LBA68_PR - 5-year survival outcomes of the CheckMate 067 phase III trial of nivolumab plus ipilimumab (NIVO+IPI) combination therapy in advanced melanoma

Results from CheckMate 067 have shown significant improvements in objective response, progression-free survival (PFS), and overall survival (OS) with NIVO+IPI and NIVO alone vs IPI in patients with advanced treatment-naive melanoma. Here we present 5-year outcomes from the study. Eligible patients with previously untreated stage III or IV melanoma (N=945) were randomly assigned 1:1:1 and stratified by programmed death ligand 1 (PD-L1) status, BRAF mutation status, and metastasis stage. Patients received NIVO 1mg/kg + IPI 3mg/kg for 4 doses Q3W followed by NIVO 3mg/kg Q2W (n=314), NIVO 3mg/kg Q2W + placebo (n=316), or IPI 3mg/kg Q3W for 4 doses + placebo (n=315) until progression or unacceptable toxicity. Co-primary endpoints were OS and PFS; the study was not powered to compare the NIVO-containing groups. Descriptive analyses were performed to evaluate efficacy between NIVO+IPI and NIVO, treatment-free status, and health-related quality of life (HRQoL). With a minimum follow-up of 60 months, the NIVO-containing arms continued to show improved OS, PFS, and response vs IPI (table). In addition, descriptive analyses showed longer OS with NIVO+IPI (median OS, > 60.0mo [not reached]) than with NIVO alone (median OS, 36.9mo), as well as a higher proportion of patients alive and treatment-free with the combination. No sustained deterioration of HRQoL (EQ-5D-3L utility index) was observed during treatment or following treatment discontinuation with NIVO or NIVO+IPI.TableLBA68_PRTableNIVO+IPINIVOIPI(n=314)(n=316)(n=315)Objective response rate, % (95% CI)58 (53–64)45 (39–50)19 (15–24)Median duration of response, mo (95% CI)NRaNR (50.4–NR)14.4 (8.3–53.6)Median PFS, mo (95% CI)11.5 (8.7–19.3)6.9 (5.1–10.2)2.9 (2.8–3.2)5-year PFS rate, % (95% CI)36 (31–42)29 (24–35)8 (5–12)Median OS, mo (95% CI)NRb (38.2–NR)36.9 (28.2–58.7)19.9 (16.8–24.6)5-year OS rate, % (95% CI)52 (46–57)44 (39–50)26 (22–31)BRAF mutant60 (50–69)46 (36–56)30 (21–39)BRAF wild-type48 (41–54)43 (37–50)25 (19–31)PD-L1 < 5%51 (44–57)43 (36–50)24 (18–30)PD-L1 ≥ 5%57 (44–68)51 (40–62)33 (23–44)Median time from randomization to subsequent systemic therapy, mo (95% CI)NR (59.6–NR)25.2 (16.0–43.2)8.0 (6.5–8.7)Patients alive and free from subsequent therapy, n/N (%)112/151 (74)75/130 (58)30/67 (45)NR, not reached.aAlthough a median was reported at the previous analysis, that estimate was immature and greater than the minimum study follow-up.b> 60.0mo. This 5-year analysis represents the longest phase III follow