Slide 1: Efficacy and safety of RO7790121 in moderately to severely active ulcerative colitis: TUSCANY-2
Scan the QR code to download this presentation Efficacy and safety of RO7790121, a fully human monoclonal antibody blocking tumour necrosis factor-like ligand 1A in moderately to severely active ulcerative colitis: Results from the randomised, double-blind, placebo-controlled, dose-ranging phase 2b
Slide 2: Disclosure of Conflicts of Interest
Disclosure of Conflicts of Interest Prof. Silvio Danese has: • Held a consultancy/advisory role/board in AbbVie, Alimentiv, Allergan, Amgen, AMT, AstraZeneca, Athos Therapeutics, Biogen, Boehringer, BMS, Celgene, Celltrion, Dr Falk Pharma, Enthera, Ferring, Gilead, Hospira, Inotrem, Janssen, J&J, Li
Slide 3: Introduction
TLR Inflammatory stimulation Stimuli TCR Stimulation Immune complexes TNFα IL-1β Monocytes Introduction Dendritic/monos Lymphocytes Dendritic cells Endothelial cells Constitutive expression • There is a need for continued evolution and novel therapeutic approaches in IBD1–3 TL1A TL1A TL1A TL1A • TL1
Slide 4: Study aim
Study aim The phase 2b TUSCANY-2 study aimed to evaluate the efficacy and safety of RO7790121 in adult patients with moderately to severely active UC ueg.eu UC, ulcerative colitis.
Slide 5: TUSCANY-2: A randomised, double-blind, placebo-controlled, treat-through, dose-ranging, phase 2b study
TUSCANY-2: A randomised, double-blind, placebo-controlled, treat-through, dose-ranging, phase 2b study Induction Period* Maintenance Period† Key eligibility criteria RO7790121 50 mg, SC, QW4 (N=12) Placebo, SC, QW4 RO7790121 150 mg, SC, QW4 (N=14) (N=45) • Patients aged 18–75 years, with RO7790121 4
Slide 6: Results
Results Meet. Exchange. Evolve ueg.eu/week
Slide 7: Baseline characteristics were generally similar between induction treatment arms
Baseline characteristics were generally similar between induction treatment arms Placebo 50 mg 150 mg 450 mg Overall (n=45) (n=47) (n=62) (n=91) (N=245) Age (yr), mean (SD) 39.9 (12.9) 37.8 (13.9) 42.2 (13) 41.6 (13.8) 40.7 (13.5) Sex, female, n (%) 21 (46.7) 19 (40.4) 23 (37.1) 36 (39.6) 99 (40.4)
Slide 8: Higher proportions of patients across all RO7790121 doses experienced clinical remission vs placebo at week 14
Higher proportions of patients across all RO7790121 doses experienced clinical remission vs placebo at week 14 Clinical remission by tMS Clinical remission by mMS 80 Δ=20.2 (3.2, 31.3) Proportion of participants (90% CI) Δ=12.2 (–0.6, 22.9) Δ=23.4 (6.2, 36.3) 60 Δ=11.71 (–1.7, 24.1) Placebo Δ=18.2 (
Slide 9: Remission rates at week 14 were sustained through week 56
Remission rates at week 14 were sustained through week 56 in participants treated with RO7790121 Clinical remission by tMS* Clinical remission by mMS* 80 80 50 mg Proportion of participants (90% CI) Proportion of participants (90% CI) 150 mg 450 mg 60 39.3% 60 38.5% 34.6% 37.9% 35.7% 31% 27.6% 30.4%
Slide 10: Rates of endoscopic improvement at week 14 were greater with RO7790121 vs placebo, sustained up to week 56
Rates of endoscopic improvement at week 14 were greater in participants receiving RO7790121 vs placebo, sustained up to week 56 Endoscopic improvement at week 14 Endoscopic improvement at weeks 14 and 56* All participants vs placebo Participants receiving the same dose of RO7790121 during induction
Slide 11: At week 14, numerically greater treatment effects were observed in biomarker-positive participants
At week 14, numerically greater treatment effects were observed in biomarker-positive participants relative to all-comer participants Clinical remission by mMS Endoscopic improvement 80 80 Proportion of patients (90% CI) Placebo Placebo Proportion of patients (90% CI) RO7790121 RO7790121 51.6% 60 60
Slide 12: Safety results
Safety results Induction period* Placebo 50 mg 150 mg 450 mg Total (N=45) (N=47) (N=62) (N=91) (N=245) With any adverse event, n (%) 25 (55.6) 16 (34.0) 28 (45.2) 48 (52.7) 117 (47.8) Participants with serious adverse events 4 (8.9) 3 (6.4) 0 (0.0) 3 (3.3) 10 (4.1) Participants discontinued study dr
Slide 13: Conclusions
Conclusions • Treatment with RO7790121 resulted in notable improvements in efficacy endpoints • Clinically meaningful improvements in clinical remission by tMS, mMS, as well as endoscopic improvements were seen across all RO7790121 doses versus placebo at week 14, and these were sustained up to week
Slide 14: Acknowledgments
Acknowledgments We as authors would like to thank the: • Patients their families, and their caregivers for their participation in TUSCANY-2 • Study investigators and their team members at each site for their support during the trial conduct • Funding: Pfizer, Inc, Roivant Sciences, Ltd, and F. Hoffm