Abstract 377P
Background
For NSCLC patients with acquired resistance to first- or second-generation EGFR-TKIs, aumolertinib is approved in the presence of the T790M resistance mutation. However, the activity of third-generation EGFR-TKIs in T790M-negative patients remains inconclusive. We hereby evaluated the efficacy and safety of aumolertinib as second-line therapy in either T790M-positive or T790M-negative patients.
Methods
We retrospectively collected data from NSCLC patients with EGFR mutation who have progressed after previous EGFR-TKI treatment and receiving aumolertinib 110mg daily between March 2020 to March 2021 in Affiliated Hospital of Qingdao University. Patients were divided into T790M-positive and T790M-negative groups based on their blood samples analysis. The primary endpoint is progression-free survival (PFS) and secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR) and safety.
Results
Of 77 patients in this study, 46 (60 %) were T790M-positive, 31 (40 %) were not. Overall median PFS was 12.0 months (95%CI：9.02-14.97), and 16.0 vs 8.0 months for T790M-positive vs -negative patients respectively (P < 0.001). Overall ORR was 47.8 % and DCR was 94.6 % for T790M-positive patients; ORR was 35.4% and DCR was 95.5% for T790M-negative patients. Median OS has not been reached. The incidence of adverseevents（AEs，Table）was 77.4% for T790M-positive patients and 71.7% for T790M-positive patients, the most common TRAEs were rash, oral ulcer and diarrhea. All grade 1-2 according to CTCAE v5.0 except one patients discontinued treatment due to musculoskeletal pain Table: 377P
| Symptoms n (%) | T790M+ (n=46) | T790M- (n=31) |
| Any symptoms Rash Oral ulcer Diarrhea Aminotransferase increased White cell count decreased Anemia Musculoskeletal pain Creatine phosphokinase increased | 33 (71.7%) 12 (26.1%) 6 (13.0%) 6 (13.0%) 3 (6.5%) 3 (6.5%) 3 (6.5%) 1 (2.2%) 1 (2.2%) | 24 (77.4%) 7 (22.5%) 5 (3.2%) 3 (9.7%) 1 (3.2%) 3 (0.9%) 2 (6.5%) 1 (3.2%) 0 |
Conclusions
As second-line therapy, this study confirmed the efficacy of aumolertinib for T790M-positive patients with a satisfied safety profile and mPFS up to 16 months in real world. And to our knowledge, this was the first report about clinical activity of aumolertinib in T790M-negative patients.
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.
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