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Positive Results Reported for Ocrelizumab in MS

Genentech releases first data from phase III studies

Ocrelizumab has become the first agent to show positive results in pivotal studies in both relapsing and primary progressive types of multiple sclerosis (MS).

Genentech has provided data from the OPERA I and II trials in relapsing-remitting MS and the ORATORIO study in primary progressive MS that are to be presented in full at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2015 meeting in Barcelona.

The data appear to be very impressive all three trials with regard to efficacy and safety. The chair of the OPERA studies, Stephen Hauser, MD, of the University of California San Francisco School of Medicine, told Medscape Medical News: "These results are a big deal. The efficacy results in relapsing-remitting MS are equivalent to the best effects seen with any other MS drug so far, but unlike the other very effective drugs, ocrelizumab appears to have a much more benign safety profile."

Key results reported from OPERA I and II were:

  • A 46% and 47% reduction in the annual relapse rate compared with interferon beta-1a over the two-year period in OPERA I and OPERA II, respectively (P < 0.0001 and P < 0.0001).
  • A 43% and 37% risk reduction in confirmed disability progression sustained for 12 weeks compared with interferon beta-1a in OPERA I and OPERA II, respectively (P = 0.0139 and P = 0.0169).
  • A 43% and 37% risk reduction in confirmed disability progression sustained for 24 weeks compared with interferon beta-1a in OPERA I and OPERA II, respectively (P = 0.0278 and P = 0.0370).
  • A 94% and 95% reduction in the total number of T1 gadolinium-enhancing lesions compared with interferon beta-1a in OPERA I and OPERA II, respectively (P < 0.0001 and P < 0.0001).
  • A 77% and 83% reduction in the total number of new and/or enlarging hyperintense T2 lesions compared with interferon beta-1a in OPERA I and OPERA II, respectively (P < 0.0001 and P < 0.0001).

Key results from ORATORIO:

  • Ocrelizumab significantly reduced the risk for progression of clinical disability sustained for at least 12 weeks by 24% compared with placebo, as measured by the Expanded Disability Status Scale (P = 0.0321).
  • Additionally, ocrelizumab was superior to placebo in significantly reducing the risk for progression of clinical disability for at least 24 weeks by 25% (P = 0.0365) and the time required to walk 25 feet by 29% (P = 0.0404).
  • Ocrelizumab decreased the volume of hyperintense T2 lesions by 3.4% over 120 weeks compared with placebo, which increased T2 volume by 7.4% (P < 0.0001). Ocrelizumab reduced the rate of whole brain volume loss over 120 weeks by 17.5% compared with placebo (P = 0.0206). 
  • Overall, the proportion of patients in the ocrelizumab group with adverse events was similar to that in the placebo group (95.1% versus 90.0%, respectively); the most common adverse event associated with ocrelizumab was infusion-related reactions (39.9% versus 25.5% for placebo).
  • The proportion of patients in the ocrelizumab group with serious adverse events, including serious infections, was also similar to that in placebo recipients (20.4% versus 22.2%, respectively).

Source: Medscape, October 8, 2015; Genentech, October 8, 2015.

 

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