- [WCLC] Abion holds Advocacy Meeting to gather expert input ahead of Korean regulatory submission
- Phase 2 study shows 54.8% ORR and median DoR of 11 months; efficacy and safety data reviewed
- Long-term response cases lasting more than 40 months shared; dosing and adverse event management discussed
- Strategies for confirmatory trials in rare cancers reviewed

[The BIO Reporter Ji Yong-jun] Korean biopharmaceutical company Abion (Abion) is developing a strategy with experts to pursue conditional approval in Korea for its lung cancer drug candidate, vabamekip (development code: ABN401). Abion has secured an objective response rate (ORR) of 54.8% and a median duration of response (DoR) of 11 months in a Phase 2 study of vabamekip, and is currently preparing an application for expedited review designation and a marketing authorization application.

On the 13th, Abion held a separate session (Advocacy Meeting) at the 2026 World Conference on Lung Cancer (WCLC) Annual Meeting held at COEX in Samseong-dong, Gangnam-gu, Seoul, where it discussed vabamekip’s clinical data and regulatory strategy with clinical researchers and regulatory experts.

The strategy meeting was organized to gather expert opinions on additional materials needed ahead of the regulatory submission, as vabamekip has been designated as a rare drug in development and Abion is currently preparing for conditional approval.

The meeting was chaired by Keunchil Park, Distinguished Professor at Sungkyunkwan University School of Medicine, and attended by Hanlim Moon, CEO of Medirama; Hye Ryun Kim, Professor of Medical Oncology at Yonsei Cancer Center; Se Hoon Lee, Professor of Hematology and Oncology at Samsung Medical Center; Dae Ho Lee, Professor of Medical Oncology at Asan Medical Center; Soo Hyeon Lee, Professor of Medical Oncology at Korea University Anam Hospital; and Kyungwon Seo, Vice Director of the Institute for Pharmaceutical Education and Training at Seoul National University College of Pharmacy, among others.

Vabamekip is an oral small-molecule tyrosine kinase inhibitor (TKI) candidate that selectively inhibits the hepatocyte growth factor receptor (c-MET). The Phase 2 monotherapy study presented on the day was conducted in patients with non-small cell lung cancer (NSCLC) harboring a MET exon 14 skipping mutation. A total of 44 patients were enrolled at 24 institutions in Korea, the United States, and Taiwan, and efficacy was analyzed in a total of 42 patients.

The analysis showed an overall ORR of 54.8%, a median DoR of 11 months, and a median progression-free survival (PFS) of 8.5 months. The study began dosing its first patient in January 2023 and completed enrollment of the last patient in February 2025. In the safety analysis, the incidence of Grade 3 or higher treatment-related adverse events was 11.4%. Among adverse events considered common, including peripheral edema and hypoalbuminemia, there was only one Grade 3 or higher case of each.

Hanlim Moon, CEO of Medirama, compared vabamekip with the clinical results of existing MET inhibitors capmatinib and tepotinib and evaluated that vabamekip showed a similar level of response rate and duration of effect. He said, “The low incidence of Grade 3 or higher treatment-related adverse events stands out.” Long-term treatment cases for individual patients were also introduced at the meeting. For example, a 79-year-old male patient showed a partial response (PR), with the tumor shrinking by approximately 35% at the first assessment, and the tumor response was reported to have been maintained for more than 40 months. In a patient case shared by MD Anderson Cancer Center in the United States, a 71-year-old male patient maintained stable disease and had been receiving treatment at the same dose for 29 months.

Based on these treatment experiences, discussions also continued on the appropriate dose. Abion did not observe dose-limiting toxicity (DLT) up to a dose of 1,200 mg in its early clinical studies, but selected 800 mg as the Phase 2 dose based on pharmacokinetic analysis.

The possibility of conditional approval was also discussed. Kyungwon Seo, Vice Director, said, “If conditional approval is granted, clinical data must be submitted within the specified period and the implementation status must be reported.” In response, Professor Keunchil Park asked about strategies for conducting the confirmatory clinical trial required after conditional approval, noting, “It can be difficult to conduct a Phase 3 trial in rare cancers with a small number of patients.” In fact, tepotinib, developed by Germany’s Merck and considered a competitor to vabamekip, obtained full approval from the U.S. Food and Drug Administration (FDA) through follow-up observation of its Phase 2 study.

Vice Director Seo emphasized, “An RCT-based Phase 3 trial is not required in every case,” adding, “Depending on the disease and the type of trial, it is possible to submit clinical data in a different format or adjust the timeline.”

Young Khee Shin, CEO of Abion, said, “This meeting was helpful in developing a strategy for conditional approval of vabamekip,” adding, “Based on the opinions presented by the experts, we will conduct additional analyses of the clinical data and continue to strengthen the evidence supporting our regulatory submission in Korea.”

Source: THE BIO(https://www.thebionews.net/news/articleView.html?idxno=28058)