#ECTRIMS2016 – Biogen and AbbVie Present New Positive Data on Zinbryta to Treat Relapsing MS

Biogen and AbbVie presented positive new post-hoc analysis from the pivotal DECIDE clinical trial, which showed that a significantly larger number of relapsing multiple sclerosis (RMS) patients treated with Zinbryta (daclizumab) had no evidence of disease activity (NEDA) compared to those treated with Avonex (interferon beta-1a). The data were given at the recent 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in London.

Zinbryta is a E.U.- and U.S. FDA-approved drug developed by Biogen and AbbVie for the treatment of relapsing-remitting multiple sclerosis (RRMS). It consists of a humanized monoclonal antibody that binds to the receptor subunit CD25 of interleukin-2 (IL-2), which is highly expressed in immune T-cells. These immune cells are overly expressed in MS, and Zinbryta is thought to deplete these overly activated cells which, in turn, increases the levels of cells that regulate the immune response (NK cells).

The DECIDE Phase 3 trial compared the clinical efficacy of subcutaneously delivered Zinbryta (every four weeks) and a commonly used intramuscular injection (IM) of Avonex.

Results presented at ECTRIMS showed that, at week 24, significantly more patients treated with Zinbryta (41.5 percent) achieved overall NEDA compared to patients given Avonex (32.6 percent). The difference was more pronounced as treatment continued: from week 24 to week 96, 44.7 percent of the Zinbryta-treated patients achieved NEDA status versus 22.4 percent for patients treated with Avonex.

These results continue to support the positive effect of Zinbryta on NEDA status in MS patients.

“ZINBRYTA is a new, once-monthly, self-administered, subcutaneous treatment option for people living with relapsing forms of MS, including those whose disease activity has been insufficiently controlled by their prior therapy,” Ralph Kern, MD, senior vice president, Worldwide Medical, Biogen, said in a press release. “These data continue to reinforce ZINBRYTA’s robust efficacy in reducing MS relapse rates, disability progression and brain lesion development, and help further define its long-term safety profile. ZINBRYTA is now available in the United States and Germany, and will soon be introduced in additional European countries.”

Early results from a long-term and ongoing extension study, also presented at ECTRIMS, further confirm Zinbryta’s efficacy on clinical measures of MS disease activity, and provide additional data of Zinbryta’s safety profile.

“ZINBRYTA had previously demonstrated significant efficacy in helping patients achieve NEDA status compared to AVONEX at week 96. This new analysis looked at ZINBRYTA’s effectiveness on NEDA both during the first six months and the following 18 months of treatment to take into account the potential impact of pre-existing disease activity, and found the efficacy of ZINBRYTA on NEDA to be more evident at the end of the evaluation period,” said Professor Gavin Giovannoni, Chair of Neurology, Blizard Institute, Barts and The London School of Medicine and Dentistry.

First interim results from this EXTEND Phase 3 study, evaluating the long-term safety and efficacy of Zinbryta in RMS patients who completed the DECIDE, SELECTED or OBSERVE clinical trials, demonstrate that Zinbryta treatment is associated with long-term benefits in patients who continued to be free from MS relapse, and in patients who did not have confirmed disability progression at week 24.

Additional efficacy data on Zinbryta include:

• The annualized relapse rate (ARR) for patients receiving Zinbryta continuously in the DECIDE and EXTEND trials remained stable (0.195 vs. 0.156, respectively).
• In the EXTEND trial, patients switching from Avonex to Zinbryta had an ARR decrease from 0.317  to 0.152.
• In EXTEND, patients had improvements in MRI findings from baseline to week 48.
• In DECIDE, patients who received Zinbryta continuously from baseline up to week 192 had a relative risk reduction of 21 percent in 24-week confirmed disability progression, compared with patients who received Avonex in the DECIDE trial and then switched to Zinbryta in EXTEND.

In EXTEND, Zinbryta’s safety profile was comparable to that observed in DECIDE. Excluding MS relapses, the incidence of serious treatment-related adverse events was stable over time, with the most commonly reported including mild to moderate complications in the liver, skin, infections and lymphadenopathy.

NEDA is defined as the absence of new or enlarging T2 legions or T1 gadolinium-enhancing lesions on MRI and no sustained Expanded Disability Status Scale (EDSS) score progression or clinical relapse. This assessment has garnered increasing attention as a possible means of allowing an earlier and more accurate prognosis, and it has become a common secondary outcome measure in clinical trials for new disease-modifying therapies in MS.