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 Korea, Lazertinib was approved in January 2021. Janssen is undergoing Phase 2 and 3 clinical trials for combo therapy with its bispecific antibody (JNJ-372).

Competitive drug

Osimertinib (AstraZeneca), Olmutinib (Hanmi)

Competitive advantages

GNS-1480 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 GNS-1480 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.