REAL-WORLD EFFICACY OF AUMOLERTINIB IN PATIENTS WITH ADVANCED EGFR T790M-POSITIVE NON-SMALL CELL LUNG CANCER: A MULTICENTRE RETROSPECTIVE COHORT STUDY IN JIANGSU PROVINCE, CHINA
Author(s)
Mengdie Zhang1, Xin Li, PhD2, yunjie su, B.A2, Xiaoning He, PhD3.
1Nanjing, China, 2Nanjing Medical University, Nanjing, China, 3Tianjin University, Tianjin, China.
1Nanjing, China, 2Nanjing Medical University, Nanjing, China, 3Tianjin University, Tianjin, China.
OBJECTIVES: Based on the efficacy demonstrated in the single-arm, phase II APOLLO trial, aumolertinib was approved for the treatment of patients with advanced EGFR T790M+ non-small cell lung cancer (NSCLC). This real-world retrospective study aimed to evaluate the generalizability of trial results.
METHODS: This multicenter, retrospective study included all patients with advanced NSCLC who were treated with aumolertinib in Jiangsu Province, China between 2020 and 2025. Multiple imputation was employed to handle missing variables. The matching-adjusted indirect comparison (MAIC) was used to adjusting for key baseline characteristics to match the patient cohort from APOLLO with the real-world (RW) cohort. The primary endpoints were overall survival (OS) and progression-free survival (PFS).
RESULTS: A total of 667 patients were included, of whom 57 did not meet the APOLLO eligibility criteria (PS score ≥2, adenocarcinoma with squamous differentiation). The median follow-up time for PFS and the median PFS were 39.23 and 11.3 months (95% CI, 10.13-12.26), respectively, which were comparable to the clinical trial results (19.4 and 12.4 months [95% CI, 9.7-15.0], p=0.55). The median follow-up time for OS and the median OS were 37.87 months (95% CI: 36.20-39.67) and 23.97 months (95% CI, 22.17-25.77), respectively, which differed from the APOLLO results (19.4 months and NR [95% CI, 22.9-NR], p=0.0312). Multivariate Cox regression analysis identified male sex, age ≥65 years, co-occurrence of L858R mutation, and distant metastasis as significant risk factors adversely affecting patient survival prognosis. After matching, no significant differences were observed between the RW and APPLLO cohorts for PFS (hazard ratio [HR]: 1.033 [95% CI, 0.863-1.238], p=0.36) and OS (HR: 1.231 [95% CI, 0.954-1.589], p=0.36).
CONCLUSIONS: Despite the more complex baseline characteristics of patients in the real-world setting, this study supports the effectiveness of aumolertinib in routine clinical practice, which is consistent with the efficacy observed in the clinical trial.
METHODS: This multicenter, retrospective study included all patients with advanced NSCLC who were treated with aumolertinib in Jiangsu Province, China between 2020 and 2025. Multiple imputation was employed to handle missing variables. The matching-adjusted indirect comparison (MAIC) was used to adjusting for key baseline characteristics to match the patient cohort from APOLLO with the real-world (RW) cohort. The primary endpoints were overall survival (OS) and progression-free survival (PFS).
RESULTS: A total of 667 patients were included, of whom 57 did not meet the APOLLO eligibility criteria (PS score ≥2, adenocarcinoma with squamous differentiation). The median follow-up time for PFS and the median PFS were 39.23 and 11.3 months (95% CI, 10.13-12.26), respectively, which were comparable to the clinical trial results (19.4 and 12.4 months [95% CI, 9.7-15.0], p=0.55). The median follow-up time for OS and the median OS were 37.87 months (95% CI: 36.20-39.67) and 23.97 months (95% CI, 22.17-25.77), respectively, which differed from the APOLLO results (19.4 months and NR [95% CI, 22.9-NR], p=0.0312). Multivariate Cox regression analysis identified male sex, age ≥65 years, co-occurrence of L858R mutation, and distant metastasis as significant risk factors adversely affecting patient survival prognosis. After matching, no significant differences were observed between the RW and APPLLO cohorts for PFS (hazard ratio [HR]: 1.033 [95% CI, 0.863-1.238], p=0.36) and OS (HR: 1.231 [95% CI, 0.954-1.589], p=0.36).
CONCLUSIONS: Despite the more complex baseline characteristics of patients in the real-world setting, this study supports the effectiveness of aumolertinib in routine clinical practice, which is consistent with the efficacy observed in the clinical trial.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
CO105
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment, Comparative Effectiveness or Efficacy, Relating Intermediate to Long-term Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Oncology