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Final Overall Survival Results From APOLLO of Aumolertinib in Advanced NSCLC

By: Vanessa A. Carter, BS
Posted: Monday, December 20, 2021

Shun Lu, MD, PhD, of Shanghai Chest Hospital, Shanghai Jiao Tong University, China, and colleagues evaluated the survival outcomes with aumolertinib—a third-generation EGFR tyrosine kinase inhibitor—in patients with pretreated, advanced non–small cell lung cancer (NSCLC). Prior results of the phase II APOLLO trial demonstrated a progression-free survival benefit, with a favorable safety profile. The final results, which showed a clinical benefit in overall survival, were presented during the European Society for Medical Oncology (ESMO) Congress 2021 (Abstract 1208P) and published in the Annals of Oncology.

This single-arm study enrolled 244 patients with previously treated, EGFR T790M–positive, locally advanced or metastatic NSCLC. Participants received 110 mg of aumolertinib per day until disease progression. If clinical benefit was expected, treatment beyond disease progression was allowed.

By the time of data cutoff, slightly more than half (51.6%) of patients had died, and the median follow-up was 34.5 months. The overall survival rate at 24 months was 57.5%, with a median overall survival of 30.2 months. Of note, patients who were female, younger than age 65, non-smokers, and/or did not have central nervous system metastases were observed to have longer overall survival.

Aumolertinib treatment was continued in 82 patients beyond disease progression. Molecular profiling was performed using the blood and tissue tumor samples of 42 individuals who demonstrated disease progression. A total of seven patients acquired a mutation in EGFR C797S in cis with T790M, and one patient had an EGFR L718Q mutation. Additionally, aberrations in bypass tracks such as JAK2, PIK3CA, FGFR3-TACC3 fusion, HER2 amplification, and BRAF and KRAS mutations were observed in eight participants.

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



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