INDIRECT TREATMENT COMPARISON (ITC) OF AUMOLERTINIB VS. OSIMERTINIB IN ADVANCED OR METASTATIC EGFR MUTATED NON-SMALL CELL LUNG CANCER (NSCLC) IN FIRST-LINE AND PREVIOUSLY TREATED SETTINGS
Author(s)
Kalliopi K. Makarounas-Kirchmann, MCom1, Carolyn Rutherford, BPharm, MBA1, Zahava Gabriel, MSc2, Amullya Pednekar, MD3, Sue Finch, PhD4.
1KMC Health Care, Mt Eliza, Australia, 2Glenmark Pharmaceuticals, Watford, United Kingdom, 3Glenmark Pharmaceuticals, Mumbai, India, 4The University of Melbourne, Melbourne, Australia.
1KMC Health Care, Mt Eliza, Australia, 2Glenmark Pharmaceuticals, Watford, United Kingdom, 3Glenmark Pharmaceuticals, Mumbai, India, 4The University of Melbourne, Melbourne, Australia.
OBJECTIVES: To evaluate the comparative efficacy and safety of aumolertinib vs. osimertinib in advanced or metastatic EGFR-mutated NSCLC in first-line and previously-treated settings.
METHODS: Two systematic literature reviews identified relevant trials. In the first line setting, the aumolertinib and osimertinib trials were similar in trial phase, randomised double-blind design, active comparator supporting the use of an ITC in the absence of head to head trials. An anchored ITC was conducted using a common comparator (gefitinib or erlotinib), applying Bucher methodology. In the previously-treated setting, the key aumolertinib study was a phase II single arm study. Due to the absence of a suitable common comparator, a naïve comparison was undertaken. The evidence for osimertinib was derived from the osimertinib study arms.
RESULTS: In the first-line setting, the anchored ITC showed no statistically significant difference in PFS between aumolertinib and osimertinib, the primary endpoint of interest (HR 0.963, 95% CI 0.702-1.320). No statistically significant differences between treatments were observed for OS, ORR, CNS outcomes, AE of grade ≥3, discontinuations due to AEs. Results included statistically significant differences favouring aumolertinib for paronychia, decreased white blood cells, decreased neutrophils, diarrhoea, pyrexia and decreased weight. Trends favouring aumolertinib were observed for rash/acne, ILD/pneumonitis and ECG QT prolongation, although these did not reach statistical significance. The previously-treated setting analyses were based on naïve comparisons, limiting interpretability due to heterogeneity in study design. The available evidence did not suggest significant differences between treatments in this setting, although these findings should be understood as being limited by the unadjusted comparison methodology.
CONCLUSIONS: Based on indirect treatment comparison methodology, including an anchored ITC in the first-line setting and a naïve comparison in the previously-treated setting, no statistically significant differences in key efficacy outcomes were observed between aumolertinib and osimertinib in first-line and previously-treated monotherapy settings for EGFR mutated NSCLC.
METHODS: Two systematic literature reviews identified relevant trials. In the first line setting, the aumolertinib and osimertinib trials were similar in trial phase, randomised double-blind design, active comparator supporting the use of an ITC in the absence of head to head trials. An anchored ITC was conducted using a common comparator (gefitinib or erlotinib), applying Bucher methodology. In the previously-treated setting, the key aumolertinib study was a phase II single arm study. Due to the absence of a suitable common comparator, a naïve comparison was undertaken. The evidence for osimertinib was derived from the osimertinib study arms.
RESULTS: In the first-line setting, the anchored ITC showed no statistically significant difference in PFS between aumolertinib and osimertinib, the primary endpoint of interest (HR 0.963, 95% CI 0.702-1.320). No statistically significant differences between treatments were observed for OS, ORR, CNS outcomes, AE of grade ≥3, discontinuations due to AEs. Results included statistically significant differences favouring aumolertinib for paronychia, decreased white blood cells, decreased neutrophils, diarrhoea, pyrexia and decreased weight. Trends favouring aumolertinib were observed for rash/acne, ILD/pneumonitis and ECG QT prolongation, although these did not reach statistical significance. The previously-treated setting analyses were based on naïve comparisons, limiting interpretability due to heterogeneity in study design. The available evidence did not suggest significant differences between treatments in this setting, although these findings should be understood as being limited by the unadjusted comparison methodology.
CONCLUSIONS: Based on indirect treatment comparison methodology, including an anchored ITC in the first-line setting and a naïve comparison in the previously-treated setting, no statistically significant differences in key efficacy outcomes were observed between aumolertinib and osimertinib in first-line and previously-treated monotherapy settings for EGFR mutated NSCLC.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
SA29
Topic
Clinical Outcomes, Methodological & Statistical Research, Study Approaches
Topic Subcategory
Literature Review & Synthesis, Meta-Analysis & Indirect Comparisons
Disease
Oncology