Within the first two months of treatment, Ocrevus (ocrelizumab) reduced relapses in multiple sclerosis (MS) patients by more than half compared to those on Rebif, and almost completely prevented new brain lesions, according to data underscoring the drug’s rapid effects.
Researchers from San Francisco-based Genentech and its Swiss parent company, Roche, on April 26 presented new analyses of data from Ocrevus clinical trials at the ongoing American Academy of Neurology (AAN) Annual Meeting 2017 in Boston.
Researchers also provided information about the superior effectiveness of Ocrevus, compared to Rebif, in early-stage relapsing patients.
In addition, Genentech and Roche shared news from the open-label extension studies of the three Phase 3 clinical trials that provided the basis for the drug’s approval by the U.S. Food and Drug Administration (FDA).
Rapid and Early
“The rapid effect seen with Ocrevus in clinical trials provides insight into how this newly FDA-approved therapy could change the way MS is treated,” Dr. Stephen Hauser, chair of the scientific steering committee of the OPERA studies, said in a press release.
Several presentations focused on the effects of Ocrevus during the first period of treatment. Analyses of data from the two Phase 3 OPERA trials (NCT01247324 and NCT01412333) showed that patients treated with Ocrevus saw their annualized relapse rate drop by 55 percent after eight weeks, with the risk of relapse at about half of that seen in Rebif-treated patients.
Looking at data from an earlier Phase 2 trial (NCT00676715), Ocrevus was shown to lower the emergence of new active inflammatory lesions and enlarged brain lesions by 62 percent compared to placebo after only four weeks. Between four and eight weeks, Ocrevus-treated patients had 97 percent fewer new brain lesions.
Early effects were also explored from another angle. A subgroup analysis involving 427 early-stage relapsing patients in the OPERA studies showed that 76 percent of those on Ocrevus reached NEDA — no evidence of disease activity in the form of relapses, new or enlarging brain lesions, or disability progression.
In total, 47.6 percent of early relapsing patients on Ocrevus reached NEDA, a similar proportion that seen in the two OPERA groups as a whole.
No progress — less fatigue
Genentech data also showed that among primary progressive patients in the original ORATORIO trial (NCT01194570), those who did progress had higher levels of fatigue. But those who received Ocrevus had numerically lower levels of fatigue. Researchers saw this across various types of fatigue, including physical and psychosocial fatigue.
Among those who did not progress, Ocrevus-treated patients had larger fatigue reductions compared to those on placebo, who did not progress during the study. Researchers therefore conclude that PPMS patients may benefit from Ocrevus treatment, even if they continue progressing.
Extension Study Updates
More than 2,200 patients treated in the original Phase 3 trials have now entered Phase 3 extension trials — one for each original trial. All patients receive Ocrevus in these studies.
Analyses have not identified any new safety concerns in either relapsing or primary progressive patients. Mostly mild or moderate infusion reactions and upper airway infections remained the most common side effects of treatment.
Analyses of data from the two extension studies in relapsing patients showed that those who switched from Rebif to Ocrevus had reduced relapse rates and fewer new brain lesions after switching, and those who received Ocrevus in the previous Phase 3 trial continued to benefit.
“Following the FDA approval of Ocrevus for relapsing or primary progressive forms of MS, it is encouraging to see the medicine’s favorable benefit-risk profile continue to play out in the data,” said Hauser, who also heads the Weill Institute for Neurosciences and chairs the Department of Neurology at the University of California San Francisco.