Overall Survival From the EORTC LCG-1613 APPLE Trial of Osimertinib Versus Gefitinib Followed by Osimertinib in...

Area of Science:

• Oncology
• Clinical Trials
• Pharmacology

Background:

• Osimertinib is a standard treatment for EGFR-mutant NSCLC.
• Sequential treatment (gefitinib then osimertinib) has not been directly compared to upfront osimertinib.

Purpose of the Study:

• To compare upfront osimertinib versus sequential gefitinib followed by osimertinib in treatment-naïve patients with advanced EGFR-mutant NSCLC.

Main Methods:

• Phase II APPLE trial (NCT02856893) randomized 156 patients.
• Two arms: upfront osimertinib or sequential gefitinib then osimertinib upon progression.
• Progression defined as molecular or radiologic.

Main Results:

• Upfront osimertinib showed a lower risk of brain progression (HR 0.54).
• Overall survival was comparable between arms (HR 1.01).
• Sequential approach had a higher proportion of baseline brain metastases.

Conclusions:

• Upfront osimertinib may reduce brain progression in advanced EGFR-mutant NSCLC.
• Both strategies demonstrated similar overall survival.
• Sequential treatment may lead to more frequent brain progression.