Belantamab mafodotin vs Ciltacabtagene 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.

NCT03548207 · Phase 1/2 · completed

This was an open-label, single-group study with no randomized comparator and no blinding. Although the overall response rate among treated participants was high (e.g., 97.1% in the Phase 2 US population with 95% CI 89.8-99.6), the lack of a control arm means the results cannot be attributed to the drug with confidence. Uncontrolled single-arm evidence is inherently limited regardless of the response rate observed.