Severance Hospital said it has published research results on the efficacy and safety of Lazertinib, Yuhan Corp.'s drug targeting epidermal growth factor receptor (EGFR)-mutated lung cancer, in the journal Lancet Oncology.
|Professor Cho Byoung-chul|
EGFR-mutated lung cancer accounts for 30 to 40 percent of all new lung cancer patients.
The drug is a third-generation lung cancer drug targeting at patients with EGFR T790M-mutated lung cancer and EGFR- mutated lung cancer that are resistant to existing EGFR-targeted therapies, including Iressa, Tarceva, and Giotrif.
The Third-generation EGFR-targeted drug has proved to have superior characteristics, efficacy, and toxicity compared to the first- and second-generation targeted therapies, the hospital said. As of now, Tagrisso is the only third-generation EGFR-targeted drug approved for marketing.
The team, led by Professor Cho Byoung-chul of Yonsei Cancer Center, assessed the efficacy and safety of Lazertinib in 127 patients from February 2017 to May 2018 through a dose-escalation and expansion study, which was part of phase 1 and 2 clinical trials for the drug.
Professor Cho found partial response where cancer shrunk 30 percent or more in 57 percent of patients with T790M mutation-positive lung cancer who are resistant to conventional anticancer drugs. Among them, 60 percent received a dose of 120 mg or more, and three patients have reached complete remission of their cancer.
The most frequent adverse reactions were rash, including acne, and itching in 30 and 27 percent of subjects, respectively, and the incidence of adverse effects grade 3 or higher was 16 percent.
Grade 3 or higher adverse drug reaction that could not be excluded from Lazertinib administration stood at a mere 3 percent, indicating the safety and tolerability of Lazertinib.
"The results of the trial demonstrate the efficacy and safety of Lazertinib, and based on these findings, the phase 3 clinical study will soon begin to confirm that the treatment can be used as a first-line treatment for EGFR-mutant advanced lung cancer," Professor Cho said. "The safety of the drug will help speed up the entry into phase 3 trial on a combination therapy based on the drug."
Considering the price of existing drugs, conditional approval to use the drug, which is a secondary treatment for advanced EGFR mutations, is also necessary, Cho added.