Contributions
Abstract: P635
Type: Poster Sessions
Abstract Category: Therapy - Others
Introduction: Patients with relapsing-remitting multiple sclerosis (RRMS) can show signs of disease activity despite disease-modifying treatment (DMT). Ocrelizumab (OCR) demonstrated superior efficacy to subcutaneous interferon β-1a in two Phase III trials (OPERA I; OPERA II) in relapsing MS.
Objective: To report Year one interim analysis (IA) results of the multicentre, open-label, Phase IIIb CHORDS study (NCT02637856) evaluating OCR effectiveness and safety in patients with RRMS and a suboptimal treatment response to ≥6 months of DMT.
Methods: Eligible patients discontinued their most recent adequate course of DMT (i.e. administered for ≥6 months) due to suboptimal response (≥1 clinically reported relapse, ≥1 T1 gadolinium-enhancing [Gd+] lesion(s) or ≥2 new or enlarging T2 lesions). The scheduled OCR infusion protocol included two 300-mg intravenous (IV) infusions separated by 14 days followed by 600-mg IV infusions every 24 weeks for up to 96 weeks. This IA evaluated efficacy and safety over 48 weeks in a modified intention-to-treat population, including patients who received ≥1 OCR infusion and reached Week 48 by September 1, 2017, and excluding those who terminated treatment by September 1, 2017 for reasons other than lack of efficacy or death, with no evidence of clinical disease activity at the time of discontinuation.
Results: The CHORDS study enrolled 608 patients with RRMS who had a recent suboptimal response to a prior DMT. Baseline characteristics of the IA population (n=153) were similar to those of the total population, and patients were relatively early in their disease, with a mean (SD) time since diagnosis of 3.9 (2.80) years. Over 48 weeks, the majority of IA patients had no protocol-defined relapse (92.7%), no T1 Gd+ lesions (96.4%), no new or enlarging T2 lesions (65.3%) and no 24-week confirmed disability progression (96.4%). Further, 58.9% of patients were free of any of these protocol-defined events (i.e. no evidence of disease activity [NEDA]). The adjusted annualised relapse rate was 0.047, and new MRI activity included five new T1 Gd+ lesions and 177 new or enlarging T2 lesions over the 48 weeks of the analysis. Interim safety data were consistent with the overall known OCR safety profile.
Conclusions: Results of this IA of patients with RRMS who had 1 year of follow-up in the CHORDS study suggest that ocrelizumab is effective and safe in patients with a suboptimal response to an adequate course of a prior DMT.
Disclosure: Sponsored by Genentech, Inc. T.P. Leist has received compensation for consulting from Bayer, Biogen, EMD Serono, Genentech, Inc., Novartis, Sanofi Genzyme and Teva Neuroscience; as a speaker from Biogen, Genentech, Inc., Novartis, Sanofi Genzyme and Teva Neuroscience; and for research from Alkermes, Novartis and Sun Pharma; A.T. Reder has, in the last year, received consulting fees from Bayer, Biogen, EMD Serono, Inc., Genentech, Inc., Genzyme, Novartis, Mallinkrodt (formerly Questcor); R. Bermel has received consulting fees from Biogen, F. Hoffmann-La Roche Ltd and Genentech, Inc., Genzyme and Novartis; B. Weinstock-Guttman has received honoraria for serving on advisory boards and educational programs from Biogen Idec, Celgene, EMD Serono, Genentech, Inc., Genzyme, Novartis, Sanofi and Teva Pharmaceuticals, and has received research support from Biogen Idec, EMD Serono, Novartis and Teva Neuroscience; M.S. Freedman has received research or educational grants from Genzyme Canada; has received honoraria for consultation fees from Actelion, BayerHealthcare, Biogen Idec, Chugai, Clene Nanomedicine, EMD Canada, F. Hoffmann La-Roche Ltd, Genzyme, Merck Serono, Novartis, Sanofi-Aventis and Teva Canada Innovation; has served as a member of a company advisory board, board of directors or other similar group for Actelion, BayerHealthcare, Biogen Idec, Clene Nanomedicine, F. Hoffmann La-Roche Ltd, Merck Serono, MedDay, Novartis and Sanofi-Aventis; and has participated in a company-sponsored speaker's bureau for Sanofi-Genzyme; G. Cutter has served on data and safety monitoring boards for AMO Pharma, Apotek, Biogen-Idec, Gilead Pharmaceuticals, GlaxoSmithKline Pharmaceuticals, Horizon Pharmaceuticals, Merck Pharmaceuticals, ModigeneTech/Prolor, the National Heart, Lung, and Blood Institute (protocol review committee), Neuren, OPKO, Sanofi-Aventis and Teva; has served on the Obstetric-Fetal Pharmaceutical Research Unit oversight committee for the Eunice Kennedy Shriver National Institute of Child Health and Human Development; and has served on consulting or advisory boards for CereSpir Inc, Consortium of Multiple Sclerosis Centers, D3, F. Hoffmann-La Roche Ltd and Genentech, Inc., Genzyme, Innate Immunotherapeutics, Janssen Pharmaceuticals, Klein Buendel Incorporated, MedDay, MedImmune, Novartis, Opexa Therapeutics, Receptos, Savara Inc, Somahlution, Spinifex Pharmaceuticals, Teva Pharmaceuticals, TG Therapeutics and Transparency Life Sciences; J. Stankiewicz has, in the past year, received consulting fees from Bayer, Biogen Idec, Celgene, EMD Serono, Genzyme and Novartis; H. Zheng is an employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd; B. Musch is an employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd; C. Csoboth is an employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd; J.S. Wolinsky has received personal compensation for consulting, serving on a scientific advisory board, speaking or other activities with AbbVie, Acetilon, Alkermes, Biogen, Bionest, Celgene, Clene Nanomedicine, EMD Serono, Forward Pharma A/S, GeNeuro, MedDay Pharmaceuticals, Novartis, Otsuka, PTC Therapeutics, Roche/Genentech, Sanofi Genzyme; royalties are received for out-licensed monoclonal antibodies through UTHealth from Millipore Corporation.
Abstract: P635
Type: Poster Sessions
Abstract Category: Therapy - Others
Introduction: Patients with relapsing-remitting multiple sclerosis (RRMS) can show signs of disease activity despite disease-modifying treatment (DMT). Ocrelizumab (OCR) demonstrated superior efficacy to subcutaneous interferon β-1a in two Phase III trials (OPERA I; OPERA II) in relapsing MS.
Objective: To report Year one interim analysis (IA) results of the multicentre, open-label, Phase IIIb CHORDS study (NCT02637856) evaluating OCR effectiveness and safety in patients with RRMS and a suboptimal treatment response to ≥6 months of DMT.
Methods: Eligible patients discontinued their most recent adequate course of DMT (i.e. administered for ≥6 months) due to suboptimal response (≥1 clinically reported relapse, ≥1 T1 gadolinium-enhancing [Gd+] lesion(s) or ≥2 new or enlarging T2 lesions). The scheduled OCR infusion protocol included two 300-mg intravenous (IV) infusions separated by 14 days followed by 600-mg IV infusions every 24 weeks for up to 96 weeks. This IA evaluated efficacy and safety over 48 weeks in a modified intention-to-treat population, including patients who received ≥1 OCR infusion and reached Week 48 by September 1, 2017, and excluding those who terminated treatment by September 1, 2017 for reasons other than lack of efficacy or death, with no evidence of clinical disease activity at the time of discontinuation.
Results: The CHORDS study enrolled 608 patients with RRMS who had a recent suboptimal response to a prior DMT. Baseline characteristics of the IA population (n=153) were similar to those of the total population, and patients were relatively early in their disease, with a mean (SD) time since diagnosis of 3.9 (2.80) years. Over 48 weeks, the majority of IA patients had no protocol-defined relapse (92.7%), no T1 Gd+ lesions (96.4%), no new or enlarging T2 lesions (65.3%) and no 24-week confirmed disability progression (96.4%). Further, 58.9% of patients were free of any of these protocol-defined events (i.e. no evidence of disease activity [NEDA]). The adjusted annualised relapse rate was 0.047, and new MRI activity included five new T1 Gd+ lesions and 177 new or enlarging T2 lesions over the 48 weeks of the analysis. Interim safety data were consistent with the overall known OCR safety profile.
Conclusions: Results of this IA of patients with RRMS who had 1 year of follow-up in the CHORDS study suggest that ocrelizumab is effective and safe in patients with a suboptimal response to an adequate course of a prior DMT.
Disclosure: Sponsored by Genentech, Inc. T.P. Leist has received compensation for consulting from Bayer, Biogen, EMD Serono, Genentech, Inc., Novartis, Sanofi Genzyme and Teva Neuroscience; as a speaker from Biogen, Genentech, Inc., Novartis, Sanofi Genzyme and Teva Neuroscience; and for research from Alkermes, Novartis and Sun Pharma; A.T. Reder has, in the last year, received consulting fees from Bayer, Biogen, EMD Serono, Inc., Genentech, Inc., Genzyme, Novartis, Mallinkrodt (formerly Questcor); R. Bermel has received consulting fees from Biogen, F. Hoffmann-La Roche Ltd and Genentech, Inc., Genzyme and Novartis; B. Weinstock-Guttman has received honoraria for serving on advisory boards and educational programs from Biogen Idec, Celgene, EMD Serono, Genentech, Inc., Genzyme, Novartis, Sanofi and Teva Pharmaceuticals, and has received research support from Biogen Idec, EMD Serono, Novartis and Teva Neuroscience; M.S. Freedman has received research or educational grants from Genzyme Canada; has received honoraria for consultation fees from Actelion, BayerHealthcare, Biogen Idec, Chugai, Clene Nanomedicine, EMD Canada, F. Hoffmann La-Roche Ltd, Genzyme, Merck Serono, Novartis, Sanofi-Aventis and Teva Canada Innovation; has served as a member of a company advisory board, board of directors or other similar group for Actelion, BayerHealthcare, Biogen Idec, Clene Nanomedicine, F. Hoffmann La-Roche Ltd, Merck Serono, MedDay, Novartis and Sanofi-Aventis; and has participated in a company-sponsored speaker's bureau for Sanofi-Genzyme; G. Cutter has served on data and safety monitoring boards for AMO Pharma, Apotek, Biogen-Idec, Gilead Pharmaceuticals, GlaxoSmithKline Pharmaceuticals, Horizon Pharmaceuticals, Merck Pharmaceuticals, ModigeneTech/Prolor, the National Heart, Lung, and Blood Institute (protocol review committee), Neuren, OPKO, Sanofi-Aventis and Teva; has served on the Obstetric-Fetal Pharmaceutical Research Unit oversight committee for the Eunice Kennedy Shriver National Institute of Child Health and Human Development; and has served on consulting or advisory boards for CereSpir Inc, Consortium of Multiple Sclerosis Centers, D3, F. Hoffmann-La Roche Ltd and Genentech, Inc., Genzyme, Innate Immunotherapeutics, Janssen Pharmaceuticals, Klein Buendel Incorporated, MedDay, MedImmune, Novartis, Opexa Therapeutics, Receptos, Savara Inc, Somahlution, Spinifex Pharmaceuticals, Teva Pharmaceuticals, TG Therapeutics and Transparency Life Sciences; J. Stankiewicz has, in the past year, received consulting fees from Bayer, Biogen Idec, Celgene, EMD Serono, Genzyme and Novartis; H. Zheng is an employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd; B. Musch is an employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd; C. Csoboth is an employee of Genentech, Inc., and a shareholder of F. Hoffmann-La Roche Ltd; J.S. Wolinsky has received personal compensation for consulting, serving on a scientific advisory board, speaking or other activities with AbbVie, Acetilon, Alkermes, Biogen, Bionest, Celgene, Clene Nanomedicine, EMD Serono, Forward Pharma A/S, GeNeuro, MedDay Pharmaceuticals, Novartis, Otsuka, PTC Therapeutics, Roche/Genentech, Sanofi Genzyme; royalties are received for out-licensed monoclonal antibodies through UTHealth from Millipore Corporation.