The results of phase 1 and 2 clinical studies for Yuhan’s cancer drug lazertinib, suggesting that it has a “tolerable” safety profile and warrants further clinical investigation, were published in the prestigious journal the Lancet Oncology, the company said Friday.

The Lancet, founded in 1823, is an international weekly medical journal.




Lazertinib is an irreversible, third-generation, mutant-selective, EGFR tyrosine kinase inhibitor. Yuhan hopes it can provide another option for patients with EGFR-mutated non-small-cell lung cancer who have become resistant to first-generation and second-generation drugs.

The trials reported in the Lancet Oncology were carried out at 14 hospitals in South Korea between Feb. 15, 2017, and May 28, 2018, on 127 patients with EGFR-mutated advanced NSCLC. The patients received varying doses of lazertinib.

A team of 11 researchers headed by Ahn Myung-ju from the hematology-oncology division at Samsung Medical Center conducted the study with funding from Yuhan.

According to the article, the most commonly reported adverse events in the study were grade 1 or 2 rash or acne in 30 percent of the patients and pruritus -- severe itching of the skin -- in 27 percent. Adverse events classed as grade 3 or 4 occurred in 16 percent of the patients, but only four of these events were related to the treatment. Six patients experienced more serious adverse events, but no one died as a result of the treatment.

The article concluded that Lazertinib had a tolerable safety profile and promising clinical activity in patients with NSCLC.

The phase 2 study is ongoing in Korea.

Lazertinib was licensed out to US-based Janssen Biotech in November 2018.

In the US, Yuhan was approved to carry out phase 1 clinical trials in May. The company plans to start recruiting trial subjects in the near future.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)