New Indication: Osimertinib after Chemoradiotherapy in NSCLC
Study
Phase 3, double-blind, placebo-controlled trial (LAURA)
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Locally advanced, unresectable stage III NSCLC with EGFR exon 19 deletion or L858R mutation after chemoradiation
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Osimertinib (80 mg once daily) vs. placebo
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Efficacy
mPFS: 39.1 [31.5 mos – NR] vs. 5.6 mos[3.7 – 7.4 mos] (HR: 0.16 [0.10-0.24])
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OS @36 mos: 84% vs. 74% (NS)
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Safety
Any Grade AEs: Radiation pneumonitis (48%), diarrhea (36%), rash (24%)
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Grade ≥3 AEs: Osimertinib 35%, Placebo 12%
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Serious AEs: Osimertinib 38%, Placebo 15%
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Fatal AEs: Osimertinib 2%, Placebo 3%
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Lu S,Kato T,Dong X Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC
Reviewed by Ulas D. Bayraktar, MD on Sep 30, 2024