Yuhan's 'Reclaza' to Reveal Phase 3 Clinical Trial Results of First-Line Monotherapy for Lung Cancer This Month

Yuhan Corporation's non-small cell lung cancer treatment 'Leclaza (active ingredient: Lazertinib)'

[Asia Economy Reporter Lee Chun-hee] The top-line results of the Phase 3 clinical trial for the first-line treatment use of Yuhan Corporation's non-small cell lung cancer (NSCLC) drug "Reclaza" (generic name: Lazertinib) are expected to be released later this month.

According to industry sources on the 12th, Yuhan Corporation is currently conducting a multinational Phase 3 clinical trial (LASER301) to evaluate the efficacy and safety of Reclaza as a first-line treatment for NSCLC patients, and plans to announce the top-line results of this trial within this month.

Reclaza is an oral third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with high selectivity for the EGFR T790M resistance mutation. It was approved by the Ministry of Food and Drug Safety in January last year as the 31st domestic new drug, intended for the treatment of patients with locally advanced or metastatic NSCLC who are positive for the EGFR T790M mutation and have previously been treated with EGFR-TKI. It has already achieved commercial success in South Korea, surpassing cumulative sales of 10 billion KRW.

However, it is currently used only as a second-line treatment for patients who have previously received other therapies as first-line treatment. This Phase 3 clinical trial is being conducted to confirm whether Reclaza monotherapy can be used as a first-line treatment for NSCLC patients.

Reclaza was licensed to Yuhan Corporation in July 2015 from Genosco, a subsidiary of Oscotec. Since then, Yuhan has enhanced the value of Reclaza through compound optimization, process development, and preclinical and clinical trials, and in November 2018, licensed the technology to Janssen, a global big pharma company and a subsidiary of Johnson & Johnson.

Janssen is expected to submit an approval application related to Reclaza to the U.S. Food and Drug Administration (FDA) sometime next year. Joaquin Duato, CEO of Janssen, has identified Reclaza and the company’s bispecific antibody cancer drug "Amivantamab" combination therapy as one of the top five major pipelines expected to generate sales exceeding 5 billion USD (approximately 7 trillion KRW) each, indicating significant expectations from Janssen as well.

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