This is a French multicenter study that was conducted between September 2020 and July 2023. The primary endpoint was objective response rate (ORR). Secondary endpoints were treatment-related adverse events (TRAEs), progression-free survival (PFS), overall survival (OS), and duration of response (DOR). Patients with primary uveal melanoma were excluded from the study. Twenty (30%) patients had active brain metastases. Thirteen (19%) and 20 (30%) patients had BRAF V600 mutations and NRAS mutations, respectively.
The majority of patients had received ≥3 prior lines of therapy (45%), while 58 (87%) had progressed on prior anti-PD-1 and anti-CTLA-4 therapy. All patients with BRAF V600 mutations had previously received targeted therapy. All patients received lenvatinib orally at doses of 20, 14, 10, or 8 mg once daily. Lenvatinib treatment could be interrupted or reduced to manage toxicity. The choice of starting dose and schedule (Pembrolizumab or Nivolumab) was at the discretion of the physicians at each participating center.
There are currently no treatment options for patients with advanced melanoma who have failed immunotherapy or targeted therapy. Recent studies show antitumor activity of combination pembrolizumab and lenvatinib in patients with melanoma progressing on immunotherapy. At the same time, lenvatinib monotherapy demonstrated a low objective response rate of 9%. In this report, the authors present data on the clinical results of the use of a combination of lenvatinib and a PD-1 protein inhibitor in this patient population.