Matching Adjusted Indirect Comparison of Asciminib vs. Flumatinib as First-Line Treatment for Chronic Myeloid Leukemia in China
Author(s)
Ying Wang, MD1, Yan Hui, MD1, Meng Tang, MSc2, Xue Gao, M. Pharm2, Abhay Choubey, MBA3, Soni Gupta, MSc3, Bingcheng Liu, MD1.
1National Clinical Research Center for Blood Diseases, Institute of Hematology, Chinese Academy of Medical Sciences, Tianjin, China, 2Beijing Novartis Pharma Co., Beijing, China, 3Novartis Healthcare Private Ltd., Hyderabad, India.
1National Clinical Research Center for Blood Diseases, Institute of Hematology, Chinese Academy of Medical Sciences, Tianjin, China, 2Beijing Novartis Pharma Co., Beijing, China, 3Novartis Healthcare Private Ltd., Hyderabad, India.
OBJECTIVES: Asciminib, an inhibitor specifically targeting the ABL myristoyl pocket, has demonstrated superior efficacy and safety versus ATP-competitive tyrosine kinase inhibitors (TKIs) in newly diagnosed patients with Philadelphia chromosome-positive chronic myeloid leukemia in chronic-phase (Ph+ CML-CP) in the ASC4FIRST trial. Flumatinib remains a China-exclusive second-generation BCR::ABL TKI and has not been used as a comparator in the global, registration studies of asciminib. Since no direct comparative evidence between these agents is available, an indirect treatment comparison, leveraging published data of flumatinib and individual-patient-data (IPD) of asciminib from ASC4FIRST, was performed to bridge this evidence gap.
METHODS: As trials for both asciminib and flumatinib have imatinib as a common comparator, an anchored matching adjusted indirect-comparison (MAIC) was conducted using IPD on asciminib and imatinib from ASC4FIRST and aggregate published data on flumatinib from FESTnd. The identification of effect modifiers/baseline variables for MAIC was based on insights from clinical experts and data from publications. Following the feasibility study, the following outcomes were included in the MAIC analysis: early molecular response (EMR), major molecular response (MMR), treatment-discontinuation due to adverse-events.
RESULTS: Among the efficacy outcomes, odds ratio (OR) of achieving EMR was significantly favourable for asciminib at 12-weeks compared with flumatinib (OR:1.95; 95%CI: 1.05, 3.73; p=0.0289). For efficacy outcomes at 48-weeks, the OR for MMR was 1.79 times greater for asciminib than flumatinib achieving statistical significance (OR:1.79; 95%CI:1.17, 2.75; p=0.0056). Regarding the safety aspect, asciminib showed a significantly favourable safety-profile compared with flumatinib, with a 71% lower risk of treatment discontinuation due to adverse-events at 48-weeks (RR:0.29; 95%CI: 0.10, 0.84; p=0.0231).
CONCLUSIONS: The results of this MAIC suggest a consistently favourable efficacy and safety profile of asciminib versus the TKI flumatinib, further highlighting its therapeutic potential as a first-line treatment for CML-CP.
METHODS: As trials for both asciminib and flumatinib have imatinib as a common comparator, an anchored matching adjusted indirect-comparison (MAIC) was conducted using IPD on asciminib and imatinib from ASC4FIRST and aggregate published data on flumatinib from FESTnd. The identification of effect modifiers/baseline variables for MAIC was based on insights from clinical experts and data from publications. Following the feasibility study, the following outcomes were included in the MAIC analysis: early molecular response (EMR), major molecular response (MMR), treatment-discontinuation due to adverse-events.
RESULTS: Among the efficacy outcomes, odds ratio (OR) of achieving EMR was significantly favourable for asciminib at 12-weeks compared with flumatinib (OR:1.95; 95%CI: 1.05, 3.73; p=0.0289). For efficacy outcomes at 48-weeks, the OR for MMR was 1.79 times greater for asciminib than flumatinib achieving statistical significance (OR:1.79; 95%CI:1.17, 2.75; p=0.0056). Regarding the safety aspect, asciminib showed a significantly favourable safety-profile compared with flumatinib, with a 71% lower risk of treatment discontinuation due to adverse-events at 48-weeks (RR:0.29; 95%CI: 0.10, 0.84; p=0.0231).
CONCLUSIONS: The results of this MAIC suggest a consistently favourable efficacy and safety profile of asciminib versus the TKI flumatinib, further highlighting its therapeutic potential as a first-line treatment for CML-CP.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
MSR143
Topic
Clinical Outcomes, Methodological & Statistical Research, Study Approaches
Disease
Oncology