Yuhan Corp. has set about to secure indications for its non-small cell lung cancer (NSCLC) drug, Leclaza (lazertinib), as the first-line treatment.

In a public notice on Friday, Yuhan unveiled part of the topline results of phase 3 clinical trial of Leclazae to win approval as the first-line treatment. Leclaza is an EGFR (epidermal growth factor receptor) mutant-positive NSCLC treatment. Currently, it has been approved as the second-line treatment in Korea.

Yuhan emphasized it has confirmed that Leclaza improved statistically significant progression-free survival period (PFS) in multinational phase 3 clinical trials as the first-line treatment.

As the result of analyzing the PFS period, the primary evaluation variable, Leclaza, reduced disease progression and death risks by 55 percent compared to Iressa, improving the PFS period with statistical significance (risk ratio 0.45, 95 percent confidence interval 0.34-0.58, p<0.001).

However, Yuhan stopped short of making public the secondary evaluation variables, including objective response rate and overall survival (OS), and safety results. Instead, the company explained that it would unveil them at a professional academic conference in December.

“It is very encouraging that lazertinib achieved its primary evaluation goal of becoming a first-line treatment through this multinational phase 3 clinical trial. As a result, Lazertinib could be a new first-line treatment option for EGFR mutant NSCLC patients worldwide, said Professor Cho Byung-cheol at Severance Hospital. “Detailed clinical trial results will be released at an academic conference in December.”

Yuhan said in the notice that it would apply for a change of permission to expand its domestic indications in the first quarter of next year.

Yuhan signed a contract with Janssen in November 2018 to export and co-develop the Leclaza technology. The two companies are conducting first-line and second-line treatment of NSCLC combined with Janssen's EGFR-MET- target double antibody treatment, Amivantamab.