Belantamab mafodotin vs Zevorcabtagene autoleucel

NCT03525678 · Phase 2 · completed

This was a randomized but open-label phase 2 study in which all participants received belantamab mafodotin at one of two doses or formulations; there was no placebo or active comparator arm and no blinding. The primary endpoint was overall response rate by independent review, a clinical response measure, but the results are reported as per-arm rates with confidence intervals and no formal statistical comparison against a control, so the study cannot distinguish drug effect from natural history or placebo effect. The evidence is therefore descriptive phase 2 evidence of activity, not strong comparative evidence.

NCT03975907 · Phase 1/2 · status unknown

This study enrolled every patient into a single treatment group, with no comparison arm and no blinding, so there is no control group to judge the response rate against. Registry results were not posted at the time of grading; the key result shown was recovered from the cited external source.

The registered phase 1 primary endpoint of this study is dose-limiting toxicity; the response rates shown are the phase 2 portion's primary endpoint (overall response rate).