373P - Safety and efficacy of aumolertinib treatment in patients with advanced NSCLC harboring uncommon EGFR mutations: Cohort 2

Background

Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitors (EGFR-TKIs) have shown poor efficacy in patients (pts) With non-small-cell lung cancer (NSCLC) Harboring uncommon EGFR Mutations. We aim to explore the efficacy and safety of third-generation TKI Aumolertinib in EGFR-uncommon mutant NSCLC pts.

Methods

Pts with locally advanced or metastatic EGFR-mutant (other than 19del, L858R) NSCLC were included. 40 pts were divided into two cohorts of 20ins mutation (cohort 1) and uncommon mutations other than 20ins (cohort 2). Pts received Aumolertinib monotherapy (165 mg, P.O, QD). The primary endpoint is objective response rate (ORR).

Results

We enrolled 20 pts in cohort 2 between February 2021 and May 2022. 16 pts have imaging assessment. We only reported the relatively mature cohort 2(Efficacy; Table), ORR was 50 %, and DCR was 100 %. In the subgroup analysis of genotypes, ORR was 53.8 % and 33.3 % in G719X&L861Q&S768I and other genotypes. G719X, L861Q and S768I mutations occurred in 8, 6 and 1 pts, other mutations included L747P/S, V774M, H773M, etc. Serious adverse events (SAE) occurred in 18.75% (3/16) pts. Creatine kinase (CK) increase occurred in 11 pts. In the subgroup analysis of CK, ORR was 40 %, 50 %, and 57.1 % in grade 0, 1-2, and 3 or higher. 3 of these pts lowered CK with coenzyme Q10. The average duration of coenzyme Q10 treatment was 3 months and the average percentage of CK reduction was 63%. Table: 373P

95% CI was calculated with Clopper-Pearson Exact Method.

Conclusions

High-dose Aumolertinib is effective in pts with NSCLC Harboring uncommon EGFR Mutations other than 20 ins. The up to date data suggested CK Increase was positively associated with the efficacy of Aumolertinib. On the other hand, Aumolertinib in G719X&L861Q&S768I genotypes showed better outcome compared to other genotypes.

Clinical trial identification

YX-L-202008.

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.