Brief Report: Aumolertinib as a Switch Therapy in Osimertinib-Intolerant NSCLC-The ACTIVE Trial.
Ziming Li, Biao Yao, Chun Huang et al.
✦ AI-curated · Sources linked
In 30 seconds
The ACTIVE trial was a prospective, multicentre, single-arm phase II study of aumolertinib as switch therapy for patients with EGFR-mutant advanced NSCLC who developed specified toxicities on osimertinib. After adverse events recovered to grade 1 or lower, patients received aumolertinib 110 mg once daily. Among 34 patients evaluable for the primary endpoint, the 3-month conversion success rate—defined by absence of progression and specified toxicities—was 70.6% (95% confidence interval: 52.5-84.9). Median postswitch progression-free survival was 11.6 months.
Key findings
- The 3-month conversion success rate was 70.6% (95% confidence interval: 52.5-84.9) among 34 evaluable patients.
- Conversion success was 78.9% in the nonhematologic toxicity subgroup and 60.0% in the hematologic toxicity subgroup.
- Median postswitch progression-free survival was 11.6 months; the 3-year postswitch overall survival rate was 52.4%.
- Treatment-related adverse events occurred in 69.2% of patients, including grade ≥3 events in 15.4%; no patient discontinued aumolertinib or died.
Why it matters
Osimertinib-related toxicity can complicate ongoing EGFR-targeted treatment. This prospective study provides evidence that some patients may maintain disease control after switching to another third-generation EGFR TKI, while also documenting treatment-related adverse events. The findings help characterize a potential toxicity-management approach, although the single-arm design does not establish comparative benefit.
What to keep in mind
The study was single-arm, and only 34 of the 40 enrolled patients were evaluable for the primary endpoint; there was no comparator group.