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Phase III Trial of Aumolertinib Versus Gefitinib in EGFR-Mutated NSCLC

By: Julia Fiederlein
Posted: Tuesday, September 6, 2022

First-line treatment with aumolertinib (formerly almonertinib; HS-10296) appears to provide longer progression-free survival than gefitinib in patients with locally advanced or metastatic EGFR-mutated non–small cell lung cancer (NSCLC), according to Shun Lu, MD, of Shanghai JiaoTong University, China, and colleagues. The results of the phase III multicenter AENEAS trial, which were published in the Journal of Clinical Oncology, suggested this third-generation EGFR tyrosine kinase inhibitor was also well tolerated. Aumolertinib has been approved in China for the second-line treatment of advanced EGFR T790M mutation–positive NSCLC and the first-line treatment of locally advanced or metastatic NSCLC harboring tyrosine kinase inhibitor–sensitizing mutations.

A total of 429 Chinese patients were randomly assigned in a 1:1 ratio to receive either aumolertinib or gefitinib once daily. The median duration of progression-free survival was significantly longer with aumolertinib than with gefitinib (19.3 vs. 9.9 months; hazard ratio = 0.46; P < .0001). Similar objective response (73.8% vs. 72.1%) and disease control (93.0% vs. 96.7%) rates were observed between the arms. The median duration of response was 18.1 months with aumolertinib and 8.3 months with gefitinib.

Rash and diarrhea of any grade were reported in 23.4% and 16.4% of patients who were treated with aumolertinib compared with 41.4% and 35.8% of those who received gefitinib. The rates of treatment-emergent adverse events of grade 3 or higher were similar between the arms (36.4% vs. 35.8%).

“This study conducted exclusively in China has findings broadly applicable to this genomically defined, global patient population, as the natural history of and approach to evaluation and treatment of patients with EGFR-mutant NSCLC are similar worldwide...,” the investigators concluded. “Additional studies…are ongoing in the adjuvant setting and the metastatic setting in combination with chemotherapy.”

Disclosure: For full disclosures of the study authors, visit ascopubs.org.


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