Abion applies to MFDS for approval to change Phase 2 clinical trial plan of Babamakeup

Abion announced on the 9th that it has applied to the Ministry of Food and Drug Safety (MFDS) of Korea to change the Phase 2 clinical trial plan for its hepatocyte growth factor receptor (c-MET) targeted anticancer drug Vabametkib (ABN401).

This application aims to evaluate the safety and efficacy of a combination therapy with Lazertinib in patients resistant to epidermal growth factor receptor (EGFR) targeted anticancer drugs. Upon approval of the change, the clinical trial will be conducted on approximately 138 patients across 14 hospitals in Korea, as well as in the United States and Taiwan. The study will select the optimal combination dosing of Lazertinib, an EGFR targeted anticancer drug, and Vabametkib, a MET (epithelial-mesenchymal transition) targeted anticancer drug, and evaluate efficacy through comparison of objective response rates (ORR) with existing treatments.

A company representative stated, “Vabametkib is a small molecule compound that selectively targets c-MET, and based on its excellent tolerability and safety, it can have an advantage in combination therapy,” adding, “If the combination treatment proceeds successfully, it is highly likely to establish itself as an innovative treatment option that overcomes the limitations of existing drugs.”

The trial is named “Phase 2 multicenter, open-label, parallel cohort expansion clinical trial to evaluate the efficacy, safety, tolerability, and pharmacokinetic profile of Vabametkib in patients with advanced solid tumors with c-MET dysregulation.” The clinical subjects are patients with advanced solid tumors of non-small cell lung cancer (NSCLC) who have shown resistance to EGFR targeted anticancer drugs and exhibit overexpression or amplification of the MET gene.

The company plans to strengthen its global market position by offering a new treatment alternative to patients resistant to EGFR targeted anticancer drugs based on Vabametkib’s excellent safety and efficacy.

This content was produced with the assistance of AI translation services.