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Abstract Details

Cladribine Tablets in Patients With Relapsing-Remitting Multiple Sclerosis or Active Secondary Progressive Multiple Sclerosis After Suboptimal Response to a Disease-Modifying Therapy (CLICK-MS and MASTER-2): Interim Baseline and Safety Review
Multiple Sclerosis
P1 - Poster Session 1 (9:00 AM-5:00 PM)
296
To review interim baseline patient characteristics and reported outcomes along with tolerability and safety of cladribine tablets 3.5 mg/kg (CladT3.5; cumulative dose over 2 years) six months after treatment in Phase 4 CLICK-MS and MASTER-2 trials.
CladT3.5 are approved for treating relapsing forms of multiple sclerosis (MS); however, real-world US data on clinical and patient-reported effectiveness and safety after switching from another disease-modifying therapy (DMT) are limited. 
CLICK-MS (n=100 expected) and MASTER-2 (n=250 expected) are US-based single-arm, observational, 54-month trials examining real-world clinical and patient-reported effectiveness and safety of CladT3.5 in patients with relapsing MS who had suboptimal response to an injectable (PriorInject; CLICK-MS) or infusion/oral (PriorInfusion/PriorOral; MASTER-2) DMT. The total MASTER-2 population will include an ocrelizumab-to-CladT3.5 switched sub-cohort (n=100). Enrollment is ongoing and patients must meet the USPI criteria for CladT3.5 treatment. Primary outcome is 24-month annualized relapse rate (ARR). Key secondary outcomes are patient-reported outcomes, treatment adherence and satisfaction, and treatment-emergent adverse events (TEAEs).
As of the datacut dates of May (CLICK-MS) and July (MASTER-2) 2021, 181 patients have received CladT3.5 (N=47 PriorInject; N=47 PriorInfusion; N=87 PriorOral). Mean (standard deviation) 24-month ARRs prior to enrollment were 0.25 (0.32; PriorInject), 0.18 (0.29; PriorInfusion), and 0.19 (0.30; PriorOral). Commonly used injectable, infusion, or oral DMTs at time of switch to CladT3.5 (≥10% patients) were glatiramer acetate (14.4%), natalizumab (11.0%), teriflunomide (15.5%), dimethyl fumarate (15.5%), and fingolimod (13.8%). Six months after treatment in CLICK-MS, 29.8%, 2.1%, and 0% of patients experienced a TEAE, serious TEAE, and TEAE leading to treatment discontinuation, respectively. Updated/new MASTER-2 (including safety) and CLICK-MS data will be shown in the presentation.
At datacut, CLICK-MS and MASTER-2 have enrolled patients switching from a variety of DMTs. TEAEs reported were low in frequency and severity, and did not lead to treatment discontinuation. 
Authors/Disclosures
Augusto A. Miravalle, MD, FAAN (Rush University)
PRESENTER 		Dr. Miravalle has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentech. Dr. Miravalle has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Miravalle has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion. Dr. Miravalle has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG. Dr. Miravalle has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Amgen. Dr. Miravalle 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. Miravalle 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. Miravalle 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. Dr. Miravalle has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for BMS. Dr. Miravalle has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Miravalle has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for TG therapeutics. Dr. Miravalle has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen. The institution of Dr. Miravalle has received research support from Genzyme. The institution of Dr. Miravalle has received research support from EMD Serono. The institution of Dr. Miravalle has received research support from Alexion.
Joshua D. Katz, MD (The Elliot Lewis Center) The institution of Dr. Katz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for TG Theraputics. The institution of Dr. Katz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Jansen Pharmaceuticals. The institution of Dr. Katz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Viela Bio. The institution of Dr. Katz has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Biogen. The institution of Dr. Katz has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Novartis. The institution of Dr. Katz has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Sanofi-Genzyme. The institution of Dr. Katz has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Genentech. The institution of Dr. Katz has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD-Serono.
Derrick Robertson, MD Dr. Robertson has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Bristol Myers Squibb. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Genentech. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Greenwich Biosciences. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Horizon. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Janssen. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sanofi Genzyme. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for TG Therapeutics. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Mallinckrodt. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Alexion. Dr. Robertson has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Biogen. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for EMD Serono. Dr. Robertson has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Genentech. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Sanofi Genzyme. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for PRIME CME. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Janssen. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Horizon. Dr. Robertson has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for TG Therapeutics. Dr. Robertson has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for McVeigh. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Mccumber. Dr. Robertson has received personal compensation in the range of $5,000-$9,999 for serving as an Expert Witness for Goodis. The institution of Dr. Robertson has received research support from Biogen. The institution of Dr. Robertson has received research support from EMD Serono. The institution of Dr. Robertson has received research support from Jansenn. The institution of Dr. Robertson has received research support from Genentech. The institution of Dr. Robertson has received research support from Patient-Centered Outcomes Research Institute. The institution of Dr. Robertson has received research support from Novartis. The institution of Dr. Robertson has received research support from Sanofi Genzyme. The institution of Dr. Robertson has received research support from TG Therapeutics. The institution of Dr. Robertson has received research support from Prime. The institution of Dr. Robertson has received research support from Greenwich Biosciences. The institution of Dr. Robertson has received research support from Atara Biotherapeutics. The institution of Dr. Robertson has received research support from CorEvitas. The institution of Dr. Robertson has received research support from Anokion. The institution of Dr. Robertson has received research support from UCB Biosciences. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Consortium of Multiple Sclerosis Centers. Dr. Robertson has received personal compensation in the range of $500-$4,999 for serving as a Speaker with Multiple Sclerosis Association of America.
Julie Aldridge, MS (EMD Serono) Ms. Aldridge has received personal compensation for serving as an employee of EMD Serono.
No disclosure on file
Danielle Harlow Danielle Harlow has received personal compensation for serving as an employee of EMD Serono, Inc..
Lori Lebson Lori Lebson has nothing to disclose.
Jacob A. Sloane, MD, PhD (Beth Israel Deaconess Medical Center) Dr. Sloane has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for biogen. Dr. Sloane has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Sloane has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Sanofi.
Ann D. Bass, MD (Lone Star Neurology - San Antonio) Dr. Bass has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Alexion, Amgen, Bristol-Myers-Squibb, EMD Serono, Novartis, Roche-Genentech, Sanofi-Genzyme, TG Therapeutics. Dr. Bass has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen, Alexion, EMD Serono, Novartis, Roche-Genentech, Sanofi-Genzyme, TG Therapeutics. Dr. Bass has received personal compensation in the range of $100,000-$499,999 for serving on a Speakers Bureau for Alexion, Amgen, Bristol-Myers-Squibb, EMD Serono, Roche-Genentech, Sanofi-Genzyme, TG Therapeutics. The institution of Dr. Bass has received research support from Bristol-Myers-Squibb, EMD Serono, Novartis, Roche-Genentech, Sanofi-Genzyme, TG Therapeutics.
Edward Fox, MD, PhD, FAAN Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alexion Pharmaceuticals. Dr. Fox has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genentech. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for EMD Serono. Dr. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GW Pharmaceuticals. Dr. Fox 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. Dr. Fox 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. Fox 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. Fox 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. Fox has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Genentech. Dr. Fox has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Bristol Myers Squibb. The institution of Dr. Fox has received research support from Biogen. The institution of Dr. Fox has received research support from Genentech. The institution of Dr. Fox has received research support from Celgene - BMS. The institution of Dr. Fox has received research support from Chugai. The institution of Dr. Fox has received research support from Novartis. The institution of Dr. Fox has received research support from EMD-Serono. The institution of Dr. Fox has received research support from TG Therapeutics. The institution of Dr. Fox has received research support from AbbVie. The institution of Dr. Fox has received research support from Sanofi Genzyme. The institution of Dr. Fox has received research support from AbbVie.