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Results from Randomized Phase II Core and Extension Studies in Relapsing‑Remitting Multiple Sclerosis Mark S

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Results from Randomized Phase II Core and Extension Studies in Relapsing‑Remitting Multiple Sclerosis Mark S 37 Long-term efficacy and safety of ponesimod: Results from randomized phase II core and extension studies in relapsing-remitting multiple sclerosis Mark S. Freedman1, Carlo Pozzilli2, Eva Kubala Havrdova3, Patricia K. Coyle4, Alexandre Lemle5, Michel Burcklen5, Anna Larbalestier5, Brian Hennessy5, Tatiana Scherz5, Andrea Vaclavkova5, Tomas Olsson6 1Multiple Sclerosis Research Unit, The University of Ottawa and The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; 2Sapienza University of Rome, Rome, Italy; 3First Medical Faculty, Charles University, Prague, Czech Republic; 4Stony Brook University Medical Center, Stony Brook, NY, USA; 5Actelion Pharmaceuticals Ltd, Part of Janssen Pharmaceutical Companies of Johnson & Johnson, Allschwil, Switzerland; 6Karolinska Institute, Stockholm, Sweden BACKGROUND METHODS • Ponesimod is an orally active, selective S1P1 Study design and patient flow Endpoints modulator that induces rapid, dose-dependent, and Efficacy reversible reductions in peripheral blood lymphocyte Core study Long-term Extension study Population • Annualized relapse rate (ARR) count by preventing the lymphocyte egress from TP1* TP2** TP3** 1 • Time to first confirmed relapse lymphoid organs. 24 weeks up to 96 weeks up to 432 weeks Follow-up */** • Number of total T1 Gd+ lesions and percentage of • In a 24-week multicenter, double-blind phase • Patients with RRMS aged 10 mg (n=31) 10 mg (n=28) 20 mg (n=24) patients free of new or enlarging T2 lesions IIb (Core) study (NCT01006265) in patients with 18–55 years 20 mg (n=31) 20 mg (n=24) 20 mg (n=21) • Time to 6-month confirmed disability accumulation relapsing remitting multiple sclerosis (RRMS), once • Active disease 24 months Placebo (n=121) prior to screening 10 mg (n=7) 20 mg (n=5) (CDA) daily ponesimod at 10, 20 and 40 mg significantly 40 mg (n=32) • Ambulatory patients with an 20 mg (n=13) 20 mg (n=11) and dose-dependently reduced inflammatory MRI EDSS score between 0 and Safety 2 5.5 Ponesimod 10 mg (n=108) 10 mg (n=84) 10 mg (n=76) 20 mg (n=58) activity vs placebo. • Treatment-emergent adverse events, clinical • Patients who completed the Ponesimod 20 mg (n=116) 20 mg (n=90) 20 mg (n=82) 20 mg (n=57) laboratory tests, 12-lead ECGs, systolic and diastolic • Patients completing the Core study were offered 24-week treatment period in 10 mg (n=40) 20 mg (n=24) the Core study entered the Ponesimod 40 mg (n=119) 40 mg (n=85) blood pressure, and pulmonary function tests enrollment into the currently ongoing double-blind Extension study 20 mg (n=35) 20 mg (n=28) long-term Extension study (NCT01093326). Patients who received placebo during the 40 mg was discontinued Patients who received 40 mg All patients received Analyses Core study were re-randomized 1:1:1 to at the end of TP1 during TP1 were re-randomized 1:1 open-label 20 mg during TP3 • We report the results of the combined data from the ponesimod 10, 20 or 40 mg in TP1 to either 10 or 20 mg in TP2. 10 mg • The data presented here cover the entire ponesimod was discontinued at the end of TP2 Core and Extension studies that led to dose-selection treatment period of Core and Extension studies, Analysis of ponesimod 10, 20 and 40 mg (up to end of TP1) during the course of the study, and long-term (up to Analyses were performed by including a total of 435 patients who received at least approximately 9 years) safety and efficacy results of the first randomized one dose of ponesimod at any time during the studies ponesimod dose (regardless Benefit-risk analysis of ponesimod 10 and 20 mg (up to end of TP2) the continuous ponesimod 20 mg in patients with of subsequent re-assignment) (Ponesimod Analysis Set). in three periods RRMS. Analysis of long-term efficacy and safety of ponesimod 20 mg (up to end of TP3) • Placebo period in the Core study was excluded. • The cutoff date for the combined analysis: 31 March *Patients who discontinued/completed during Core or TP1 had EOT visit and follow-up visits at 8 and 30 days after the last study drug intake; **Patients who discontinued/completed during TP2 or TP3 had EOT visit and follow-up visits at 8, 30 and 90 days after the last study drug intake; Placebo period was excluded from the analysis. Patients were grouped according to their first randomized ponesimod dose 2019 (up to 9 years of total study treatment). (10/20/40 mg). n is the number of patients randomized in each period. EDSS, Expanded Disability Status Scale; EOT, end of treatment; TP, treatment period; RRMS, relapsing remitting multiple sclerosis RESULTS Patient disposition and premature treatment discontinuation Analysis of ponesimod 10, 20 and 40 mg: from Core up to end Ponesimod Ponesimod Ponesimod 100 of Extension TP1 10 mg 20 mg 40 mg Total • The median (range) exposure from Core to end of Extension TP1 in 10, 20 and 40 mg was 2.0 (0-2.57), 2.1 (0-2.76), and Randomized and 80 1.9 (0-2.59) years, respectively treated with % Meier) 139 145 151 435 - ponesimod at any time*, n 60 Efficacy Safety Completed treatment 9 (6.5) 13 (9.0) 11 (7.3) 33 (7.6) 16.0% at any time* 100 Ponesimod 40 0.3 vs 10 mg 1.5 100 Ponesimod 10 mg Parameter, 10 mg 20 mg 40 mg 90 Ponesimod 20 mg Treatment ongoing 73 (52.5) 75 (51.7) 66 (43.7) 214 (49.2) 90 n (%) 0.25 Ponesimod 40 mg (N=139) (N=145) (N=151) Ponesimod 10 mg (N = 139) 11.8% 80 Interrupted treatment 20 0.25 80 Patients with 125 126 140 - - 2 (1.3) 2 (0.5) vs 20 mg for planned pregnancy Ponesimod 20 mg (N = 145) 47.6% 70 70 ≥1 TEAE (89.9) (86.9) (92.7) 0.2 0.21 1 vs 10 mg Ponesimod 40 mg (N = 151) 60 Patients with ≥1 Prematurely Survival Probabilities (Kaplan 0 0.19 60 66.4 7.0% 14 (10.1) 15 (10.3) 7 (4.6) 8.7% 61.8 vs 10 mg serious TEAE discontinued 0.86 50 57 (41.0) 57 (39.3) 72 (47.7) 186 (42.8) 0 48 96 144 192 240 288 336 384 432 0.15 vs 20 mg 50 treatment at any 23.0% Patients with ≥1 Time from first dose of ponesimod (weeks) 40 40 44.0% time* Ponesimod 10 mg 42.1 vs 20 mg vs 10 mg TEAE leading to Percentage(%) 17 (12.2) 12 (8.3) 27 (17.9) 0.1 0.5 36.9 Meanestimate 30 30 treatment Data are presented as n (%) unless otherwise noted at risk 139 111 107 99 96 93 88 87 81 64 0.45 0.41 30.3 20.0% discontinuation event(s) 0 21 25 32 35 38 42 43 49 55 20 20 25.0 vs 20 mg censored 0 7 7 8 8 8 9 9 9 20 0.05 %KM estimate atWeek 120 17.8 Death 0 0 0 Ponesimod 20 mg 10 10 • A higher rate of premature treatment 9.1 6.8 at risk 145 113 110 102 97 91 83 81 78 66 0 0 0 0 The most frequently reported TEAEs (≥10% of patients in discontinuation was observed in the event(s) 0 23 26 32 37 42 49 51 54 56 ARR (Confirmed Number of Gd+ T1 Patients free of Time to first Time to 6-month any group): nasopharyngitis, headache, URTI, ALT increased, censored 0 9 9 11 11 12 13 13 13 23 relapses) lesions, new or enlarging confirmed relapse CDA 40 mg group than in the 20 mg and 10 mg influenza, dyspnea, cough, and peripheral edema Ponesimod 40 mg mean/scan T2 lesions groups. at risk 151 106 99 88 84 79 76 71 70 61 event(s) 0 38 42 52 56 61 64 69 70 71 • A dose-response trend was observed for most of the efficacy endpoints, suggesting an increased benefit with the 20 and • Treatment was ongoing in 214 (49%) censored 0 9 10 11 11 11 11 11 11 19 40 mg doses vs the 10 mg dose. However, ponesimod 40 mg dose was associated with reduced tolerability compared patients as of 31 March 2019. Placebo period was excluded from the analysis. Patients were grouped according to their first randomized ponesimod dose with the lower doses. (10/20/40 mg); *At any time during the core or extension studies; TP, treatment period. • The overall benefit/risk profile of 20 mg dose was favorable compared to 40 mg, which supported the decision to stop the development of 40 mg dose and re-randomize patients receiving 40 mg dose to 10 mg or 20 mg at the entry of TP2. ALT, alanine aminotransferase; ARR, annualized response rate; CDA, confirmed disability accumulation; T1 Gd+, T1-weighted gadolinium-enhanced; TEAEs, treatment-emergent adverse events; TP, treatment period; URTI, upper respiratory tract infection; UTI, urinary tract infection. Placebo period was excluded from the analysis. Patients were grouped according to their first randomized ponesimod dose (10/20/40 mg). Benefit-risk analysis of ponesimod 10 and 20 mg: from Core up Long-term efficacy of ponesimod 20 mg: from Core up to end of to end of Extension TP2 Extension TP3 • The median (range) exposure from Core to end of Extension TP2 in 10 and 20 mg was 6.9 (0-8.12) and 6.7 (0-8.07) years, • The cumulative exposure across all doses was 2372.5 patient-years and the median (range) exposure in the 20 mg group respectively was 8.0 (0-9.4) years Efficacy Safety Efficacy Safety Ponesimod 0.3 1.5 100 100 0.3 100 100 Ponesimod Ponesimod 10 mg Parameter, 10 mg 20 mg 40 mg 1.5 Ponesimod 10 mg Ponesimod 20 mg Parameter, 10 mg 20 mg 40 mg Total 90 90 n (%) (N=139) (N=145) (N=151) 90 90 Ponesimod 20 mg 0.25 30.1% Ponesimod 40 mg 0.25 Ponesimod 40 mg n (%) (N=139) (N=145) (N=151) (n=435) 80 80 Patients with 132 132 146 80 80 vs 10 mg Patients with 132 132 148 0.23 18.0% ≥1 TEAE (95.0) (91.0) (96.7) 412 (94.7) 70 70 0.22 70 70 ≥1 TEAE (95.0) (91.0) (98.0) 0.2 1 50.7% vs 10 mg Patients with ≥1 0.2 1 23 (16.5) 23 (15.9) 20 (13.2) Patients with ≥1 vs 10 mg 60 60 60 60 27 (19.4) 27 (18.6) 23 (15.2) 77 (17.7) 0.92 serious TEAE serious TEAE 50 0.15 0.85 50 50 0.15 0.16 0.16 50 46.0% Patients with ≥1 0.16 54.1 52.1 0.15 49.4 Patients with ≥1 40 48.6 40 vs 10 mg TEAE leading to 40 47.9 45.8 40 45.8 42.8 44.3 19 (13.7) 15 (10.3) 34 (22.5) 43.9 TEAE leading to Percentage(%) 20 (14.4) 16 (11.0)
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