RWD results reaffirm Leclaza’s efficacy in practice

First real-world data since its release was published in Lung Cancer

“Confirmed consistent efficacy and safety in 103 patients”

“Showed effect in patients with brain metastasis...dose reduction did not reduce effect”

Professor Lim Sun Min (right) and Professor Beung-Chul Ahn (left) are presenting Leclaza study results

Study results that confirm the efficacy and safety of Yuhan Corp's new anticancer drug ‘Leclaza’ in the real world has been released.

 

Lim Sun Min, Professor of Oncology at Yonsei Cancer Center, and Beung-Chul Ahn, Professor of Oncology at the National Cancer Center, met with reporters at the Korea Pharmaceutical and Bio-Pharma Manufacturers Association head office in Seocho-gu, Seoul on the 22nd to introduce the real-world data (RWD) that confirms the efficacy and safety of Leclaza in practice.

 

This was the first-ever real-world study results announced since Leclaza’s approval, and was published in the journal, Lung Cancer.

 

Leclaza is an NSCLC treatment that was approved as the 31st homegrown novel drug in January last year.

 

It is a 3rd generation EGFR TKI that inhibits the proliferation and growth of lung cancer cells.

 

It is currently approved as a treatment for patients with locally advanced or metastatic NSCLC who developed resistance after being previously treated with 1st generation or 2nd generation EGFR-TKIs.

 

The research team conducted a retrospective study on 103 patients with EGFR T790M mutation-positive NSCLC patients who developed resistance after being previously treated with EGFR-TKI that received Leclaza from January 2021 to August 2022 at Yonsei Cancer Center and the National Cancer Center.

 

90 of the 103 patients received Leclaza as a second- or third-line treatment.

 

The patients’ primary efficacy endpoint in the study, median progression-free survival (mPFS), was 13.9 months.

 

This was consistent with the mPFS of 11.1 months confirmed in LASER201, the study that became the basis of Leclaza’s approval.

 

The objective response rate (ORR) was 62.1%, slightly higher than the 55.3% observed in the LASER201 study.

 

In terms of safety, the drug was also well-tolerated, similar to previous studies.

 

The research team explained, “ The real-world study reaffirmed the consistent effect and efficacy of Leanza as a second-line treatment for EGFR T790M mutation-positive NSCLC patients in practice.” Leclaza also showed similar efficacy in patients with the Exon19 deletion mutation (Exon19del) and the L858R substitution mutations (L858R), and the team saw no decrease in efficacy in patients whose dose was reduced.

 

Professor Lim said, “The study holds significance for being results from the first real-world study that confirmed the efficacy and safety profile of Leclaza in NSCLC patients in Korea’s actual prescription environment.“ Lim added, “Study results showed consistent data with LASER201, the trial that was conducted for Leclaza’s approval.

 

Along with other clinical data, these RWD results will be actively used as grounds for prescribing Leclaza to patients in practice.” In the study, Leclaza’s treatment effect was also significant in patients with brain metastasis as in the LASER201 study.

 

The mlPFS (median intracranial progression-free survival) was 17.1 months, and ORR was 57.6%.

 

Professor Ahn said, “Brain metastasis is found in about 25% of NSCLC patients upon diagnosis, and the condition is so common that 50% of patients eventually experience brain metastases as the condition progresses.

 

This is why a drug’s effect in NSCLC with brain metastasis is a very important consideration in prescribing drugs for NSCLC in the field.” Professor Ahn added, "In the real-world study, Leclaza has consistently demonstrated its antitumor effect in NSCLC patients with brain metastases, and we are thus accumulating evidence to further prescribe Leclaza for those patients in Korea.”