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First-in-Human Study of Lazertinib in EGFR-Mutated Advanced Lung Cancer

By: Kelly M. Hennessey, PhD
Posted: Tuesday, December 10, 2019

In a first-in-human, open-label, multicenter, phase I/II study, Myung-Ju Ahn, MD, of the Sungkyunkwan University School of Medicine in Seoul, Korea, and colleagues reported that the third-generation EGFR tyrosine kinase inhibitor lazertinib had a “tolerable” safety profile and “promising” clinical activity in patients with EGFR-mutated non–small cell lung cancer (NSCLC) that had progressed after EGFR tyrosine kinase inhibitor therapy. The results on dose escalation and dose expansion were published in The Lancet Oncology. A phase II dose-extension study is ongoing.

Prior to the study, all patients had a confirmed diagnosis of locally advanced or metastatic NSCLC and experienced disease progression after previous treatment with first-generation or second-generation EGFR tyrosine kinase inhibitors. In total, 127 patients were evaluable for response. Of those patients, 38 were enrolled into the dose-escalation group, and 89, in the dose-expansion group. The oral doses of this agent tested were 20 mg, 40 mg, 80 mg, 120 mg, 160 mg, 240 mg, or 320 mg once daily continuously in 21-day cycles.

According to an independent central review assessment, 69 patients (54%) had an objective response, including 66 patients (52%) with confirmed partial responses and 3 patients (2%) with confirmed complete responses. Disease control was achieved in 110 patients (87%). No dose-limiting toxicities were observed up to the highest dose tested.

The median duration of response in the overall population was 15.2 months, and the median progression-free survival was 9.5 months. The median progression-free survival was longer in patients with tumors harboring EGFR mutations than in patients with EGFR-negative tumors.

“Lazertinib has a potential therapeutic role in the treatment of NSCLC harboring EGFR mutations, either alone or in combination with other drugs,” the investigators concluded.

Disclosure: Full disclosures of study authors can be found at thelancet.com.



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