New two-year data from Biogen Idec’s Phase 3 trial for peginterferon beta-1a presented at AAN annual meeting

May 5 2014

New two-year data from the Phase 3 ADVANCE clinical trial for peginterferon beta-1a in adults with relapsing forms of multiple sclerosis (RMS) has been presented at the 66th American Academy of Neurology (AAN) annual meeting.

The data indicated that peginterferon beta-1a dosed once every two weeks demonstrated favourable results on relapse rates, magnetic resonance imaging (MRI) findings and disease progression. Over two years, the safety profile of peginterferon beta-1a was consistent with other multiple sclerosis (MS) interferon therapies.

“The two-year data from ADVANCE further establish the efficacy and safety profile of peginterferon beta-1a demonstrated in the first year of the pivotal trial,” said Terry O’Regan, Vice President and Managing Director at Biogen Idec. “If approved, we believe that peginterferon beta-1a dosed once every two weeks will provide MS patients with one of the most significant developments in the interferon class in over a decade.”

ADVANCE was a two-year, Phase 3, placebo-controlled (in year one) study that evaluated the efficacy and safety profile of peginterferon beta-1a administered subcutaneously. The analysis for all primary and secondary efficacy endpoints occurred at the end of year one. After the first year, patients on placebo received peginterferon beta-1a for the duration of the study.

New Analysis of ADVANCE Data Showed Peginterferon Beta-1a Benefits Maintained Over Two Years
A new analysis of data from the second year of ADVANCE presented at AAN demonstrated:

• The efficacy of peginterferon beta-1a dosed once every two weeks was maintained throughout year two. Relative to year one, the annualised relapse rate (ARR) was further reduced and the number of new or newly-enlarging T2 lesions was numerically lower in year two

• The safety and tolerability profile of peginterferon beta-1a was consistent between years one and two

These data were presented in a platform presentation on Tuesday, April 29 at 2:00 p.m. EDT:

• Analysis of 2-year Clinical Efficacy and Safety of Peginterferon Beta-1a in Patients with Relapsing-Remitting Multiple Sclerosis: Data from the Pivotal Phase 3 ADVANCE Study (S4.005)

“ADVANCE provides us with insight about the efficacy and safety profile of peginterferon beta-1a and its every two-week dosing schedule,” said Dr Chris McGuigan, Consultant Neurologist, St. Vincent's University Hospital, Dublin “The reduced dosing regimen of this investigational treatment could be an attractive option for many adults with relapsing forms of MS.”

“The UK, and particularly Scotland, has one of the highest prevalence rates of MS in the world and we are continually seeking effective treatment options to provide our patients.  Efficacy alone is not our sole consideration and we have to consider the lifestyle of patients when prescribing disease-modifying therapies to achieve the best adherence. Peginterferon beta-1a is showing promising signs that adult MS patients may soon have another treatment option,” said Mhairi Coutts, MS Specialist Nurse, The Red Deer Centre, Scotland.

Additional Year-One Analyses Affirmed Efficacy of Peginterferon Beta-1a
Two new post-hoc analyses from year one of the ADVANCE study were also presented at the AAN annual meeting:

• The first analysis showed that peginterferon beta-1a increased the proportion of patients with RMS who achieved freedom from measured disease activity (FMDA), defined as no relapses, no disability progression, no Gd+ lesions and no new or newly enlarging T2-hyperintense lesions compared to baseline

Results show the proportion of patients with overall-, clinical- and MRI-FMDA were significantly higher with peginterferon beta-1a dosed once every two weeks compared to placebo

• A second analysis showed treatment with peginterferon beta-1a was associated with improved recovery from relapses compared to placebo (as measured by the proportion of patients with a relapse associated with sustained disability progression)

The first analysis was presented in a platform presentation on Tuesday, April 29 at 2:30 p.m. EDT:

• Peginterferon Beta-1a Significantly Increases the Proportion of Patients with Freedom from Measured Disease Activity in Relapsing-Remitting Multiple Sclerosis: Findings from the ADVANCE Study (S4.007)

The second analysis was presented in a platform presentation on Tuesday, April 29 at 1:30 p.m. EDT, followed by a poster presentation today at 4:30 p.m. EDT:

• Peginterferon Beta-1a May Improve Recovery Following Relapses: Data from the Pivotal Phase 3 ADVANCE Study in Patients with Relapsing-Remitting Multiple Sclerosis – Platform (S4.003); Poster (I7-1.002)