#CMSC16 – Ocrevus (Ocrelizumab) in PPMS Prevented Disability Progression, Lowered MRI Lesion Volume, Study Shows

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Phase 3 study of Ocrevus (ocrelizumab) in PPMS

Data recently presented at the Consortium of Multiple Sclerosis Centers (CMSC) 2016 Annual Meeting showed that Roche/Genentech’s investigational drug ocrelizumab (Ocrevus) lowered the risk of disability progression in primary progressive multiple sclerosis (PPMS), a condition for which no approved treatments exist.

The study was presented during the “Disease Management, Imaging, and Therapeutics” session of the June 1-4 CMSC 2016 meeting in National Harbor, Maryland. The CMSC annual meeting is a highlight among MS researchers and clinicians from around the globe who come to attend world-class symposiums and discuss their data.

Ocrelizumab is an antibody targeting B-cells expressing the CD20 molecule on their cell surface. It is the first drug to receive U.S. FDA Breakthrough Therapy Designation for PPMS — a label that will fast-track the review process of the drug, allowing it to reach patients desperately in need of treatment as soon as possible.

At the meeting, Dr. Jerry Wolinsky, a neurologist at the University of Texas Health McGovern Medical School in Houston, presented data from the clinical trial ORATORIO, comparing ocrelizumab to placebo in patients with PPMS. The study, funded by Roche, was a collaboration between researchers from several institutions.

Wolinsky’s presentation was titled “Ocrelizumab Efficacy in Primary Progressive Multiple Sclerosis Patients in the Presence/Absence of T1 Gadolinium-Enhancing Lesions at Baseline in a Phase 3, Placebo-Controlled Trial.”

In the ORATORIO trial, 732 PPMS patients were randomized so that two patients received ocrelizumab for every patient receiving placebo. Ocrelizumab was administered through two intravenous infusions 14 days apart, every 24 weeks, for at least 120 weeks until a predetermined number of 12-week confirmed disability progression events occurred. All patients in the trial were moderately disabled with Expanded Disability Status Scale (EDSS) scores of 3.0–6.5.

Wolinsky showed that ocrelizumab was able to reduce 12-week confirmed disability progression by 24 percent, and 24-week confirmed disability progression by 25 percent. Also, a significant 29 percent reduction in change in timed 25-foot walk (testing exercise capacity/functionality) from baseline to week 120 was observed.

The drug also significantly reduced T2 lesion volume measured through magnetic resonance imaging (MRI) by 3.4 percent, compared to an increase of 7.4 percent in the placebo group. From week 24 to week 120, a significant reduction (17.5 percent) in the rate of whole brain volume loss was also observed. The presence of T1 gadolinium-enhancing lesions was similar among the two groups, affecting about a quarter of participants at study start.

“Ocrelizumab met the primary and key secondary clinical and MRI endpoints,” Wolinsky said. “Overall, the proportion of patients experiencing AEs [adverse events] and SAEs [serious adverse events] associated with ocrelizumab, including serious infections, was similar to placebo,” an observation that reinforces the concept that ocrelizumab is a safe therapy.

“The benefit-risk profile of ocrelizumab in ORATORIO supports it as a potential therapeutic approach in PPMS,” Wolinsky concluded.

At the CMSC 2016 meeting, Multiple Sclerosis News Today discussed the effectiveness and safety of ocrelizumab and the company’s development plans for the drug with Genentech’s principal medical director of Global Neuroscience Development, Dr. Peter Chin. You can watch the interview by visiting this link.


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