Dacomitinib (Vizimpro) is accepted for use within NHSScotland...as monotherapy, for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.

Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.

First-line treatment of EGFR-mutated NSCLC: Patients with a tumour with a sensitising EGFR mutation should receive first-line EGFR TKIs including erlotinib, gefitinib or afatinib [I, A], or dacomitinib.

…the NCCN NSCLC Panel preference stratified first-line therapy for patients with EGFR mutation positive metastatic NSCLC. Erlotinib, gefitinib, afatinib, or dacominitib are "other recommended " EGFR TKI options for first-line therapy.

...- The tumor harbored common EGFR mutations (Del19, L858R) at start of first-line treatment...

...- Biopsy proven recurrent or metastatic NSCLC (adenocarcinoma) with major EGFR mutation (exon 19 deletion or Leu858Arg mutation without the Thr790Met)...

...- The presence of an EGFR activating mutation (exon 19 deletion or the L858R mutation in exon 21) in tumor specimen determined by the local laboratory....

...Progression-Free Survival (PFS) at Month 6 (PFS6m) - Phase 2`Overall Survival (OS) at Month 6 (OS6m) - Phase 2`Percentage of Participants With Objective Response - Phase 1`Soluble Protein Biomarkers Level`Number of Participants With Epidermal Growth Factor Receptor (EGFR), Kirsten Rat Sarcoma (KRAS), and Human Epidermal Growth Factor Receptor-2 (HER2) Mutation Status`Maximum Observed Plasma Concentration (Cmax) of PF-00299804 30 mg and PF-00299804 45 mg`Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-00299804 30 mg and PF-00299804 45 mg`Plasma Decay Half-Life (t1/2) of PF-00299804 30 mg and PF-00299804 45 mg - Phase 1`Area Under the Curve From Time Zero to 24 Hour Post-Dose (AUC0-24) of PF-00299804 30 mg and PF-00299804 45 mg`Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-00299804 30 mg and PF-00299804 45 mg- Phase 1`Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-00299804 30 mg and PF-00299804 45 mg - Phase 1`Accumulation Ratio (Rac) of PF-00299804 30 mg and PF-00299804 45 mg - Phase 1`Average Plasma Concentration (Cavg) of PF-00299804 30 mg and PF-00299804 45 mg`Linearity Ratio (Rss) of PF-00299804 30 mg and PF-00299804 45 mg - Phase 1`Minimum Observed Plasma Trough Concentration (Ctrough) of PF-00299804 30 mg and PF-00299804 45 mg`Number of Participants With Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Phase 2`Number of Participants With Change in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) - Phase 2`Dermatology Life Quality Index (DLQI) Total Score - Phase 2`Best Overall Response (BOR) - Phase 2`Duration of Response (DR)...

...- confirmed diagnosis of EGFR mutation-positive NSCLC...

...Evidence of histologically or cytologically confirmed diagnosis of metastatic NSCLC with EGFR activating mutations as detected by an appropriate test....

...- Presence of any EGFR-activating mutation (exon 19 deletion or exon 21 L858R substitution) or other uncommon EGFR mutations prior to anti-cancer treatment;...

...- The presence of an EGFR activating mutation (exon 19 deletion or the L858R mutation in exon 21) in tumor specimen determined by the local laboratory;...

...- patient with EGFR mutation-positive inoprable or recurrent NSCLC who have...

...- Evidence of histo or cytopathology confirmed, advanced NSCLC (with known histology) with the presence of EGFR-activating mutation (exon 19 deletion or the L858R mutation in exon 21)....

...Overall Survival in KRAS-WT Patients`Overall Survival in EGFR-mutant Patients`Progression-free Survival`Objective Response Rate`Number of Participants With Toxicity as Measured by NCI CTCAE Version 4.0...

...Patients harboring uncommon EGFR mutations....

...- patients with known EGFR activating mutation regardless of smoking status...

Dacomitinib showed promising efficacy and manageable safety profile for advanced NSCLC with brain metastasis harboring EGFR mutation in the first-line treatment.

ORR was 68.8% (95% CI 41.3 to 89.0%) and DCR was 93.8% (95%CI 69.8 to 99.8%), including three achieving complete remission (CR) and eight achieving partial remission (PR). Median PFS for patients with brain metastasis was 9.0 (95%CI 6.9 to 11.1) months. For patients with brain metastasis, intracranial ORR was 100%, including 2 CR and 4 PR...Dacomitinib showed good activity and manageable toxicity in NSCLC patients with uncommon EGFR mutations...

…we report interim analysis of ARIA, a non-interventional study of dacomitinib’s real-world (RW) utilization and associated clinical outcomes in Asian patients with advanced EGFR mutation–positive NSCLC….Interim analysis shows efficacy of 1L dacomitinib...

This is single centre retrospective study of EGFR mutated advanced NSCLC pts treated with dacomitinib between July’19 and Feb’23….Dacomitinib showed very good PFS with manageable safety profile.

This is a multi-center retrospective study of advanced non-small cell patients with EGFR mutations who received dacomitinib treatment from January 2019 to 2021.All patients received a 30 mg oral dose of dacomitinib….The control rate (DCR) was 100%, and PFS and OS were not reached in 30 patients....As a first-line treatment, 30 mg dacomitinib has a good curative effect on patients with classic EGFR mutations and has fewer adverse reactions of grade 3 or higher.

Dacomitinib demonstrated favorable activity with manageable toxicity in patients with NSCLC harboring major uncommon EGFR mutations.

In the whole cohort, 55.3 % of patients (21/38) had a confirmed partial response and 89.5 % (34/38) had disease control, and the median PFS was 10.3 months (95 % confidence interval [CI], 5.8–14.8)....This real-world study indicates that dacomitinib is potent and well-tolerated in NSCLC patients harboring uncommon EGFR mutations in multi-line settings, and has favourable activity for brain metastases.

Ninety-nine patients with advanced NSCLC who received dacomitinib (30mg daily or 45 mg daily) after initial diagnosis or 1-4 cycle of chemotherapy treatment were included in this ambispective (both retrospective and prospective) multicentric study. Treatment outcomes of these patients were analyzed....Dacomitinib showed significantly active in EGFR TKI-naïve patients with advance EGFR-positive NSCLC, and was well tolerated.

The hazard ratio (HR) for OS was 0.748 (95% CI 0.591-0.947; two-sided P = 0.0155); median OS was 34.1 months with dacomitinib versus 27.0 months with gefitinib. The HR for OS in patients with dose reduction(s) in the dacomitinib arm (n = 154) compared with all patients in the gefitinib arm was 0.554 (95% CI 0.420-0.730); median OS was 42.5 months for patients with dose reduction(s) in the dacomitinib arm.

Among subgroups, dacomitinib showed a numerical improvement of OS compared with all other EGFR TKIs among patients with exon 21 L858R substitution mutation and among Asian patients while osimertinib showed a numerical improvement of OS compared with all other EGFR TKIs among patients with exon 19 deletion mutation and among non-Asian patients.

Patients with NSCLC, Eastern Cooperative Oncology Group performance status 0 to 2, no prior HER-directed therapy, and one/two prior chemotherapy regimens received dacomitinib 45 mg or erlotinib 150 mg once daily….For the EGFR mutant subset, median PFS was 7.44 months for both dacomitinib and erlotinib...