KEY TAKEAWAYS
- AENEAS, Phase III trial (NCT03849768) compared the efficacy of aumolertinib and gefitinib for first-line treatment of EGFR-mutated NSCLC.
- The study’s primary endpoint was investigator-assessed PFS on taking either Aumolertinib or Geftinib.
- A randomized, double-blind trial was conducted at 53 sites across China among 429 patients with NSCLC.
- The study showed that aumolertinib exhibited significantly better PFS than gefitinib.
The third-generation epidermal growth factor receptor tyrosine kinase inhibitor aumolertinib (formerly almonertinib; HS-10296) has been approved for use in China. First-line treatment for patients with locally progressed or metastatic EGFR-mutated non-small-cell lung cancer was compared between aumolertinib and gefitinib in this randomized, double-blind, phase III trial (NSCLC; ClinicalTrials.gov identifier: NCT03849768).
Participants were randomly assigned to receive either aumolertinib (110 mg) or gefitinib (250 mg) once daily at 53 sites across China. Investigator-assessed progression-free survival (PFS) was the principal endpoint.
Four hundred twenty-nine patients with locally advanced or metastatic NSCLC who had never received prior treatment were included. Compared to gefitinib, “PFS was significantly better with aumolertinib (hazard ratio, 0.46; 95% CI, 0.36 to 0.60; P <.0001).” The median PFS for patients using aumolertinib was “19.3 months (95% CI, 17.8 to 20.8), but those taking gefitinib saw just 9.9 months (95% CI, 8.3 to 12.6).” Both aumolertinib and gefitinib groups achieved comparable rates of objective response (73.8 and 72.1%, respectively) and disease control (93.1 and 96.7%, respectively). When comparing aumolertinib and gefitinib, the median duration of response was “18.1 months (95% CI, 15.2 to not applicable) and 8.3 months (95% CI, 6.9 to 11.1),” respectively. As for adverse events, 36.4% of patients in the aumolertinib group and 35.8% in the gefitinib group experienced grade 3 severity (any cause) adverse events. Those who took aumolertinib were less likely to get rash and diarrhea (any grade) than those who took gefitinib (41.4%) and gefitinib (35.8%), respectively.
In conclusion, aumolertinib is a third-generation epidermal growth factor receptor tyrosine kinase inhibitor with good safety profiles that shows promise as a frontline treatment for EGFR-mutant non-small cell lung cancer.
Source: https://pubmed.ncbi.nlm.nih.gov/35580297/
Clinical trial: https://clinicaltrials.gov/ct2/show/NCT03849768
Lu, S., Dong, X., Jian, H., Chen, J., Chen, G., Sun, Y., Ji, Y., Wang, Z., Shi, J., Lu, J., Chen, S., Lv, D., Zhang, G., Liu, C., Li, J., Yu, X., Lin, Z., Yu, Z., Wang, Z., Cui, J., … Wu, Q. (2022). AENEAS: A Randomized Phase III Trial of Aumolertinib Versus Gefitinib as First-Line Therapy for Locally Advanced or MetastaticNon-Small-Cell Lung Cancer With EGFR Exon 19 Deletion or L858R Mutations. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 40(27), 3162–3171. https://doi.org/10.1200/JCO.21.02641
