Abstract Details

Title The Safety Profile of Fenebrutinib in Patients with Multiple Sclerosis Is Consistent with Those in Previously Studied Autoimmune Indications

Topic Multiple Sclerosis

Presentation(s) P9 - Poster Session 9 (8:00 AM-9:00 AM)

Poster/Presentation
Number 6-012

Objective To compare the safety and tolerability of fenebrutinib in people with multiple sclerosis (MS) and those with autoimmune indications (AIs).

Background Fenebrutinib is a potent, highly selective, reversible oral Bruton’s tyrosine kinase inhibitor being evaluated in a Phase 3 clinical program for MS. Fenebrutinib has been studied in relapsing MS (RMS) and three AIs (rheumatoid arthritis [RA], systemic lupus erythematosus [SLE], chronic spontaneous urticaria [CSU]).

Design/Methods Adverse events (AEs) and safety laboratory tests were analyzed for patients who received fenebrutinib at the highest dose (200 mg twice daily [BID]) or placebo in Phase 2 studies of MS and AIs.

Results Across Phase 2 studies, 73 patients with RMS and 577 patients with AIs received fenebrutinib 200 mg BID, and 36 with RMS and 278 with AIs received placebo/standard of care. AEs reported in >5% of fenebrutinib-treated patients with RMS were abnormal hepatic transaminase elevation and urinary tract infection (5.5% each). There was no imbalance in rate of infections between treatment arms, and no serious or fatal AEs were reported across all indications. Grade ≥2 hepatic transaminase elevations were observed more frequently in the fenebrutinib vs placebo arms: RMS, 8.2% vs 2.8%; across AIs, 4% vs 1.4% (RA, 1.9% vs 1.3%; SLE, 4.5% vs 2.4%; CSU, 9.6% vs 0%). Nonserious Grade 1 bleeding/bruising AEs were reported in 1.4% of RMS-fenebrutinib (n=1) and 7.7% AI-fenebrutinib (n=23) patients vs 0% RMS-placebo (n=36) and 3.2% AI-placebo (n=9) patients. Irrespective of the indication, there were no cases of major hemorrhage (Grade ≥3, serious) or cardiovascular events reported in patients receiving fenebrutinib.

Conclusions The safety and tolerability profile of fenebrutinib in MS remains consistent with that in previously studied AIs (RA, SLE and CSU). These data further support fenebrutinib’s favorable safety profile as well as its clinical development across the Phase 3 MS clinical program.

Authors/Disclosures
Jiwon Oh, MD, FAAN (St Michael's Hospital) PRESENTER	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.
Anastasiia Raievska	No disclosure on file
Malgorzata Sierzega (Roche)	Malgorzata Sierzega has stock in Roche.
Joao J. Cerqueira, MD, PhD	Dr. Cerqueira has received personal compensation for serving as an employee of João José Cerqueira Unipessoal Lda. Dr. Cerqueira has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BIOGEN. Dr. Cerqueira has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Dr. Cerqueira has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis. Dr. Cerqueira has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ROCHE. Dr. Cerqueira has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merck. Dr. Cerqueira has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Sanofi. Dr. Cerqueira has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Cerqueira 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. Cerqueira 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. Cerqueira 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. Cerqueira 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. Cerqueira has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck. Dr. Cerqueira has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. The institution of Dr. Cerqueira has received research support from Biogen.
Claire Riley, MD, FAAN	Dr. Riley has received personal compensation for serving as an employee of AstraZeneca. Dr. Riley has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Riley 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. Riley 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. Riley has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Horizon. Dr. Riley 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. Riley has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Riley has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Immunic AG. Dr. Riley has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Cabaletta Bio. Dr. Riley 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. Riley 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. Riley 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.
Maresa Caunt (Genentech)	Mrs. Caunt has received personal compensation for serving as an employee of Genentech. Mrs. Caunt has stock in Genentech.
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.
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.
Konstantina Vanevski	No disclosure on file
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.
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.

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