1. The 6.5-year progression-free survival for the nivolumab combination group, nivolumab group and in the ipilimumab group were 34%, 29% and 7%, respectively.
2. There were no new safety signals that were identified since the 5-year analysis.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Patients with advanced melanoma have improved survival outcomes from immune checkpoint inhibitors and BRAF- and MEK-targeted therapies. Previous phase II CheckMate 069 and phase III CheckMate 067 trials established nivolumab and ipilimumab as a standard care option for patients with metastatic melanoma. The 5-year follow-up overall survival (OS) rate from the phase III CheckMate 067 study was 52% for the nivolumab plus ipilimumab group, 44% for nivolumab and 26% for those receiving ipilimumab. To explore long-term outcomes beyond the 5 years follow-up period, this study aimed to evaluate the 6.5-year efficacy and safety outcomes from the CheckMate 067 study. Both efficacy primary end points (progression-free survival (PFS) and overall survival (OS)) were longer in the nivolumab combination compared to the monotherapy group at the 77 months minimum follow-up. The 6.5-year PFS rates for the nivolumab combination group, nivolumab monotherapy group and in the ipilimumab group were 34%, 29% and 7%, respectively. The median OS for the nivolumab combination group, nivolumab monotherapy group and in the ipilimumab group were 72.1 months, 36.9 months and 19.9 months respectively. There were no new safety signals reported since the last safety analysis cutoff. Overall, this study demonstrated that nivolumab plus ipilimumab or nivolumab alone shows promise in its long-term efficacy and safety profile to treat patients with advanced melanoma.
In-Depth [randomized controlled trial]: Patients were eligible if they had previously untreated, unresectable or metastatic stage III or IV melanoma with known BRAF V600 mutation status. The primary endpoints were progression-free survival (PFS) and overall survival (OS) in the combination or the nivolumab group versus the ipilimumab group. In total, 1296 patients were enrolled in the study between July 2013 to March 2014 and 945 were randomly, equally assigned to each treatment group (314 to combination therapy, 316 to nivolumab, 315 to ipilimumab). The minimum follow-up period for the study was 77 months at the October 2020 data cutoff. The median follow-up for each group were the following: combination (57.5 months), nivolumab (36.0 months) and ipilimumab (18.6 months). The median investigator assessed PFS in the combination group was 11.5 months (95% confidence interval [CI]: 8.7-19.3), 6.9 months (95% CI: 5.1-10.2) in the nivolumab group and 2.9 months (95% CI: 2.8-3.2) in the ipilimumab group. The median OS for the combination group, nivolumab group and in the ipilimumab group were 72.1 months (95% CI: 38.2 to not reached), 36.9 months (95% CI: 28.2-58.7) and 19.9 months (95% CI: 16.8-24.6) respectively. 11 patients (3 in combination, 3 in nivolumab, 2 in ipilimumab therapy) died between the previous 5-year analysis and the current analysis and are considered to be unrelated to the treatment.
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