Abstract 77P
Background
Aumolertinib, the 3rd generation EGFR-TKI, has achieved significant efficacy for patients with advanced EGFR-mutated NSCLC and has been the standard treatment for targeting T790M mutation. APOLLO study demonstrated the mPFS was 12.4 months and OS was 30.2 months with aumolertinib as second-line treatment. However, a certain of patients were resistant to TKIs and how to choose a regimen when progression occurred after second-line treatment. Thus, we conducted a retrospective study to evaluate the efficacy of different strategies.
Methods
We retrospectively analyzed advanced EGFR-mutant NSCLC patients from April, 2020 to April, 2024 in over 10 hospital centers in Jiangxi Province. All the patients were orally given aumolertinib (110 mg QD) as second-line treatment. When progression occurred, patients were treated with increased dose of aumolertinib (165 mg/220 mg) or combined therapy (aumolertinb with chemotherapy, VEGFR inhibitor or radiotherapy). PFS1 was defined as the time from the first administration of aumolertinib to initial progression and PFS2 was the time from switched treatment scheme to second progression. The primary endpoint is mPFS2. Secondary endpoints included mPFS1, ORR, DCR and safety.
Results
32 patients were analyzed and the median age is 61 years old (range 48–81) at data cut-off (December, 2024) and female accounted for 59.4%. 28 patients had an ECOG score of 1 or greater. In total, the mPFS1 was 15.0 months (95%CI:12.1–17.7). Two deaths occurred and the rest continued treatment either high-dose aumolertinib or combined therapy. The mPFS2 was 14 months (95%CI:5.4–22.8). The ORR was 37% and DCR was 87% at second progression. Consistent with prior clinical trials, no grade≥3 AE was observed.
Conclusions
Aumolertinib showed superior antitumor activity with a manageable safety profile as second-line therapy in EGFR-mutant NSCLC patients. Moreover, both aumolertinib monotherapy of high dose and combined therapy are promising options as post second-line treatments. Patients can continuously benefit from aumolertinib. Further analyses are warranted to determine which approach is the best suit.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.