TY - JOUR
T1 - Efficacy of Ipilimumab and Nivolumab in Patients with Melanoma and Brain Metastases-A Danish Real-World Cohort
AU - Kattenhøj, Karoline Dreyer
AU - Møberg, Christine Louise
AU - Guldbrandt, Louise Mahncke
AU - Friis, Rasmus Blechingberg
AU - Mapendano, Christophe Kamungu
AU - Petersen, Søren Kjær
AU - Ruhlmann, Christina Halgaard Bruvik
AU - Svane, Inge Marie
AU - Donia, Marco
AU - Ellebaek, Eva
AU - Schmidt, Henrik
PY - 2024/7/17
Y1 - 2024/7/17
N2 - Combination immunotherapy using ipilimumab/nivolumab is the golden standard treatment for patients with melanoma and asymptomatic brain metastases (MBM). However, it remains uncertain if real-world patients have the same treatment effects compared to patients enrolled in clinical trials. The aim of this study was to compare clinical benefits between real-world patients and patients enrolled in clinical trials when administering ipilimumab/nivolumab in treatment-naive patients with asymptomatic MBM. Using data from the Danish Metastatic Melanoma Database (DAMMED), 79 patients with clinical parameters similar to the inclusion criteria from two phase II trials, the ABC and the CheckMate-204 trials, were included in the analyses. Thirteen patients (16.5%) achieved complete response (CR) and an overall response rate (ORR) of 46.9%. We found an overall 6-month Progression-Free Survival (PFS) rate of 53.5% and a median PFS of 6.5 months. Median overall survival (mOS) was not reached during the 5-year follow-up. These results were comparable to the phase II trials. In conclusion, clinical benefits from phase II studies were comparable to Danish real-world data regarding OS, PFS, and CR. Confirming that combination immunotherapy can be recommended as first-line treatment for patients with asymptomatic, treatment-naive melanoma brain metastases.
AB - Combination immunotherapy using ipilimumab/nivolumab is the golden standard treatment for patients with melanoma and asymptomatic brain metastases (MBM). However, it remains uncertain if real-world patients have the same treatment effects compared to patients enrolled in clinical trials. The aim of this study was to compare clinical benefits between real-world patients and patients enrolled in clinical trials when administering ipilimumab/nivolumab in treatment-naive patients with asymptomatic MBM. Using data from the Danish Metastatic Melanoma Database (DAMMED), 79 patients with clinical parameters similar to the inclusion criteria from two phase II trials, the ABC and the CheckMate-204 trials, were included in the analyses. Thirteen patients (16.5%) achieved complete response (CR) and an overall response rate (ORR) of 46.9%. We found an overall 6-month Progression-Free Survival (PFS) rate of 53.5% and a median PFS of 6.5 months. Median overall survival (mOS) was not reached during the 5-year follow-up. These results were comparable to the phase II trials. In conclusion, clinical benefits from phase II studies were comparable to Danish real-world data regarding OS, PFS, and CR. Confirming that combination immunotherapy can be recommended as first-line treatment for patients with asymptomatic, treatment-naive melanoma brain metastases.
KW - DAMMED
KW - brain metastases
KW - immunotherapy
KW - ipilimumab
KW - melanoma
KW - nivolumab
U2 - 10.3390/cancers16142559
DO - 10.3390/cancers16142559
M3 - Journal article
C2 - 39061198
SN - 2072-6694
VL - 16
JO - Cancers
JF - Cancers
IS - 14
M1 - 2559
ER -