- Randomized, multicenter Phase II study (N = 204): 1st-line carboplatin/paclitaxel + control, concurrent or phased ipilimumab (IPI)
- Phased IPI improved immune-related PFS and PFS vs control (median irPFS 5.7 vs 4.6 mo, median PFS 5.1 vs 4.2 mo)
- Grade 3 and 4 immune-related AEs: 15% vs 6%
The modest level of activity observed in this study was enough to encourage the development of a Phase III trial that is now comparing the best arm (phased or sequential chemotherapy followed by ipilimumab) to chemotherapy alone. Of particular interest is the activity of this combination in patients with squamous cell cancer, for which targeted treatment currently has no role. One issue that must be considered is the need for modest amounts of corticosteroids as premedication for paclitaxel and the potential of these to increase adverse immune effects. One wonders whether nab paclitaxel, which does not require steroids, might therefore be a better choice in future combinations of this type. Perhaps more relevant, currently it is not clear how chemotherapy/ipilimumab will stack up against various other promising immunotherapeutic strategies, including single-agent monoclonal antibodies to PD-1 and PD-L1.
