- Results from a randomized phase 2 study indicate that combined ziv-aflibercept/high-dose interleukin 2 (IL-2) is associated with superior PFS compared with IL-2 alone in patients with inoperable stage III/IV melanoma.
Why this matters
- This trial supports the use of VEGF inhibitors such as ziv-aflibercept to enhance the therapeutic benefits of IL-2.
- Patients treated with combination therapy had improved PFS compared with patients treated with monotherapy (median, 6.9 vs 2.3 months; P=.002).
- The association between combination therapy and improved PFS was observed in patients with high baseline VEGF (8.7 vs 3.1 months; P=.003), low VEGF (6.9 vs 4.0 months; P=.02), high VEGFR2 (10.2 vs 3.9 months; P=.004), and low VEGFR2 (6.1 vs 1.6 months; P=.0002).
- Patients treated with combination therapy and those treated with monotherapy had similar OS (median, 26.9 vs 24.2 months; P=.43).
- Response rates were 22% in patients who received combination therapy and 17% in patients who received monotherapy.
- Adverse events were consistent with the profiles of IL-2 and ziv-aflibercept monotherapy.
- 84 patients with inoperable stage III/IV melanoma, 55 treated with ziv-aflibercept/IL-2 combination therapy, and 29 treated with IL-2-only monotherapy, were analyzed for outcomes.
- Funding: National Cancer Institute/NIH.
- Small patient sample size.