Early versus late response to PD-1-based immunotherapy in metastatic melanoma.
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Lodde Georg C, Zhao Fang, Herbst Rudolf, Terheyden Patrick, Utikal Jochen, Pföhler Claudia, Ulrich Jens, Kreuter Alexander, Mohr Peter, Gutzmer Ralf, Meier Friedegund, Dippel Edgar, Weichenthal Michael, Jansen Philipp, Kowall Bernd, Galetzka Wolfgang, Hörst Fabian, Kleesiek Jens, Hellwig Birte, Rahnenführer Jörg, Rajcsanyi Luisa, Peters Triinu, Hinney Anke, Placke Jan-Malte, Sucker Antje, Paschen Annette, Becker Jürgen C, Livingstone Elisabeth, Zimmer Lisa, Tasdogan Alpaslan, Roesch Alexander, Hadaschik Eva, Schadendorf Dirk, Griewank Klaus, Ugurel Selma
Аннотация
METHODS: Patients who received PD-1-based immunotherapy for non-resectable stage-IV melanoma in any therapy line were selected from the prospective multicenter real-world DeCOG study ADOREG-TRIM (NCT05750511). Patients showing complete (CR) or partial (PR) response already during the first 3 months of treatment (Early Responders, EarlyR) were compared to patients showing CR/PR at a later time (Late Responders, LateR), a stable disease (SD) and to patients showing progressive disease (Non-Responders, NonR).
RESULTS: Of 522 patients, 8.2 % were EarlyR (n = 43), 19.0 % were LateR (n = 99), 37.0 % had a SD (n = 193) and 35.8 % were NonR (n = 187). EarlyR, LateR and SD patients had comparable baseline characteristics. Multivariate logbinomial regression analyses adjusted for age and sex revealed positive tumor PD-L1 (RR=1.99, 95 %-CI=1.14-3.46, p = 0.015), and normal serum CRP (RR=1.59, 95 %-CI=0.93-2.70, p = 0.036) as independently associated with the achievement of an early response compared to NonR. The median progression-free and overall survival was 46.0 months (95 % CI 19.1; NR) and 47.8 months (95 %-CI 36.9; NR) for EarlyR, NR (95 %-CI NR; NR) for LateR, 8.1 months (7.0; 10.4) and 35.4 months (29.2; NR) for SD, and 2.0 months (95 %-CI 1.9; 2.1) and 6.1 months (95 %-CI 4.6; 8.8) for NonR patients.
CONCLUSION: Less than 10 % of metastatic melanoma patients achieved an early response during the first 3 months of PD-1-based immunotherapy. Early responders were not superior to late responders in terms of response durability and survival.