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Abstract Details

OCARINA II, Phase III Study: Results of Subcutaneous Ocrelizumab Administration in Patients with Multiple Sclerosis
Multiple Sclerosis
S31 - Multiple Sclerosis: Therapeutics and Clinical Decision Making (2:00 PM-2:12 PM)
006

OCR is an effective treatment for people with relapsing and primary progressive multiple sclerosis (RMS/PPMS). The currently available formulation is administered IV every 6 months. A novel OCR SC formulation in combination with recombinant human hyaluronidase (rHuPH20) is being developed.

To report the results of OCARINA II (NCT05232825), a Phase III, randomized, open-label, controlled study designed to demonstrate non-inferiority in serum exposure of ocrelizumab (OCR) when administered via subcutaneous (SC) versus intravenous (IV) routes.

Patients with RMS/PPMS (18?65 years; Expanded Disability Status Scale score 0–6.5) were randomized (1:1) to receive OCR 600mg IV or 920mg OCR SC (selected based on pharmacokinetic data from the OCARINA I study [NCT03972306]). Study endpoints: comparison of serum OCR area under the concentration-time curve from baseline to Week 12 (AUCW1?12), MRI lesion activity, number of relapses, immunogenicity, B-cell depletion and safety.

Baseline demographics and disease characteristics were balanced (OCR SC: n=118; 89.0% RMS, 9.3% PPMS; OCR IV: n=118; 89.8% RMS, 10.2% PPMS). At Week (W) 12, the geometric mean ratio (90% CI) for AUCW1?12 of OCR SC versus IV was 1.29 (1.23?1.35). OCR SC 920mg resulted in near-complete suppression of MRI and relapse activity up to W24, similar to OCR IV. In both cohorts, treatment with OCR led to rapid and sustained B-cell depletion. The safety profile of OCR SC was consistent with that of OCR IV; both were well tolerated. No new safety concerns were identified in addition to the known risks associated with OCR or SC administration. No OCR-antidrug antibodies or antibodies to rHuPH20 were detected. Data up to W48 will be presented.

Ocrelizumab SC 920mg demonstrated non-inferiority to IV 600mg with respect to AUCW1?12, and similar clinical and imaging measures. SC administration of ocrelizumab provides treatment flexibility and additional treatment options for patients and healthcare providers.

Authors/Disclosures
Scott D. Newsome, DO, FAAN (Johns Hopkins Hospital)
PRESENTER
Dr. Newsome has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Newsome has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Newsome has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Newsome has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Newsome has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Greenwich Biosciences. Dr. Newsome has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Myers Squibb. Dr. Newsome has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon Therapeutics. Dr. Newsome has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. The institution of Dr. Newsome has received research support from Biogen. The institution of Dr. Newsome has received research support from Genentech/Roche. The institution of Dr. Newsome has received research support from Department of Defense. The institution of Dr. Newsome has received research support from Patient Centered Outcomes Research Institute. The institution of Dr. Newsome has received research support from National MS Society. The institution of Dr. Newsome has received research support from The Stiff Person Syndrome Research Foundation. The institution of Dr. Newsome has received research support from Lundbeck. Dr. Newsome has received personal compensation in the range of $10,000-$49,999 for serving as a Lead PI for Clinical Trial with Roche.
Ewa Krzystanek Ewa Krzystanek has nothing to disclose.
Krzysztof W. Selmaj (University of Warmia and Mazury) Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astra. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Astra. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Biogen. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Roche. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for BMS. Krzysztof W. Selmaj has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck.
Lawrence P. Goldstick, MD (University of Cincinnati UC Physcians Department of Neurology) Dr. Goldstick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for biogen. Dr. Goldstick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Bristol Meyers Squibb. Dr. Goldstick has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for genentech. Dr. Goldstick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for sanofi Aventis genzyme. Dr. Goldstick has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for emd serono. Dr. Goldstick has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TGA therapeutics. Dr. Goldstick has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for biogen. Dr. Goldstick has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for emd serono. Dr. Goldstick has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi Aventis genzyme. Dr. Goldstick has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for genentech. Dr. Goldstick has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Bristol Meyers Squibb. Dr. Goldstick has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TGA therapeutics. Dr. Goldstick has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for biogen. Dr. Goldstick has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for bristol meyers squibb. Dr. Goldstick has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for genentech. Dr. Goldstick has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for sanofi aventis genzyme. Dr. Goldstick has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for emd serono. Dr. Goldstick has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for TGA therapeutics. The institution of Dr. Goldstick has received research support from biogen. The institution of Dr. Goldstick has received research support from lily. The institution of Dr. Goldstick has received research support from sanofi Aventis genzyme. The institution of Dr. Goldstick has received research support from genetech.
Catarina Figueiredo No disclosure on file
Ben Townsend (F. Hoffmann-La Roche AG) No disclosure on file
Christian Wolf, MD (Lycalis srl) Dr. Wolf has received personal compensation for serving as an employee of F. Hoffmann-La Roche.
Dusanka Zecevic No disclosure on file
Caroline Giacobino No disclosure on file
Oscar Bortolami (Roche ExBP) No disclosure on file
Yun-An Shen (Genentech) No disclosure on file
Heidemarie Kletzl Heidemarie Kletzl has received personal compensation for serving as an employee of Hoffmann-La Roche.
Susanne Clinch No disclosure on file
Diego Centonze No disclosure on file