ESMO Asia Congress 2022

Abstract 367P

Background

Aumolertinib has shown efficacy in EGFR-mutant NSCLC patients with brain metastases in the phase III AENEAS study. ACHIEVE (NCT04808752) is an ongoing multicenter, open-label, single-arm study evaluating high-dose (165mg) third-generation EGFR-TKI aumolertinib (formerly almonertinib; HS-10296) as first-line therapy in EGFR-mutant NSCLC patients with brain metastases. Here we report primary data from ACHIEVE.

Methods

Treatment-naïve EGFR-mutant NSCLC patients with asymptomatic brain metastases received aumolertinib 165mg orally once daily. Endpoints included progression free survival (PFS), objective response rate (ORR), disease control rate (DCR), CNS ORR and CNS DCR by RECIST v1.1.

Results

At data cut-off (July 4, 2022), 22 patients were included in the analysis. Median age was 61 years (range, 48-75 years), 63.6% were female, and all patients had measurable CNS lesions on baseline brain scan. Efficacy outcomes are summarized in the table. The overall ORR was 90.9% (20/22; 95% CI: 70.8-98.9). The CNS ORR was 86.3 (19/22; 95% CI: 65.1-97.1). The overall and CNS DCR were both 100%. 5 patients experienced blood creatine phosphokinase (CPK) increased, and the ORR was 100% (5/5) and 88.2% (15/17; 95% CI: 63.6-98.9) for patients with or without CPK increased, respectively. PFS data was immature. The safety profile of aumolertinib was consistent with previous reports. Table: 367P

	Overall^a	CNS^b
	All (N=22)	CPK increased – Yes (n=5)	CPK increased – No (n=17)	All (N=22)
ORR, % (95% CI)	90.9 (70.8, 98.9)	100.0	88.2 (63.6, 98.5)	86.3 (65.1, 97.1)
CR, No. (%)	0	0	0	1 (4.5)
PR, No. (%)	20 (90.9)	5 (100.0)	15 (88.2)	18 (81.8)
SD, No. (%)	2 (9.0)	0	2 (11.8)	3 (13.6)
PD, No. (%)	0	0	0	0
DCR, % (95% CI)	100.0	100.0	100.0	100.0

Data cutoff date: July 4, 2022.^aEvaluable for response analysis set. Overall response is derived by combining the CNS and non-CNS lesion time point responses.^bEvaluable for measurable CNS response analysis set.

Conclusions

Aumolertinib showed preliminary efficacy at 165 mg once daily as first-line therapy in EGFR-mutant NSCLC patients with brain metastases. Enrollment for the trial will continue.