OCTAVA was an international, multi-center, randomized, double-blind, phase III study evaluating the fixed-dose combination of nurulimab (anti-CTLA-4) and prolgolimab (anti-PD-1) (BCD-217, Nuru+Prolgo) followed by prolgolimab maintenance versus prolgolimab monotherapy as first-line treatment for unresectable or metastatic melanoma (un/mM). We present the primary analysis results.
Methods:Treatment-naïve patients with un/mM were randomized 1:1 to Nuru+Prolgo (n = 135) or prolgolimab (n = 136) for 4 cycles, followed by prolgolimab maintenance for up to two years. The primary endpoint was progression-free survival (PFS) by iRECIST.
Results:With a median follow-up of 15.8 months, median PFS was significantly longer with nurulimab+prolgolimab [15.4 months (95 % CI, 10.3-ND)] compared to prolgolimab monotherapy [10.8 months (4.7-ND)] (HR 0.68; 95 % CI, 0.482-0.957; iRECIST). RECIST 1.1 analysis confirmed this benefit (mPFS 9.9 vs 2.8 months). ORR and DCR were also higher in the combination arm. Grade 3-4 treatment-related AE: 16.3 % (combination) vs 14.0 % (monotherapy). Immune-related AEs (irAE): 52.6 % vs 32.4 % (p = 0.0007); Gr. ≥ 3 irAE: 13.3 % vs 5.9 % (p = 0.04). Discontinuations due to AE: 9.6 % vs 4.4 %.