TG Therapeutics publishes five-year Briumvi comparison study

TG Therapeutics, Inc. (NASDAQ: TGTX) announced the publication of a five-year matching-adjusted indirect comparison (MAIC) analyzing outcomes of its multiple sclerosis drug Briumvi (ublituximab-xiiy) against ocrelizumab and ofatumumab in patients with relapsing multiple sclerosis (RMS).

The study, published in Multiple Sclerosis and Related Disorders, used individual patient data from 545 participants in the Phase 3 ULTIMATE I and II trials and compared outcomes against published aggregate data from the Phase 3 OPERA I/II trials of ocrelizumab and ASCLEPIOS I/II trials of ofatumumab.

According to the analysis, Briumvi was associated with a 44% lower relative hazard of 24-week confirmed disability progression versus ocrelizumab (HR 0.560; 95% CI: 0.380–0.826) and a 49% lower relative hazard versus ofatumumab (HR 0.509; 95% CI: 0.350–0.741). Estimated cumulative disability progression rates at 240 weeks were 9.3% for Briumvi versus 16.1% for ocrelizumab, and 9.4% versus 17.9% for ofatumumab.

Briumvi was also associated with more time free from confirmed disability progression, averaging 8.1 additional weeks compared with ocrelizumab and 13.1 additional weeks compared with ofatumumab. Annualized relapse rates for Briumvi declined from 0.118 in year one to 0.032 in year five in the ocrelizumab comparison, and from 0.116 to 0.030 in the ofatumumab comparison.

The authors note the findings are exploratory and carry inherent limitations, as the methodology cannot adjust for unmeasured differences between trials and residual confounding cannot be excluded. The findings require confirmation through direct comparative studies or real-world evidence.

The study was funded by Neuraxpharm, TG Therapeutics' European commercialization partner for Briumvi.

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