Looking to cement its lead in packed MS market, Roche's Ocrevus uncorks new data in early-stage patients
Among a positively jam-packed multiple sclerosis market, Roche’s Ocrevus has managed to stand out for what the Swiss drugmaker is calling the most successful launch in its long history. But in order to press its advantage, Ocrevus is looking to earlier-stage patients, and new interim data should help build its case there.
After 48 weeks on Roche’s Ocrevus, 85% of newly diagnosed primary progressing or relapsing MS patients without a history of disease modifying therapy posted no disease activity, including disease progression or relapse, according to interim data set to be presented this weekend at the virtual American Academy of Neurology meeting.
In the open-label Phase IIIb ENSEMBLE study, Ocrevus, a CD20 targeting monoclonal antibody, cut patients’ average annualized relapse rate to 0.005 and showed consistent benefit in targeted biomarkers. Ocrevus cut neurofilament light chain — a biomarker for neuron function — to “nearly healthy levels” after nearly a year of treatment.
The newest data were part of a three-part rollout at AAN for Roche, which also released post hoc data for Ocrevus in reducing tumor lesions in primary progressing MS and a two-year study on liability claims.
Ocrevus is one of the best selling MS drugs in the world, raking in $4.68 billion in sales in 2020 at a 24% year-over-year growth clip. But plenty of competitors are aiming for the throne, including a small biotech chasing the same CD20 B cell target as Roche’s drug.
Back in December, TG Therapeutics rolled out data showing its ublituximab led to reductions of around 60% and 50% in annualized relapse rate compared to Sanofi’s Aubagio in a pair of Phase III trials (p<0.005). In each of the studies, the ARR is less than 0.10. TG said the data were good enough to spur an FDA submission at some point in the middle of 2021.
Aubagio, or teriflunomide, is an 8-year-old drug that’s often used as a benchmark in these trials. Novartis got the green light for its blockbuster-to-be Kesimpta after demonstrating a significant reduction in ARR of 51% and 59% over the active control arm in a pair of trials. J&J’s ponesimod, meanwhile, met the primary endpoint by hitting an ARR of just 20% compared to 29% for Aubagio, translating to a reduction of 30.5%.
If approved, ublituximab would come with the added benefit of a twice-yearly, one-hour infusion schedule. That’s a big convenience step up from Ocrevus, which is also administered twice a year but requires 2.5 hours to infuse.