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) - No abstract available

Biomarker • Clinical • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • 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

Signal Detection and Network Pharmacology Analysis of Paronychia Associated With eGFR Inhibitors (ISPOR-EU 2025) - "To evaluate the potential association between EGFR inhibitors (Afatinib, Erlotinib, Dacomitinib, and Gefitinib) and paronychia, the ROR was calculated. A significant association between EGFR inhibitors and paronychia was identified, highlighting the need to explore potential underlying molecular mechanisms. The overlap between paronychia-related genes and the off-target interactions of EGFR inhibitors, particularly involving ABCG2, ERBB2, and ERBB4, suggests that these pathways may contribute to the observed adverse effects."

ABCG2 • ERBB4 • HER-2

DeepEGFR a graph neural network for bioactivity classification of EGFR inhibitors. (PubMed, Sci Rep) - "To ensure interpretability, the top 20 features identified by DeepEGFR were validated against the five key characteristics of FDA-approved EGFR inhibitors (Afatinib, Gefitinib, Osimertinib, Dacomitinib, Erlotinib), confirming the biological relevance of the features. These results highlight the effectiveness of graph neural networks in advancing molecular activity classification, setting a potential new benchmark for EGFR inhibitor prediction. These findings demonstrate the DeepEGFR's ability to highlight the promising EGFR inhibitors, that have received limited prior investigation, thereby supporting its role in facilitating the rational development of targeted therapies for precision oncology."

Journal • Oncology

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

Sequential tyrosine kinase inhibitor therapy for EGFR L747P-mutated lung adenocarcinoma in a renal transplant recipient: a 24-month case report. (PubMed, Front Med (Lausanne)) - "The patient was treated sequentially with three generations of EGFR TKIs-gefitinib, osimertinib, and dacomitinib-while continuing immunosuppressive therapy for graft function. To our knowledge, this is the first reported case of an EGFR L747P-mutated lung adenocarcinoma in a renal transplant recipient benefiting from sequential multi-TKI therapy. This case underscores the importance of vigilant cancer surveillance in transplant recipients and suggests that individualized TKI sequencing may offer clinical benefit, although further evidence is required."

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

Update on the Treatment of Non-Small Cell Lung Carcinoma (NSCLC). (PubMed, J Clin Med) - "Crucial therapeutic approaches, including dacomitinib, lorlatinib, durvalumab, osimertinib, and rivaroxban, are discussed, highlighting their mechanisms of action, uses, and adverse effects. The review also investigates cooperation therapies, such as targeting immune checkpoint inhibitors and hemostasis, alongside chemotherapy, as they offer potential for future therapies. However, further research is needed to improve the safety and efficacy of current treatments, and to explore novel ways to achieve better long-term outcomes."

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

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

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

Phase IV clinical trials for the treatment of non-small cell lung carcinoma (NSCLC): A systemic review from 2020-2025. (PubMed, Saudi Med J) - "The studies reviewed reported high rates of adverse events, alongside reduced subjective outcomes and faster response periods. This warrants for continuous research to develop safer and more efficient therapy methods for NSCLC patients.PROSPERO No.: CRD420251038011."

Journal • P4 data • Review • Infectious Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Respiratory Diseases • Solid Tumor

Efficacy of Sunvozertinib in Advanced NSCLC With HER2 Exon 20 Insertion After Prior Treatment Failure: A Real-World Case Series (IASLC-WCLC 2025) - "Prior treatments included first-line chemotherapy plus immunotherapy (PFS 3 months) and second-line dacomitinib (PFS 4 months)...Subsequent sunvozertinib plus vinorelbine yielded stable disease (SD) for 1 month, followed by progression after 2 months...The AE profile (rash, diarrhea, mucositis) was tolerable and manageable. These real-world data suggest sunvozertinib as a promising option for this population, meriting further prospective research."

Clinical • HER2 exon 20 • IO biomarker • Metastases • Real-world • Real-world evidence • Anorexia • Lung Adenocarcinoma • Lung Cancer • Mucositis • Non Small Cell Lung Cancer • Solid Tumor • Stomatitis • EGFR • HER-2

EGFR-Mutated Lung Cancer in Randomized Investigator-Initiated Study (ERIS): A National Phase III Trial From the Swedish Lung Cancer Study Group (IASLC-WCLC 2025) - "Current Swedish guidelines recommend either a third-generation inhibitor, osimertinib, or one of the second-generation EGFR-inhibitors, afatinib or dacomitinib. The longitudinally sampled blood and tumor tissue will be used for explorative analyses on the DNA, RNA, and protein level. An inclusion of minimum 200 patients over a three year-period in Sweden is planned and the study will end 36 months after the last inclusion."

Clinical • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A real-world pharmacovigilance assessment of drug-related carcinoembryonic antigen increase. (PubMed, Medicine (Baltimore)) - "And dacomitinib, regorafenib, fruquintinib, vandetanib, and panitumumab were the top 5 drugs with high risk. Non-antitumor drugs were all moderate risk, involving atorvastatin, zoledronic acid, amiodarone hydrochloride, lithium, and teduglutide...The number of related adverse event reports increased year by year. The results of this study provided the relevant basis for pharmacovigilance, and provided the basis for strengthening drug safety and making correct drug decision in clinical practice."

Adverse events • Journal • Real-world evidence • Oncology • CEACAM5