TG Therapeutics Announces Positive Topline Results from Phase 3 ENHANCE Trial
TG Therapeutics announced positive topline results from its Phase 3 ENHANCE trial for BRIUMVI, meeting the primary endpoint of bioequivalence between the current two-infusion initiation regimen and a new single-infusion regimen. The study demonstrated that a single 600 mg infusion on Day 1 provides comparable drug exposure to the current 150 mg Day 1 and 450 mg Day 15 regimen, with a geometric mean ratio of approximately 1.0. Safety profiles were consistent with prior studies, with no new safety signals and fewer infusion-related reactions in the consolidated arm.
Key figures
- Drug Name
- BRIUMVI (ublituximab-xiiy)
- Phase Of Trial
- Phase 3
- Gmr
- 1.0
- Bioequivalence ci
- 0.80 to 1.25
- Consolidated dose
- 600 mg
- Current dose day1
- 150 mg
- Current dose day15
- 450 mg
AI analysis
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