Lazertinib by Yuhan launches global phase III clinical trial

Researchers' meeting was held for 27 Korean Institutions, subject recruitment imminent

Plans to expand to 17 countries around the world including Serbia and Malaysia

(From left) Professor Kyung-Hee Lee, Youngnam University Hospital, Jin-Hyung Kang, Seoul St.

 

Mary

Global Phase III clinical trial of anticancer drug candidate 'Lazertinib' by Yuhan is in full swing.

 

On the 3rd, Yuhan Corporation announced that it will hold an initiation meeting for each institution after receiving the Lazertinib phase III clinical trial approval (IND) from the MFDS in December last year, and will soon begin recruiting patients.

 

So far, Serbia and Malaysia have completed application for the approval of Lazertinib for Phase III clinical trials and plan to gradually expand the clinical process to 17 countries worldwide.

 

The research name was set to 'LASER301'.

 

The Phase III trial aims to evaluate the potential of Lazertinib as a primary treatment in 380 patients with epidermal growth factor receptor (EGFR) mutant-positive non-small cell lung cancer (NSCLC).

 

After randomization, the subjects were divided into four groups, and then the Lasertinib and AstraZeneca's target anticancer drugs 'Iressa (brand name for Gefitinib)' or placebo were used to compare efficacy and safety.

 

In Korea, which has the fastest pace, 27 hospitals, including Severance Hospital, Samsung Seoul Hospital, Seoul National University Hospital, Seoul St.

 

Mary's Hospital, and Seoul Asan Hospital, confirmed the participation.

 

More than 100 researchers and officials attended the research conference held by Yuhan Corporation for domestic participating organizations.

 

Lazertinib is a targeted anticancer agent being developed for primary treatment of EGFR mutant positive non-small cell lung cancer patients or secondary treatment of EGFR T790M mutant non-small cell lung cancer patients.

 

Yuhan Corporation received $ 50 million in November 2018 from Janssen Biotech, with no obligation to return Lasertinib to technology transfer.

 

Successful commercialization requires up to $1.25 billion, including a tiered technology fee (milestone).

 

In phase I/II clinical trial in patients with EGFR T790M mutant-positive non-small cell lung cancer, a dose of 120 mg or more resulted in 12.3 months of progression free survival (PFS) and safety.

 

Byung-cheol Cho, a professor at Severance Hospital, who is leading the global phase III of Lasertinib, said, “The Lazertinib study paper, which proved safety and anti-tumor effect in the Phase I/II trial of non-small cell lung cancer patients, was recognized for its value in October last year at the Lancet Oncology, and we will do our best to be a good treatment alternative for patients with high prevalence of EGFR mutation-positive non-small cell lung cancer in our country”.

 

An official of Yuhan Corporation said, "Korea is the first country in this multinational clinical trial phase III.

 

We will make every effort to ensure that many countries enter the clinical trial phase III successfully in the future".