Real-world effectiveness of dabrafenib and trametinib in patients with BRAF-positive melanoma treated in routine Bulgarian clinical practice

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  TAFINLAR

  MEKINIST
• Study drug International non-proprietary name (INN) or common name:
  DABRAFENIB

  TRAMETINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01EC02) dabrafenib

  dabrafenib

  (L01EE01) trametinib

  trametinib
• Medical condition to be studied:
  Malignant melanoma

Population studied

• Short description of the study population:
  The study analyzed real-world data (RWD) consisting of 335 patients who were treated with dabrafenib and trametinib from clinical practice between 2018 and 2022.
• Age groups:
  All

  In utero

  Paediatric Population (< 18 years)

  Neonate

  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adult and elderly population (≥18 years)

  Adults (18 to < 65 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Elderly (≥ 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)

Study design details

• Study design:
  To assess the real-world effectiveness of dabrafenib and trametinib in patients with BRAF-positive malignant melanoma in a real-world setting.; Compare outcomes, including overall survival (OS) and progression-free survival (PFS), to pivotal clinical trials (COMBI-d and COMBI-v).
• Comparators:
  COMBI-d: comparing the combination of dabrafenib and trametinib to dabrafenib.; COMBI-v: comparing the combination of dabrafenib and trametinib to vemurafenib.
• Outcomes:
  Clinical Outcomes; Progression-Free Survival (PFS). The median PFS based on RWD is 16.1 (95% CI: NC-NC) months in comparison to 9.3 months from COMBI-d trial and 17.0 (95% CI: NC-NC) months vs. 11.4 months from COMBI-v trial.; Overall Survival (OS). In comparison to COMBI-d, RWD outcomes were overall more favorable: OS for RWD was consistently higher than RCT over the first 24 months. Similarly, in comparison to COMBI-v, RWD outcomes were more favorable: OS was close to or higher than the RCT.; Clinical Benefit Rates (CBR) were comparable: RWD is 84.6% (95% CI: 77.9–89.5) vs. 92% for COMBI-d and 90% for COMBI-v.