Vizimpro (dacomitinib) / SFJ Pharma, Pfizer - LARVOL DELTA

Dacomitinib in advanced NSCLC patients with uncommon EGFR mutations: A multicenter, single-arm, phase II study and biomarker analysis (DANCE study) (ELCC 2026) - P2 | "Grade 3 or higher AEs were reported in 12 (40.0%) patients. The secondary T790M mutation was the most common resistance mechanism (33.3%).Conclusions Dacomitinib has high anti-tumor activity and response duration with manageable toxicity in NSCLC patients with uncommon EGFR mutations."

Biomarker • Clinical • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

A panel of patient-derived organoid models from rare cancers for high-throughput preclinical pharmacology studies (AACR 2026) - "Under assay conditions, the organoid models exhibited diverse morphologies and varied growth kinetics with doubling times ranging from 48 - 363 h with an average of 129 h. Among the patients that received prior chemotherapy, four had a partial response as the best outcome, two of which were sarcoma patients treated with regimens including doxorubicin, vincristine, and etoposide...A patient with lip/oral cavity squamous cell carcinoma partially responded to a regimen including temozolomide and the corresponding organoid demonstrated ≥1 log of cytotoxicity following exposure to temozolomide and other drugs below the clinical Cmax. A patient with stomach adenocarcinoma partially responded to a regimen with 5-fluorouracil and cisplatin, but the organoid was minimally sensitive to these drugs. However, genomic characterizations of the tumor tissue indicated an amplification of ERBB2 and the organoid demonstrated sensitivity to the ERBB2 inhibitors neratinib, dacomitinib, and..."

Preclinical • Gastric Adenocarcinoma • Oncology • Oral Cancer • Sarcoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • BRAF • PIK3CA

Double-pillar co-culture (DPC) platform for evaluating cancer invasion and immunotherapy efficacy (AACR 2026) - "Among them, the EGFR inhibitor Dacomitinib reduced invasion by 95% viability, demonstrating anti-invasive activity independent of cytotoxicity. The DPC platform provides a physiologically relevant, high-throughput system for simultaneous assessment of cancer invasion and immune cytotoxicity. It enables identification of compounds with selective anti-invasive effects and evaluation of immunotherapy efficacy, offering a versatile tool for preclinical cancer research."

Lung Cancer • Oncology • Solid Tumor

Dacomitinib as a First-Line Therapy for Advanced EGFR-Mutated Non-Small Cell Lung Cancer Without Brain Metastases: A Multicenter Retrospective Observational Study. (PubMed, Cancer Med) - "Dacomitinib demonstrated favorable efficacy and tolerability as a first-line therapy in advanced NSCLC patients with common EGFR mutations (exon 19 deletion or L858R). A baseline ECOG PS ≥ 2 and the presence of bone or liver metastases were significantly associated with worse PFS, suggesting a need for additional therapeutic strategies in these subgroups."

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

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

Effect of Tongdu Jieyu acupuncture on hippocampal neuronal damage in post-stroke depression rats based on the NRG1/ErbB4 pathway (PubMed, Zhongguo Zhen Jiu) - "A total of 75 successfully modeled rats were randomly divided into a model group, an acupuncture group, a paroxetine group, a dacomitinib (ErbB4 inhibitor) group, and an acupuncture+dacomitinib group, with 15 rats in each one. The results of these indexes in the acupuncture+dacomitinib group were inferior to the acupuncture group, but superior to the dacomitinib group (P<0.05). Tongdu Jieyu acupuncture alleviates hippocampal neuronal damage and attenuates PSD in rats, which is obtained probably by activating the NRG1/ErbB4 pathway."

Journal • Preclinical • Cardiovascular • CNS Disorders • Depression • Mood Disorders • Psychiatry • BDNF • CAT • EGFR • ERBB4 • NRG1 • SYP

Beyond EGFR inhibition in Head and Neck Squamous Cell Carcinoma: overcoming resistance mechanisms and novel therapeutic frontiers. (PubMed, Crit Rev Oncol Hematol) - "Cetuximab, a chimeric IgG1 monoclonal antibody anti-EGFR, is the only EGFR-targeted agent approved for HNSCC and has shown efficacy in both locally advanced (in platinum-unfit patients) and recurrent/metastatic (R/M) settings...Irreversible pan-HER tyrosine kinase inhibitors (e.g., afatinib, dacomitinib), dual-target bispecific antibodies such as duligotuzumab (EGFR/HER3), petosemtamab (EGFR/LGR5) or ficerafusp alfa (EGFR/TGF-β) have led to promising preclinical and early-phase clinical activity...While EGFR remains a valid therapeutic target, future efforts must focus on biomarker-driven patient selection and combination strategies to enhance efficacy and durability of response. Ongoing trials will further define the role of emerging anti-EGFR agents and their integration into HNSCC treatment algorithms."

Journal • Review • Head and Neck Cancer • Immunology • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ERBB3 • PIK3CA • PTEN • TGFB1

Computational and Experimental Verification of Cabozantinib Targeting DDX11 to Inhibit DNA Damage Repair in Liver Cancer. (PubMed, ACS Omega) - "Although Afatinib showed the strongest docking score (-7.674 kcal/mol), it lacked hydrogen-bond interactions with Ser237 and Gln238 and was therefore excluded. In contrast, dacomitinib, ergotamine, and cabozantinib displayed both favorable affinities and stable hydrogen-bonding with these key residues...Proteomic profiling further revealed that cabozantinib downregulates DNA repair proteins and attenuates homologous recombination (HR) repair capacity in liver cancer cells. Together, computational and experimental findings indicate that targeting DDX11, particularly at Ser237, may effectively suppress ATM-mediated DDR signaling and impede liver cancer progression, warranting further preclinical and clinical evaluation."

Journal • Ataxia • Hepatocellular Cancer • Immunology • Liver Cancer • Movement Disorders • Oncology • Primary Immunodeficiency • Solid Tumor

From Gefitinib to Amivantamab: Progress and Perspectives of Therapies Targeting the Epidermal Growth Factor Receptor in the Era of Precision Oncology. (PubMed, J Cancer Prev) - "This review provides a comprehensive overview of the evolution of four generations of EGFR tyrosine kinase inhibitors (EGFR-TKIs): first-generation reversible inhibitors such as gefitinib and erlotinib; second- and third-generation irreversible inhibitors, including afatinib, dacomitinib, and osimertinib; and emerging fourth-generation agents, such as amivantamab. Future studies should explore combination therapies, antibody-drug conjugates, and next-generation allosteric inhibitors as promising strategies to overcome resistance. The evolution of EGFR-targeted therapy exemplifies the progress of precision oncology and serves as a basis for designing new paradigms in the management of lung cancer."

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

Korea Post Marketing Surveillance (PMS) Study of Vizimpro (clinicaltrials.gov) - P=N/A | N=188 | Completed | Sponsor: Pfizer | Recruiting ➔ Completed

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

ANALYZING CLINICAL TRIAL DISCONTINUATION REASONS FOR ADVANCED EGFR-DRIVEN NON-SMALL CELL LUNG CANCER (WRMC 2026) - "FDA-approved drugs in the terminated trials for "EGFR" noticed in the sample include Erlotinib (Tarceva) (OSI-774), Afatinib (Gilotrif), Osimertinib (Tagrisso), and Dacomitinib (Vizimpro). Clinical trials are often terminated due to company/business decisions or low patient accrual. Careful analysis of these factors is essential to reduce the risk of premature discontinuation, particularly in NSCLC studies where many trials involve experimental therapies with significant future potential. By addressing these challenges proactively, we can help ensure that promising treatments are not lost before their benefits are fully realized."

Clinical • Metastases • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Phase II, Single-Center, Prospective, Open-Label Study Evaluating Three Combination Regimens in the Treatment of Refractory Advanced Ewing Sarcoma (ChiCTR) - P=N/A | N=90 | Not yet recruiting | Sponsor: Shanghai Sixth People's Hospital; Shanghai Sixth People's Hospital

New trial • Ewing Sarcoma • Oncology • Sarcoma • Solid Tumor

Dacomitinib in EGFR-mutant non-small-cell lung cancer with brain metastasis: a single-arm, phase II study. (PubMed, ESMO Open) - "Dacomitinib has outstanding intracranial efficacy in patients with EGFR-mutant NSCLC with brain metastases."

Journal • P2 data • Brain Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Multimodal investigation of dacomitinib-calf thymus DNA binding interaction: insights from spectroscopy, thermodynamics, and in-silico studies. (PubMed, RSC Adv) - "The observed interaction reflects a binding interaction under in vitro conditions and is not intended to imply a direct role in the established anticancer mechanism of dacomitinib. Beyond characterizing a specific drug-DNA system, these findings highlight general principles governing minor groove recognition by non-classical DNA-binding small molecules and underscore the importance of evaluating potential off-target nucleic acid interactions of targeted therapeutics."

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

Medicinal chemistry perspective on quinazoline derivatives: Sustainable synthetic routes, anticancer evaluation, and SAR analysis. (PubMed, Eur J Med Chem) - "FDA-approved drugs like Gefitinib, Erlotinib, Afatinib, Dacomitinib, and Vandetanib validate the therapeutic significance of the quinazoline framework in modulating different cancer pathways. Structure activity relationship (SAR) analyses reveal that adding halogen, methoxy, or heteroaryl groups at specific ring positions enhance kinase affinity and cytotoxic efficacy. Overall, this review highlights recent progress linking synthetic design, molecular docking, and biological response, establishing quinazoline derivatives as promising multitargeted scaffolds for the design of next-generation anticancer agents."

Journal • Review • Oncology • BRAF • EGFR • HER-2 • PARP1

Hepatotoxicity and efficacy associated with first- and new-generation EGFR-TKIs in patients with NSCLC: a systematic review and meta-analysis. (PubMed, BMC Cancer) - "New-generation EGFR-TKIs (afatinib, osimertinib, and dacomitinib) demonstrate a superior efficacy and safety profile, with a significantly lower risk of hepatotoxicity, compared to gefitinib and erlotinib."

Clinical • Journal • Retrospective data • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer (clinicaltrials.gov) - P1 | N=22 | Completed | Sponsor: Memorial Sloan Kettering Cancer Center | Active, not recruiting ➔ Completed

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

Recurrent cancer-associated ERBB4 mutations are transforming and confer resistance to targeted therapies. (PubMed, Mol Oncol) - "More detailed analyses of the most potent mutations, S303F, E452K, and L798R, showed that they are activating, can co-operate with other ERBB receptors and are sensitive to clinically available second-generation pan-ERBB inhibitors neratinib, afatinib, and dacomitinib. Furthermore, the S303F mutation, together with a previously identified activating ERBB4 mutation, E715K, promoted resistance to third-generation EGFR inhibitor osimertinib in EGFR-mutant lung cancer model in vitro and in vivo. Together, these results are expected to facilitate clinical interpretation of the most recurrent cancer-associated ERBB4 mutations. The findings provide rationale for testing the efficacy of clinically used pan-ERBB inhibitors in patients harboring driver ERBB4 mutations both in the treatment-naïve setting, and upon development of resistance to targeted agents."

Journal • Lung Cancer • Oncology • Solid Tumor • ERBB4

Analysis of the efficacy and safety of radioactive seed Implantation combined with EGFR-TKI in the first-line treatment of classical EGFR mutation NSCLC (ESMO Asia 2025) - "Background: Representative EGFR-TKIs, such as gefitinib, afatinib, and osimertinib, have become the first-line standard treatment for patients with classical EGFR mutations (exon 19 deletions and exon 21 L858R) non-small cell lung cancer, with PFS ranging from 10 to 20 months...PFS has not yet reached for those receiving 2nd agents (only two patients, both treated with dacomitinib, still in follow-up currently), and 39.9m for those receiving 3rd agents. EGFR-TKI therapy combined with RSI confers a significant PFS benefit and merits further prospective investigation."

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • TP53

Cancer therapy-related cardiac dysfunction associated with EGFR-TKIs in advanced EGFR-mutant non-small cell lung cancer: A single-center prospective observational study (ESMO Asia 2025) - "Global longitudinal strain (GLS), tricuspid regurgitation peak gradient (TRPG), E/e′ ratio, Troponin-T and N-terminal prohormone of B-type natriuretic peptide (NT-proBNP), were also analyzed using generalized estimating equations. Among 100 patients included in this study (median age 64; 39.0% male, 61.0% female; 72.0% non-smokers), 66.0% patients received osimertinib, 16.0% received erlotinib, 13.0% received afatinib, and 5.0% received dacomitinib. Our study demonstrates the incidence of CTRCD in patients with advanced or recurrent EGFR-mutant NSCLC receiving EGFR-TKI treatment, and compares the effect between osimertinib and first or second generation TKIs. Increased E/e′ ratio was found in osimertinib group, indicating increased diastolic dysfunction. These findings highlight the importance of clinical monitoring of cardiac function in patients receiving TKIs, particularly in those treated with osimertinib."

Clinical • Metastases • Observational data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Real-world use of and clinical outcomes with dacomitinib as first-line therapy in Asian patients with EGFR mutation-positive locally advanced or metastatic non-small cell lung cancer: Final analysis of the ARIA study. (PubMed, Lung Cancer) - P, P3 | "To our knowledge, ARIA is the largest real-world study of dacomitinib's efficacy and safety. Final analysis of this study showed substantial clinical efficacy of dacomitinib and revealed treatment patterns, such as starting dose, in the real world. Safety data were consistent with dacomitinib's known safety profile. These results support first-line dacomitinib use in Asian patients with EGFR mutation-positive advanced NSCLC."

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

Inhibition of primary ciliogenesis enhances efficacy of EGFR‑TKIs against non‑small cell lung cancer cells. (PubMed, Oncol Rep) - "Importantly, treatment with EGFR‑TKIs (gefitinib and dacomitinib) results in a dose‑dependent increase in cilia number and length in A549 and H23 cells, an effect not observed in HCC827 and PC9 cells. Furthermore, it was demonstrated by immunoblotting and immunofluorescence colocalization analysis that both the expression and ciliary localization of adenylate cyclase 3 (AC3) are significantly upregulated following EGFR‑TKIs treatment, and the reduction of AC3 expression effectively mitigates cellular drug resistance in A549 cells. These findings highlight a critical role for the cilia‑AC3 axis in modulating cellular response to EGFR‑TKIs, suggesting it as a potential therapeutic target for the treatment of NSCLC."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • ARL13B

N-phenylquinazolin-4-amine-based EGFR TKIs suppress pulmonary fibrosis by modulating the EGFR/ERBB3 axis in epithelial-macrophage interaction. (PubMed, Commun Biol) - "This study evaluates N-phenylquinazolin-4-amine-based EGFR tyrosine kinase inhibitors (TKIs) in murine models of bleomycin- and radiation-induced PF...Dacomitinib more effectively suppressed TNF-α, IFN-γ, and IL-6 than nintedanib, suggesting a feedback loop driving fibrosis. Elevated phosphorylated EGFR/ERBB3 in RIPF and IPF tissues, and EGFR-related gene expression in epithelial cells from IPF single-cell RNA-seq data, further support clinical relevance. These findings highlight the importance of targeting immune-epithelial EGFR/ERBB3 signaling and support EGFR TKIs as a promising antifibrotic strategy."

Journal • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • ERBB3 • EREG • IFNG • IL6 • NRG1 • TNFA

Korea Post Marketing Surveillance (PMS) Study of Vizimpro (clinicaltrials.gov) - P=N/A | N=180 | Recruiting | Sponsor: Pfizer | Trial completion date: Oct 2025 ➔ Jan 2026 | Trial primary completion date: Oct 2025 ➔ Jan 2026

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

Assessing first-line treatment for advanced EGFR-mutated NSCLC in diverse clinicopathological subgroups: a systematic review and network meta-analysis. (PubMed, BMC Cancer) - "This NMA revealed that cases with EGFR-mutated NSCLC may benefit from different first-line treatment regimens according to their clinicopathological characteristics. On the whole, osimertinib plus CT and amivantamab plus lazertinib emerged as the most noticeable treatment modalities for such cases. (PROSPERO ID: CRD42024506995)."

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