South Korea’s Yuhan Corporation said on Monday interim data from phase 1 and 2 clinical trials of its new non-small cell lung cancer (NSCLC) drug lazertinib have demonstrated efficacy and safety, brightening the prospects for the new drug after gaining clearance from U.S. authority to proceed with phase 1 trial in America.

The third-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) is being developed for the treatment of patients with T790M-positive locally advanced or metastatic NSCLC who are resistant to existing targeted cancer therapies. Yuhan out-licensed the global rights to the drug to Janssen Biotech for $1.2 billion last November.

In the clinical trials which involved 127 NSCLC patients, 54 percent in the treatment arm achieved a tumor size reduction of greater than 30 percent. The corresponding figure in those with T790M mutations in the EGFR gene was 57 percent. Three reached complete response.

The interim results were presented during a Poster Session at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL.

The median duration of tumor reduction was 15.2 months in the treatment arm with the median progression-free survival (PFS) 9.5 months. The drug’s safety profile was also excellent as only 3 percent of the patients discontinued treatment due to adverse events.

Meanwhile, the U.S. Food and Drug Administration approved a phase 1 study of lazertinib last Friday. Patient recruitment will begin in the third quarter in the U.S., according to the company.

By Kim Byung-ho and Minu Kim

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