Celgene's Ozanimod Versus Biogen's Avonex: Celgene Has the Edge


Celgene Corporation presented data at the 34th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS) held in Berlin, Germany with results from two Phase III trials.

The company released post hoc analyses of data from the Phase III SUNBEAM and RADIANCE Part B trials. They evaluated the efficacy and safety of Celgene’s drug ozanimod compared to Biogen’s Avonex (interferon beta-1a) in patients with relapsing multiple sclerosis (RMS).

“Slowed cognitive processing, which is common in multiple sclerosis, often impairs quality of life for people living with this chronic condition,” said Bruce Cree, professor of Neurology at the University of California, San Francisco (UCSF) Weill Institute for Neurosciences and author of both analyses, in a statement. “The findings from these new analyses suggest that, when compared to interferon, ozanimod has a beneficial effect on processing speed.”

SUNBEAM studied two doses of ozanimod, 0.92 mg and 0.46 mg, in 1,346 patients with RMS treated for at least a year. Post hoc analysis of the data looked at cognitive processing speed based on performance on the Symbol Digit Modalities Test (SDMT). More patients showed clinically meaningful improvements in processing speed on ozanimod compared to Avonex.

A second analysis on annualized relapse rate (ARR) and MRI lesions was conducted, looking at the effect of ozanimod in patients with early RMS compared to patients with a more advanced disease. In patients with early RMS, ARR was lower at 12 months with ozanimod compared to Avonex. ARR was also lower on ozanimod than Avonex in patients with more advanced RMS.

“These analyses provide additional encouraging data for ozanimod in relapsing multiple sclerosis, from its potential to influence cognitive processing to showing results in patients with either early or more advanced forms of the disease,” said Jay Backstrom, Celgene’s chief medical officer, in a statement. “Ozanimod has the potential to offer the multiple sclerosis community a new oral option for the treatment of relapsing multiple sclerosis, and we continue to work with regulatory bodies in the U.S. and EU in our efforts to bring this treatment to patients.”

There is quite a bit of industry news coming out of ECTRIMS this week. Genentech, a Roche company, released data from a long-term clinical trial of Ocrevus (ocrelizumab) in multiple sclerosis. The research is five-year data from the Phase III open-label extension trials of OPERA I, OPERA II and ORATORIO. The data indicate that the efficacy of Ocrevus continues on key measures of disease activity as well as indicating that patients treated earlier with the drug had “superior disability progression outcomes” compared to patients who switched from interferon beta-1a or primary progressive MS (PPMS) patients who switched from placebo.

“From the moment of diagnosis, reducing disease progression is an important goal for people with MS,” said Stephen Hauser, chair of the Scientific Steering Committee of the OPERA studies, professor of neurology at the University of California, San Francisco, and director of the UCSF Weill Institute for Neurosciences. “The new data presented at ECTRIMS demonstrate that Ocrevus’ efficacy continued over five years in relapsing and primary progressive MS, and notably, include the largest body of evidence for any medicine to significantly slow disability progression in primary progressive MS.”

Earlier this week Novartis announced that both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) had accepted its New Drug Application (NDA) and Marketing Authorization Application (MAA), respectively, for siponimod (BAF312) to treat secondary progressive multiple sclerosis (SPMS) in adults.

Novartis used a review voucher to expedite siponimod’s review in the U.S. Regulatory response in the U.S. is expected in March 2019, and in Europe in late 2019.

Of people with relapsing-remitting MS (RRMS), which is the most common form at the time of diagnosis, more than 80 percent go on to develop SPMS, with or without relapses. SPMS leads to progressive, irreversible disability, including the need for enhanced walking aids and wheelchairs, bladder dysfunction and cognitive decline. After the first RRMS course, the number of patients transitioning to SPMS gradually increase, with about 25 percent progressing by 10 years after onset, 50 percent by 20 years and more than 75 percent by 30 years.

And Germany’s Merck KGaA is presenting 23 studies, including safety and efficacy data on Rebif (interferon beta-1a), cladribine tablets (sold in Europe as Mavenclad), and evobrutinib.

“We are proud to be presenting new data across our Neurology and Immunology franchise at Merck KGaA, Darmstadt, Germany during ECTRIMS 2018,” said Luciano Rossetti, head of Merck KGaA’s global research and development for the biopharma business, in a statement. “As we continue to enhance our understanding of the benefit-risk profile of cladribine tablets and the use of Rebif, we are also excited by the presentation of the first clinical data for a BTK inhibitor (evobrutinib) in an MS patient population.”

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