The AENEAS2 study demonstrated that aumolertinib combined with chemotherapy significantly improved progression-free survival compared to aumolertinib monotherapy in patients with EGFR-mutated advanced non-small-cell lung cancer. While the combination therapy led to increased toxicity, these adverse events were manageable with dose adjustments and supportive care. Long-term follow-up is needed to assess overall survival benefits.
Study
|
Randomised, open-label, multicentre, controlled, phase 3 trial [AENEAS2, NCT04923906] |
| Untreated locally advanced or metastatic NSCLC with EGFR-sensitive mutations (ex19del/L858R) |
| Aumolertinib 110 mg/day + platinum-based chemotherapy (n=310) vs Aumolertinib 110 mg/day monotherapy (n=314)
|
Efficacy
|
mPFS: 28.9 mos [26.3-NA] vs 18.9 mos [17.8-21.1] (HR 0.47 [0.37-0.60]) |
| ORR: 93.2% [89.8-95.8] vs 87.3% [83.1-90.7] (OR 2.03 [1.16-3.55]) |
| mDoR: 27.6 mos [24.8-NA] vs 19.3 mos [16.6-22.0]) |
| mOS: Not reported (HR 0.44 [0.31-0.64])
|
Safety
|
Grade >=3 AE: Neutropenia (55% vs 1%), thrombocytopenia (20% vs 1%), anemia (11% vs 1%) |
| Treatment-related deaths: <1% vs 1% |
| Treatment discontinuation due to AEs: 21% vs 2%
|
Lancet Oncol 2026;27:785-94
http://doi.org/10.1016/S1470-2045(26)00090-2
Reviewed by Ulas D. Bayraktar, MD on Aug 13, 2026
