Abion "FDA Approval for Lazertinib Combination Therapy... Benefiting from Babamekip Combination Strategy"

ABION announced on the 21st that it expects benefits from the combination strategy of its pipeline drug Babamekipa (ABN401) and Lazertinib following the U.S. Food and Drug Administration (FDA) approval of the combination therapy of Lazertinib (domestic name: Reclarza, U.S. name: Razcluze) and Rybrevant (active ingredient: Amivantamab).

On the 20th (local time), the FDA approved the combination therapy of Yuhan Corporation's Lazertinib and Janssen's Rybrevant for patients with epidermal growth factor receptor (EGFR) mutation non-small cell lung cancer (NSCLC). This is the first domestically developed anticancer drug approved by the FDA. It comes six months after the combination therapy was designated for priority review in February.

ABION's c-MET inhibitor Babamekipa and Lazertinib combination clinical trial targets patients with EGFR mutation NSCLC who developed resistance due to c-MET mutation after receiving EGFR tyrosine kinase inhibitors (TKIs).

A company representative stated, “About half of the patients show c-MET gene mutations after first-line treatments such as Tagrisso or the newly approved combination therapy. The need for combination therapy of EGFR inhibitors and MET inhibitors is increasing to address this resistance treatment.”

They added, “The number of such patients reaches 200,000 annually, and the market size exceeds 5 trillion KRW, but so far, no approved combination therapies of EGFR inhibitors and MET inhibitors exist in various clinical trials. We expect the Babamekipa and Lazertinib combination therapy to be the first approved case.” With the recent FDA approval of Lazertinib proving the drug’s efficacy and safety, it is explained that the combination strategy with Babamekipa can benefit.

The Babamekipa and Lazertinib 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. Babamekipa is currently undergoing a global phase 2 clinical trial as a monotherapy (cohort 1) with 40 patients in the U.S., Korea, and Taiwan. The company plans to pursue conditional approval from the Korean Ministry of Food and Drug Safety and accelerated approval from the FDA in the first half of next year. The combination trial will be incorporated as cohort 2 of Babamekipa’s phase 2 trial.

ABION emphasized, “We are pushing forward with the clinical trial aiming to enroll the first patient within this year. Since Lazertinib is supplied free of charge by Janssen for the trial, we will focus on ensuring Babamekipa is recognized as a highly valuable domestically developed anticancer drug following Lazertinib’s FDA approval.”