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Abstract Details

MRI Outcomes from the Long-term Extension Study of Tolebrutinib in Patients with Relapsing Multiple Sclerosis: 2-Year Results
Multiple Sclerosis
P6 - Poster Session 6 (5:30 PM-6:30 PM)
3-012

To report MRI outcomes at Week (W) 96 (2 years) in LTS16004 (NCT03996291), an ongoing long-term safety (LTS) extension study of the Phase 2b trial (NCT03889639) of tolebrutinib, a brain-penetrant Bruton’s tyrosine kinase inhibitor in participants with relapsing multiple sclerosis.

In the double-blind phase (DBP) of the Phase 2b trial, tolebrutinib was well-tolerated over 12 weeks with dose-dependent reductions in new gadolinium-enhancing T1 and new/enlarging T2-lesions.

In LTS Part A, participants continued receiving their DBP tolebrutinib dose (5, 15, 30, or 60mg/day) until Phase 3 dose selection. In open-label Part B, all participants received 60mg/day. MRI outcomes included numbers of new gadolinium-enhancing T1 and new/enlarging T2-lesions, T2-lesion volume change, slowly evolving lesions (SEL), and paramagnetic rim lesions (PRL).

124/125 participants completed Part A and transitioned to Part B; 114 (90.5%) remained on study as of 18 February 2022 (W96 cut-off). Mean age±SD at DBP baseline was 37.7±9.6 years (range 19–56); 69% were women. New gadolinium-enhancing lesion counts remained low in 60/60-mg arm through W96 and were reduced in other arms W48 through W96 (W96 mean±SD: 0.85±2.5, 0.41±0.91, 0.90±2.16, 0.31±0.66 in 5/60-, 15/60-, 30/60-, 60/60-mg arms, respectively). New/enlarging T2-lesion counts remained low for 60/60-mg. T2-lesion volume change remained low for 60/60-mg (W96 vs baseline [mean±SD]: +0.38±2.11 cm3). Median (IQR) W96 SEL volume was 247.5 (84–420), 258 (66–906), 570 (133.5–1011), and 244.5 (87–939) mm3 for 5/60-, 15/60-, 30/60-, and 60/60-mg, respectively. PRL count remained unchanged in 18 participants; 2 had 1 PRL at baseline but none at W96, and 3 had 1–3 additional PRL at W96 vs baseline (none in the 60/60-mg arm).
New gadolinium-enhancing lesion counts remained low for tolebrutinib 60/60-mg and were reduced in lower dose arms W48 through W96, when all participants had switched to 60mg. 
Authors/Disclosures
Sana Syed, MD (Sanofi Genzyme)
PRESENTER 		Dr. Syed has received personal compensation for serving as an employee of Sanofi US.
Daniel Reich, MD, PhD (National Institutes of Health, Neuroimmunology Branch, NINDS) Dr. Reich has received research support from NIH. The institution of Dr. Reich has received research support from Adelson Medical Research Foundation. The institution of Dr. Reich has received research support from Sanofi. The institution of Dr. Reich has received research support from Abata Therapeutics. The institution of Dr. Reich has received research support from National Multiple Sclerosis Society. The institution of Dr. Reich has received research support from Cure Alzheimer's Fund. Dr. Reich has received intellectual property interests from a discovery or technology relating to health care. Dr. Reich has received personal compensation in the range of $5,000-$9,999 for serving as a CME Faculty with Integrity. Dr. Reich has received personal compensation in the range of $500-$4,999 for serving as a CME Faculty with Letters and Sciences. Dr. Reich has received personal compensation in the range of $500-$4,999 for serving as a CME Faculty with Academic CME. Dr. Reich has a non-compensated relationship as a Advisor with Sanofi that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Board of Directors with ACTRIMS that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Advisor with Abata Therapeutics that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Advisor with University of Basel RC2NB that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Advisor with Multiple Sclerosis Society of Canada that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Advisor with Tuscan Doctorate in Neuroscience that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Editorial Board with Multiple Sclerosis Journal that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Collaborator, Advisor with Hyperfine that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Collaborator with Imaginab that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Collaborator with Annexon that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Collaborator, Advisor with Philips that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Collaborator with Siemens that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Advisor with Calico Life Sciences that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Advisor with Cognito Therapeutics that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Advisor with Sudo that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Advisor with Allumis that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Advisor with BioCentury that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Collaborator with Regeneron that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Collaborator with Eli Lilly that is relevant to AAN interests or activities. Dr. Reich has a non-compensated relationship as a Advisor with SetPoint that is relevant to AAN interests or activities.
Anthony Traboulsee, MD (University of British Columbia) Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Traboulsee has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Traboulsee 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. Traboulsee 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. Traboulsee has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for EMD Serono. Dr. Traboulsee has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. The institution of Dr. Traboulsee has received research support from Roche. The institution of Dr. Traboulsee has received research support from Consortium of MS Centers. The institution of Dr. Traboulsee has received research support from MS Canada. Dr. Traboulsee has received personal compensation in the range of $500-$4,999 for serving as a Workshop Chair with Consortium of MS Centers.
No disclosure on file
Timothy J. Turner Timothy J. Turner has received personal compensation for serving as an employee of Sanofi. Timothy J. Turner has stock in Sanofi. Timothy J. Turner has received intellectual property interests from a discovery or technology relating to health care.
Douglas L. Arnold, MD, FAAN (Montreal Neurological Institute, McGill Univ) Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for BMS. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Frequency Therapeutics. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Merck. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Arnold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Arnold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Shionogi. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Xfacto communications. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eli Lilly. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD Serono. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biohaven. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Find therapeutics. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for GSK. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Idorsia. Dr. Arnold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Kiniksa. Dr. Arnold has received personal compensation in the range of $100,000-$499,999 for serving as a Consultant for Clario.