BRIGHTLINE-1: When a Negative Trial Reveals Two Active Therapies.

Shahnam, Adel; Gounder, Mrinal M · Clin Cancer Res · 2026

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Abstract

Although BRIGHTLINE-1 was headlined as a "negative trial," brigimadlin showed clear biological activity, with median PFS of 8.4 months, ORR of 22.3%, and translational evidence of p53 reactivation. Its failure largely reflects flawed control-arm assumptions, as doxorubicin outperformed retrospective expectations and established a new prospective benchmark in DDLPS.