Roche has reported data from the Phase III OCARINA II study of a subcutaneous (SC) injection of OCREVUS (ocrelizumab) in individuals with relapsing or primary progressive multiple sclerosis (RMS or PPMS).
A humanised monoclonal antibody designed to target CD20-positive B cells, OCREVUS is given twice yearly via subcutaneous (SC) injection of ten minutes.
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The multicentre, global, randomised trial compared the pharmacokinetics, safety, radiological and clinical effects of OCREVUS SC with the intravenous (IV) infusion.
A total of 236 patients with RMS or PPMS were enrolled in the trial.
The latest study results indicated near-complete suppression of clinical relapses and brain lesions in MS patients.
Furthermore, OCREVUS SC treatment led to quick and lasting B-cell depletion in the blood.
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By GlobalDataFollowing OCREVUS SC treatment, 97.2% of participants had no relapse during the treatment phase, with an annualised relapse rate (ARR) of 0.04 up to 48 weeks.
Additionally, most patients showed no T1 gadolinium-enhancing (T1 Gd+) lesions and no new/enlarging T2 lesions, which are indicative of active inflammation and disease burden, respectively.
In terms of patient-reported outcomes, a high level of satisfaction was noted, with 92.3% of patients satisfied or very satisfied and 90.1% finding the treatment convenient or very convenient.
OCREVUS SC’s safety profile was found to be in line with the already established data of the IV infusion without any new safety signals seen.
Injection reactions such as erythema, pain, swelling, and pruritus were found to be the most frequently seen adverse events, all of which were mild or moderate in severity.
The company has filed the data from the Phase III OCARINA II trial to health authorities globally.
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have accepted Roche’s submissions, with the decision on approval expected this year.
Roche Global Product Development head and chief medical officer Levi Garraway said: “With a full year of data demonstrating near-complete suppression of relapse activity and minimal progression of lesion development, this ten-minute subcutaneous OCREVUS injection shows results that are consistent with the long-established benefits of intravenous OCREVUS.
“We look forward to continuing ongoing conversations with regulatory bodies worldwide to potentially bring an additional treatment option to more people living with MS in a shorter injection time.”
Recently, the company released data from the Phase III STARGLO trial where its Columvi (glofitamab) plus gemcitabine plus oxaliplatin (GemOx) improved overall survival in relapsed or refractory diffuse large B-cell lymphoma patients.
