Is S1800A data sufficient to adopt ramucirumab + pembrolizumab in your clinical practice immediately, or is phase 3 data needed?
The control arms in S1800A were docetaxel + Ram (67%) but the other 33% received single-agent docetaxel, gemcitabine, etc. The primary endpoint was overall survival which was reached, but for what it was worth no difference in PFS. In my opinion, it is possible that the modest survival benefit with ...
The overall survival benefit seen in S1800A was significant in the phase II trial and may be appropriate for some patients. A phase 3 confirmatory trial would ideally be done.
Personally, while I think these data are compelling, I do not think it will lead me to adopt this regimen immediately. My slight bias in this direction could be changed by three things: (1) read-out of several ongoing trials testing ICI-VEGF combinations in NSCLC in various settings; (2) a trial com...
As the S1800A authors note, the small sample size for this randomized phase II study limits its interpretability in a real-world population. Beyond the post-hoc insights into subgroups that may be more or less likely to benefit that can be gleaned from a phase III study, the phase II results, while ...
In my view, the data seem compelling though, I feel that a phase III trial is needed to confirm the benefit observed in the phase II trial. If ramucirumab + pembrolizumab is available for clinical use, I would discuss the regimen with patients who I think may benefit from the treatment.