Ivesa (firmonertinib)

P2, N=63, Not yet recruiting, Jiangmen Central Hospital

The management of human epidermal growth factor receptor 2 (HER2)-mutant non-small cell lung cancer (NSCLC) remains a significant clinical challenge, with limited effective and accessible treatment options beyond antibody-drug conjugates such as trastuzumab deruxtecan (T-DXd)...Following chemotherapy and sintilimab failure in August 2025 due to progressive disease, furmonertinib rechallenge at 160 mg/day again induced a response within 5 days, with no grade ≥3 adverse events...The structural homology between HER2 p.Y772_A775dup and EGFR exon 20 "near-loop" insertions may facilitate TKI binding. Furmonertinib emerges as a potential, cost-effective oral therapeutic alternative for this patient population, especially when standard therapies are not feasible, warranting further prospective investigation.

This case suggests that, in EGFR-mutant advanced NSCLC with extensive CNS progression after multiline treatment failure in whom radiotherapy is not feasible, high-dose furmonertinib may represent a potential salvage option and may help inform individualized treatment strategies in this high-risk population. This single case is hypothesis-generating and larger cohorts/prospective studies are needed to confirm efficacy, safety, and appropriate patient selection.

P1, N=160, Active, not recruiting, ArriVent BioPharma, Inc. | Trial completion date: Dec 2025 --> Dec 2026

P1, N=94, Not yet recruiting, Fuzhou General Hospital

High-dose Furmonertinib combined with IP is an effective and well-tolerated regimen for EGFR-mutant NSCLC-LM. The addition of Bevacizumab may further improve outcomes, offering a promising strategy for refractory patients.

The G719X subtype was predominant, and compound mutations were frequently observed in patients with EGFR PACC-mutant NSCLC. The combination of chemotherapy and TKIs was associated with significant OS benefits, warranting future prospective clinical studies for confirmation.

The patient was treated with furmonertinib and radiotherapy...It illustrates that even with imaging suggestive of a single primary carcinoma, meticulous pathological evaluation is essential to uncover synchronous MPMNs, thereby guiding precise therapy. The patient demonstrated a positive response to targeted treatment.

Since 1997, EGFR tyrosine kinase inhibitors (EGFR-TKIs) have evolved from first-generation agents, such as gefitinib, erlotinib, and icotinib, to second-generation agents like afatinib and dacomitinib, now to third-generation agents, including osimertinib, aumolertinib, furmonertinib, befotertinib, rezivertinib, rilertinib, limertinib, lazertinib, mifanertinib for EGFR L858R, sunvozertinib for EGFR exon 20 insertion (20ins), and zorifertinib for EGFR-sensitive mutation with brain metastases. Over the past 30 years, substantial advancements have been made in the comprehensive management of EGFR-mutant NSCLC. This systemic review provides the history of the development of EGFR-TKI therapy for NSCLC from 1997 to 2026, highlighting clinical milestones, emerging therapies, and future directions in this rapidly evolving field.

Following the Chinese Society of Clinical Oncology and National Comprehensive Cancer Network guidelines for lung cancer, the patient was treated with furmonertinib, a third-generation targeted antitumor therapy. The present case provides notable insights for the diagnosis and treatment of NSCLC with coexisting EGFR exon 19 deletion and exon 20 T790M missense mutation, and a rare clinical example of breast metastasis from lung cancer.

P2/3, N=36, Recruiting, Arrivent Biopharma Inc.

Case 2 had suboptimal benefit from first-line osimertinib but attained PR with resolution of pleural effusion after switching to the combination; subsequent computed tomography (CT) confirmed stable disease (SD). Both patients tolerated treatment without severe treatment-related adverse events. These observations suggest that furmonertinib plus pemetrexed may have antitumor activity and acceptable tolerability in EGFR Ex19del lung adenocarcinoma, and may inform personalized approaches following resistance to first-line therapy in EGFR-sensitizing NSCLC.