Yuhan's Lung Cancer Drug Leclaza Secures European Approval in Combination Therapy
Key Insights
Yuhan Corporation (search)'s third-generation EGFR (search)-TKI lazertinib (Leclaza) has received European Commission approval in combination with J&J (search)'s Rybrevant for first-line treatment of EGFR-mutated non-small cell lung cancer (search).
The Phase 3 MARIPOSA study demonstrated the combination therapy reduced disease progression risk by 30% compared to osimertinib, with median progression-free survival of 23.7 months versus 16.6 months.
This milestone marks the first Korean anticancer drug approved in both the U.S. and Europe, triggering a $30 million payment to Yuhan as part of their $1.255 billion licensing deal with Johnson & Johnson.
Yuhan Corporation (search)'s innovative lung cancer (search) treatment lazertinib has secured European Commission (EC) approval as a combination therapy with Johnson & Johnson's bispecific antibody Rybrevant (amivantamab). The approval marks a significant milestone as the first Korean-developed anticancer drug to receive regulatory clearance in both the United States and Europe.
The combination therapy has been approved as a first-line treatment for adult patients with advanced non-small cell lung cancer (search) (NSCLC (search)) harboring epidermal growth factor receptor (EGFR (search)) exon 19 deletions or exon 21 L858R substitution mutations. This approval follows the therapy's U.S. Food and Drug Administration (FDA) clearance in August 2023.
Groundbreaking Clinical Results
The EC approval is supported by compelling data from the Phase 3 MARIPOSA clinical trial, which compared the amivantamab-lazertinib combination against osimertinib (marketed as Tagrisso) in patients with metastatic NSCLC (search). The study demonstrated a 30% reduction in the risk of disease progression or death with the combination therapy compared to osimertinib at a median follow-up of 22 months.
Patients receiving the combination therapy experienced a median progression-free survival of 23.7 months versus 16.6 months with osimertinib alone. Additionally, the duration of response was significantly longer with the combination, showing a nine-month improvement compared to the standard of care.
Dr. Henar Hevia, Senior Director and EMEA Therapeutic Area Lead for Oncology at J&J (search) Innovative Medicine, emphasized the therapy's potential: "The combination of amivantamab and lazertinib offers significant potential to delay disease progression and improve early treatment outcomes while preserving chemotherapy as an option for more advanced stages of treatment when resistance mechanisms become more complex."
Mechanism of Action
Lazertinib, marketed as Leclaza in Korea and Lazcluze in the U.S., is an oral, third-generation EGFR (search) tyrosine kinase inhibitor that works by interrupting signal transmission involved in the growth of lung cancer (search) cells, thereby inhibiting their proliferation. Rybrevant is a fully human bispecific antibody targeting both EGFR and mesenchymal-epithelial transition factor (MET) receptors.
The dual mechanism approach provides a more comprehensive blockade of cancer growth pathways, potentially addressing resistance mechanisms that can develop with single-agent therapies.
Significant Financial Milestone
With this European approval, Yuhan Corporation (search) is set to receive a milestone payment of $30 million from Johnson & Johnson. This follows a previous milestone payment of $60 million received in September 2023 after the U.S. FDA approval.
The payments are part of a landmark 2018 licensing agreement between Yuhan and Janssen, a J&J (search) subsidiary, valued at up to $1.255 billion. Under the terms of this agreement, Yuhan received a non-refundable upfront payment of $50 million, with Janssen securing exclusive worldwide rights to develop, manufacture, and commercialize lazertinib. Yuhan remains eligible for additional milestone payments and royalties exceeding 10-12% based on commercial performance.
Market Impact and Future Prospects
Lung cancer (search) represents the leading cancer type in Europe, with NSCLC (search) accounting for approximately 85% of all lung cancer cases. EGFR (search) mutation-positive NSCLC is a specific subtype linked to mutations in the EGFR gene, with exon 19 deletions and L858R being the most common alterations.
The approval of this combination therapy provides a new treatment option for patients with these specific genetic profiles, potentially establishing a new standard of care in the first-line setting.
Johnson & Johnson, which holds global development and marketing rights to lazertinib, has also filed for marketing authorization in China and Japan, with approvals expected in the first half of 2024. These potential approvals would further expand the global reach of this innovative therapy.
Development History
Lazertinib was initially developed by Oskotech (search), a Korean biotech company, before being acquired by Yuhan Corporation (search) in 2015. Yuhan subsequently advanced the drug's development before partnering with Johnson & Johnson in 2018 through a technology export deal.
This successful progression from domestic development to global approval demonstrates the growing capabilities of Korean pharmaceutical innovation in the oncology space and highlights the value of strategic international partnerships in bringing novel therapies to patients worldwide.