Melanoma: add-on trametinib shows PFS, ORR benefit in UK PACMEL study

  • Urbonas V & al.
  • Ann Oncol
  • 14 Nov 2018

  • curated by Brian Richardson, PhD
  • Univadis Clinical Summaries
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Takeaway

  • Results from a multicenter, open-label, randomized controlled phase 2 trial suggest that adding trametinib to paclitaxel chemotherapy is associated with improved PFS and objective response rate (ORR), but not OS, in patients with advanced, BRAF-wild-type melanoma.

Why this matters

  • Evidence that adding the kinase inhibitor trametinib may improve paclitaxel chemotherapy in patients who do not benefit from BRAF inhibitor therapy.

Key results

  • Trametinib/paclitaxel was associated with longer PFS (time ratio [TR], 1.47; P=.04) and ORR (OR, 4.7; P=.01) compared with paclitaxel alone.
  • Trametinib/paclitaxel was not associated with OS (TR, 0.71; P=.18).
  • Pazopanib (Votrient)/paclitaxel was not associated with PFS (TR, 1.36; P=.14), ORR (OR, 1.82; P=.34), or OS (TR, 0.87; P=.34) compared with paclitaxel alone.
  • Grade 3+ adverse events were experienced by 24% of patients in the paclitaxel-alone group, 75% of patients in the trametinib/paclitaxel group, and 78% of patients in the pazopanib/paclitaxel group.

Study design

  • 111 patients with advanced, BRAF-wild-type melanoma were randomly assigned 1:1:1 to paclitaxel alone (n=38), paclitaxel and trametinib (n=36), or paclitaxel and pazopanib (n=37) and analyzed for efficacy and safety.
  • Funding: GlaxoSmithKline/Novartis; UK National Cancer Research Network.

Limitations

  • Open-label study.
  • No placebo control.

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