Vizimpro (dacomitinib)

Initial low-dose dacomitinib demonstrated promising efficacy with an improved safety profile in patients with EGFR exon 21-mutated NSCLC. These findings support the feasibility of a dose-optimization strategy, although further prospective studies are warranted.

P=N/A, N=29, Completed, Pfizer | Active, not recruiting --> Completed | Trial completion date: Dec 2026 --> Sep 2025 | Trial primary completion date: Dec 2026 --> Sep 2025

This study reveals that Cd may promote the malignant progression of PC by regulating ECM remodeling through key genes such as FN1. Dacomitinib shows promise as an FN1-associated therapy, offering new insights for the precise prevention and treatment of Cd-associated PC.

Combination studies revealed that W1B acts synergistically with the EGFR inhibitor dacomitinib, effectively overcoming compensatory activation of parallel pathways...The in vivo studies on Danio rerio have shown a good safety profile, as well as strong antitumor potential of the tested compound. Therefore, these findings establish W1B as a promising derivative for the development of next-generation dual IGF1R/EGFR inhibitors in GBM.

The patient initially received pemetrexed plus carboplatin chemotherapy. The treatment efficacy was evaluated as a partial response (PR), with manageable adverse events including skin rash and paronychia. Dacomitinib may provide sustained clinical benefit and an acceptable safety profile in lung adenocarcinoma patients with L747P mutation and bone metastases.

P=N/A, N=29, Active, not recruiting, Pfizer | Trial completion date: Mar 2026 --> Dec 2026 | Trial primary completion date: Mar 2026 --> Dec 2026

All reported RORs for the identified AEs were statistically significant, as defined by a lower limit of the 95% confidence interval that exceeded 1. This study systematically evaluates AEs associated with dacomitinib, confirming its known safety profiles and identifying some emerging safety concerns in real-world settings. These findings provide crucial insights for clinicians and pharmacists to better manage dacomitinib's safety profile.

This study identifies/validates key mechanisms of EGFR-TKI resistance and suggests combinatorial therapeutic strategies as potential interventions against EGFR-TKI-resistant lung cancers, with promising implications for improving clinical outcomes.

P=N/A, N=29, Active, not recruiting, Pfizer | Trial completion date: Dec 2025 --> Mar 2026 | Trial primary completion date: Dec 2025 --> Mar 2026

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.

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.

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.