Yuhan’s new lung cancer drug Leclaza shows OS benefit

Final OS results of Phase I/II LASER201 clinical trial on Leclaza were presented at the AOS 2022 & KCA Annual Meeting 2022

The Median OS of patients treated with Leclaza 240mg was 38.9 months

Yuhan Corp (CEO and President Wook Je Cho) announced on the 23rd that it had confirmed the overall survival (OS) benefit of Leclaza (lasertinib) in the Phase I/II LASER201 trial (NCT03046992).

 

Leclaza is a treatment for epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).

 

Leclaza is a third-generation oral EGFR Tyrosine Kinase Inhibitor (TKI) that has high selectivity against the EGFR T790M resistant mutation.

 

The drug showed superior efficacy and safety in NSCLC patients with brain metastasis as it can pass through the blood-brain-barrier (BBB).

 

Lecalza’s OS results had been presented at the AOS 2022 & KCA Annual Meeting 2022 which was held from the 16th to 18th of this month.

 

The OS results were updated from the Phase I/II LASER201 trial that had been the basis for Leclaza’s approval in Korea.

 

The Phase I/II trial evaluated the efficacy and safety of continuous daily oral administration of Leclaza 240mg on 78 adult patients with EGFR mutation-positive NSCLC whose disease had progressed after EGFR TKI at 17 centers in Korea.

 

Analysis results on the 76 patients with EGFR T790M mutation-positive patients showed that the median overall survival (mOS) was 38.9 months.

 

Ji-Youn Han, Professor of Hemato -Oncology at the National Cancer Center who presented Leclaza’s OS results at the AOS 2022 & KCA Annual Meeting 2022, said, “It is encouraging that the mOS of EGFR T790M mutation-positive patients who are at high risk of brain metastasis had reached 38.9 months in the study, showing over 3 years of survival.

 

Also, Leclaza is associated with the superior effect of achieving median intracranial progression-free survival (mPFS) of 26 months in patients with measurable brain lesions (25 patients).” Han added, “When considering that the ultimate treatment goal of treating cancer patients is in extending life, the OS benefit identified in the trial shows potential to extend life expectancy in T790M mutation-positive patients.” Meanwhile, the latest results of the Phase I/II LASER201 trial had previously been published in the April edition of the Journal of Thoracic Oncology (JTO), the official journal of the International Association for the Study of Lung Cancer (IASLC).

 

Yeol-Hong Kim, Professor of Hemato Oncology at Korea University Anam Hospital, who is also the President of the Asian Oncology Society, said, “It is meaningful that Leclaza’s OS benefit had been presented at the AOS 2022 & KCA Annual Meeting 2022.

 

The fact that Leclaza, a novel homegrown lung cancer drug, has demonstrated an mOS of 38.9 months in the second-line treatment of EGFR mutation-positive NSCLC is remarkable.

 

The results show the possibility that Leclaza could bring a new turning point to the lung cancer treatment landscape in the future.” Wook Je Cho, CEO of Yuhan Corp, said, “We are pleased to share the news that Leclaza showed an OS benefit that meets the expectations as a novel homegrown lung cancer drug.

 

Yuhan Corp will continue to make efforts, including completing the ongoing clinical trials and global commercialization so that Leclaza can become a useful treatment option for patients suffering from EGFR mutation-positive NSCLC in Korea and around the globe.

 

Meanwhile, Yuhan is currently conducting a multinational Phase III trial (LASER 301) to evaluate the efficacy and safety of Leclaza as a first-line treatment in patients with EGFR mutation-positive NSCLC, and the top-line results of the Phase III trial are expected to be disclosed by the end of this year.

 

A global Phase III trial on the combination of Leclaza with amivantamab, Janssen’s fully human bispecific antibody targeting both EGFR and MET, is also in progress.