Ivesa (firmonertinib) / Allist, ArriVent - LARVOL DELTA

Furmonertinib Plus Radiotherapy for EGFR+ NSCLC With Pleural Effusion (clinicaltrials.gov) - P2 | N=63 | Not yet recruiting | Sponsor: Jiangmen Central Hospital

New P2 trial • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • EGFR

Phase II study of firmonertinib in patients with previously treated advanced/metastatic non-small cell lung cancer (mNSCLC) with EGFR exon 20 insertion (ex20ins) mutations (ESMO 2025) - P2, P3 | "These results support firmo as a valuable treatment option for this pts population. Firmo is also under evaluation in a global, randomized Ph III trial for 1L NSCLC pts w/ex20ins (FURVENT; NCT05607550) and has completed enrollment."

Clinical • EGFR exon 20 • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Furmonertinib in EGFR-mutated NSCLC with or without CNS metastasis: A systematic review and meta-analysis (ELCC 2026) - "No common or severe adverse events were reported, proposing its safety. Future studies are recommended with larger sample sizes, and longer follow-up durations."

Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

First-line oral vinorelbine plus furmonertinib in refractory epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC): A multicenter, non-randomized, two-cohort study (ELCC 2026) - P4 | "Primary endpoint is investigator-assessed PFS. Secondary endpoints are objective response rate, disease control rate, OS, and safety."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • PD-L1

ArriVent to Present Two Preclinical Posters on the EGFR Inhibitor Firmonertinib and on the Novel dual-target MUC16/NaPi2b Tetravalent ADC ARR-002 at the 2026 AACR Annual Meeting (GlobeNewswire) - "Unique structural features of firmonertinib enhance binding and activity against EGFR mutant proteins including ex20ins mutant proteins in cell lines and NSCLC animal models. Superior anti-tumor activity of ARR-002 in ovarian cancer models compared to single-target or bivalent approaches with favorable tolerability underscores best-in-disease ADC potential."

Preclinical • Non Small Cell Lung Cancer • Ovarian Cancer

Discovery and characterization of firmonertinib, a novel EGFR inhibitor with broad activity against both EGFR classical and exon 20 insertion mutations (AACR 2026) - P3 | "Findings from this study support the structural mechanism of EGFR binding and inhibition by firmonertinib, eliciting strong anti-tumor activity in multiple in vitro and in vivo models harboring EGFR ex20ins mutations. These findings provide scientific support for the ongoing global Phase 3 study for first-line NSCLC patients with EGFR ex20ins mutations (NCT05607550)."

EGFR exon 20 • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Case Report: Furmonertinib dose escalation in heavily pretreated EGFR-mutant lung adenocarcinoma with diffuse brain metastases. (PubMed, Front Oncol) - "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."

Journal • CNS Disorders • CNS Tumor • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Exceptional response to furmonertinib in lung adenocarcinoma harboring HER2 exon 20 insertion mutation: a case report. (PubMed, Front Oncol) - "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."

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

FURTHER: Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations (clinicaltrials.gov) - P1 | N=160 | Active, not recruiting | Sponsor: ArriVent BioPharma, Inc. | Trial completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

FURMO-006: Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (clinicaltrialsregister.eu) - P2/3 | N=36 | Recruiting | Sponsor: Arrivent Biopharma Inc.

New P2/3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Therapy for Advanced NSCLC With EGFR 19delins Mutation (clinicaltrials.gov) - P1 | N=94 | Not yet recruiting | Sponsor: Fuzhou General Hospital

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Efficacy and Safety of High-dose Furmonertinib plus Intrathecal Pemetrexed for EGFR-mutant Non-small Cell Lung Cancer with Leptomeningeal Metastasis (PubMed, Zhongguo Fei Ai Za Zhi) - "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."

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

Received National Medical Products Administration (NMPA) approval in China in second-line EGFR exon 20 insertion mutations (GlobeNewswire) - "In February 2026, our partner Shanghai Allist Pharmaceutical Technology Co., Ltd., received NMPA approval for firmonertinib for adults with locally advanced or metastatic NSCLC who have progressed on or after prior platinum-based chemotherapy or who are intolerant to platinum-based chemotherapy and who have been tested for the presence of EGFR exon 20 insertion mutations."

China approval • EGFR exon 20 • Non Small Cell Lung Cancer

Upcoming Milestones: Firmonertinib pivotal EGFR exon 20 insertions data (GlobeNewswire) - "Top-line firmonertinib monotherapy data from the global pivotal FURVENT Phase 3 (NCT05607550) study for first-line EGFR exon 20 insertions mutant NSCLC is projected to be in mid-2026."

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

Epidermal growth factor receptor tyrosine kinase inhibitor for the treatment of non-small cell lung cancer in the past 30 years (1997-2026). (PubMed, Chin Med J (Engl)) - "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."

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

Survival analysis and prognostic factors in advanced NSCLC harboring EGFR PACC mutations: A multicenter retrospective study. (PubMed, Lung Cancer) - "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."

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

First pathologically confirmed case of concurrent primary renal cell carcinoma and metastatic lung adenocarcinoma in the same kidney. (PubMed, Front Oncol) - "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."

Journal • Genito-urinary Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • EGFR

Firmonertinib plus 4 cycles platinum-pemetrexed as first-line treatment for EGFR-mutant locally advanced or metastatic NSCLC?FLAMES?: Study design and preliminary outcomes (ELCC 2026) - No abstract available

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

Metastatic breast cancer in primary lung cancer with compound EGFR mutations: A case report. (PubMed, Oncol Lett) - "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."

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

Furmonertinib plus pemetrexed in the treatment of EGFR exon 19 deletion lung adenocarcinoma: two case reports. (PubMed, Front Oncol) - "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."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor • CEACAM5 • EGFR

Prolonged survival in EGFR exon 20 insertion mutant lung adenocarcinoma: case report of sequential osimertinib and furmonertinib with research trend analysis. (PubMed, Front Med (Lausanne)) - "This analysis demonstrated a growing global research focus on third-generation EGFR-TKIs and variant-specific treatment strategies for EGFR ex20ins-mutant NSCLC, supporting the rationale underpinning the therapeutic approach adopted in this report. Sequential high-dose third-generation EGFR-TKIs may offer clinically meaningful benefit in selected EGFR ex20ins cases; however, this strategy remains non-standard and should be regarded as hypothesis-generating, warranting further prospective evaluation."

IO biomarker • Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • ETV6 • PD-L1 • SETD2 • SMAD4 • TP53

Exploration of the Efficacy and Safety of metronomic chemotherapy with vinorelbine capsules combined with third-generation EGFR-TKI as First-Line Treatment in Elderly Patients with Advanced Non-Small Cell Lung Cancer with EGFR Mutations (ChiCTR) - P=N/A | N=66 | Not yet recruiting | Sponsor: Beijing hospital; Beijing hospital

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

Favorable response to third-generation TKI furmonertinib in a patient with early-stage non-small cell lung cancer​ harboring rare compound EGFR mutations: Exon 18 G719C and Exon 20 S768I - A Case Report. (PubMed, Front Oncol) - "Here, we describe a case of early-stage non-small cell lung cancer (NSCLC) harboring a G719C+S768I compound mutation that achieved complete remission following treatment with furmonertinib. These findings suggest that furmonertinib may represent a promising therapeutic option to improve cure rates in this subset of patients."

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

Zipalertinib-A Novel Treatment Opportunity for Non-Small Cell Lung Cancers with Exon 20 Insertions and Uncommon EGFR Mutations. (PubMed, Cancers (Basel)) - "The role and the integration of therapies targeting exon20ins or uncommon mutations into the first- and second-line treatment armamentarium for NSCLC patients is not yet fully established, and the therapeutic impact of monotherapies (e.g., sunvozertinib, firmonertinib) versus combinations with standard platinum-based chemotherapy (e.g., zipalertinib, amivantamab) currently still lacks robust evidence to further change the therapeutic landscape for these patients. Therefore, results from the ongoing trials are eagerly awaited and are expected to shed some light on these open questions."

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

A Single-Arm, Multicenter, Phase II Clinical Trial of Firmonertinib in Combination With Definitive Radiotherapy for Patients With Stage III Unresectable Pulmonary Adenocarcinoma Harboring Positive EGFR Uncommon Driver Mutations (ChiCTR) - P2 | N=15 | Not yet recruiting | Sponsor: Hunan Cancer Hospital; Hunan Cancer Hospital

New P2 trial • Lung Adenocarcinoma • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR