Osimertinib After Definitive Chemoradiotherapy in Unresectable Stage III EGFR-Mutated NSCLC: Subsequent Treatments and PPO From the Phase III LAURA Study

Abstract Introduction: In the phase III LAURA study, osimertinib demonstrated statistically significant improvement in progression-free survival (PFS) versus placebo in patients with unresectable stage III EGFR-mutated non-small cell lung cancer (NSCLC) without disease progression during/after chemoradiotherapy. We report pre-specified post-progression outcomes, subsequent treatments and a second interim analysis of overall survival (OS). Methods: Patients were randomized 2:1 to receive osimertinib or placebo until progression (blinded independent central review) or discontinuation. Open-label osimertinib was offered post-progression. Secondary endpoints included time to first and second subsequent treatment (TFST and TSST), second PFS (PFS2) and OS. Results: At primary data cutoff (January 5, 2024), TFST (hazard ratio [HR], 0.13; 95% CI, 0.08–0.21), PFS2 (0.62; 0.35–1.08) and TSST (0.51; 0.28–0.91) were improved with osimertinib versus placebo. As reported previously, 63/143 (44%) and 66/73 (90%) patients had discontinued randomized osimertinib and placebo treatment, respectively. The most common first subsequent systemic treatment was an EGFR-tyrosine kinase inhibitor in the osimertinib and placebo arms (22/63 [35%] and 56/66 [85%], respectively), primarily osimertinib (14/63 [22%] and 50/66 [76%]). At the second interim OS analysis (data cutoff: November 29, 2024), there was a trend towards OS benefit with osimertinib versus placebo (HR, 0.67; 95% CI, 0.40–1.14; 31% maturity). Conclusions: Osimertinib demonstrated clinically meaningful improvements versus placebo in TFST, PFS2 and TSST, and a trend towards OS benefit. These data indicate that clinical benefit with osimertinib was preserved beyond first progression, supporting long-term benefits of osimertinib for unresectable stage III EGFR-mutated NSCLC without progression during/after definitive chemoradiotherapy.

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Journal
Clinical Cancer Research
Published
2026-09-09
DOI
https://doi.org/10.1158/1078-0432.ccr-25-4523
Primary Topic
Lung Cancer Treatments and Mutations
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article
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article

Osimertinib After Definitive Chemoradiotherapy in Unresectable Stage III EGFR-Mutated NSCLC: Subsequent Treatments and PPO From the Phase III LAURA Study

Shun Lü, Mustafa Özgüroğlu, Manuel Cobo, Myung‐Ju Ahn et al.
Clinical Cancer Research
Lung Cancer Treatments and Mutations
article

Osimertinib After Definitive Chemoradiotherapy in Unresectable Stage III EGFR-Mutated NSCLC: Subsequent Treatments and PPO From the Phase III LAURA Study

Shun Lü, Mustafa Özgüroğlu, Manuel Cobo, Myung‐Ju Ahn, Kōichi Goto, Satoshi Oizumi, Sang‐We Kim, Natalia Valdiviezo, James Chih‐Hsin Yang, Te‐Chun Hsia, Xiaorong Dong, Jarin Chindaprasirt, Elena Armenteros-Monterroso, Suresh S. Ramalingam, Terufumi Kato, Xiangning Huang, Azura Evans, Ignacio A. Casarini, Fernanda Fujiki, Ana Bolanos
article en

Abstract

Abstract Introduction: In the phase III LAURA study, osimertinib demonstrated statistically significant improvement in progression-free survival (PFS) versus placebo in patients with unresectable stage III EGFR-mutated non-small cell lung cancer (NSCLC) without disease progression during/after chemoradiotherapy. We report pre-specified post-progression outcomes, subsequent treatments and a second interim analysis of overall survival (OS). Methods: Patients were randomized 2:1 to receive osimertinib or placebo until progression (blinded independent central review) or discontinuation. Open-label osimertinib was offered post-progression. Secondary endpoints included time to first and second subsequent treatment (TFST and TSST), second PFS (PFS2) and OS. Results: At primary data cutoff (January 5, 2024), TFST (hazard ratio [HR], 0.13; 95% CI, 0.08–0.21), PFS2 (0.62; 0.35–1.08) and TSST (0.51; 0.28–0.91) were improved with osimertinib versus placebo. As reported previously, 63/143 (44%) and 66/73 (90%) patients had discontinued randomized osimertinib and placebo treatment, respectively. The most common first subsequent systemic treatment was an EGFR-tyrosine kinase inhibitor in the osimertinib and placebo arms (22/63 [35%] and 56/66 [85%], respectively), primarily osimertinib (14/63 [22%] and 50/66 [76%]). At the second interim OS analysis (data cutoff: November 29, 2024), there was a trend towards OS benefit with osimertinib versus placebo (HR, 0.67; 95% CI, 0.40–1.14; 31% maturity). Conclusions: Osimertinib demonstrated clinically meaningful improvements versus placebo in TFST, PFS2 and TSST, and a trend towards OS benefit. These data indicate that clinical benefit with osimertinib was preserved beyond first progression, supporting long-term benefits of osimertinib for unresectable stage III EGFR-mutated NSCLC without progression during/after definitive chemoradiotherapy.

Clinical Cancer Research
Ulsan College (KR), Khon Kaen University (TH), Shanghai Jiao Tong University (CN), China Medical University (TW), Tokyo Metropolitan Komagome Hospital (JP), University of Ulsan (KR), Instituto do Câncer do Estado de São Paulo (BR), Piedmont Cancer Institute (US), National Hospital Organization Hokkaido Medical Center (JP), Istanbul University-Cerrahpaşa (TR), AstraZeneca (Singapore) (SG), AstraZeneca (Brazil) (BR), Instituto Nacional de Enfermedades Neoplásicas (PE), China Medical University Hospital (TW), National Taiwan University Hospital (TW), AstraZeneca (Poland) (PL), National Cancer Center Hospital East (JP), AstraZeneca (Spain) (ES), AstraZeneca (Canada) (CA), Hospital Clínico Universitario Virgen de la Victoria (ES), Centro Científico Tecnológico Mar del Plata (AR), Japan Cancer Society (JP), Huazhong University of Science and Technology (CN), Sungkyunkwan University (KR)
Good health and well-being
Openalex Percentile: Top 11%
Lung Cancer Treatments and Mutations
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