Ivesa (firmonertinib)

Our integrative single-cell analysis reveals that Furmonertinib therapy induces significant cellular and molecular changes in EGFR-positive LUAD, including TME remodeling, transcriptomic adaptation, and reprogramming of intercellular communication networks. These findings provide insight into the mechanisms of Furmonertinib response and resistance, and may inform strategies to optimize EGFR-TKI therapy.

P=N/A, N=300, Completed, Beijing Tiantan Hospital

P1, N=30, Active, not recruiting, Allist Pharmaceuticals, Inc. | Trial completion date: Aug 2025 --> Feb 2026

P1/2, N=300, Recruiting, Minghui Pharmaceutical (Hangzhou) Ltd

Osimertinib (HR, 0.90; 95% CrI, 0.83-0.99) and lazertinib (HR, 0.89; 95% CrI, 0.79-1.00) showed overall survival benefits over first-gen TKIs. Furmonertinib, aumolertinib, and osimertinib had lower rates of severe treatment-related adverse events (TRAEs), while befotertinib exhibited the highest risk of grade ≥3 TRAEs (RR, 3.96; 95% CrI, 2.35-7.17). This study is the first head-to-head comparison of third-gen EGFR-TKIs using a Bayesian network meta-analysis, offering critical insights into efficacy and safety. Our results support personalized selection of third-gen EGFR TKIs for patients with advanced EGFR-mutated NSCLC, particularly for subpopulations with CNS metastases or different mutation subtypes.

The patient received a treatment regimen consisting of the third-generation EGFR TKI furmonertinib, combined with localized radiotherapy, which resulted in a marked and significant clinical response. Our findings indicate that furmonertinib may effectively address the therapeutic uncertainties associated with EGFR/ERBB2 co-mutations, presenting a promising clinically actionable strategy while we continue to await the advent of more personalized and tailored treatment solutions.

P4, N=131, Not yet recruiting, Shanghai Chest Hospital; Shanghai Chest Hospital

P2, N=80, Recruiting, The Affiliated Hospital of Qingdao University; The Affiliated Hospital of Qingdao University

P2, N=29, Not yet recruiting, Nanjing Brain Hospital; Nanjing Brain Hospital

P4, N=25, Not yet recruiting, Qilu Hospital of Shandong University; Qilu Hospital of Shandong University

After multidisciplinary discussion, it was decided to administer targeted therapy with furmonertinib, chemotherapy with pemetrexed and lobaplatin, and immunotherapy with tislelizumab. For patients with metastatic advanced NSCLC, systemic treatment involving chemotherapy plus immunotherapy and targeted therapy is expected to become one of the options. Moreover, it is likely to achieve successful conversion surgery and further efficacy after combined therapy.

Double-dose furmonertinib demonstrates significant efficacy and favorable tolerability in advanced EGFR ex20ins-mutant NSCLC, particularly in treatment-naïve patients. Pretreatment peripheral T-lymphocyte profiles and systemic inflammatory indices may serve as predictive biomarkers for therapeutic response and prognosis.