Abstract 697P
Background
Aumolertinib has showed promising efficacy and safety in EGFR mutations NSCLC patients. Anlotinib is an oral multi-targeted tyrosine kinase inhibitor for tumor angiogenesis and proliferation. The combination of two targeted drugs with different mechanisms may have broad clinical application prospects. However, there had limited evidence to show the efficacy of Aumolertinib and Anlotinib as 1st-line therapy for EGFR mutant NSCLC. Here, we conduct the ALWAYS study to evaluate the efficacy and safety of combined treatment with aumolertinib and anlotinib, and to provide regimen for further prolong the progression-free survival of 1st-line treatment of advanced NSCLC patients with EGFR mutations.
Methods
ALWAYS study is an open-label, single-arm, prospective phase II study enrolled untreated patients with advanced EGFR-mutant NSCLC. All patients were treated with aumolertinib plus anlotinib. Anlotinib is continuously used for 2 weeks and then stopped for 1 week. The primary endpoint was PFS, secondary endpoints included ORR, DCR, OS, DoR and safety.
Results
Total 26 patients were recruited and the median age was 67.5 years (range 31- 81), 16 cases are male (61.5%). In the total population, 19 patients (73.1%) never smokers, 17 patients (65.4%) had brain metastases, 25 (94.8%) patients harbored 19 del (42.3%) or 21L858R mutations (53.8%). At the data cutoff 12 Mar 2024, patients receiving aumolertinib with anlotinib displayed an ORR and DCR of 96.15% (95% CI: 80.4%-99.9%) and 100% (95% CI: 86.8%-100%), respectively. Intracranial target lesions were evaluated in 17 patients with brain metastases, and iORR was 76.47% (95% CI:50.1%-93.2%) and iDCR was 100% (95% CI: 80.5%-100.00%). The mPFS was 23.0 months (95% CI: 19.8-23.8). There was no grade ≥3 adverse events occurred during combined treatment, and the most common adverse reactions were rash, pruritus and diarrhea.
Conclusions
ALWAYS study demonstrated that aumolertinib plus anlotinib as 1st-Line Treatment for advanced EGFR mutant NSCLC had a promising anti-tumor activity with a manageable safety profile. In addition, this combination treatment also showed a meaningful clinical control in NSCLC patients with brain metastases.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.