Abstract Details

Title OLIKOS Study: 6-month Interim Efficacy and Safety in Patients with Relapsing Multiple Sclerosis Who Switched to Subcutaneous Ofatumumab from Intravenous Anti-CD20 Therapies

Topic Multiple Sclerosis

Presentation(s) P10 - Poster Session 10 (11:45 AM-12:45 PM)

Poster/Presentation
Number 6-006

Background

Anti-CD20 therapies are effective treatments for relapsing multiple sclerosis (RMS). Unlike intravenously (IV) administered ocrelizumab and rituximab, ofatumumab is administered subcutaneously (SC) via autoinjector pen.

Objective

Describe 6-month interim efficacy and safety results for patients enrolled in OLIKOS.

Design/Methods

OLIKOS (single-arm, open-label, phase 3b study [NCT04486716]) enrolled patients (aged 18-60 years) with RMS who received ≥2 courses of IV anti-CD20 therapy (ocrelizumab or rituximab). Patients were required to be stable on their previous therapy and switched for reasons other than safety or lack of efficacy. Eligible patients received ofatumumab 20 mg SC via autoinjector over 12 months. The primary endpoint was the proportion of patients with no change or reduction in the number of gadolinium-enhancing (Gd+) lesions from baseline to Month 12. Safety endpoints included treatment-emergent adverse events (TEAEs). Exploratory endpoints included changes in hematology parameters.

Results

OLIKOS enrolled 111 patients; 102 received ofatumumab and were included in the analysis. The mean (SD) age at baseline was 44 (8.2) years, and most patients were White (76.5%), female (67.6%), and previously received ocrelizumab before switching (99.0%). Median (range) baseline Expanded Disability Status Scale score and mean (SD) disease duration were 2.9 (0.0-5.5) and 9.4 (7.1) years, respectively. At baseline, mean (SD) number of Gd+ T1 lesions (n=101) was 0.01 (0.1), and immunoglobulin G (IgG) and IgM levels (g/L) were 9.9 (2.8) and 0.6 (0.4), respectively. At 6 months, all patients with available Gd+ T1 lesion data (n=77) met the primary endpoint (95% CI: 0.95-1.00). TEAEs occurred at the same frequency as in the phase 3 clinical trials. Six-month mean (SD) IgG and IgM levels (g/L; n=95) were 9.8 (2.9) and 0.5 (0.3), respectively.

Conclusions

Ofatumumab 20 mg SC maintained efficacy at 6 months in patients with RMS transitioning from IV anti-CD20 therapies, as demonstrated by no Gd+ T1 lesions. No new safety signals were identified.

Authors/Disclosures
Enrique Alvarez, MD, PhD (University of Colorado) PRESENTER	Dr. Alvarez has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Therapeutics. Dr. Alvarez has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Alvarez has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for EMD Serono. Dr. Alvarez has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Alvarez has received personal compensation in the range of $50,000-$99,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Alvarez has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Alvarez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Alvarez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Celgene/BMS. The institution of an immediate family member of Dr. Alvarez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for UCB. The institution of Dr. Alvarez has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon.
Brandon Brown	No disclosure on file
Elizabeth Camacho	No disclosure on file
Benjamin M. Greenberg, MD, FAAN (UT Southwestern Medical Center)	Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Greenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Greenberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Amgen. Dr. Greenberg has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi/Genzyme. Dr. Greenberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech/ROche. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Signant. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for IQVIA. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Greenberg has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Clene. Dr. Greenberg has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for TG Therapeutics. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for IQVIA. Dr. Greenberg has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Abcuro. Dr. Greenberg has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Siegel Rare Neuroimmune Association. Dr. Greenberg has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for Carlton Fields. Dr. Greenberg has stock in GenrAb. Dr. Greenberg has stock in Clene. The institution of Dr. Greenberg has received research support from Anokion. The institution of Dr. Greenberg has received research support from Regeneron. Dr. Greenberg has received intellectual property interests from a discovery or technology relating to health care. Dr. Greenberg has received publishing royalties from a publication relating to health care.
Roland G. Henry, PhD (University of California, San Francisco)	Dr. Henry has received personal compensation in the range of $500-$4,999 for serving as a Consultant for MEDDAY. Dr. Henry has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. Dr. Henry has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Henry has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sanofi/Genzyme.
Rebecca Piccolo, PhD (Novartis)	Dr. Piccolo has received personal compensation for serving as an employee of Novartis. Dr. Piccolo has stock in Novartis.
Le Hua, MD, FAAN (Cleveland Clinic)	Dr. Hua has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Hua has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Serono. Dr. Hua has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Horizon. Dr. Hua has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Hua has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genzyme. Dr. Hua 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. Hua 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. Hua has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for TG Therapuetics. The institution of Dr. Hua has received research support from Genentech.