Yuhan Corp.’s lung cancer treatment Leclaza (lazertinib) has made the first step into the global pharmaceutical market as a Korean-made anticancer drug. 

On Thursday, Janssen Pharmaceuticals, a pharmaceutical company wholly-owned by Johnson & Johnson, said that it submitted a marketing authorization application to the U.S. FDA and the European Medicines Agency (EMA) for Yuhan’s Leclaza (lazertinib), in combination with Rybrevant (amivantamab) for the first-line treatment of patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).

The application was based on the MARIPOSA phase 3 trial, which tested amivantamab in combination with lazertinib in lung cancer patients. The MARIPOSA study compared patients treated with the Leclaza + Rybrevant combo to those treated with AstraZeneca's Tagrisso (Osimertinib).

The MARIPOSA study, led by Cho Byoung-chul, Professor in the Division of Medical Oncology at Yonsei University College of Medicine in Seoul, demonstrated an improvement in progression-free survival (PFS). Some adverse events were identified during the trial but most were not serious.

In 1,074 patients with non-small cell lung cancer (NSCLC), the risk of cancer progression or death was about 30 percent lower in patients treated with Leclaza + Rybrevant combo than with Tagrisso.

“Despite advances in EGFR-mutated NSCLC treatment, novel targeted therapies and regimens are needed to address resistance and disease progression, which are nearly inevitable with current treatments,” said Cho. “With the combination of amivantamab and lazertinib in the MARIPOSA study, progression-free survival was significantly improved in patients with previously untreated EGFR-mutated NSCLC compared to osimertinib. These results support the potential of this amivantamab and lazertinib combination to be a future standard of care.”

In Korea, from Jan. 1 next year, Leclaza will get health insurance coverage for the first-line treatment of locally advanced and metastatic NSCLC, following approval in December from the Ministry of Food and Drug Safety (MFDS) for changing Leclaza’s indications by meeting all conditions for the second-line treatment for T790M mutation-positive NSCLC.

"As an oncologist and a member of a Korean pharmaceutical company, I am very proud and honored that a global anti-cancer drug will be born in Korea," said Kim Yeul-hong, R&D President of Yuhan Corp. "The reality that our drug can be used by lung cancer patients around the world is right in front of us, which further enhances the status of K-bio."

"We will continue to do our best to ensure that Leclaza is firmly established as the standard of care for lung cancer treatment worldwide."