Aumolertinib significantly prolongs progression-free survival (PFS) with fewer side effects in first-line treatment of advanced EGFR-mutated NSCLC.- EQRx + Hansoh Pharma

Detailed results from the Phase III AENEAS trial showed that treatment with aumolertinib from EQRx + Hansoh Pharma, resulted in a clinically significant improvement in progression-free survival (PFS) as compared to gefitinib (Iressa) in first-line treatment in patients with Stage IIIB or IV non-small cell lung cancer (NSCLC) in patients with the most common types of EGFR mutations. In addition, the encouraging safety findings of less frequent rash and diarrhea confirmed the previously reported findings in the second-line APOLLO study. Aumolertinib is already approved in China in the second-line setting and is being jointly developed by EQRx and Hansoh Pharma globally. These results will be discussed in a Poster Discussion Session during the American Society of Clinical Oncology (ASCO) 2021 Virtual Annual Meeting on June 4, 2021 (abstract #9013). AENEAS is a double-blind randomized phase III trial comparing aumolertinib 110 mg once daily (n=214) to gefitinib 250 mg once daily (n=215) in patients with EGFR-mutated NSCLC. AENEAS met its primary endpoint of prolongation of PFS at the time of the pre-specified event driven analysis. The median PFS was estimated at 19.3 months for aumolertinib and 9.9 months for gefitinib with a hazard ratio 0.46 (p<0.0001). at a landmark one-year analysis, 69 percent of patients treated with aumolertinib were free of disease progression compared to 46 percent of patients treated with gefitinib. improvement in pfs in patients who received aumolertinib over gefitinib was observed across relevant subgroups of patients, including those with brain metastases. the study has not yet met the cutoff for overall survival. aumolertinib was well-tolerated. adverse events that caused patients to temporarily stop or discontinue treatment altogether were less common with aumolertinib than with gefitinib.aumolertinib was associated with lower incidence of commonly observed egfr-related adverse events of rash and diarrhea and no new safety signals were identified. these results further suggest aumolertinib to be an excellent choice for combination studies and studies in the adjuvant setting in this subset of patients with nsclc..>