Roche’s Ocrevus is trying to protect its lead in multiple sclerosis, and adding more longer-term data seems like a legitimate tactic that never grows old against newcomers.
Starting Ocrevus early has its benefits, Roche says. In relapsing multiple sclerosis, treatment with Ocrevus over seven and a half years reduced the risk of a patient’s need for a walking aid by 35% compared with initiation two years later, according to data unveiled at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual congress.
The new analysis comes as other MS players aim for a bigger portion of the market by piling on additional data for their recently approved offerings, including Bristol Myers Squibb’s Zeposia and Johnson & Johnson’s rival S1P modulator Ponvory.
The Ocrevus data came from the open-label extension stage of two phase 3 trials. In the extensions, patients either continued to receive Ocrevus or switched from the old school interferon beta-1a treatment to the Roche antibody drug after a 96-week blinded period.
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In addition to the disability measure, Ocrevus also showed it could quickly reduce MS relapses and maintain the effect through a long period of time. Before switching to the Roche drug, patients on interferon beta treatment had an average of 0.2 relapses per year. The rate dropped to 0.1 after one year of Ocrevus treatment and stood at 0.03 after five and a half years in the open-label period. In Ocrevus continuers, the annualized relapse rate was 0.03 at the longer-term analysis.
Among patients with the less common, primary-progressive form of MS (PPMS), Ocrevus also demonstrated sustained ability to slow disability progression when used early. Compared with switching to Ocrevus after at least 120 weeks on a dummy drug, earlier intervention with Ocrevus led to a 29% reduction in confirmed disability progression lasting for at least 48 weeks among PPMS patients over eight years. The data came from the phase 3 Oratorio trial.
Ocrevus has established itself as a leading MS drug thanks to its strong efficacy and less frequent, twice-a-year dosing schedule. But adoption took a hit during the pandemic amid concerns that its anti-CD20, B cell-blocking mechanism could compromise a patient’s immune defenses against the novel coronavirus.
Several recent studies have linked Ocrevus to lower antibody response compared with other non-CD20 drugs in MS patients who got COVID-19. Similar fears have suggested a potential reduced response to a COVID-19 vaccine. A recent Penn Medicine study found that MS patients receiving an anti-CD20 drug may still launch a robust T-cell response to mRNA COVID-19 vaccines despite an inferior antibody response. The researchers argue that it’s still worthwhile for these patients to receive a COVID shot to prevent severe illness.
RELATED: J&J nabs FDA nod for Ponvory, joining Novartis, Bristol Myers in crowded MS market
Also at ECTRIMS, Bristol Myers released more data for Zeposia in relapsing forms of MS. In the long-term Daybreak study, which rolled over patients from three earlier trials, Zeposia reached an annualized relapse rate of 0.1 among 2,494 patients with relapsing MS. The patients had received the daily oral BMS drug for an average 46.8 months in the open-label extension study by the data cutoff.
Novartis is also presenting COVID-related data for its rival anti-CD20 drug Kesimpta at ECTRIMS 2021.
Despite an initial blunt during the early days of COVID, Ocrevus uptake appears to be on the recovery, with sales up 23% year over year to CHF 2.44 billion ($2.64 billion) in the first half of the year.