Clinical trial of ‘lazertinib’ and ‘vabametkib’ combination: “Aiming to develop innovative new drugs”
Abion announced on February 17 that the Ministry of Food and Drug Safety has approved a change to the Phase 2 clinical trial plan (IND) for its anticancer drug candidate, ‘vabametkib (development code ABN401)’. The Phase 2 clinical trial is the ‘lazertinib’ and ‘vabametkib’ combination therapy study, aimed at assessing its safety, efficacy, and tolerability.
This clinical trial targets patients with advanced solid tumors, particularly ‘non-small cell lung cancer (NSCLC)’, who have developed resistance to epidermal growth factor receptor (EGFR)-targeted anticancer treatments. The combined clinical study will be conducted in the U.S., Korea, and Taiwan, enrolling a total of 138 patients who exhibit overexpression or amplification of mesenchymal-epithelial transition (MET).
The clinical trial will be conducted in three phases, with completion expected by Q4 2027. In Part 1, the doses of lazertinib and vabametkib will be adjusted to assess safety. Part 2 will involve a randomized clinical trial to determine the optimal dose of the two drugs, ensuring confirmed safety and tolerability. Finally, Part 3 will compare the efficacy of the combination therapy with existing treatments.
“The interim results of the phase 2 monotherapy trial demonstrated higher efficacy than competing drugs, so we are optimistic about achieving innovative outcomes in the combination clinical trial as well,” an Abion official said. “We are committed to successfully completing the global combination phase 2 clinical trial and develop an innovative novel drug for the treatment of non-small cell lung cancer, with the goal of becoming a leading global biotechnology company.”
Conversely, the company announced that the Taiwan Food and Drug Administration (TFDA) has also approved the phase 2 clinical trial of the combination treatment. The trial will be conducted at six hospitals in Taiwan, following the same three-part methodology used in the US and Korea.
Following the approval of the changes, Abion intends to accelerate the clinical trial process. The combination clinical trial in Korea, the U.S., and Taiwan aims to administer the first patient as soon as possible. The company plans to collaborate with global research institutes to expedite patient recruitment and ensure data collection.
Published by: https://www.thebionews.net/news/articleView.html?idxno=12872
