On December 2, 2022, Hansoh Pharmaceutical Group Co., Ltd. (3692.HK,"Hansoh Pharma") announced that European Medicines Agency (EMA) has accepted the company's strategic partner EQRx’s marketing authorization application (“MAA”) for aumolertinib, a novel, third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (“EGFR-TKI”), for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) with activating EGFR mutations and for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC. The MAA is primarily supported by data from the Phase 3 study (the “AENEAS Study”). This is the second MAA of aumolertinib filed outside of the People’s Republic of China by EQRx.
In 2020, lung cancer was the third most diagnosed cancer in Europe and the leading cause of cancer-related mortality, accounting for one fifth of cancer deaths.[1] Globally, it is estimated that almost a third of patients with NSCLC, which accounts for approximately 85% of all lung cancers, have EGFR mutations.[2]
Aumolertinib, marketed as AMEILE (aumolertinib mesilate) in China, is a novel, third-generation, irreversible EGFR-TKI with favorable pharmacologic properties that selectively inhibits both EGFR sensitizing and resistance mutations. Aumolertinib is approved for both first-line and second-line treatment of patients with locally advanced or metastatic EGFR-mutated NSCLC in China. It is currently being evaluated in several clinical development programs for lung cancer.
In July 2020, Hansoh Pharma and EQRx entered into a License Agreement. Under the License agreement, EQRx has the exclusive right to research, develop, manufacture and commercialize aumolertinib outside of the People’s Republic of China.
About the AENEAS Trial
AENEAS Study is a randomized, double-blind, multicenter, Phase 3 study designed to evaluate the efficacy and safety of aumolertinib versus gefitinib as first-line treatment for adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC). The study met its primary endpoint, demonstrating statistically significant improvement in progression-free survival as compared to gefitinib. Secondary endpoints include overall survival, overall response rate and safety. Results from AENEAS were published in the Journal of Clinical Oncology in 2022.[3]
About EQRx
EQRx is a new type of pharmaceutical company committed to developing and expanding access to innovative medicines for some of the most prevalent disease areas, including cancer and immune-inflammatory conditions. Launched in January 2020, EQRx is leveraging cutting-edge science, technology and strategic partnerships with stakeholders from across the healthcare system toward the goal of increasing access for patients around the world.
[1] Dyba T, et al. The European cancer burden in 2020: Incidence and mortality estimates for 40 countries and 25 major cancers. Eur J Cancer. 2021;157:308-347.
[2] Zhang, et al. The prevalence of EGFR mutation in patients with non-small cell lung cancer: a systematic review and meta-analysis. Oncotarget. 2016;7:78985-78993.
[3] Lu S, et al. AENEAS: A Randomized Phase III Trial of Aumolertinib Versus Gefitinib as First-Line Therapy for Locally Advanced or Metastatic Non–Small-Cell Lung Cancer With EGFR Exon 19 Deletion or L858R Mutations. Journal of Clinical Oncology. 2022;40(27):3162-3171.
