Abstract No : Abstract: #1076O
Indication : Melanoma
Intervention : Nivolumab
Company : Bristol-Myers Squibb
Technology : PD-1/PD-L1 inhibitor
Results:
At 48 mo of follow-up, NIVO continued to demonstrate superior RFS vs IPI (HR 0.71; 95% CI 0.60–0.86; P = 0.0003; Table). DMFS in pts with stage III disease favored NIVO (HR 0.79; 95% CI 0.63–0.99). At 48 mo, the number of OS events (n = 211) was lower than anticipated (n = 302) and OS rates were comparable: 78% (95% CI 73.7–81.5) with NIVO and 77% (95% CI 72.2–80.3) with IPI (HR 0.87, 95.03% CI 0.66–1.14, P = 0.3148). Subsequent systemic next-line therapy was received by 150 (33%) NIVO-treated pts and 189 (42%) IPI-treated pts; more IPI-treated pts (34% vs 23%) received subsequent systemic immunotherapy (IO). Any-grade late-emergent treatment-related adverse events (TRAEs; reported > 100 d after last dose) were observed in 18 (4%) NIVO-treated pts and 25 (6%) IPI-treated pts, with grade 3/4 in 3 (1%) and 7 (2%), respectively.
Conclusion:
NIVO continued to demonstrate improved RFS and DMFS vs IPI at 48 mo in pts with stage III/IV melanoma at high risk of recurrence. OS events (n = 211) were lower than anticipated (n = 302). OS rates were similar to NIVO and IPI, although use of subsequent IO therapy was higher in the IPI arm. Late-emergent TRAEs were consistent with the established safety profile of NIVO and IPI, with more events reported with IPI.
