Osimertinib OS Benefit Persists in NSCLC

Osimertinib (Tagrisso, AstraZeneca), continues to provide an overall survival (OS) benefit after definitive chemoradiotherapy (CRT) in patients with unresectable stage III epidermal growth factor receptor (EGFR)–mutated non–small cell lung cancer (NSCLC), according to the latest results from the pivotal phase 3 LAURA study.

“This updated analysis…demonstrates an improved favorable trend for overall survival benefit with osimertinib over placebo,” lead investigator Suresh Ramalingam, MD, reported at the European Lung Cancer Congress 2025.

The 216 study participants were randomized 2:1 to receive 80 mg osimertinib once daily — a third generation EGFR tyrosine kinase inhibitor — or placebo until disease progression or treatment discontinuation. The current analysis looked at the key secondary endpoint of OS at a data cut-off of November 29, 2024 (31% data maturity). Median OS was 58.8 months vs 54.0 months in the osimertinib and placebo arms, respectively (hazard ratio [HR], 0.67) — an improvement over the non-significant improvement in OS observed at the interim analysis (20% data maturity). The HR for OS at the interim analysis was 0.81.

The improved OS was seen despite nearly 80% of patients in the placebo group crossing over to receive osimertinib, noted Ramalingam, a professor at Emory University, Atlanta, Georgia, where he is also the Roberto C. Goizueta Distinguished Chair for Cancer Research and the executive director of the Emory Winship Cancer Institute.

Clinically meaningful improvements were also observed in the time to first subsequent therapy, time to progression after the first subsequent therapy, and time to second subsequent therapy, he said.

Ramalingam presented updated progression-free survival (PFS) data — the primary study end-point — in June 2024 at that annual American Society of Clinical Oncology conference, as reported by Medscape Medical News.

PFS at that analysis was 39.1 vs 5.6 months, respectively (HR, 0.16). In September 2024, the US Food and Drug Administration expanded the indication for osimertinib to certain patients with unresectable stage III EGFR-mutated NSCLC. The agent already carried indications for metastatic disease and for adjuvant use in earlier-stage EGFR-mutated NSCLC.

The final OS analysis will occur at 60% data maturity Ramalingam noted, concluding that the findings thus far “further substantiate the fact that osimertinib after definitive CRT is the new standard of care” in this setting.

Invited discussant Sara Ramella, MD, professor of radiation oncology at Campus Bio-Medico University, Rome, Italy, emphasized the role of radiotherapy along with a tyrosine kinase inhibitor for disease control in patients with EGFR-mutated disease. 

“Test, test, test!” for the EGFR mutation, she said.

Ramella also stressed the importance of patient input and “understanding what the patient truly desires most from the treatment we are offering them.”

The LAURA trial is funded by AstraZeneca. Ramalingam disclosed personal and/or institutional financial relationships with Amgen, AstraZeneca, GSK, Pfizer, BMS, and AbbVie. Ramella disclosed financial relationships with AstraZeneca, Roche, Merck, Amgen, Tema Sinergie, and Elekta. 

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape Medical News, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at [email protected] or on X @SW_MedReporter.