EGFR double mutation inhibitor (Lazertinib)

Indications

Non-small cell lung cancer third-generation target

Unmet medical needs

EGFR-mutant derived non-small cell lung cancer patients account for 10-15% of all non-small cell lung cancer patients in Europe and 30-40% in Asia. These patients exhibited EGFR mutations at the time of diagnosis and progressed to T790 mutations in two of three patients with non-small cell lung cancer progressing after EGFR-TKI treatment. For patients with these mutations, therapies are currently limited. Therefore, the development of a third-generation EGFR drug that can treat the T790M mutation is urgently required. Expansion to 1st therapy for the patients of EGFR-mutant non-small cell lung cancer.

Target patient

· Patients resistant to existing EGFR inhibitor drugs, Iressa and Tarceva.
· 1st line treatment of EGFR

Development stage

Lead IND enabling candidate was transferred to Yuhan. And in the middle of phase ½ clinical trial, Yuhan Licensed it out to Janssen at $1.255 Bil. in 2018. Received the first approval in Korea on Jan 2021. FDA approved lazertinib in combination with amivantamab in Aug 2024.

Competitive drug

Osimertinib (AstraZeneca), Olmutinib (Hanmi)

Competitive advantages

Lazertinib has excellent drug efficacy against dual mutant non-small cell lung cancer resistant to the existing EGFR inhibitor drugs, iressa and tarceva. Because of its high blood-brain barrier permeability lazertinib is a potential candidate expected to have excellent effects for patients with brain metastatic non-small-cell lung cancer who do not have an effective treatment even at a high incidence rate.