Abstract 57P
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 previously reported the primary data of high-dose aumolertinib in pts with NSCLC harboring uncommon EGFR mutations other than 20ins (ESMO ASIA 2022, 373P; WCLC 2023, P2.09-07). Here, we report the data in two cohorts.
Methods
Pts with locally advanced or metastatic NSCLC harboring uncommon EGFR mutations were enrolled and divided into two groups. Cohort 1 was 20ins mutation, cohort 2 was other than 20 ins mutation such as G719X, L861Q, S768I, etc. Previously accepted ≤ second-line chemotherapy were allowed. Pts received aumolertinib monotherapy (165 mg PO QD). The primary endpoint was safety. The secondary endpoints included objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS).
Results
41 pts were enrolled, and 33 of them were included in the efficacy analysis set (data cutoff March 31, 2023). 16 pts in cohort 1 and 17 pts in cohort 2. The median age was 55 years (38–75) and 58 years (ranged 42–73), 68.8% and 52.9% were female in two groups, 4 pts and 3 pts had previously undergone chemotherapy, respectively. The overall ORR was 12.5% and 47.1%, DRC were both 100%. The median PFS was 6.5 m and 11.8 m, the median OS was 20.6 m and 29.4 m. No new safety signals or concerns were identified.
Conclusions
In patients with advanced NSCLC harboring 20 ins and uncommon EGFR mutations, high-dose aumolertinib demonstrated a tolerable safety profile and encouraging antitumor activity. High-dose aumolertinib is also currently being evaluated in a phase III clinical trial for patients with uncommon EGFR mutations (NCT04951648).
Clinical trial identification
NCT04785742.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.