Excerpt:VIZIMPRO is a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.
Evidence Level:Sensitive: A2 - Guideline
New
Excerpt:The NCCN NSCLC Panel recommends dacomitinib as a first-line treatment option for patients with sensitizing EGFR-positive metastatic NSCLC based on these clinical trial data and the FDA approval….The most commonly described mutations in EGFR (exon 19 deletions, p.L858R point mutation in exon 21) are associated with responsiveness to EGFR tyrosine kinase inhibitor (TKI) therapy...
EGFR EXON 19 DELETION OR L858R MUTATIONS….Progression on erlotinib (± ramucirumab or bevacizumab), afatinib, gefitinib, or dacomitinib….SUBSEQUENT THERAPY...Continue erlotinib (± ramucirumab or bevacizumab) or afatinib or gefitinib or dacomitinib (if T790M-).
Evidence Level:Sensitive: B - Late Trials
Title:
Safety and Efficacy of First-Line Dacomitinib in Advanced Non-Small Cell Lung Cancer by EGFR Mutation SUBtype in ARCHER 1050
Excerpt:Dacomitinib is the first second-generation TKI to improve PFS and OS over gefitinib in patients with dose reduction in both Del19 and L858R subgroups.
Evidence Level:Sensitive: B - Late Trials
Title:
Improvement in Overall Survival in a Randomized Study That Compared Dacomitinib With Gefitinib in Patients With Advanced Non-Small-Cell Lung Cancer and EGFR-Activating Mutations
Excerpt:In a multinational, multicenter study, patients age 18 years or older (≥ 20 years in Japan and Korea) who had an Eastern Cooperative Oncology Group performance status of 0 or 1 and newly diagnosed NSCLC with activating mutations in EGFR (exon 19 deletion or exon 21 L858R) were enrolled and randomly assigned in a 1:1 manner to dacomitinib (n = 227) or gefitinib (n = 225). Conclusion In patients with advanced NSCLC and EGFR activating mutations, dacomitinib is the first second-generation epidermal growth factor receptor tyrosine kinase inhibitor (TKI) to show significant improvement in OS in a phase III randomized study compared with a standard-of-care TKI.
DOI:10.1200/JCO.2018.78.7994
Evidence Level:Sensitive: B - Late Trials
Title:
Dacomitinib (daco) versus gefitinib (gef) for first-line treatment of advanced NSCLC (ARCHER 1050): Final overall survival (OS) analysis
Excerpt:Pts with newly diagnosed stage IIIB/IV or recurrent NSCLC harboring an EGFR mutation (exon 19 del or exon 21 L858R ± exon 20 T790M) and without central nervous system metastasis were randomized….n pts with advanced EGFR mutation-positive NSCLC, daco is the first to show a significant improvement in OS in a phase 3 trial compared with a standard-of-care tyrosine kinase inhibitor.
DOI:10.1200/JCO.2018.36.15_suppl.9004
Evidence Level:Sensitive: B - Late Trials
New
Title:
Dacomitinib versus gefitinib as first-line treatment for patients with EGFR-mutation-positive non-small-cell lung cancer (ARCHER 1050): a randomised, open-label, phase 3 trial
Excerpt:In this international, multicentre, randomised, open-label, phase 3 study (ARCHER 1050), we enrolled adults (aged ≥18 years or ≥20 years in Japan and South Korea) with newly diagnosed advanced NSCLC and one EGFR mutation...Median duration of follow-up for progression-free survival was 22·1 months (95% CI 20·3-23·9). Median progression-free survival according to masked independent review was 14·7 months (95% CI 11·1-16·6) in the dacomitinib group and 9·2 months (9·1-11·0) in the gefitinib group (hazard ratio 0·59, 95% CI 0·47-0·74; p<0·0001).
DOI:10.1016/S1470-2045(17)30608-3
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Central Nervous System(CNS) Efficacy of Dacomitinib
Excerpt:...- Biopsy proven recurrent or metastatic NSCLC (adenocarcinoma) with major EGFR mutation (exon 19 deletion or Leu858Arg mutation without the Thr790Met)...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Phase 2 Study of Dacomitinib in NSCLC
Excerpt:...- 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;...
More C2 evidence
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Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Dacomitinib in Lung Cancer With Uncommon EGFR Mutations
Excerpt:...Patients harboring uncommon EGFR mutations....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Real World Utilization and Outcomes With Dacomitinib First Line Treatment for EGFR Mutation-positive Advanced Non Small Cell Lung Cancer Among Asian Patients - A Multi Center Chart Review
Excerpt:...- Presence of any EGFR-activating mutation (exon 19 deletion or exon 21 L858R substitution) or other uncommon EGFR mutations prior to anti-cancer treatment;...
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
ARCHER1050: A Study of Dacomitinib vs. Gefitinib in 1st-Line Treatment Of Advanced NSCLC.
Excerpt:...- 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)....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
Korea Post Marketing Surveillance (PMS) Study of Vizimpro
Excerpt:...Vizimpro® naïve patients to whom Vizimpro® can be prescribed as per the local labeling (the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations 2....
Evidence Level:Sensitive: C2 – Inclusion Criteria
New
Title:
An Open Label, Multicenter, Phase II Study of Dacomitinib for EGFR Mutated Non-Small Cell Lung Cancer (NSCLC) With Brain Metastases
Excerpt:...- 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....
Less C2 evidence
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Evidence Level:Sensitive: C3 – Early Trials
Title:
571P - Dacomitinib in treatment-naïve EGFR-mutant NSCLC patients with multiple brain metastases: Initial efficacy and safety data from a phase II study
Excerpt:For all patients, the mPFS was 15.3m(8/14), ORR was 78.6% while DCR was 100%.The iORR was 80% and iDCR was 100%. The mPFS in patients with 19Del (8/14,57.1%) and21L858R (6/14,42.9%) are 15.3 and 15.2m, ORR are 87.5% and 66.7%, respectively...Dacomitinib showed promising intracranial antitumor activity with a manageable safety profile as first-line therapy in EGFR-mutant NSCLC patients with multiple brain metastases.
Evidence Level:Sensitive: C3 – Early Trials
Title:
Dacomitinib in EGFR-mutant non-small-cell lung cancer with brain metastasis: a single-arm, phase II study
Excerpt:This single-arm phase II study enrolled 30 patients with treatment-naïve advanced NSCLC harboring activating EGFR mutations from January 2021 to June 2021 and started them on dacomitinib (45 mg/day)….Patients had exon 19 deletions (46.7%) and L858R mutations in exon 21 (55.3%). The confirmed iORR was 96.7% (29/30), with an intracranial complete response of 63.3%....Dacomitinib has outstanding intracranial efficacy in patients with EGFR-mutant NSCLC with brain metastases.
DOI:https://doi.org/10.1016/j.esmoop.2023.102068
Evidence Level:Sensitive: C3 – Early Trials
Title:
362P - Intracranial activity of dacomitinib in treatment naïve advanced EGFR mutated non-small cell lung cancer (NSCLC): Prespecified subgroup analysis of the ATORG-003 trial
Excerpt:ATORG-003 (9 sites, 5 Asian countries) is enrolling newly diagnosed stage IIIB-IV NSCLC pts with EGFR mutations (exon 19 deletion [ex19del] or L858R). Pts receive dacomitinib 30 mg orally once daily….The iORR was 67% (1 intracranial CR [iCR], 5 intracranial PR), and median intracranial duration of response (iDoR) was not reached (NR). In 14 pts with non-measurable CNS mets only, iCR was seen in 6 (43%) pts. Median iPFS was NR with only n=5 CNS progression events in the entire cohort and n=7 remain on treatment. Overall (intra and extracranial) ORR was 67% and PFS rate at 12 mo was 42%.....Dacomitinib has significant intracranial activity with observed durable responses in advanced EGFR mutated NSCLC with CNS mets.
Evidence Level:Sensitive: C3 – Early Trials
Title:
EP08.02-134 - Real-world Efficacy of Dacomitinib in Patients with Previously EGFR-TKI Treated Non-small Cell Lung Cancer
Excerpt:In this retrospective study, 21 enrolled patients who had progressed on previous EGFR-TKI and chemotherapy were treated with dacomitinib 45 mg or 30 mg orally daily until disease progression or intolerability....Three patients with an original sensitizing EGFR L858R mutation and one patient with exon 19 deletion had partial responses…
Evidence Level:Sensitive: C3 – Early Trials
Title:
A real-world study of dacomitinib in later-line settings for advanced non-small cell lung cancer patients harboring EGFR mutations
Excerpt:Among 49 evaluable patients, 26.5% (13 patients) had a confirmed partial response and 73.5% (36 patients) had disease control...the median progression-free survival was 5.4 months (95% CI, 3.5–7.3 months), and the half-year, 1-year, and 2-year OS rate were 79.2%, 70.6%, and 64.1%, respectively....As to mutation types, the ORRs of 19del, 21L858R, and rare mutations were 28.6%, 12.5%, and 54.5%, respectively (Figure S1D)...different mutation subtypes demonstrated different PFS (mPFS, 10.3 vs. 6.4 vs. 3.8; p = 0.351) (Figure 2G) and OS (1-year OS rate, 90.0% vs. 79.0% vs. 60.9%; p = 0.288) (Figure 2H), with rare mutations (n = 11) demonstrating better treatment responses and prognosis, followed by 19del (n = 15) and 21L858R (n = 30)....This real-world study has shown that dacomitinib is active and well-tolerated in NSCLC patients harboring different EGFR mutations in later-line settings, even for those with brain metastases.
DOI:https://doi.org/10.1002/cam4.4495
Evidence Level:Sensitive: C3 – Early Trials
Title:
Real-world experience of dacomitinib in EGFR mutated advanced NSCLC: A single center experience from India.
Excerpt:...single center retrospective study of EGFR mutated advanced NSCLC patients treated with dacomitinib…Type of mutations was Del 19 in 27 pts, L858R in 12 pts, G719X in 2pts, and Del 19 + L858R, L861Q in one patient each....38 pts have evaluable response: complete response in 2, partial response in 34 and stable disease in 2 pts....Response rate was high and durable.
DOI:10.1200/JCO.2021.39.15_suppl.e21043
Evidence Level:Sensitive: C3 – Early Trials
Title:
Dacomitinib Induces a Drastic Response in Metastatic Brain Lesions of Patients with EGFR-mutant Non-small-cell Lung Cancer: A Brief Report
Excerpt:This real-world cohort study with 14 patients has shown for the first time that dacomitinib have potent efficacy for CNS metastasis in both L858R and 19del EGFR-positive patients with NSCLC.
Evidence Level:Sensitive: C3 – Early Trials
Title:
Dacomitinib induces objective responses in metastatic brain lesions of patients with EGFR-mutant non-small-cell lung cancer: A brief report
Excerpt:In total, 14 of 59 EGFR-mutant advanced NSCLC patients who received first-line dacomitinib therapy had brain metastasis before treatment….Eight patients harbored EGFR 19del, 5 had EGFR L858R, and one patient had EGFR G719A and I706 T co-mutations….The ORR was 92.9 % (13/14) and the disease control rate (DCR) was 100 %.
DOI:10.1016/j.lungcan.2020.12.008
Evidence Level:Sensitive: C3 – Early Trials
Title:
Indirect analysis of first-line therapy for advanced non-small-cell lung cancer with activating mutations in the Japanese population
Excerpt:...the presence of exon 19 deletion and exon 21 L858R mutations in each trial ranged from 43 to 65% and 35 to 57%, respectively....Dacomitinib demonstrated a trend toward improved PFS and therefore, should be considered one of the standard first-line therapies for Japanese patients diagnosed with EGFR+ non-small-cell lung cancer.
DOI:10.2217/fon-2020-0651
Evidence Level:Sensitive: C3 – Early Trials
Title:
Network meta analysis of first-line therapy for advanced EGFR mutation positive non-small-cell lung cancer: updated overall survival
Excerpt: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.
DOI:https://doi.org/10.2217/fon-2020-0541
Evidence Level:Sensitive: C3 – Early Trials
Title:
Clinical activity and safety profile of dacomitinib in advanced epidermal growth factor receptor-positive non-small cell lung cancer patients with brain metastases.
Excerpt:The intracranial ORR and DCR among 5 response- evaluable patients with at least one follow-up disease assessment were 40% and 100% (2/5 complete response, 3/5 stable disease)….dacomitinib may have CNS efficacy in patients with untreated EGFR+ NSCLC in the real-world setting.
DOI:10.1200/JCO.2020.38.15_suppl.e21656
Evidence Level:Sensitive: C3 – Early Trials
Title:
Safety and efficacy of first-line dacomitinib in Japanese patients with advanced non-small cell lung cancer
Excerpt:...patients with EGFR-activating mutation-positive (EGFR-positive; exon 19 deletion or exon 21 L858R substitution mutations)...In 81 Japanese patients (40 dacomitinib, 41 gefitinib), PFS was longer with dacomitinib compared with gefitinib…Our results confirm the efficacy and safety of first-line dacomitinib in Japanese patients with EGFR-positive advanced NSCLC.
Evidence Level:Sensitive: C3 – Early Trials
New
Title:
Dacomitinib versus erlotinib in patients with EGFR-mutated advanced nonsmall-cell lung cancer (NSCLC): pooled subset analyses from two randomized trials
Excerpt:For patients with exon 19 mutations, the estimate of median PFS was 14.6 months (95% CI 9.2–20.6) with dacomitinib and 10.0 months (95% CI 7.2–12.8) with erlotinib. The HR for PFS favored dacomitinib with a HR of 0.585 (95% CI 0.335–1.024, two-sided log-rank, P = 0.058)
DOI:https://doi.org/10.1093/annonc/mdv593