- Results from a phase 2 study suggest that nivolumab monotherapy and combined nivolumab/ipilimumab are feasible neoadjuvant therapies for patients with high-risk resectable melanoma.
Why this matters
- This phase 2 trial supports the feasibility of neoadjuvant immune checkpoint blockers but raises toxicity concerns for combined ipilimumab/nivolumab and suggests a need for further studies.
- Combined ipilimumab/nivolumab with associated with a higher RECIST overall response rate (73% vs 25%) and pathologic complete response rate (45% vs 25%) but also a higher rate of grade 3 treatment-related adverse events (73% vs 8%) compared with nivolumab monotherapy.
- Combined ipilimumab/nivolumab was associated with significantly improved radiologic outcomes (P=.039) but similar PFS (82% at 17.2 months vs 58% at 22.6 months; P=.19) and OS (100% at 24.4 months vs 76% at 22.6 months; P=.18) compared with nivolumab alone.
- 23 patients with high-risk resectable melanoma, 12 who received nivolumab monotherapy and 11 who received combined ipilimumab and nivolumab, were analyzed.
- Funding: Bristol-Myers Squibb; University of Texas MD Anderson Cancer Center Melanoma Moon Shot Program; Parker Institute for Cancer Immunotherapy; US Department of Defense.
- Small patient sample size.