Abion announced on December 27 that the U.S. Food and Drug Administration (FDA) approved modifications to the phase 2 clinical trial plan for ‘vabametkib (development code name ABN401),’ a c-MET targeted anticancer drug candidate.
Following this approval, Abion will proceed with phase 2 clinical trials of vabametkib for advanced solid non-small cell lung cancer (NSCLC) patients and those with epithelial-mesenchymal transition (MET) overexpression or amplification who have developed resistance to epidermal growth factor receptor (EGFR) targeted anticancer drugs.
The objective of the phase 2 trial is to evaluate the safety, efficacy, and tolerability of the combination therapy of the EGFR-targeting anticancer drug ‘Leclaza (lazertinib, marketed in the U.S. as Lazcluze)’ and vabametkib, a MET-targeted anticancer drug candidate.
The clinical trial will be divided into three parts, involving a total of 138 patients from Korea, Taiwan, and four hospitals in the United States. Part 1 will focus on adjusting doses to determine the safety and tolerability of the combination therapy. Part 2 will establish the optimal combination dosage by assessing efficacy at varying doses of the two drugs. Part 3 will compare the optimal combination dose and its efficacy against current treatment options.
Abion stated that approximately 30% of NSCLC patients treated with EGFR-targeting drugs often develop resistance due to c-MET overexpression or amplification. For such cases, vabametkib and lazertinib target the c-MET and EGFR signaling pathways, respectively, offering a complementary approach. The company explains that the combination therapy is anticipated to simultaneously achieve dual benefits: inhibiting cancer cell growth and improving patient survival rates.
“This clinical modification approval enables us to move forward with full-scale clinical trials with lazertinib,” a company official stated. “Since no drugs have yet been approved for this specific combination therapy, there is significant potential for a first-in-class innovative treatment.”
Conversely, according to Evaluate Pharma, a U.S.-based market research firm, the global c-MET inhibitor market is projected to reach approximately USD 4.726 billion (approximately KRW 5.2 trillion) by 2026.
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