IIT seeks use of Leclaza in the first line in Korea

Investigator-Initiated trial (IIT) approved in Korea

Phase IIb trial comparing Leclaza monotherapy vs. Leclaza+Avastin combination conducted in 5 centers in Korea

11 IITs approved over the past 3 years… indicates rise in HCP’s interest in the use of Leclaza

New third generation lung cancer drug developed by Yuhan Corp

Investigator-Initiated trials (IIT) are being conducted on the use of ‘Leclaza (lasertinib),’ Yuhan Corp’s new third-generation drug for non-small-cell lung cancer (NSCLS), as a first-line treatment.

 

Over the past 3 years, a total of 11 IITs have been approved for Leclaza, indicating the high interest among HCPs in finding a new treatment method using Leclaza.

 

According to industry sources on the 14th, the Ministry of Food and Drug Safety approved a randomized Phase IIb trial the day before that compares Leclaza monotherapy with Leclaza+Avastin combination in patients with advanced EGFR mutation-positive NSCLC who have a smoking history.

 

The Phase IIb trial that compares Leclaza as monotherapy with the Leclaza+Avastin combination will be led by the National Cancer Center and conducted in 5 institutions including the Ajou University Hospital, Severance Hospital, Gangnam Severance Hospital, and St.

 

Vincent Hospital.

 

The trial is an investigator-initiated trial that uses Leclaza as the primary treatment.

 

According to Yuhan Corp, this is the first clinical trial that investigates Leclaza’s use in the first line.

 

Leclaza is a third-generation EGFR TKI class drug that received conditional approval in Korea in January 2021.

 

It inhibits the signaling pathway involved in tumor cell growth and supresses lung cancer cell proliferation and growth.

 

In Korea, Leclaza received conditional approval as a second-line treatment in patients with locally advanced or metastatic NSCLC who developed T790M resistance after prior treatment with a first- or second-generation EGFR TKI.

 

Avastin is a drug used for the treatment of metastatic colorectal cancer, metastatic breast cancer, NSCLC, etc.

 

The drug is approved for use in combination with platinum-based chemotherapy regimens to treat inoperable, locally advanced or metastatic non-squamous NSCLC.

 

Also, the drug can be used in combination with erlotinib as a first-line treatment for inoperable EGFR mutation-positive, advanced, metastatic, or recurrent non-squamous NSCLC.

 

During the past 3 years, a total of 11 IITs have been approved for Leclaza.

 

This rise in number of clinical trials for Leclaza reflects the HCPs' rising interest in finding new treatment methods with Leclaza.

 

Among the trials, major IITs include the Phase II trial being led by Seoul National University Hospital that is investigating the use of Leclaza+’Alimta (pemetrexed)’ combination in EGFR mutation-positive NSCLC patients with leptomeningeal metastases.

 

The Phase II trial was approved in April 2021, and patient recruitement for the trial in complete, enrolling 43 patients.

 

Also, patient recruitment is underway for a Phase II trial for NSCLC patients including those with rare EGFR mutations.

 

The trial, which is led by Severance Hospital, has been approved in 2021 Since 2021, Seoul St.

 

Mary’s Hospital has been conducting a Phase II trial studying the combined use of Leclaza, Alimta, and ‘Neoplatin (carboplatin)’ in EGFR mutation-positive metastatic NSCLC patients with asymptomatic or mild symptomatic brain metastases who have failed treatment with ‘Tagrisso (osimbertinib).’ Also, Samsung Medical Center has received approval for a single-arm Phase II trial investigating the use of Leclaza in EGFR mutation-positive NSCLC patients with no prior TKI treatment experience and is currently recruiting patients.