TG Therapeutics’ Phase 3 ENHANCE Trial Shows Bioequivalence for Single 600 mg Infusion
TGTX•TG Therapeutics’ Phase 3 ENHANCE trial demonstrated bioequivalent overall exposure (AUC0–Wk16 GMR≈1.0 within 0.80–1.25) for a single 600 mg Day 1 infusion of BRIUMVI versus the approved 150 mg/Day 1 and 450 mg/Day 15 regimen. Safety and infusion-related reactions matched established profiles, with supplemental BLA planned for 2H 2026.
1. Trial Design and Objectives
The Phase 3 ENHANCE trial randomized RMS patients to either the approved BRIUMVI initiation regimen of 150 mg on Day 1 plus 450 mg on Day 15 or a single 600 mg infusion on Day 1, measuring overall drug exposure (AUC0–Wk16) and secondary safety, pharmacodynamic, and MRI endpoints.
2. Topline Efficacy and Safety Results
The study achieved bioequivalent overall exposure with a geometric mean ratio of approximately 1.0 (90% CI within 0.80–1.25) between regimens. Infusion-related reactions were lower than prior studies, B-cell depletion and MRI outcomes aligned with historical data, and no new Grade 3+ safety signals were observed.
3. Regulatory Path and Commercial Impact
TG Therapeutics plans to submit a supplemental biologics license application in the second half of 2026 to seek approval of the single-infusion regimen. If approved, BRIUMVI would become the first IV anti-CD20 therapy initiated with one infusion, potentially reducing scheduling burdens and accelerating treatment initiation.
