TG Therapeutics (Nasdaq: TGTX) reported that its Phase III ENHANCE trial met its primary endpoint, demonstrating that a consolidated single 600 mg infusion of ublituximab-xiiy (Briumvi) on Day 1 produces bioequivalent drug exposure to the currently approved two-infusion initiation regimen. If successful in gaining US FDA clearance for an expanded label, this would eliminate a mandatory second clinic visit for patients starting the therapy.
The ENHANCE trial is a randomized, double-blind, placebo-controlled, multicenter Phase IIIb study in adults with relapsing forms of multiple sclerosis (RMS). Participants were assigned to either the approved initiation regimen of 150 mg on Day 1 followed by 450 mg on Day 15, or a consolidated 600 mg single infusion on Day 1 with a placebo infusion on Day 15; both arms then continued on the standard approved maintenance schedule. The primary endpoint — overall drug exposure measured by area under the serum concentration-time curve from baseline through Week 16 (AUC₀–Wk16) — was met, with a geometric mean ratio of approximately 1.0 and a 90% confidence interval within the pre-specified bioequivalence bounds of 0.80 to 1.25. Secondary endpoints covering B-cell depletion and MRI outcomes were comparable between arms and consistent with data from the earlier ULTIMATE I and II registration trials. Infusion-related reactions occurred at lower rates than those recorded in the ULTIMATE studies, with no Grade 3 or higher reactions in either arm, and reaction rates were statistically indistinguishable between the two dosing regimens.
Ublituximab is a glycoengineered anti-CD20 monoclonal antibody that deploys enhanced antibody-dependent cellular cytotoxicity through removal of fucose residues from its Fc region, enabling B-cell depletion at lower doses. The IV anti-CD20 class is dominated by Roche's Ocrevus (ocrelizumab), which requires a two-infusion initiation sequence and carries a roughly 3.5-hour infusion time for maintenance doses; ublituximab's approximately one-hour maintenance infusion was its initial commercial differentiator. Novartis's Kesimpta (ofatumumab) addresses the clinic-visit burden differently through monthly subcutaneous self-injection. Cross-trial comparisons are limited by differences in trial design, patient populations, and endpoints, but if the consolidated dosing is approved, TG Therapeutics would hold a distinct label claim as the only IV anti-CD20 therapy initiable with a single infusion. The company is targeting a supplemental BLA submission in the second half of 2026.
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