The FLAURA2 trial found that osimertinib plus chemotherapy resulted in significantly longer overall survival compared to osimertinib alone in patients with EGFR-mutated advanced NSCLC. The addition of chemotherapy increased the occurrence of adverse events, primarily myelosuppressive effects, but these were reversible with supportive care.
Study
|
Randomized, open-label, phase 3 study [FLAURA2; NCT04035486] |
| EGFR-mutated advanced NSCLC (exon 19 deletion or L858R mutation) who had not received prior treatment for advanced disease |
| Osimertinib + platinum-pemetrexed (n=279) vs Osimertinib monotherapy (n=278)
|
Efficacy
|
mOS: 47.5 mos vs 37.6 mos (HR 0.77 [0.61-0.96])
|
Safety
|
Grade >=3 AE: 70% vs 34% |
| Adverse events leading to discontinuation of osimertinib: 12% vs 7%
|
N Engl J Med. Published online October 17, 2025
http://doi.org/10.1056/nejmoa2510308
Reviewed by Ulas D. Bayraktar, MD on Oct 21, 2025
