FDA OKs phase-1 trial for Yuhan’s investigational lung cancer drug

Jeong Sae-im  Published 2019.06.04  14:21  Updated 2019.06.04 14:21


Yuhan Corp. is gearing up to develop a new lung cancer drug Lazertinib (YH25448) in the global market. In an earlier local phase-1/2 study, the agent proved efficacy and safety to extend the progression-free survival (PFS) of lung cancer patients.

The company said Tuesday the U.S. Food and Drug Administration approved to go ahead with a phase-1 trial on the investigational drug on May 30. The company will recruit patients in the third quarter.

Lazertinib is a targeted therapy for locally advanced or metastatic non-small cell lung cancer (NSCLC) with T790M mutation in the epithelial growth factor receptor (EGRF), after treatment with an existing drug.

The company revealed the latest updates of the local phase-1/2 revealed during the American Society of Clinical Oncology (ASCO) 2019 convention in Chicago, Sunday.

Yuhan said in a poster session at ASCO that 54 percent of the total 127 patients had an objective response rate with tumor size reduced more than 30 percent. In T790M positive patients, the ORR was 57 percent.

Three patients showed complete remission. The median duration of response (DoR), which is a time from documentation of tumor response to disease progression, was 15.2 months.

The median progression-free survival (PFS) was 9.5 percent in total patients, and 9.7 months in T790M-positive patients. Additional analysis showed that patients treated with over 120mg dose of Lazertinib had a longer 12.3-month PFS. The company is testing 240mg Lazertinib in a phase-2 study.

Regardless of Lazertinib use, the most frequent adverse reactions included rash (30 percent), itching (27 percent), constipation (20 percent), appetite reduction (19 percent) and diarrhea (14 percent) while 3 percent of patients discontinued the treatment due to side effects. Only 3 percent of adverse reactions related to Lazertinib was Grade 3 or more serious, meaning that the drug showed excellent safety.

“On May 15, Janssen paid attention to Lazertinib as one of the new drug candidates that are highly likely to win approval by 2023,” an official at Yuhan said. “With the latest disclosure of our study, Janssen, which has global development rights, is likely to accelerate clinical trials.”

Yuhan licensed out Lazertinib to Janssen for $1.25 billion last November.

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