Ivesa (firmonertinib)

Furmonertinib shows promising intracranial efficacy with manageable safety as first-line treatment for EGFR-mutated NSCLC with CNS metastases. This study is registered at ClinicalTrials.gov (NCT05379803).

P2, N=154, Not yet recruiting, Anhui Provincial Cancer Hospital

P1/2, N=45, Recruiting, Second Affiliated Hospital of Nanchang University

To the best of our knowledge, this study represents the first evaluation of vinorelbine plus firmonertinib in EGFR-mutated locally advanced or metastatic NSCLC with M1c2 disease or elevated PD-L1 expression, aiming to provide an effective, tolerable, and convenient all-oral treatment option for this refractory population. The study protocol (version 1.2; July 18, 2025) was registered on October 24, 2025, at the Chinese Clinical Trial Registry (ChiCTR2500111096).

This large real-world study suggests that furmonertinib-based therapy, particularly the triplet regimen with antiangiogenic agent and chemotherapy, is associated with meaningful clinical outcomes over mono or dual therapy in patients with EGFRm NSCLC and LM, including those with prior third-generation TKI resistance or poor performance status.

P2, N=150, Not yet recruiting, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

She was initially treated with icotinib for an EGFR exon 21 L858R mutation but the disease progressed after 4 months. CONCLUSIONS As a single case with multiple confounders, this study generates hypotheses but does not confirm efficacy. Further investigation is required to validate high-dose furmonertinib for NSCLC with EGFR exon 14 missense mutations.

P2, N=60, Not yet recruiting, Peking University Cancer Hospital & Institute

Subsequently, the patient received furmonertinib targeted therapy. Herein, we discuss the diagnostic challenges and the potential pathogenic mechanisms of this novel mutation. How to identify rare genes and translate their identification into clinical benefits is a worthwhile avenue for exploration in our future work.

Sunvozertinib, an oral, selective EGFR inhibitor, received U.S. Food and Drug Administration (FDA) accelerated approval in 2025, with an ORR of 46% and a median duration of response (DOR) of 11.1 months in platinum-pretreated patients. Emerging therapies, including zipalertinib and furmonertinib, have shown promising results in early-phase trials, with zipalertinib demonstrating activity in patients pretreated with amivantamab (ORR 31.5%) and furmonertinib achieving remarkable responses in treatment-naive patients (ORR 78.6% at 240 mg). This comprehensive review analyzes the molecular biology, structural mechanisms, current therapeutic options, and novel investigational agents for EGFR ex20ins-mutated NSCLC.

This comparative study demonstrated the improved and consistent activity of aumolertinib across diverse uncommon EGFR E19del subtypes compared to osimertinib, due to its enhanced binding affinity and structural adaptability. These findings support molecular subtype-guided TKI selection, aumolertinib as a first-line option for patients harboring uncommon EGFR E19del variants, particularly in settings lacking comprehensive molecular stratification.

P=N/A, N=4000, Completed, Fudan University | Trial completion date: Sep 2024 --> Feb 2026