Yuhan Corp reports that it made three poster presentations at the virtual meeting of the American Society of Clinical Oncology (ASC) centering on the positive results of Lazertinib. Its investigational anticancer drug has evidencing efficacy and safety against lung cancer based on the result of their latest multiple clinical trials.
The Poster Presentations
The company presented on positive progress with its targeted therapy for patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation including Lazertinib’s therapeutic effect on 1) lung cancer, 2) brain metastasis, and 3) findings on clinical genetics on the mechanisms of resistance after the drug administration.
Also known as YH25448, it is an oral, highly potent, mutant-selective, and irreversible EGFR Tyrosine-kinase inhibitor (TKI) that targets both the T790M mutation and activating EGFR mutations while sparing wild type EGFR.
Clinical Investigator’s Position
Kim Sang-we, lead author of the entire study as well as a professor at the Oncology Department of Asan Medical Center, disclosed, “This study showed that Lazertinib could help treat lung cancer with EGFR mutation, even with brain metastasis.
Investigators administered Lazertinib 240mg to 76 patients with T790M mutation in EFGR, reported Korea Biomedical Review’s Park Gi-taek. Overall, the patient objective response rate (ORR) by an independent central review panel equaled 57.9%—with complete response in two patients. The investigator-assessed ORR turned out at 72.4%. With a median progression-free survival (PFS) at 11 months (as measured by the independent central review), the investigator-assessed measure equaled 13.2 months. These measures represented improvements from last year’s reported outcomes of 240mgs ORR at 50%.
A rash at 35% was the most common adverse event, followed by pruritus at 33% and paresthesia at 32%, but these were mostly mild. In 5% of the patients, adverse reactions were the cause of patients dropping out of the study.
Other reported results included the following:
The effect of Lazertinib’s intracranial anti-tumor effect in NSCLC patients with brain metastasis. In these cases, writes Park Gi-taek, the drug was administered to patients whose tumor had already spread to the brain prior to the commencement of medication. With an intracranial disease control rate (IDCR) at 90.6%, the group dosed with 240mg revealed 16.4 months of PFDS. Of those patients that experienced brain metastasis that could be evaluated, 22 of them had an objective intracranial response rate (OIRR) at 54.5%.
Planning Phase III Clinical Trial
The company reports that it will recruit patients for the Phase III clinical trial involving Lazertinib as the first-line treatment. Moreover, the company has started a collaboration where it will test the combination of Lazertinib with Amivantamab—an experimental bispecific antibody made by Janssen.
Yuhan Corp Background
Yuhan Corporation, an integrated healthcare company, was founded back in 1926. It is a larger pharmaceutical company in Korea based on sales. With two subsidiaries, including Yuhan Chemical and Yuhan Medica, and the affiliates including Joint Ventures with Janssen (Belgium), The Clorox Company (USA) and Kimberly-Clark Corporation (USA).
Kim Sang-we, MD, PhD, Asan Medical Center