Yuhan Corp. and Genosco have presented the results of phase 1 and 2 clinical trials for Lazertinib, a non-small cell lung cancer (NSCLC) therapy, at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting.

Lazertinib is Genosco’s 3rd-generation EGFR-tyrosine kinase inhibitor (EGFR-TKI) candidate. The drug is an oral, potent, irreversible EGFR-TKI that is highly selective for activating (EGFRm) and T790M resistance mutations. Genosco partnered with Yuhan for the drug’s clinical development and commercialization,

The two companies conducted an open-label, multi-center dose-escalation, Phase 1 and 2 studies of lazertinib for patients with advanced EGFR-TKI-resistant NSCLC with or without CNS metastasis.

“These data are impressive and underscore the potential of lazertinib becoming a best-in-class 3rd-generation EGFR-TKI medication for patients with advanced EGFR T790M mutant NSCLC, including brain metastasis,” said Professor Cho Byoung-chul of the department of Internal Medicine at Yonsei Cancer Center. “Also, the treatment was well-tolerated with no dose-limiting toxic effects.”

Results indicate that lazertinib compares favorably with those from the similar phase clinical trials of Osimertinib, the existing 3rd generation EGFR-TKI, Cho added.

Genosco was equally upbeat about the presented data.

“The efficacy signals and safety profiles are highly encouraging and validate lazertinib as a promising 3rd-generation EGFR-TKI inhibitor for patients with limited options,” Genosco CEO Koh Jong-sung said. “Yuhan and Genosco initiated a global phase 2 trial evaluating Lazertinib for patients with NSCLC and anticipate a global Phase 3 trial in 2019.”