Novartis reports positive top-line data from Phase IIIb Gilenya trial

12th October 2018 (Last Updated October 12th, 2018 00:00)

Novartis has reported positive top-line results from the Phase IIIb ASSESS trial that examines the efficacy and safety of Gilenya (fingolimod) in comparison with Copaxone (glatiramer acetate) for the treatment of patients with relapsing remitting multiple sclerosis (RRMS).

Novartis reports positive top-line data from Phase IIIb Gilenya trial
Photomicrograph of a demyelinating multiple sclerosis lesion. Credit: Marvin 101.

Novartis has reported positive top-line results from the Phase IIIb ASSESS trial that examines the efficacy and safety of Gilenya (fingolimod) in comparison with Copaxone (glatiramer acetate) for the treatment of patients with relapsing remitting multiple sclerosis (RRMS).

During the randomised, rater-blinded and dose-blinded trial, patients received a once-daily dose of Gilenya at 0.5mg and 0.25mg, and subcutaneous injections of Copaxone 20mg.

The results demonstrated that Gilenya at 0.5mg met its primary objective of significantly reducing the annualised relapse rate (ARR) over Copaxone.

Compared to Copaxone, patients treated with Gilenya at 0.5mg experienced a 40.7% relative reduction in the rate of relapses over a period of one year.

Additional initial data also revealed that adult patients receiving Gilenya at 0.25mg achieved a numerical risk reduction in relapses compared to Copaxone, but unable to reach statistical significance.

"Head-to-head trials, such as ASSESS, are extremely important to help clinicians better understand the relative efficacy and safety of MS therapies, thereby making better-informed treatment decisions."

The safety of Gilenya across both doses was found to be consistent with the known safety profile of the drug, while patients in the Copaxone group reported more discontinuations due to adverse events and unsatisfactory treatment effects.

ASSESS trial principal study investigator Bruce Cree said: “ASSESS is the first controlled head-to-head study of a MS disease-modifying therapy versus Copaxone to show superior efficacy in reducing relapses, a key measure of disease activity and a significant burden for patients.

“Head-to-head trials, such as ASSESS, are extremely important to help clinicians better understand the relative efficacy and safety of MS therapies, thereby making better-informed treatment decisions.”

Novartis is expected to complete full analyses of the ASSESS data and plans to provide the full report to upcoming medical meetings and for other publication.

The ASSESS trial, which was initiated in 2012, enrolled a total of 1,064 patients, with 352, 370 and 342 of them randomised in the Gilenya 0.5mg, Gilenya 0.25mg and Copaxone 20mg arms, respectively.