On October 13, 2023 ABION (KOSDAQ: 203400) reported data from an ongoing Phase 2 trial of ABN401, the company’s wholly owned tyrosine kinase inhibitor intended to treat adult patients with advanced non-small cell lung cancer that exhibit the MET Exon 14 skipping mutation (Press release, ABION, OCT 13, 2023, View Source [SID1234635963]). In eight treatment-naïve patients, the objective response rate was 75% (6/8), and in the evaluable population of 17 patients, the objective response rate was 52.9% (9/17).

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Patients were dosed 800 mg QD and the median duration of response was 5.4 months as of the data cut-off on July 25, 2023. The data are not mature enough to measure progression-free survival and duration of response. All patients are MET inhibitor naïve. Overall efficacy was comparable to currently marketed drugs and demonstrate superior efficacy in treatment-naïve patients.

The cut-off data reaffirm ABN401’s excellent safety profile as shown in an earlier Phase 1 trial. A total of 24 patients received ABN401 800 mg QD, including 17 METex14 NSCLC patients. Of 24 patients evaluable for safety, 2 (8.3%) experienced grades ≥3 treatment-related adverse events (TRAE). The most common treatment-related adverse events were nausea (70.8%), vomiting (29.2%), and diarrhea (33.3%). Grade ≥3 treatment-emergent adverse events occurred in 20.8% (5/24) patients. Treatment-related adverse events leading to permanent discontinuation occurred in none of the patients (0/24). Peripheral edema was observed in 29.2% (grade 1-2) and there was no grade 3 or greater event in all safety-evaluable populations, and 17.6% (grade 1-2) and 0% (grade 3) in METex14 NSCLC population. None of the patients discontinued treatment due to SAE or TRAE.

For the 17 METex14 NSCLC patients, one was not evaluable because the patient had not had the first tumor assessment at the time of the data cut-off. The median age is 69 (41-81) and 70.6% were male, with 1 (0-3) as the median prior lines of treatment. 41.2% of 17 patients were non-smokers and 58.8% were smokers. ABN401 continued to demonstrate outstanding safety compared to the currently marketed drugs.

The results were presented in a poster session at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in Boston, and at a separate company event nearby.

"We are delighted to see the outstanding data from the global Phase 2 clinical trial to evaluate this potential best-in-class treatment, which continues to exhibit an outstanding safety profile," said Young Kee Shin, M.D., Ph.D., CEO of ABION. "Notably, these results follow and further expand the potential of ABN401 combination therapy with other treatment regiments. "The excellent safety enables the potential combination of ABN401 with EGFR treatment, chemotherapy, or KRAS or immuno-oncology treatments. Our goal is to increase options for patients with c-MET positive NSCLC."

Based on these results, ABION plans to initiate a Phase 2 combination trial with a multiple drug regimen. The c-MET mutation is the most common mutation shown by NSCLC patients after treatment with EGFR TKIs.