Yuhan's Novel Anticancer Drug 'Reclaza' Achieves Success in Phase 3 Clinical Trial as First-Line Treatment Option

Phase 3 Multinational Clinical Trial 'LASER301' in 13 Countries
55% Reduction in Cancer Progression and Death Risk Compared to Control Group

Approval Change Planned for Indication Expansion in 1Q Next Year

Yuhan Corporation's non-small cell lung cancer (NSCLC) treatment new drug, "Reclaza" (generic name: Lazertinib), has succeeded in a Phase 3 clinical trial for use as a first-line treatment. Currently, Reclaza can only be used for patients who have previously undergone other treatments, but it is expected that treatment with Reclaza from the beginning will become possible in the future.

On the 14th, Yuhan Corporation announced that the top-line results of the multinational Phase 3 clinical trial (LASER301), which evaluated the efficacy and safety of Reclaza as a first-line treatment for NSCLC patients, met the primary efficacy endpoint. This clinical trial was conducted on 393 patients at 119 domestic and international institutions across 13 countries, including Korea, Australia, Turkey, and Hungary.

Compared to the control group receiving AstraZeneca's "Iressa tablets" (generic name: Gefitinib), analysis of progression-free survival (PFS) in the Reclaza treatment group showed a 55% reduction in the risk of cancer progression or death. Progression-free survival is a variable used to evaluate the efficacy of anticancer drugs, representing the period during which the disease does not progress or lead to death. Yuhan Corporation plans to present detailed results, including secondary efficacy endpoints such as objective response rate (ORR) and overall survival (OS), at a professional conference in December.

Professor Byung-Chul Cho of Severance Hospital, who led LASER301, stated, "It is very encouraging that Lazertinib has achieved the primary endpoint as a first-line treatment through this multinational Phase 3 clinical trial," adding, "Lazertinib could become a new first-line treatment option for patients worldwide with active epidermal growth factor receptor (EGFR) mutation-positive NSCLC."

Reclaza is an oral third-generation EGFR tyrosine kinase inhibitor (TKI) that selectively targets EGFR mutations. It became the 31st domestic new drug after receiving approval from the Ministry of Food and Drug Safety in January last year for the treatment of patients with locally advanced or metastatic NSCLC positive for the EGFR T790M mutation who had previously been treated with EGFR-TKI. It has already achieved commercial success, with cumulative domestic sales exceeding 10 billion KRW.

However, until now, it has only been used as a second-line treatment for patients who have previously received first-line treatment with other therapies. This Phase 3 clinical trial was conducted to verify whether Reclaza can be used as a monotherapy first-line treatment.

A Yuhan Corporation official said, "The top-line results analysis of this global Phase 3 clinical trial confirmed the efficacy of Reclaza as a first-line treatment," and added, "We plan to apply for a change in approval to expand indications domestically by the first quarter of next year."

This content was produced with the assistance of AI translation services.