UK MHRA Accepts Marketing Application for Almetinib

On June 14, EQRx, Inc announced that the UK Medicines and Health Products Regulatory Agency (MHRA) has accepted a Marketing Authorization Application (MAA) for the third-generation EGFR tyrosine kinase inhibitor (TKI) almetinib for the treatment of adults First-line treatment of locally advanced or metastatic non-small cell lung cancer. The application is primarily based on data from the pivotal Phase III AENEAS trial, which is the first time EQRx has submitted a marketing application to a regulatory agency.

AENEAS (NCT03849768) is a randomized, double-blind, multicenter Phase III study to evaluate the efficacy and safety of almetinib versus gefitinib as first-line treatment for adults with locally advanced or metastatic EGFR-mutant non-small cell lung cancer sex. The study, conducted by Hansoh Pharmaceuticals, enrolled 429 patients who were randomized to receive almetinib (n=214) or gefitinib (n=215). The study met its primary endpoint, data have been published in the Journal of Clinical Oncology, and data on almetinib activity in CNS metastases were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting.

In July 2020, Hansoh Pharma and EQRx reached a strategic cooperation and licensing agreement for Ametinib. Under the terms of the agreement, EQRx will be responsible for the development and commercialization of almetinib in all global markets outside of Greater China, and Hansoh Pharma will continue to develop and commercialize almetinib in Greater China.