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Gregory J. Riely, MD, PhD


Early-Phase Study Shows Activity of Lazertinib in Advanced EGFR-Mutated NSCLC

By: Joshua D. Madera, MD
Posted: Thursday, April 11, 2024

For patients with EGFR-mutated locally advanced or metastatic non–small cell lung cancer (NSCLC), the use of the EGFR tyrosine kinase inhibitor lazertinib may improve clinical outcomes, according to the results of the LASER201 study, published in the journal Lung Cancer. Lazertinib therapy demonstrated activity and a favorable safety profile in this patient population, according to the study authors Myung-Ju Ahn, MD, PhD, of Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea, and colleagues.

A total of 43 patients with EGFR-mutated NSCLC were recruited for the study. All patients were naive to treatment with an EGFR tyrosine kinase inhibitor. EGFR mutations were characterized as exon 19 deletions (n = 24), L858R (n = 18), or G719X (n = 1) and were confirmed by local or central testing. Most patients (98%) had adenocarcinoma, and about half of the patients had never smoked. Patients received 240 mg of lazertinib daily and were monitored to assess their clinical responses to treatment.

The study authors reported an objective response and disease control rates of 70% and 86%, respectively. In addition, a 24.6-month median progression-free survival was recorded in this patient population. Furthermore, the median overall survival had not been reached at the point of final data cutoff. However, the rates of overall survival at the 36-month and 54-month intervals were 66% and 55%, respectively. In addition, the first-line cohort of this trial included 22 patients with neurologically stable brain metastases at baseline. According to the investigators, more than half of those with brain metastases were alive at 54 months, with a 3-year survival rate of 59%.

Moreover, treatment-related adverse events reported by patients included rash (54%), diarrhea (47%), paresthesia (35%), and pruritus (35%). The most common grade 3 or higher treatment-related adverse events reported with lazertinib included diarrhea (7%) and paresthesia (2%).

Disclosure: For full disclosures of the study authors, visit

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