marked.bio

EGFR TKI (2nd generation) · small molecule

dacomitinib

5 active trials across 7 of our biomarkers, targeting EGFR/HER2. 2 active approvals for a biomarker on marked.bio.

Also known as PF-00299804, Vizimpro.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
dacomitinib
FDA, 2018
first line, metastatic, EGFR exon 19 deletion or exon 21 L858R Current label: first-line metastatic NSCLC with exon 19 deletion or exon 21 L858R. Year confirmed: FDA approval announced 27/09/2018. Source
EU (EMA), 2019
first line, locally advanced or metastatic with activating EGFR mutations Initial MA 02/04/2019. Source
Vizimpro 		EGFR exon 19 deletion / L858R NSCLC Approved 2018 Approved 2019

In the US label

ARCHER 1050 vs gefitinib, 227 vs 225 patients
PFS 14.7 months vs 9.2 months, HR 0.59 (0.47-0.74)Response 75% vs 72%

Serious side effects 27%Stopped for side effects 18%

Trial details and side effects
Patients
first-line EGFR exon 19 deletion or L858R NSCLC (NCT01774721)
Most common side effects
diarrhoea 87%, rash 69%, paronychia 64%, stomatitis 45%, decreased appetite 31%, dry skin 30% (227 patients)
Notes
US label rev. 12/2020, sections 6 and 14.
Source
US label

In the EU product information

ARCHER 1050 vs gefitinib, 227 vs 225 patients
PFS 14.7 months vs 9.2 months, HR 0.59 (0.47-0.74)Response 75% vs 72%OS 34.1 months vs 26.8 months, HR 0.76 (0.58-0.99), not formally tested

Trial details and side effects
Patients
first-line EGFR exon 19 deletion or L858R NSCLC (NCT01774721)
Most common side effects
diarrhoea 87%, rash 69%, paronychia 64%, stomatitis 45%, decreased appetite 31%, dry skin 30% (227 patients)
Notes
EU SmPC section 5.1 (ARCHER 1050). Side effects from the US label.
Source
EU product information

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
EGFR exon 19 deletion / L858R 5 11 Phase 3
ALK fusion 1 1 Phase 2
BRAF V600E 1 1 Phase 2
BRCA1/2 mutation 1 1 Phase 2
ROS1 fusion 1 1 Phase 2
KRAS G12C 0 1 –
KRAS G12D 0 1 –

Trials

5 of 12 trials shown

  1. EGFR-mutated Lung Cancer in Randomized Investigator-Initiated Study

    Recruiting Phase 3 Region Skane Started 2022Primary completion 2028-09 NCT06486142

    afatinib FDA EUdacomitinib FDA EUosimertinib FDA EU

    EGFR-mutation in tumor (in cases where tumor tissue is not available for mutation analysis, circulating…

    EGFR exon 19 deletion / L858RNon-Small Cell Lung Cancer

  2. First-line Treatment With Dacomitinib Plus Anlotinib for Patients With Advanced NSCLC With EGFR 21L858R Mutations

    Recruiting Phase 1/2 Shanghai Chest Hospital Started 2022Primary completion 2025-01 NCT05271916

    dacomitinib FDA EUanlotinib

    It is acceptable for subjects with the presence of EGFR activating mutation (exon 19 deletion and the L858R mutation in exon 21) to be included in this Phase I study

    EGFR exon 19 deletion / L858RStatus may be outdated, last updated 2023-04-19Non-Small Cell Lung Cancer (NSCLC)

  3. Dacomitinib in Lung Cancer With Uncommon EGFR Mutations

    Active, not recruiting Phase 2 Shanghai Chest Hospital Started 2020Primary completion 2022-12 NCT04504071

    dacomitinib FDA EU

    Mutation in exon 19:

    EGFR exon 19 deletion / L858RNon-small Cell Lung Cancer Metastatic, EGF-R Positive Non-Small Cell Lung Cancer

  4. PLATFORM Study of Precision Medicine for Rare Tumors

    Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Started 2020Primary completion 2026-07 NCT04423185

    aumolertinibdacomitinib FDA EUalectinibcrizotinibpyrotinibimatinibniraparibpalbociclibvemurafenibsintilimabatezolizumab

    when obtaining EGFR mutation, ALK fusion, ROS-1 fusion, C-MET amplification, C-MET mutation, BRAF mutation, BRCA1/2 mu…

    EGFR exon 19 deletion / L858RBRAF V600EBRCA1/2 mutationALK fusionROS1 fusionRare Tumor

  5. Phase 2 Study of Dacomitinib in NSCLC

    Active, not recruiting Phase 2 National Cancer Centre, Singapore Started 2019Primary completion 2026-03 NCT04027647

    dacomitinib FDA EU

    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;

    EGFR exon 19 deletion / L858RNSCLC Stage IIIB, NSCLC Stage IIIC, NSCLC Stage IV, Recurrent NSCLC