European journal of cancer (Oxford, England : 1990) · 2026
Real-world data on anti-PD-1 plus lenvatinib as a treatment option in pretreated advanced melanoma patients - a retrospective DeCOG study.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Albrecht Lea Jessica, Garnier Jana, Zaremba Anne, Brauch Lisa, Brunnert Fiona, Rauschenberg Ricarda, Forschner Andrea, Vazquez Xiomara Garza, Mangana Joanna, Erdmann Michael, Angela Yenny, Franklin Cindy, Tietze Julia, Lodde Georg, Tasdogan Alpaslan, Seier Johanna A, Roesch Alexander, Ugurel Selma, Berking Carola, Gutzmer Ralf, Heinzerling Lucie, Meier Friedegund, Mohr Peter, Hassel Jessica C, Schadendorf Dirk, Livingstone Elisabeth, Zimmer Lisa
Аннотация
BACKGROUND: Patients with advanced melanoma progressing after immune checkpoint inhibition (ICI) and BRAF/MEK inhibition have limited therapeutic options. In the LEAP-004 trial, pembrolizumab plus lenvatinib demonstrated activity in PD-1-refractory melanoma. The combination has emerged as a potential option when approved therapies have been exhausted; however, real-world evidence regarding its efficacy remains limited.
METHODS: This retrospective, multicenter DeCOG study included patients with advanced melanoma treated with anti-PD-1 plus lenvatinib after failure of anti-PD-1-based therapy at 11 major skin-cancer centers in Germany and Switzerland between October 2020 and March 2025.
RESULTS: Overall, 120 patients were analyzed (median age 59 years); 70 % were male and 38 % had an ECOG performance status > 1. Most patients had ≥ 3 metastatic sites (69 %), brain metastases (42 %), and elevated LDH (58 %). Median follow-up was 13.4 months. Patients received a median of two prior systemic therapy lines; 98 % had been pretreated with ipilimumab/nivolumab, and 66 % exhibited primary resistance to prior ICI. The objective response rate was 23 %, with a median duration of response of 10 months; disease control rate was 47 %. Median progression-free survival (mPFS) was 4 months and median overall survival (mOS) was 10 months, with 12-month PFS and OS rates of 17 % and 42 %, respectively. Durable disease control beyond six months was observed in 23 % of patients, with mPFS of 21 months. Grade ≥ 3 treatment-related adverse events occurred in 21 % of patients.
CONCLUSIONS: In this real-world cohort, anti-PD-1 plus lenvatinib demonstrated meaningful efficacy in a subset of heavily pretreated patients, predominantly in those with BRAF wild-type melanoma.
METHODS: This retrospective, multicenter DeCOG study included patients with advanced melanoma treated with anti-PD-1 plus lenvatinib after failure of anti-PD-1-based therapy at 11 major skin-cancer centers in Germany and Switzerland between October 2020 and March 2025.
RESULTS: Overall, 120 patients were analyzed (median age 59 years); 70 % were male and 38 % had an ECOG performance status > 1. Most patients had ≥ 3 metastatic sites (69 %), brain metastases (42 %), and elevated LDH (58 %). Median follow-up was 13.4 months. Patients received a median of two prior systemic therapy lines; 98 % had been pretreated with ipilimumab/nivolumab, and 66 % exhibited primary resistance to prior ICI. The objective response rate was 23 %, with a median duration of response of 10 months; disease control rate was 47 %. Median progression-free survival (mPFS) was 4 months and median overall survival (mOS) was 10 months, with 12-month PFS and OS rates of 17 % and 42 %, respectively. Durable disease control beyond six months was observed in 23 % of patients, with mPFS of 21 months. Grade ≥ 3 treatment-related adverse events occurred in 21 % of patients.
CONCLUSIONS: In this real-world cohort, anti-PD-1 plus lenvatinib demonstrated meaningful efficacy in a subset of heavily pretreated patients, predominantly in those with BRAF wild-type melanoma.