Yuhan Corp. said it would start a phase-3 global study to evaluate the efficacy of Lazertinib (YH25448) as the first-line treatment for non-small cell lung cancer (NSCLC).
The company received approval from the Ministry of Food and Drug Safety on Wednesday to go ahead with the phase-3 trial.
The study aims to confirm the safety and efficacy of Lazertinib as the first-line treatment in NSCLC. It will be a multinational, randomized, double-blind trial comparing the first-line treatment gefitinib (brand name: Iressa) with Lazertinib in patients with NSCLC with epidermal growth factor receptor (EGFR) mutation.
In Korea, 27 institutions, including Severance Hospital and Samsung Medical Center, will participate in the study.
The company obtained the first nod in Korea among the countries participating in the trial.
Yuhan licensed out Lazertinib to Janssen in November 2018. Under the deal, Yuhan receives $50 million in upfront payment and up to $1.25 billion in milestone payment.
In a local phase-1 and phase-2 trials, Lazertinib showed efficacy and safety in lung cancer treatment. In NSCLC patients who had T790M mutation after the administration of other EGFR TKI (tyrosine kinase inhibitor), the overall response rate (ORR) was 57 percent. Among them, patients with Lazertinib 120mg doses or higher had 60 percent ORR. Patients treated with Lazertinib had 12.3 months of progression-free survival (PFS), whereas all the patients with T790M mutation had 9.7 months of PFS.
Concerning safety, 30 percent of patients had mild rash or acne, and 27 percent had itching, which was the most frequently reported adverse reactions. Three percent had severe adverse events associated with Lazertinib.
The phase-2 study, conducted jointly with Janssen, tests two methods – one is a monotherapy as the second-line treatment, and the other is a combination therapy mixing Lazertinib with Janssen’s JNJ-6372, a bispecific antibody by Janssen. Yuhan hopes to prove Lazertinib’s effect as a monotherapy in the first-line treatment through the global phase-3 study.
Yuhan Corp. CEO Lee Jung-hee said in a forum in September that Yuhan would spend about 100 billion won ($84.2 million) on the phase-3 trial for the advancement of the drugmaker.
“With the food and drug safety ministry’s approval for the phase-3 test on Lazertinib, we can begin our multinational clinical development of the drug in earnest,” an official at Yuhan said.
On Nov. 30, the company invited researchers from clinical institutions around the world to kick off a steering committee for the phase-3 trial, the official said. In Korea, the company plans to recruit patients from the first quarter of next year, he added.