T. Dörner 1, M. Weinblatt 2, P. Durez 3, R. Alten 4, K. Van Beneden 5, E.J. Dombrecht 5, K. De Beuf 5, P. Schoen 5, R.K. Zeldin 5
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1 Remission and Maintenance of Efficacy in a Phase 2b study of Vobarilizumab, an Anti-Interleukin 6 Receptor Nanobody, in Patients with Moderate-to-Severe Rheumatoid Arthritis despite Treatment with Methotrexate T. Dörner 1, M. Weinblatt 2, P. Durez 3, R. Alten 4, K. Van Beneden 5, E.J. Dombrecht 5, K. De Beuf 5, P. Schoen 5, R.K. Zeldin 5 1 Charité University Hospitals, Berlin, Germany, 2 Brigham and Women's Hospital, Boston, MA, US, 3 Cliniques Universitaires St-Luc, Sint-Lambrechts-Woluwe, Belgium, 4 Schlosspark-Klinik, Berlin, Germany 5 Ablynx NV, Zwijnaarde, Belgium EULAR Congress, June 14-17, 2017, Madrid 1
2 EULAR Congress, June 14-17, 2017, Madrid 2 Disclosures T. Dörner; Consultant for Ablynx, Roche/Chugai, Janssen, Eli Lilly, Sanofi, Celgene; Study Support: Roche, Janssen, Sanofi, UCB M. Weinblatt; Consultant for Ablynx P. Durez; None, study investigator R. Alten; Research Grants and Consulting Fees from Ablynx K. Van Beneden; Employee of Ablynx E.J. Dombrecht; Employee of Ablynx K. De Beuf; Employee of Ablynx P. Schoen; Employee of Ablynx R.K. Zeldin; Employee of Ablynx
3 EULAR Congress, June 14-17, 2017, Madrid 3 Vobarilizumab IL-6R targeting Nanobody
4 Vobarilizumab IL-6R targeting Nanobody Bispecific Nanobody (26 kda) No induction of antibody-dependent cell cytotoxicity due to lack of Fc Half-life extension by binding to human serum albumin At therapeutic doses the apparent half-life is ± 14 days Preferential sil-6r engagement with a high affinity for sil-6r Anti-IL-6R Vobarilizumab (26 kda) Anti-HSA EULAR Congress, June 14-17, 2017, Madrid 4
5 EULAR Congress, June 14-17, 2017, Madrid 5 Study Design N=69; placebo q2w + MTX N=69; vobarilizumab 75 mg q4w + MTX 345 patients MTX-IRs N=70; vobarilizumab 150 mg q4w + MTX N=68; vobarilizumab 150 mg q2w + MTX OLE N=69; vobarilizumab 225 mg q2w + MTX placebo s.c. vobarilizumab s.c. Wk * 14 16* 18 20* Primary Endpoint: ACR20 at Week 12 * Forced discontinuation based on less than 20% improvement in both SJC and TJC at Weeks 12, 16 or 20
6 EULAR Congress, June 14-17, 2017, Madrid 6 Key Inclusion and Exclusion Criteria Inclusion Criteria Active RA (2010 EULAR/ACR classification criteria) for at least 6 months: 6 swollen and 6 tender joints (66/68-joint count) CRP 1.2 x ULN (> 1.0 x ULN, amendment) MTX inadequate responders: Minimum treatment duration of 4 months Stable dose of MTX of mg/week for at least 6 consecutive weeks Use of NSAIDs, other analgesics for RA and oral corticosteroids if doses stable for 2 weeks Exclusion Criteria Use of DMARDs other than MTX during previous 4 weeks Use of bdmard or JAK inhibitor during previous 6 months Have reported a history of toxicity, non-tolerance, primary non-response or inadequate response to a bdmards or JAK inhibitor Have received prior therapy blocking the IL-6 pathway
7 EULAR Congress, June 14-17, 2017, Madrid 7 Primary and Main Efficacy Endpoints Primary efficacy endpoint ACR20 at Week 12 Secondary efficacy endpoints included: ACR20 at Week 24 ACR50 and ACR70 at Week 12 and Week 24 DAS28 CRP at Week 12 and Week 24 Proportion of subjects in sustained remission (DAS28 CRP ) at 4 consecutive time points (i.e., at Weeks 12, 16, 20 and 24) Proportion of subjects with sustained ACR50/ACR70 at 4 consecutive time points* * post-hoc analysis
8 Overall Well Balanced Baseline Demographics and Disease Characteristics PBO q2w N = mg q4w N = mg q4w N = mg q2w N = mg q2w N = 69 Female, % Age, years 53 (12) 53 (10) 52 (13) 52 (12) 52 (13) Duration of RA, years 7.4 (7.0) 7.3 (6.8) 8.9 (9.8) 8.6 (7.8) 8.0 (8.1) SJC (10) 16 (7) 15 (8) 18 (10) 15 (10) TJC (13) 26 (12) 24 (12) 27 (14) 24 (13) CRP, mg/l 23 (26) 22 (23) 24 (26) 29 (42) 20 (22) ESR, mm/h 42 (26) 44 (21) 43 (21) 46 (23) 39 (22) HAQ-DI score 1.7 (0.5) 1.7 (0.7) 1.6 (0.6) 1.8 (0.7) 1.6 (0.7) RF positive, % Anti-CCP positive, % DAS28 CRP 6.0 (0.9) 6.0 (0.8) 5.8 (0.9) 6.2 (0.9) 5.8 (0.9) DAS28 ESR 6.5 (1.1) 6.6 (0.8) 6.4 (0.9) 6.8 (0.8) 6.4 (1.1) MTX dose, mg/week 16 (4) 17 (4) 17 (4) 16 (3) 17 (5) Data are mean (SD) unless stated otherwise EULAR Congress, June 14-17, 2017, Madrid 8
9 EULAR Congress, June 14-17, 2017, Madrid 9 ACR20/50/70 Responses at Week 12 and Week 24 Week 12 Week 24 * Week 12 * ** * *nominal p<0.05 vs. placebo; ** nominal p<0.01 vs. placebo; Intent-to-treat (ITT) population; Non-responder imputation (NRI) Weinblatt et al. (Annual Scientific Meeting, Canadian Rheumatology Association, 2017, poster)
10 Substantial Proportion of Patients with Sustained ACR Response in Groups Receiving Higher Dose Regimens of Vobarilizumab Proportion of Patients achieving ACR50/ACR70 at Weeks 12, 16, 20 and 24 * ** Post-hoc analysis; *nominal p<0.05 vs. placebo; ** nominal p<0.01 vs. placebo; ITT population; NRI EULAR Congress, June 14-17, 2017, Madrid 10
11 DAS28 CRP < 2.6 and Low Disease Activity at Week 12 and Week 24 ** ** * ** * ** ** ** *nominal p<0.05 vs. placebo; ** nominal p<0.01 vs. placebo; nominal p<0.001 vs. placebo; ITT population; NRI Low Disease Activity: DAS28 CRP 3.2 EULAR Congress, June 14-17, 2017, Madrid 11
12 EULAR Congress, June 14-17, 2017, Madrid 12 More Stringent Endpoint (Sustained DAS28 CRP < 2.6) Confirms Treatment Effect in Groups Receiving Higher Dose Regimens of Vobarilizumab Proportion of Patients Achieving Sustained DAS28 CRP < 2.6 at Weeks 12, 16, 20 and 24 ** ** ** nominal p<0.01 vs. placebo; nominal p<0.001 vs. placebo; ITT population; NRI
13 EULAR Congress, June 14-17, 2017, Madrid 13 Favorable Safety Profile through Week 24 and Follow-Up Period Number of subjects (%) placebo N=69 75 mg q4w N= mg q4w N= mg q2w N= mg q2w N=69 Any TEAE 36 (52) 42 (61) 44 (63) 44 (65) 45 (65) - Treatment-related 18 (26) 26 (38) 25 (36) 26 (38) 26 (38) - Leading to study drug discontinuation 3 (4) 4 (6) 5 (7) 5 (7) 4 (6) Any serious TEAE 4 (6) 5 (7) 5 (7) 0 2 (3) - Treatment-related 2 (3) 1 (1) 3 (4) 0 2 (3) - Leading to death 0 1 (1) * Serious infections** 2 (3) 1 (1) 4 (6) 0 1 (1) - Gastrointestinal perforation (1) * Fatal cardiac arrest, considered not related to study drug. A 74-year old female with medical history of hypertension, myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, COPD and depression. ** Pneumonia (3), herpes zoster, ear infection, cellulitis/sepsis, pharyngitis, arthritis bacterial/staphylococcal sepsis/intervertebral discitis Large intestine perforation in subject who had discontinued the study drug for other reason and received last dose 17 days before the event TEAE: treatment-emergent adverse event
14 EULAR Congress, June 14-17, 2017, Madrid 14 Conclusions In patients with established RA, despite receiving MTX, treatment with vobarilizumab had a positive impact on stringent clinical efficacy endpoints (ACR50, ACR70, DAS28 CRP < 2.6 and LDA) while primary endpoint at Week 12 was not met Maintenance of ACR responses and DAS28 CRP < 2.6 during the last 4 consecutive visits (at Weeks 12, 16, 20 and 24) was observed for a substantial proportion of patients These results are indicative of a strong potential for disease modifying activity of vobarilizumab supporting treat-to-target management of RA Results are supported by data from a monotherapy study of vobarilizumab and tocilizumab, poster FRI0239
15 EULAR Congress, June 14-17, 2017, Madrid 15 Thanks to the Investigators & Site Staffs Argentina Georgia Mexico Romania Casado G. Kilasonia L. Ceceña M. Tamas S. Lazaro M. Kirvalidze N. Limón J. Ancuta I. Rosemffet M. Lortkipanidze M. Rodríguez A. Popoviciu H. Lucero E. Shalamberidze L. Torres J. Pavel M. Asnal C. Kurashvili N. Medina F. Arvunescu M. Alvarellos A. Villareal A. Alvarado D. Lorenzo R. Belgium Germany Serbia USA Van den Bosch F. Konig R. Stojanovic S. Ho G. Durez P. Alten R. Stupar N. Hull J. Malaise M. Wollenhaupt J. Moldova Stefanovic D. Hazan L. Badot V. Behrens F. Minodora M. Damjanov N. Clarke P. Rubbert-Roth A. Bodrug I. Bobic B. Garcia J. Feist E. Abinader A. Bulgaria Bretton E. Toncheva A. Hungary Poland Steinberg A. Batalov A. Kun R. Mazurek M. Spain Alvares H. Jordanova N. Sulyok G. Porawska W. Montes J. Roche N. Stoilov R. Keszthelyi P. Rosiak K. Gonzalez C. Williams H. Kadinov V. Drescher E. Goździk J. Pablos J. Singhal A. Yablanski K. Somos É. Wronisz M. Meijide J. Mehta C. Velkova M. Pulai J. Jaworski J. Poiley J. Balázs T. Jeka S. Birbara C. Czech-Republic Nagy M. Wojciechowski R. Gupta R. Vitek P. Niebrzydowski J. Edwards W. Vencovsky J. Bazela B. Fondal M. Skacelova M. Macedonia Brzezicki J. Stejfova Z. Kafedjiska I. Lapcikova A. Perchinkova S. Coordinating Investigators Dörner T. Weinblatt M.
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