Overall Survival with Amivantamab-Lazertinib in EGFR-Mutated Advanced NSCLC

Area of Science:

• Oncology
• Pharmacology
• Clinical Trials

Background:

• Phase 3 trial results previously demonstrated improved progression-free survival for amivantamab-lazertinib versus osimertinib in previously untreated EGFR-mutated advanced non-small-cell lung cancer (NSCLC).
• The final overall survival analysis from this trial was pending.

Purpose of the Study:

• To report the final overall survival results of amivantamab-lazertinib compared to osimertinib in previously untreated EGFR-mutated advanced NSCLC.
• To evaluate the safety profile of amivantamab-lazertinib in this patient population.

Main Methods:

• A phase 3 trial randomly assigned 429 participants with previously untreated EGFR-mutated advanced NSCLC to amivantamab-lazertinib or osimertinib.
• Overall survival was assessed as a key secondary endpoint, with safety also monitored.

Main Results:

• Amivantamab-lazertinib demonstrated significantly longer overall survival compared to osimertinib (HR, 0.75; P=0.005), with 3-year survival rates of 60% and 51%, respectively.
• Higher rates of grade 3 or higher adverse events were observed with amivantamab-lazertinib (80%) versus osimertinib (52%), primarily skin-related events, venous thromboembolism, and infusion reactions.
• No new safety signals emerged with extended follow-up.

Conclusions:

• Amivantamab-lazertinib significantly enhances overall survival in patients with previously untreated EGFR-mutated advanced NSCLC compared to osimertinib.
• The improved survival benefit of amivantamab-lazertinib comes with an increased risk of severe adverse events.