– [Interview] Combination strategy unveiled at ASCO: “Safety confirmed, Cohort 2 to launch in H2 2024”
– Plans to proceed in Korea and the U.S. for patients resistant to existing EGFR-targeted treatments
– “Vabametkib boasts a high c-MET inhibition rate and high safety by not inhibiting other tyrosine kinases (TK)”
Abion revealed its intention to seek approval for a Cohort 2 clinical trial in Q3 2024, using its small molecule ‘Vabametkib (ABN401)’, an anticancer candidate targeting hepatocyte growth factor c-MET, in combination with ‘Lazertinib (Korean brand name: Leclaza)’, a new anticancer drug developed by Yuhan Corporation.
This decision stems from the increased confidence in the combination therapy of ‘c-MET TKI (tyrosine kinase inhibitor)’ and ‘EGFR (epidermal growth factor receptor) TKI’, following the confirmation of vabametkib’s safety from the phase 2 clinical trial cutoff results announced at the American Society of Clinical Oncology (ASCO) 2024 earlier this month.
Although the specific reason for selecting lazertinib as the combination partner drug was not disclosed, it is speculated that its high safety profile among EGFR TKIs played a significant role.
In an interview with at the ASCO site, Abion CEO Shin Young Kee stated, “We will apply for the Lazertinib Cohort 2 study,” and added, “We plan to submit the application in the 3rd quarter and start clinical trials in the 3rd to 4th quarter.”
This initiative represents an expansion of the ongoing Phase 2 clinical trial of vabametkib to include Cohort 2. The trial will target patients resistant to existing EGFR-targeted treatments and will be conducted in both Korea and the United States.
“(Vabametkib) has a high c-MET inhibition rate, and also offers high safety as it does not inhibit other tyrosine kinases,” Shin explained.
c-MET inhibitors are considered to be a challenging class of new drugs to develop due to repeatedly past failures by other companies.
When c-MET is activated, it causes cancer cells to proliferate and divide. Vabametkib works by binding to the TK domain in cancer cells, thereby blocking c-MET signaling.
Abion presented the phase 2 clinical trial cutoff results for vabametkib during an industry expert theater (IET) session at ASCO. It was introduced as a ‘From Lung Cancer to Expanding Our Oncology Horizons’ company, emphasizing vabametkib’s high safety profile and impressive response rate compared to global treatments.
Abion reported a 10% rate of treatment-related adverse events (TRAEs) of grade 3 or higher, significantly lower than the 37.6% and 28% reported for competing drugs Tabrecta (capmatinib) and Tepmetko (tepotinib), respectively. The objective response rate (ORR) for vabametkib was 54%, surpassing the 48% and 43% rates of Tabrecta and Tepmetko. Grade 3 or higher treatment-related adverse events (TRAEs) were also noted at 10%, outperforming the 28-37.6% range of competing drugs.
Vabametkib’s median progression-free survival (mPFS) reached 11.6 months as of May 9, with expectations for further improvement expected as clinical trials continue.
In addition, the administration of vabametkib, which has been approved by the Ministry of Food and Drug Safety for therapeutic use, have shown encouraging results, raising expectations. “The results of treating one brain tumor (glioblastoma) were confirmed,” Shin noted. “It showed promising results, with the tumor size reduced by 90% in 16 days.”
Conversely, Abion announced on June 17 that patient registration for the phase 2 clinical trial of vabametkib is nearing completion. The company aims to quickly recruit the target number of 40 patients and seek conditional approval from the Ministry of Food and Drug Safety and accelerated approval from the U.S. Food and Drug Administration (FDA).
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