'Leclaza effective as 1st-line treatment in Koreans'

Yuhan Corp holds press conference to celebrate Leclaza's approval as first-line treatment

Professor Byoung-Chul Cho, "Clinical trial results, including PFS outcomes, were consistent in global and Asian patients"

Professor Jin-Hyoung Kang, "Consistent efficacy in Koreans, regardless of brain metastasis or L858R mutation"

On the morning of the 10th, Professor Jin-Hyoung Kang of Medical Oncology at the Catholic University of Korea Seoul St.

 

Mary's Hospital, said, "LASER 301,' the global Phase III clinical trial on Leclaza (lazertinib), is the only study that demonstrated the drug's efficacy as a first-line treatment for EGFR mutation-positive non-small cell lung cancer patients in Korea,” during a press conference held to celebrate Leclaza's approval as first-line treatment at Seoul Plaza Hotel.

 

Leclaza is Korea's 31st homegrown novel drug that was approved for the treatment of NSCLC in January 2021.

 

At the time of its approval, the drug was approved as a second-line treatment for patients with locally advanced or metastatic NSCLC who developed resistance after being previously treated with 1st generation or 2nd generation EGFR-TKIs.

 

Last month, the company received additional approval for Leclaza as a ‘first-line treatment for non-small-cell lung cancer.

 

During the conference, Professor Byoung-Chul Cho of Medical Oncology at the Yonsei Cancer Center explained the results of the LASER 301 Phase III clinical trial, which served as the basis for the approval of Leclaza as a first-line treatment.

 

Among the total of 393 patients worldwide that were enrolled in the trial, 258 were Asians, and 172 of those were Korean patients.

 

Cho emphasized that there were no significant differences between the overall results and the results in Asian patients.

 

Professor Byoung-Chul Cho of Medical Oncology at the Yonsei Cancer Center

Cho said, "The median progression-free survival (mPFS) in the Leclaza arm was 20.6 months, which is a statistically significant improvement compared with the 9.7 months in the gefitinib arm.

 

The mPFS in Asian patients were consistent with those of the overall global patient population." “The subgroup analysis of patients with EGFR mutation subtypes also yielded noteworthy results.

 

In patients with exon 19 deletion mutation, the mPFS in the Leclaza arm was 20.7 months, compared with the 10.9 months in the gefitinib arm.

 

In patients with exon 21 L858R substitution mutation, the mPFS for the Leclaza arm was 17.8 months, compared with the 9.6 months in the gefitinib arm." "The results are encouraging.

 

Leclaza demonstrated superior antitumor effect even in patients with an exon 21 L858R substitution mutation, who are known to have a relatively poorer prognosis than those with an ex19del mutation.

 

Leclaza showed consistent results regardless of EGFR mutation subtypes.” Kang also mentioned the therapeutic benefits of Leclaza in Korean patients.

 

He particularly highlighted the fact that although a higher proportion of patients with brain metastasis or the L858R mutation - factors known to have a poor prognosis - were present in Korean patients, the results were similar or even slightly better.

 

Kang explained, "The LASER 301 trial included 172 Korean patients, and among them, one-third already had brain metastasis before the trial began.

 

The investigator-assessed mPFS in the gefitinib arm was 9.6 months, compared with the 20.8 months in the Leclaza arm."

Professor Jin-Hyoung Kang of Medical Oncology at the Catholic University of Korea Seoul St.

 

Mary

"These PFS results were consistently observed even in the subgroup of patients with brain metastasis.

 

The safety data were also consistent with the previously reported clinical results." Kang noted, "Leclaza is the first treatment to demonstrate therapeutic benefits in a clinical trial that included a significant number of patients among the third-generation EGFR TKIs.

 

The investigator-assessed mPFS of Korean patients with ex19del mutation in the Leclaza arm was approximately 2 years (23.3 months)." “The mPFS of Korean patients with exon 21 L858R substitution mutation who were treated with Leclaza was 17.8 months, compared with the 9.6 months in the gefitinib arm.

 

Leclaza showed consistent effect regardless of type of EGFR mutation in all Korean patients, just as in the global patient population." Kang added that not enough data has been accumulated yet to determine overall survival (OS), which is another major endpoint.

 

“Regarding the much-anticipated OS data, the follow-up period is still too short to obtain sufficient overall survival data.

 

Only 29% of the data has been obtained so far.”