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Ultimate general survival (OS) outcomes from the Part III FLAURA2 trial reveal that first-line osimertinib plus chemotherapy considerably improves OS in comparison with osimertinib monotherapy in sufferers with EGFR-mutated (EGFRm) superior non-small cell lung most cancers (NSCLC).
These findings, introduced on the Worldwide Affiliation for the Examine of Lung Most cancers (IASLC) 2025 World Convention on Lung Most cancers, help osimertinib plus chemotherapy as a brand new standard-of-care remedy possibility on this affected person inhabitants, in keeping with David Planchard, MD, Ph.D., Division of Medical Oncology, Institut Gustave Roussy, Thoracic Unit.
Osimertinib, a third-generation, CNS-active EGFR tyrosine kinase inhibitor (EGFR-TKI), is presently a most popular first-line remedy for EGFRm superior NSCLC.
The worldwide, open-label, randomized Part III FLAURA2 examine (NCT04035486) evaluated whether or not including chemotherapy (pemetrexed with cisplatin or carboplatin) to osimertinib might present extra survival profit.
A complete of 557 sufferers with beforehand untreated, EGFRm (Ex19del/L858R) domestically superior or metastatic NSCLC have been randomized 1:1 to obtain osimertinib plus chemotherapy (n=279) or osimertinib monotherapy (n=278). The first endpoint was progression-free survival (PFS), with OS as a key secondary endpoint. Sufferers have been eligible if they’d a WHO efficiency standing of 0 or 1, and secure CNS metastases have been permitted.
At a median follow-up of roughly 57% maturity, osimertinib plus chemotherapy demonstrated a statistically vital and clinically significant enchancment in OS versus osimertinib monotherapy (HR 0.77; 95% CI 0.61–0.96; p=0.02). Median OS was 47.5 months with mixture remedy versus 37.6 months with monotherapy.
The 36-month survival fee was 63% versus 51%, respectively. The OS profit was constant throughout predefined subgroups.
The protection profile of the mixture was manageable and according to the recognized profiles of the person therapies. No new security indicators emerged with longer follow-up. Hostile occasions (AEs) resulting in discontinuation of osimertinib occurred in 12% of sufferers within the mixture arm versus 7% within the monotherapy arm.
“These compelling overall survival results confirm osimertinib plus chemotherapy as a first-line standard of care for patients with EGFR-mutated advanced NSCLC,” mentioned Dr. Planchard.
“By combining osimertinib with chemotherapy, we are able to extend survival for these patients while maintaining a manageable safety profile.”
The FLAURA2 trial outcomes reinforce osimertinib because the spine remedy on this setting, with the addition of chemotherapy providing a significant OS benefit for sufferers with EGFRm superior NSCLC, he mentioned.
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Worldwide Affiliation for the Examine of Lung Most cancers
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Trial exhibits osimertinib plus chemotherapy improves general survival in EGFR-mutated superior NSCLC (2025, September 7)
retrieved 7 September 2025
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