[ESMO ASIA 2022(싱가포르) = 황재선 기자] Yuhan’s Lazertinib (product name: Lexraza) increased the median progression-free survival period more than twice as much as Gefitinib (product name: Iressa) in the first-line clinical trial for EGFR-mutated advanced non-small cell lung cancer.
Professor Cho Byeong-cheol of Yonsei Cancer Center presented the liver analysis results of Lazertinib’s global phase 3 clinical trial (LASER301) at the ESMO ASIA 2022 ‘Presidential Symposium’ session on the 3rd.
“Lazertinib is the first domestically developed EGFR-mutated non-small cell lung cancer (NSCLC) treatment to complete global phase 3 clinical trials,” said Professor Byung-Chul Cho. “The safety of Lazertinib and Gefitinib did not deviate from the previously reported safety profile.” .
Lazertinib is a third-generation EGFR-TKI (tyrosine kinase inhibitor) targeting therapy that targets both EGFR T790M and sensitizing mutations.
Professor Byung-Cheol Cho’s research team targeted adults with progressive EGFR mutation (Ex19del/L858R) NSCLC who had no prior EGFR-TKI or systemic chemotherapy experience. Patients who had metastasis to the central nervous system but were neurologically stable were targeted, and treatment and steroid therapy were completed for two weeks.
The patients were then orally administered 240mg of Lazertinib per day, and the control group was set to 250mg of Gefitinib. They were randomly assigned 1:1 according to mutation and race.
The research team set the primary validation index as PFS (progression-free survival) calculated with RECIST v1.1.
393 patients were randomized, blinded, and conducted at 96 sites in 13 countries (196 patients in the lasertinib group and 197 patients in the gefitinib group). In particular, the median progression-free survival was longer with Lazertinib (20.6 months) than with Gefitinib (9.7 months). Also, the HR (hazard ratio, 95% confidence interval) for disease progression or death was 0.45 (0.34-0.58).
The progression-free survival (PFS) advantage of Lazertinib over gefitinib was consistent across all subgroups.
The median progression-free survival was 20.6 months and 9.7 months for gefitinib and 9.7 months for gefitinib and 9.7 months for gefitinib and Lexraza among non-Asians, respectively.
Lazertinib lasted 20.7 months and Gefitinib 10.8 months in patients with Ex19del mutation, and 17.8 months and 9.6 months in patients with L858R mutation, respectively.
The objective response rate (ORR) was 76% (95% confidence interval, 0.62-1.59) in both groups, and the median duration of response (DOR) was 19.4 months and 8.3 months.
Professor Byung-Cheol Cho said, “In the interim analysis, data on overall survival (OS) have not been sufficiently followed up. The 18-month survival rate was higher with Lazertinib (80%) than with Gefitinib (72%). , the hazard ratio for death was 0.74.”
Meanwhile, in the past, Hanmi Pharm’s Olmutinib, a drug with the same mechanism, received domestic approval, but the approval was withdrawn due to safety issues. Accordingly, industry insiders evaluate Lazertinib as the first new drug in Korea that has proven its efficacy and safety through a confirmatory test.