Positive Phase III Results for Peginterferon in Multiple Sclerosis
Regulatory submission expected this year (Jan. 24)
In a pivotal phase III trial, peginterferon beta-1a (Biogen Idec) has shown promise as a potential treatment dosed every 2 or 4 weeks for relapsing-remitting multiple sclerosis (RRMS). Peginterferon beta-1a is a new molecular entity in which interferon beta-1a is pegylated to extend its half-life and to prolong its exposure in the body, allowing a less frequent dosing schedule. Pegylation is the process of covalent attachment of polyethylene glycol (PEG) polymer chains to another molecule, normally a drug or a therapeutic protein.
The phase III ADVANCE trial was designed to evaluate the efficacy, safety, and tolerability of peginterferon beta-1a 125 mcg compared with placebo in more than 1,500 patients with RRMS. The study’s primary endpoint — the annualized relapse rate (ARR) at 1 year — was met for both the 2-week and 4-week dose regimens. Peginterferon beta-1a also met the secondary endpoints of the risk of 12-week confirmed disability progression, the proportion of patients who relapsed, and magnetic resonance imaging (MRI) assessments for both regimens.
At 1 year, the ARR reduction with the 2-week dosing regimen was 35.6% (P < 0.001) compared with placebo, and the reduction with the 4-week regimen was 27.5% (P < 0.02).
Peginterferon beta-1a also met all of the trial’s secondary endpoints compared with placebo for both dosing regimens:
- Peginterferon beta-1a reduced the risk of 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38% in both dosing arms (P < 0.04).
- Peginterferon beta-1a reduced the proportion of patients who relapsed by 39% in the 2-week dosing arm (P < 0.001) and by 26% in the 4-week dosing arm (P < 0.03).
- Peginterferon beta-1a reduced the number of new or newly enlarging T2-hyperintense lesions on brain MRI scans by 67% in the 2-week dosing arm (P < 0.001) and by 28% in the 4-week dosing arm (P < 0.001).
Regulatory submission in the U.S. is expected this year.
Source: Biogen Idec; January 24, 2013.