In a licensing deal potentially worth more than $1.2 billion, Janssen, Johnson & Johnson’s Biotech unit, has gained global rights—excluding South Korea—to Yuhan’s third-generation EGFR tyrosine kinase inhibitor (TKI) Lazertinib for the treatment of patients with non-small cell lung cancer (NSCLC).
Janssen will make an upfront payment of $50 million for Lazertinib. Yuhan’s also will be eligible for approximately $1.2 billion in developmental and commercialization milestones, as well as double-digit royalties on sales, if the experimental drug is approved.
In return, Janssen will assume responsibility for development, manufacturing, and commercialization with exclusive worldwide rights to Lazertinib excluding Korea, where Yuhan is currently conducting studies of Lazertinib.
Interim results of current phase 1 and 2 clinical trials show Lazertinib exhibits promising systemic and intracranial antitumor activities at multiple dose levels and was well-tolerated with low rates of Grade 3 or higher adverse events.
Yuhan believes that these results suggest that Lazertinib, a potent, mutant-selective, irreversible, brain-penetrant, and orally active inhibitor NSCLC shows the potential to become a first-line therapy. The company says the drug may offer the possibility of a wider therapeutic index, making it a potential best-in-class candidate as a combination regimen.
If successful development and approval are achieved, Lazertinib is expected to become serious competition for AstraZeneca’s Tagrisso (osimertinib), which was approved by the FDA in April as a first-line therapy for NSCLC patients with EGFR mutations.