Genentech studies fenebrutinib Part III outcomes for PPMS
Roche’s Genentech has reported new information from the Part III FENtrepid trial of fenebrutinib, an investigational Bruton’s tyrosine kinase inhibitor, for the therapy of main progressive a number of sclerosis (PPMS).
The Part III research met its main endpoint and demonstrated non-inferiority to Ocrevus in lowering incapacity development in PPMS sufferers.
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Extra data
It additionally confirmed that fenebrutinib decreased the chance of incapacity development by 12% in opposition to Ocrevus, which is presently the one accepted therapy for PPMS.
This was measured by time to onset of the 12-week composite confirmed incapacity development (cCDP12), with a danger ratio of 0.88. The curves separated as early as 24 weeks and a constant impact was noticed throughout affected person subgroups and all through the therapy interval.
The cCDP12 endpoint used three parts: the timed 25-foot stroll (T25FW) for gait velocity, the nine-hole peg check (9HPT) for higher extremity perform, and the prolonged incapacity standing scale (EDSS) for practical incapacity.
Essentially the most pronounced profit was noticed with the 9HPT, with fenebrutinib lowering the chance of worsening by 26% in comparison with Ocrevus.
A submit hoc evaluation confirmed fenebrutinib to be superior to Ocrevus on a composite endpoint combining EDSS and 9HPT, with a 22% decrease danger.
Negative effects had been comparable between the teams: nausea, bleeding and infections. Transient elevations in liver enzymes occurred extra regularly with fenebrutinib and resolved upon discontinuation of therapy.
Severe adversarial occasions occurred in 19.1% of fenebrutinib sufferers versus 18.9% with Ocrevus, resulting in discontinuation charges of 4.3% and three.0%, respectively. Deadly instances had been noticed in 1.4% of sufferers with fenebrutinib and in 0.2% of sufferers with Ocrevus; none had been attributed to therapy.
Upon completion of the FENhance 1 research, information from all Part III research shall be submitted to regulatory authorities.
Levi Garraway, Roche’s Chief Medical Officer and head of worldwide product improvement, stated: “Fenebrutinib represents the primary potential scientific breakthrough for the PPMS group in additional than a decade, demonstrating a significant scientific profit in lowering incapacity development in a trial versus the one accepted therapy in PPMS.
“We stay up for advancing our submission to regulators following the upcoming readout of our second pivotal RMS research, FENhance 1.”
In June 2025, Roche and Genentech introduced outcomes from the randomized, multicenter, worldwide Part III SUNMO trial for individuals with relapsed or refractory LBCL who are usually not eligible for transplantation.
