Abstract 698P
Background
ARISE (NCT04354961) is a study evaluating the efficacy and safety of aumolertinib as first-line treatment in patients(pts) with EGFR-mutant adenosquamous carcinoma (ASC). The primary efficacy was previously presented at WCLC 2023. Here, we update the report on overall survival from the ARISE trial.
Methods
Eligible pts were treatment-naïve pts with histologically confirmed locally advanced or metastatic pulmonary ASC harboring sensitive EGFR mutations. Pts with asymptomatic, stable central nervous system (CNS) metastases were eligible. Aumolertinib 110 mg was given orally once daily until disease progression or unacceptable toxicity. Follow-up were performed every 6 weeks conducted by independent central review, based on the RECIST 1.1 criteria. The primary endpoint was progression free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety.
Results
18 pts were recruited and 12 pts were finally enrolled (median age 66 years, 58.3% male), with exon 19 deletion in 7 pts and L858R in 5 pts. At data cutoff (July, 2024), the median follow-up was 29 months. The best response of the target lesions remained consistent with previous assessments. 7 of 12 patients achieved partial response with ORR 58.3 % and DCR 83.3 %. The median PFS was 11.1 months, while the median OS was 16.7 months. EGFR 19del (58.3%) pts were more likely to achieve better survival benefits, with mPFS of 15.1 months and prolonged mOS not yet reached. Among 3 pts with CNS metastases at baseline, 1 patient achieved intracranial complete response. Treatment-related adverse events (TRAEs) of any grade occurred in 83.3% of pts. No new safety signals were detected, with the most common TRAEs of anemia (27.3%) and increased aspartate aminotransferase (18.2%). No treatment-related deaths occurred.
Conclusions
This is the first prospective clinical study and the highest level of evidence showing that aumolertinib is an effective and well tolerated for ASC with EGFR mutations, with favorable PFS and OS. Given the inferior outcomes compared to pure adenocarcinoma, we need to explore more therapeutic options for ASC, such as combination therapy.
Clinical trial identification
NCT04354961.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
This study was supported by Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.