Abion announced on the 2nd that the abstract of their liquid biopsy study to strengthen the competitive edge of the combination clinical trial of Babamekip (ABN401) has been accepted at the European Society for Medical Oncology (ESMO 2024).
The study was conducted as an investigator-initiated trial (IIT) by the research team led by Professor Sehoon Lee of Samsung Seoul Hospital. It focused on disease progression related to hepatocyte growth factor receptor-positive circulating tumor cells (MET CTC) in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer who received EGFR tyrosine kinase inhibitor (TKI) treatment.
Analysis of disease progression within 2 months in 212 patients treated with EGFR TKI showed that patients with 8 or more MET CTCs detected exhibited sensitivity of 50%, specificity of 89.3%, positive predictive value of 55%, negative predictive value of 87.2%, and accuracy of 81.1%. The company explained that this suggests MET CTC can serve as a complementary marker to existing imaging methods.
An Abion representative stated, “This study signifies the ability to early identify patients with MET mutations and apply appropriate treatment. During the combination clinical trial of Babamekip and Lazertinib, utilizing MET CTC for pre-screening allows treatment to start at the optimal time, thereby increasing the likelihood of clinical success.”
The Babamekip combination clinical trial will proceed with up to 158 patients, starting with 18 in phase 1, 60 in phase 2, and 80 in phase 3. Babamekip is currently undergoing a global phase 2 clinical trial as a monotherapy (cohort 1) with 40 patients in the United States, Korea, and Taiwan. The combination trial uses already validated drugs together to increase response rates.
The company emphasized, “We will continue to strive to provide effective cancer treatments to patients.”
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