Hideki Garren, MD, PhD: The Past and Future of Ocrelizumab Analysis

The Group Medical Director of Neuroscience at Genentech discussed the drug's background, which has evolved into continued multi-year trials.

The first topline data presented for ocrelizumab (Ocrevus) — Genentech’s monoclonal antibody therapy that made history as the first approved treatment of patients with primary progressive multiple sclerosis (PPMS) — was actually for the relapsing form of the neurological condition, at the European Committee for Treatment and Research in Multiple Sclerosis (ECRTIMS) annual meeting in 2015.

This data, from the OPERA trials, showed the drug’s potential. New OPERA data, presented last week at the 70th annual meeting of American Academy of Neurology (AAN) in Los Angeles, CA, has shown the drug’s benefit for both forms of the disease in the same patients after years of care, Hideki Garren, MD, PhD, told MD Magazine.

“Patients started on ocrelizumab have now been followed for a total of 4 years — 2 years in the study, 2 years in the open label,” Garren said.

Garren, the Group Medical Director of Neuroscience at Genentech, said the therapy is showing sustained efficacy on 3 different levels: relapse rates, MRI lesions, and disability progression.

That doesn’t mean the analysis should be punctuated anytime soon. Garren said Genentech is committed to following the same patients with MS for “a long, long time,” with routine presentations on both efficacy and safety rates. At this point of trial duration, the latter report is just as crucial to update.

“The safety data shows there’s no new safety concerns, and we continue to have a favorable benefit-risk for patients, and we will continue to report these data every 6 months at the congresses,” Garren said.