Ivesa (firmonertinib) / Allist, ArriVent - LARVOL DELTA

Ivonescimab for EGFR-mutant lung adenosquamous carcinoma after multiline therapy: A case report. (PubMed, Front Oncol) - "Despite initial responses to first-line firmonertinib-based combination therapy, progression-free survival (PFS) 13 months, the patient developed sequential resistance to subsequent regimens, including liver/brain metastases and treatment-related toxicities. After fourth-line therapy failure and severe intolerance to albumin-bound paclitaxel and bevacizumab, two cycles of ivonescimab-a first-in-class programmed cell death protein receptor-1 (PD-1)/vascular endothelial growth factor-A (VEGF-A) bispecific antibody-induced significant regression of pulmonary target lesions (PR), sustained over six cycles with minimal toxicity...While the rapid PR and favorable safety profile are promising, longer follow-up is required to assess durability and survival benefits. These findings underscore the need for further investigation of bispecific antibodies in precision oncology paradigms for multi-refractory EGFR-driven NSCLC."

IO biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • PD-1 • PD-L1 • TP53

Case Report: Two cases of non-small cell lung cancer with coexistence of NTRK2 fusion and EGFR mutations. (PubMed, Front Oncol) - "Case 1 received osimertinib combined with savolitinib, had 33 months of follow-up, and achieved a partial response. Case 2 received furmonertinib and achieved a complete response. NTRK2 fusion coexisting with EGFR mutations is a rare molecular characteristic of non-small cell lung cancer, accompanied by positive PD-L1 expression, and may serve as a promising biomarker for targeted therapy."

IO biomarker • Journal • Tumor mutational burden • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • FGFR1 • MET • Napsin A • NKX2-1 • NTRK2 • PD-L1 • TMB

A 66-Year-Old Woman with EGFR-Mutant Lung Adenocarcinoma and Brain Metastases Achieving 96-Month Overall Survival with serially deploying three distinct third-generation EGFR-TKIs (ESMO Asia 2025) - "First-line icotinib plus paclitaxel/nedaplatin was given and achieved PR and 36-month PFS...Osimertinib 80mg qd combined with pemetrexed chemotherapy for 5 cycles, followed by osimertinib monotherapy, yielded 25-month PFS until isolated CNS progression. Despite concomitant whole-brain radiotherapy and bevacizumab with Osimertinib, intracranial lesions advanced...This exceptional survival in advanced EGFR+ NSCLC was achieved through initial chemo-TKI therapy, sequential third-generation TKIs (osi→almo→furmo) for CNS control, and furmonertinib dose escalation for late CNS progression. The persistent TP53 co-mutation suggests a resistance mechanism, while PD-L1 negativity excluded immunotherapy, demonstrating the efficacy of optimized TKI sequencing alone."

Clinical • IO biomarker • Brain Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1 • TP53

Furmonertinib combined with bevacizumab in EGFR-TKI resistant leptomeningeal metastasis: Analysis of CSF ctDNA molecular response and survival outcomes (ESMO Asia 2025) - "Bevacizumab synergizes with high-dose furmonertinib to significantly improve survival in TKI-resistant LM. CSF ctDNA molecular response (≤0.8×baseline) predicts clinical benefit, supporting its utility for real-time monitoring. This combination represents a promising strategy for a population with unmet needs."

Circulating tumor DNA • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Double-dose firmonertinib (formerly furmonertinib) for untreated EGFR-mutated non-small-cell lung cancer with brain metastases (ESMO Asia 2025) - P2 | "Double-dose firmonertinib exhibited clinically meaningful antitumor activity with manageable safety profile in patients with untreated EGFR-mutated NSCLC and brain metastases. Long-term outcomes will be further evaluated."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

ABSK043 plus firmonertinib (Firmo) for the treatment of advanced non-small cell lung cancer (NSCLC) patients (pts) with EGFR mutations: Results from a phase II study (ESMO Asia 2025) - P1 | "The combination of ABSK043 with Firmo demonstrated a favorable safety profile, with no signals of ILD. These results support further exploration of this combination in the first-line setting, where EGFR TKIs combined with PD-(L)1 antibodies are restricted."

Clinical • IO biomarker • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Survival benefit of targeted therapy in EGFR-mutant NSCLC patients with leptomeningeal metastases (SNO 2025) - "The interventions included Afatinib, Erlotinib, Furmonertinib, Gefitinib, Osimertinib, and Rociletinib. This meta-analysis provides the first pooled survival estimate in EGFR-mutant NSCLC patients with LMD receiving targeted therapies. The findings suggest that modern EGFR TKIs may offer clinically meaningful survival benefits in this otherwise high-risk group. Prospective studies are needed to validate these results and to define optimal treatment strategies."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

Third-Generation EGFR-TKIs Combined With Chemotherapy in Advanced Non-Small Cell Lung Cancer: A Real-World Study. (PubMed, Cancer Sci) - "Of these patients, 120, 165, and 97 patients received osimertinib, aumolertinib, and furmonertinib plus chemotherapy as first-line therapy, respectively. Different third-generation EGFR-TKI groups show no statistically significant difference in PFS (HR = 0.75; 95% CI: 0.51-1.10; p = 0.25) after inverse probability of treatment weighting (IPTW), nor in AEs or severe AEs (p = 0.852; p = 0.502). First-line third-generation EGFR-TKI combined with pemetrexed-based chemotherapy demonstrated a favorable ORR and PFS benefit in advanced EGFRm NSCLC."

Journal • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Single-cell transcriptomic analysis reveals cellular and molecular changes in EGFR-positive lung adenocarcinoma before and after Furmonertinib treatment. (PubMed, Genes Genomics) - "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."

Journal • Review • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CD4 • CD8 • EGFR • LAMC1

High-dose Furmonertinib or Combined With Chemotherapy in EGFR-mutant Advanced NSCLC After Disease Progression on Third-generation EGFR-TKI (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Jialei Wang | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Firmonertinib in the Treatment of EGFR(+) NSCLC Patients With Central Nervous System Metastasis (clinicaltrials.gov) - P=N/A | N=300 | Completed | Sponsor: Beijing Tiantan Hospital

New trial • Real-world evidence • CNS Tumor • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Furmonertinib in EGFR-Mutant NSCLC With Brain Metastases (iFORCE) (clinicaltrials.gov) - P2 | N=43 | Completed | Sponsor: Peking Union Medical College | Recruiting ➔ Completed | Trial completion date: Jun 2023 ➔ Nov 2025 | Trial primary completion date: Jun 2023 ➔ Nov 2025

Trial completion • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

FAVOUR: Study of FURMONERTINIB in Patients With NSCLC Having Exon 20 Insertion Mutation (clinicaltrials.gov) - P1 | N=30 | Active, not recruiting | Sponsor: Allist Pharmaceuticals, Inc. | Trial completion date: Aug 2025 ➔ Feb 2026

Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Survival benefit of targeted therapy in EGFR-mutant NSCLC patients with leptomeningeal metastases (WFNOS 2025) - "The interventions included Afatinib, Erlotinib, Furmonertinib, Gefitinib, Osimertinib, and Rociletinib. This meta-analysis provides the first pooled survival estimate in EGFR-mutant NSCLC patients with LMD receiving targeted therapies. The findings suggest that modern EGFR TKIs may offer clinically meaningful survival benefits in this otherwise high-risk group. Prospective studies are needed to validate these results and to define optimal treatment strategies."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

A Study of MHB036C Combined With Anti-tumor Therapies in Patients With Advanced Lung Cancer (clinicaltrials.gov) - P1/2 | N=300 | Recruiting | Sponsor: Minghui Pharmaceutical (Hangzhou) Ltd

New P1/2 trial • Lung Cancer • Oncology • Solid Tumor

First-Line Third-Generation EGFR Tyrosine Kinase Inhibitor Monotherapy for Advanced EGFR-Mutated Non-Small Cell Lung Cancer: A Systematic Review and Network Meta-Analysis. (PubMed, MedComm (2020)) - "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."

Journal • Monotherapy • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • EGFR

Upcoming Milestones (GlobeNewswire) - "First-line EGFR PACC registrational study. Enrollment of first patient in the randomized, global pivotal ALPACCA Phase 3 study for first-line firmonertinib monotherapy in EGFR PACC mutant NSCLC expected in Q4 2025; Firmonertinib Pivotal EGFR exon 20 insertion data. Top-line firmonertinib monotherapy data from the global pivotal FURVENT Phase 3 (NCT05607550) study for first-line EGFR exon 20 insertion mutant NSCLC is projected to be in early 2026."

EGFR exon 20 • New P3 trial • P3 data: top line • Non Small Cell Lung Cancer

Case report: First report of metastatic esophageal squamous cell carcinoma with EGFR p.S768I mutation: remarkable response to third-generation EGFR-TKI. (PubMed, NPJ Precis Oncol) - "Following progression on conventional therapies, the patient received the third-generation EGFR tyrosine kinase inhibitor (TKI), Firmonertinib...This represents the first globally reported case of an ESCC patient with the rare EGFR p.S768I mutation who was successfully treated and achieved 4 months of near-complete response. Further validation in larger cohorts is needed to establish the efficacy of EGFR-TKIs in ESCC patients with rare EGFR mutations."

Journal • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Hepatocellular Cancer • Oncology • Squamous Cell Carcinoma

Furmonertinib activity in NSCLC Harbouring EGFR L858R and ERBB2 S310F co-mutations: a case report with literature review. (PubMed, J Chemother) - "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."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HER-2

Firmonertinib 160 mg for Advanced EGFR-Positive NSCLC with Coexisting Non-Driver Mutations Demonstrating Slow, Local, or Potential Disease Progression During First-Line Firmonertinib Therapy (ChiCTR) - P2 | N=80 | Recruiting | Sponsor: The Affiliated Hospital of Qingdao University; The Affiliated Hospital of Qingdao University

New P2 trial • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MDM2 • PIK3CA • PTEN • RB1 • TP53

The efficacy and safety of vinorelbine combined with Furmonertinib as first-line treatment in refractory EGFR mutation NSCLC patients: a prospective, non-randomized, dual cohorts clinical study (ChiCTR) - P4 | N=131 | Not yet recruiting | Sponsor: Shanghai Chest Hospital; Shanghai Chest Hospital

New P4 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Firmonertinib 160 mg Neoadjuvant Therapy for Stage II-IIIB Resectable EGFR Mutation-Sensitive NSCLC (ChiCTR) - P4 | N=25 | Not yet recruiting | Sponsor: Qilu Hospital of Shandong University; Qilu Hospital of Shandong University

New P4 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A real-world, prospective clinical study of zorifertinib combined with furmonertinib in leptomeningeal metastases patients with EGFR mutation-positive NSCLC and third-generation EGFR-TKIs resistance (ChiCTR) - P2 | N=29 | Not yet recruiting | Sponsor: Nanjing Brain Hospital; Nanjing Brain Hospital

New P2 trial • Real-world evidence • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Pathological complete response to conversion therapy for lung adenocarcinoma with brain metastasis: a case report. (PubMed, Front Oncol) - "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."

IO biomarker • Journal • Brain Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MAP2K1 • MAPK1 • PD-L1

Resistance to third-generation EGFR-TKIs: Re-challenge or switch to second-generation agents? (ESMO 2025) - "Background This retrospective cohort study evaluated 120 EGFR-mutant NSCLC patients who progressed on third-generation EGFR-TKIs (osimertinib/aumolertinib/furmonertinib), comparing outcomes between those switched to second-generation EGFR-TKIs (3+2 group, n=60) (dacomitinib/afatinib) versus continuing third-generation agents (3+3 group, n=60) (osimertinib/aumolertinib/furmonertinib). Legal entity responsible for the study The authors. Funding Has not received any funding."

Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor