LAURA Updated OS Data Support ‘New Standard of Care’ for Unresectable Stage III EGFR-Mutated NSCLC

By Cecilia Brown - Last Updated: March 28, 2025

Updated overall survival (OS) results from the phase 3 LAURA study “further substantiate the fact that osimertinib after definitive chemoradiotherapy is the new standard of care” for patients with unresectable stage III EGFR-mutated non–small cell lung cancer (NSCLC), study investigators said during a presentation today at the European Lung Cancer Congress (ELCC) 2025.

Suresh S. Ramalingam, MD, FACP, FASCO, of the Winship Cancer Institute at Emory University, presented the updated data on the EGFR tyrosine kinase inhibitor (TKI) during the second proffered paper session of ELCC 2025, which was held in Paris, France.

“This updated overall survival analysis from the LAURA study demonstrates an improved favorable trend for overall survival benefit with osimertinib over placebo,” he said during the ELCC 2025 presentation. “This was seen despite the high proportion of patients in the placebo group that went on to receive another third-generation TKI.”

The double-blinded phase 3 study previously showed that treatment with osimeritinib after definitive chemoradiotherapy (CRT) significantly improved progression-free survival (PFS) compared with placebo for patients with unresectable stage III EGFR-mutated NSCLC, with a hazard ratio (HR) of 0.16 (95% CI, 0.10-0.24; P<0.001), which led to its approval for this population of patients.

“The study demonstrated that patients treated with osimertinib after definitive chemoradiotherapy experienced a clinically and statistically significant improvement in progression-free survival compared to placebo,” Dr. Ramalingam said during the ELCC 2025 presentation.

However, the HR for OS was 0.81 and was “not statistically significant at the interim analysis,” which had a maturity of 20% at that time. Dr. Ramalingam reported the updated OS and subsequent treatment data from the LAURA study at ELCC 2025, with a data cutoff of November 29, 2024.

Compared with the interim analysis, the updated analysis, which has a maturity of 31%, showed an “improved trend towards OS benefit” with osimertinib versus placebo. The median OS was 58.8 months (95% CI, 54.1-not calculable [NC]) in those receiving osimertinib, compared with 54 months (95% CI, 42.1-NC), with an HR of 0.67 (95% CI, 0.40-1.14). As of the cutoff date, death occurred in 40 patients (28%) in the osimertinib arm and 26 patients (36%) in the placebo arm.

Dr. Ramalingam spoke about the survival curves during his presentation at ELCC and highlighted key findings.

“The 2 main things to notice in these curves are that the censoring has decreased in the 18-to-30-month time range, and the gap between the curves has widened compared to the previous analysis,” he said. “…. Keep in mind that 80% of the patients in the placebo group went on to receive osimertinib in the post-study setting, and this explains the later separation of the curves and the earlier superimposition of the 2 curves in the study.”

LAURA Trial Methods, Treatment Discontinations, and Subsequent Treatments

The study investigators randomized adults with unresectable stage III EGFR-mutated NSCLC to receive osimertinib 80 mg daily (n=143) or placebo (n=73) after definitive concurrent or sequential platinum-based CRT. Treatment continued until disease progression or discontinuation. Open-label osimertinib was offered to patients in both treatment arms after progression. The primary end point was PFS by blinded independent central review per RECIST 1.1 criteria, and OS was a key secondary end point.

At the cutoff date, 52% of patients had discontinued osimertinib, compared with 95% of patients who had discontinued placebo. Among those receiving osimertinib as a study treatment, 73% received subsequent treatment. Nearly all of the patients (87%) who received placebo during the study received subsequent treatment.

The most common types of subsequent treatment, in any line, were:

EGFR tyrosine kinase inhibitor, received by 37 patients (50%) in the osimertinib arm and 60 (87%) in the placebo arm
Cytotoxic chemotherapy, received by 28 patients (38%) in the osimertinib arm and 15 (22%) in the placebo arm
Radiotherapy, received by 28 patients (38%) in the osimertinib arm and 7 (10%) in the placebo arm

Dr. Ramalingam concluded the presentation by explaining the next steps and implications of the LAURA study.

“The final analysis for overall survival will occur at 60% maturity,” he said. “In conclusion, these data further substantiate the fact that osimertinib after definitive chemoradiotherapy is the new standard of care for patients with locally advanced non–small cell lung cancer bearing an EGFR exon 19 or 21 mutation.”

Reference

Ramalingam S, Özgüroglu M, Ahn M, et al. Osimertinib (osi) after definitive chemoradiotherapy (CRT) in patients (pts) with unresectable (UR) stage III EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC): updated overall survival (OS) analysis from the LAURA study. Abstract #LBA4 presented at: European Lung Cancer Congress 2025, March 26-29; Paris, France.

In the photo at top, the entrance to the European Lung Cancer Congress (ELCC) is shown in Paris, France (Photo courtesy of the European Society for Medical Oncology)