1226 - Feasibility of Aumolertinib followed by SRT in EGFR+ NSCLC Patients with Intracranial Oligo-Progression: A Phase II, Prospective Study

01:30pm - 01:35pm ET

Room 156

Presenter(s)

Huiting Li, MD - Fudan University Shanghai Cancer Center, Shanghai, Shanghai

J. Chen¹, M. Fan², J. Wen³, H. Li⁴, X. Xu⁵, Y. Cao⁶, S. Wang⁷, H. Yu⁷, and C. Zhou⁷; ¹Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China, ²Department of Radiation Oncology, Sichuan Cancer Hospital and Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China, ³Department of Radiation Oncology, Fudan University Shanghai Cancer Center, Shanghai, China, ⁴Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China, ⁵Department of Thoracic Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, ⁶Department of Neurosurgery, Fudan University Shanghai Cancer Center, Shanghai, China, ⁷Fudan University Shanghai Cancer Center, Shanghai, China

Purpose/Objective(s):

The optimal timing of stereotactic radiotherapy (SRT) for intracranial oligo-progression in EGFR-mutant NSCLC patients on third-generation EGFR-TKIs remains unclear. This phase II study evaluates the efficacy and safety of aumolertinib followed by SRT in this setting.

Materials/Methods:

41 EGFR-mutant NSCLC patients with brain metastases (=10 lesions) received aumolertinib (110 mg/day). Upon intracranial oligo-progression with stable extracranial disease, patients received SRT to progressive brain lesions while continuing aumolertinib. The primary endpoint was intracranial progression-free survival (iPFS).

Results:

At a median follow-up of 34.5 months, median iPFS was 22.2 months (1-year: 76.9%; 2-year: 41.2%). Median overall survival (OS) was not reached (2-year OS: 74.8%; 3-year OS: 57.8%). The intracranial objective response rate (iORR) was 78%. Of the 31 patients who eventually progressed, 18 had initial intracranial progression. The regimen was well-tolerated, with Grade 3 adverse events in 12% of patients and no Grade 4–5 events.

Conclusion:

Continuing aumolertinib combined with SRT for intracranial oligo-progression is an effective and safe strategy. A phase III trial (ALMORA, NCT05800223) is currently ongoing to further investigate the optimal timing of SRT.