 65% did not have any cancer growth after 24 months, compared with 22% and 13% in the placebo group, respectively. Osimertinib resulted in a higher objective response rate vs placebo (57% vs 33%, respectively). The rate of new metastases to the brain was lower in the osimertinib arm (8%) compared with the placebo arm (29%).
Researchers also compared subgroups, including differences in the type of chemoradiotherapy received and whether a patient had stage IIIA or IIIB/IIIC disease. The progression-free survival benefit seen for the osimertinib arm was found across all analyzed subgroups. Of the participants who had disease progression in the placebo arm, 81% went on to receive osimertinib.
The adverse event profile of osimertinib was generally consistent with what has been noted in previous studies. The most common side effects in both arms of the study were radiation pneumonitis, diarrhea, and rash. Most cases of radiation pneumonitis were mild to moderate. In the osimertinib arm, 13% of patients discontinued treatment due to adverse events compared with 5% in the placebo arm.
“There are currently no approved targeted treatments specifically for unresectable stage III EGFR-mutant NSCLC. With the superior efficacy results along with the robust magnitude of benefit in the LAURA study, osimertinib provides [a] solution to a large unmet need for this patient population,” said lead study author Dr. Ramalingam, of Winship Cancer Institute of Emory University.
Next Steps
Researchers will continue to follow the participants to try to understand if osimertinib has an impact on overall survival, brain metastases, and other outcomes.
ASCO Perspective
David R. Spigel, MD
“The LAURA trial is the first to define the role of EGFR-directed therapy in unresectable stage III [NSCLC]. While the study did not compare osimertinib to the current standard-of-care immunotherapy, these data have major implications for both patients and oncologists and will change the standard of care for patients with [lung cancer and] EGFR mutations,” said David R. Spigel, MD, Chief Scientific Officer at Sarah Cannon Research Institute in Nashville, Tennessee.
Disclosure: This study was funded by AstraZeneca. For full disclosures of the study authors, visit coi.asco.org.
