Abstract 1087P
Background
Anti-programmed cell death-1 antibodies (anti-PD-1) has become a standard treatment option for melanoma patients. Unfortunately, there are no clinical data on the efficacy of anti-PD-1 at fixed-doses in routine practice.
Methods
Consecutive patients treated with nivolumab (N) or pembrolizumab (P) for inoperable and metastatic melanoma in comprehensive cancer centers between 2016 and 2020 were enrolled in the study. The initial anti-PD-1 dose in mg/kg was calculated in patients. Baseline factors together with the initial dose anti-PD-1 were evaluated to identify predictors of progression-free (PFS) and overall (OS) survival. PFS and OS were assessed using Kaplan–Meier and Cox models. The Chi Square statistic was used for testing relationships between categorical variables.
Results
Overall, 1053 patients were included in the present analysis (N=590, P=463). In N group there were no differences in OS and PFS between the group 240 mg Q2W vs. 480 mg Q4W and in OS between the group that received the first dose of N ≤ 3 vs. > 3 mg/kg or treatment Q2W vs. Q4W. However, in univariate analysis there were statistically significant differences in PFS between the group that received the first dose of N ≤ 3 vs. > 3 mg/kg (p=0.0002, HR=1.6, Cl 95% 1.2-2.0) or treatment Q2W vs. Q4W (p=0.0023, HR=1.4, Cl 95% 1.1-1.8), this was not confirmed in the multivariate analysis. The first dose of N < 3 vs. ≥ 3mg/kg correlated with response to treatment (RR) and disease control rate (DCR) (p=0.03 and p=0.0132, respectively) but not correlated with the occurrence of immune related adverse events (irAEs). Treatment Q2W vs. Q4W and 240 mg Q2W vs. 480 mg Q4W were not correlated with RR and DCR, however there were correlated with the occurrence of irAE (p=0.0025 and p=0.0047, respectively). In P group there were no significant differences in OS and PFS between the group that received the first dose of P ≤ 2 and >2 mg/kg, treatment Q3W vs. Q6W and 200 mg Q3W vs. 400 mg Q6W. There were also no correlation with RR and DCR however, there was correlation with the occurrence of irAEs.
Conclusions
Anti-PD-1 dosing had no effect on OS and PFS in the study population. However, a correlation of dosing with the occurrence of irAE was demonstrated, but this requires confirmation in further studies.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding
Disclosure
B. Cybulska-Stopa: Financial Interests, Personal, Invited Speaker: BMS, Novartis, Roche, Pierre Fabre, MSD; Financial Interests, , Sponsor/Funding: Pierre Fabre, Astellas, BMS. A.M. Czarnecka: Financial Interests, Personal, Invited Speaker: BMS, Novartis, Roche, Pierre Fabre, MSD; Financial Interests, Personal, Sponsor/Funding: BMS, Novartis, Roche, Pierre Fabre, MSD. K. Ostaszewski: Financial Interests, Personal, Sponsor/Funding: BMS. M. Ziętek: Financial Interests, Personal, Invited Speaker: BMS, Novartis, Roche, Pierre Fabre, MSD. L. Galus: Financial Interests, Personal, Invited Speaker: Roche, Merk, Astellas. J. Calik: Financial Interests, Personal, Invited Speaker: BMS, Novartis, Roche, Pierre Fabre, and MSD. J. Seredyńska: Financial Interests, Personal, Invited Speaker: Pfizer, Roche, Amgen, Sandoz, Lilly, Roche, Novartis, . P. Rogala: Financial Interests, , Invited Speaker: BMS, Novartis, Roche, Pierre Fabre, MSD. G. Kamińska-Winciorek: Financial Interests, Personal, Invited Speaker: Takeda, Novartis, Pierre Fabre , Recordati ; Financial Interests, , Sponsor/Funding: Novartis, Takeda . T. Kubiatowski: Financial Interests, Personal, Invited Speaker: Bristol-Myers Squibb, Novartis, Roche, and Merck. R. Suwinski: Financial Interests, Personal, Invited Speaker: BMS, MSD, Astellas Pharma. J. Mackiewicz: Financial Interests, Personal, Invited Speaker: BMS, Novartis, Roche, Pierre Fabre, MSD; Financial Interests, Personal, Advisory Board: BMS, MSD. P. Rutkowski: Financial Interests, Personal, Invited Speaker: BMS, Novartis, Roche, Pierre Fabre, MSD, Merk, Sanofifi; Financial Interests, Personal, Advisory Board: BMS, Novartis, Roche, Pierre Fabre, MSD, Merk, Sanofi. All other authors have declared no conflicts of interest.