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Abstract Details

Efficacy and Safety of Fenebrutinib vs Ocrelizumab in Primary Progressive Multiple Sclerosis: Primary Results of the Phase III FENtrepid Study
Multiple Sclerosis
S40 - Multiple Sclerosis: Clinical Trials/Science and Real-world Evidence (1:36 PM-1:48 PM)
004
To evaluate the efficacy and safety of fenebrutinib compared with ocrelizumab in adult patients with primary progressive multiple sclerosis (pwPPMS).
Bruton's tyrosine kinase inhibitors (BTKi) have potential to impact both relapsing and progressive MS disease biologies. Fenbrutinib is an oral, highly selective, noncovalent, reversible BTKi that is CNS-penetrant, as shown in the Phase II FENopta study (NCT05119569) in relapsing MS in which fenebrutinib treatment rapidly reduced acute inflammatory disease activity. Currently the effect of fenebrutinib on progressive MS subtypes has not been demonstrated. Ocrelizumab remains the only approved treatment for PPMS, and an unmet need exists for treatments that can better control disability progression. FENtrepid (NCT04544449) is the first clinical trial of a new therapy in PPMS using ocrelizumab as an active comparator.
FENtrepid is a Phase III, multicenter, randomized, double-blind, double-dummy, parallel-group study evaluating the efficacy and safety of fenebrutinib compared with ocrelizumab in pwPPMS (18-65 years old; PPMS diagnosis [2017 revised McDonald criteria]; Expanded Disability Status Scale [EDSS] score 3.0-6.5). Patients were randomized 1:1 to either oral fenebrutinib 200 mg twice daily or intravenous ocrelizumab 600 mg every 24 weeks. The primary endpoint was time to onset of composite confirmed disability progression, defined as a 12-week confirmed increase in one or more of the EDSS, Timed 25-Foot Walk Test or 9-Hole Peg Test.
FENtrepid enrolled 985 patients with PPMS; 84% were not exposed to recent prior disease modifying therapies. Mean (SD) age at baseline was 48.9 (10.3) years. Median baseline EDSS score was 5.0; mean (SD) duration since MS symptom onset and diagnosis was 9.0 (6.7) and 4.7 (5.4) years, respectively. Primary efficacy and safety results will be presented.
FENtrepid will provide the first evidence on the effect of fenebrutinib treatment on disability progression in PPMS, relative to an active comparator of ocrelizumab.
Authors/Disclosures
Amit Bar-Or, MD, FRCPC (University of Pennsylvania)
PRESENTER 		Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche Genentech. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merk/EMD Serono. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving as a Consultant for cabaletta. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche/Genentech. Dr. Bar-Or 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. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck/EMD Serono. Dr. Bar-Or has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi/Genzyme. The institution of Dr. Bar-Or has received research support from Novartis. The institution of Dr. Bar-Or has received research support from Biogen. The institution of Dr. Bar-Or has received research support from Roche/Genentech.
Jiwon Oh, MD, FAAN (St Michael's Hospital) Dr. Oh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Roche. The institution of Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen-Idec. Dr. Oh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD-Serono. Dr. Oh has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi-Genzyme. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Amgen. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Astra Zeneca. Dr. Oh has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen-Idec. Dr. Oh has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi-Genzyme. The institution of Dr. Oh has received research support from Biogen-Idec. The institution of Dr. Oh has received research support from Roche.
Gavin Giovannoni, MD (QMUL) Dr. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Merck KGaA. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche-Genentech. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Moderna. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sandoz. Dr. Giovannoni has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Astoria Biologica. Dr. Giovannoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Zenas. Dr. Giovannoni 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. Giovannoni has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Giovannoni 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. Giovannoni has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Medscape.
Maria Pia Sormani (University of Genoa) Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol meyer. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Immunic. Maria Pia Sormani 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, Roche. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Maria Pia Sormani has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche.
Martin Weber, MD (Universitätsmedizin Göttingen) Dr. Weber has nothing to disclose.
Sharon Stoll, DO (Stoll Medical Group) Dr. Stoll has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for roche Genentech. Dr. Stoll 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/Genentech . Dr. Stoll 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. Stoll has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for novartis. Dr. Stoll 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/genzyme. Dr. Stoll has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Dr. Stoll has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. Dr. Stoll has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon. Dr. Stoll 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. Stoll 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. Stoll 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. Stoll has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Biogen. Dr. Stoll has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi Genzyme. Dr. Stoll has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for alexion. Dr. Stoll has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono . Dr. Stoll has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Horizon. Dr. Stoll has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for BMS. Dr. Stoll has stock in BeCare Link LLC. Dr. Stoll has stock in Global Consult MS .
Jacqueline A. Nicholas, MD (OhioHealth Riverside Methodist Hospital) Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biogen. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squib. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Nicholas 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. Nicholas 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. Nicholas 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. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genentech. Dr. Nicholas has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for EMD Serono. Dr. Nicholas has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Genentech. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Vielo Bio. Dr. Nicholas has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bristol Myers Squibb. The institution of Dr. Nicholas has received research support from Novartis. The institution of Dr. Nicholas has received research support from Biogen. The institution of Dr. Nicholas has received research support from Genentech. The institution of Dr. Nicholas has received research support from PCORI. Dr. Nicholas has a non-compensated relationship as a Physician with National MS Society that is relevant to AAN interests or activities. Dr. Nicholas has a non-compensated relationship as a Physician with Siegal Rare Neuroimmune Association that is relevant to AAN interests or activities.
H.-Christian C. von Büdingen, MD, FAAN (F. Hoffmann-La Roche Ltd) Dr. von Büdingen has received personal compensation for serving as an employee of F. Hoffmann-La Roche Ltd. Dr. von Büdingen has stock in F. Hoffmann-La Roche Ltd.
Jonathan Lopez, MD (Genentech) An immediate family member of Dr. Lopez has received personal compensation for serving as an employee of Novartis Pharmaceuticals. An immediate family member of Dr. Lopez has received personal compensation for serving as an employee of Syneos Health. An immediate family member of Dr. Lopez has received personal compensation for serving as an employee of The Mast Cell Society. Dr. Lopez has received personal compensation for serving as an employee of Genentech, Inc.. Dr. Lopez has stock in Genentech, Inc.,.
Louise A. Roberts, PhD (Genentech) Ms. Roberts has stock in Genentech.
Miriam Triyatni Miriam Triyatni has received personal compensation for serving as an employee of Hoffmann-La Roche Inc. Miriam Triyatni has stock in F-Hoffmann La Roche Inc.
Qi Qi (Genentech) Qi Qi has nothing to disclose.
John Ratchford, MD (Genentech) Dr. Ratchford has received personal compensation for serving as an employee of Genentech. Dr. Ratchford has stock in F. Hoffman La-Roche.
Julie Napieralski Julie Napieralski has received personal compensation for serving as an employee of Genentech/Roche.
Alexandra L. Goodyear, MD (Genentech) Dr. Goodyear has received personal compensation for serving as an employee of Genentech. Dr. Goodyear has received personal compensation for serving as an employee of Novartis. Dr. Goodyear has stock in Novartis. Dr. Goodyear has stock in Genentech.
Stephen L. Hauser, MD (UCSF Weill Institute for Neurosciences) Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for NGM Bio. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Moderna. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BD. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Pheno Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nurix Therapeutics. Dr. Hauser has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Gilead. Dr. Hauser has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Accure. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alector. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Hinge Therapeutics. Dr. Hauser has received personal compensation in the range of $10,000-$49,999 for serving as an officer or member of the Board of Directors for Neurona. Dr. Hauser has a non-compensated relationship as a Clinical Trial/Primary Investigator with Roche that is relevant to AAN interests or activities. Dr. Hauser has a non-compensated relationship as a Clinical Trial/Primary Investigator with Novartis that is relevant to AAN interests or activities.
Ludwig Kappos, MD, FAAN (RC2NB, University Hospital Basel) Dr. Kappos has nothing to disclose.