TG Therapeutics ENHANCE Trial Achieves Primary Endpoint
TG Therapeutics announced topline results from the Phase 3 ENHANCE trial, a randomized, double-blind study evaluating a consolidated single infusion regimen for initiation of Briumvi in adults with relapsing forms of multiple sclerosis. The trial met its primary endpoint, demonstrating bioequivalent drug exposure between the currently approved initiation dosing regimen of 150 mg on Day 1 and 450 mg on Day 15 and a consolidated single 600 mg infusion on Day 1, eliminating the need for a Day 15 infusion. Topline outcomes from the ENHANCE Phase 3 study are highlighted below, and full results are expected to be presented at an upcoming medical meeting. The trial met its primary endpoint, demonstrating bioequivalence between the new single Day 1 Briumvi infusion regimen and the currently approved initiation regimen administered on Days 1 and 15. Total drug exposure over 16 weeks was comparable between treatment arms, with a geometric mean ratio of approximately one and a 90% confidence interval within the protocol-defined bioequivalence range of 0.80 to 1.25. Secondary endpoints, including safety, B-cell depletion, and MRI outcomes, were consistent with prior Briumvi clinical studies and comparable between treatment arms through the primary assessment period with no new safety signals observed. Infusion-related reactions in both arms were lower than previously reported in the ULTIMATE I and II approval studies for Briumvi, with no Grade 3 or higher infusion reactions occurring in either arm. In addition, infusion-related reactions were statistically indistinguishable between treatment arms in this study with fewer infusion reactions observed in the consolidated single-infusion treatment arm.