Bristol Myers Squibb announced detailed results from True North, a pivotal, placebo-controlled Phase 3 trial evaluating oral Zeposia (ozanimod) as an induction and maintenance therapy in adult patients with moderate to severe ulcerative colitis (UC).
True North met both primary endpoints, demonstrating highly statistically significant and clinically meaningful results for clinical remission compared to placebo at induction at Week 10 (18.4% versus 6.0%; p-value<0.0001) and in maintenance at Week 52 (37.0% vs 18.5%; p<0.0001). The study also met key secondary endpoints, including clinical response, endoscopic improvement and mucosal healing in induction at Week 10 and in maintenance at Week 52. Significantly more patients treated with Zeposia compared to placebo achieved clinical response at Week 10 (47.8% vs 25.9%; p<0.0001) and at Week 52 (60.0% vs 41.0%; p<0.0001) with consistent results across sub-analyses. The overall safety observed was consistent with the known safety profile for Zeposia and patients with moderate to severe UC.
Efficacy and safety results from the 10-week induction period (Abstract LB02, UEG Research Prize 2020 Session) and from the maintenance period at Week 52 (Abstract LB10) from True North will be presented on October 11 at 12:32 CEST and at 15:24 CEST, respectively, in two late-breaking oral presentations at UEG Week Virtual 2020.
“The data from the Zeposia True North trial demonstrate patients with moderate to severe ulcerative colitis achieved clinically meaningful improvements in key clinical, endoscopic and mucosal healing endpoints,” said William Sandborn, M.D., chief, Division of Gastroenterology and director, Inflammatory Bowel Disease Center at University of California (UC), San Diego Health and professor of medicine, UC San Diego School of Medicine. “Notably, the endoscopic and histologic benefits, which can be difficult to achieve, suggest Zeposia has the potential to address the need for a safe and effective oral treatment option for this serious, chronic disease.”
All key secondary efficacy endpoints showed statistically significant improvements for patients treated with Zeposia compared to placebo at Week 10 and Week 52. Findings include:
Induction Period (Week 10)
- At Week 10, key secondary endpoints were highly statistically significant and showed more patients treated with Zeposia achieved clinical response, endoscopic improvement and mucosal healing compared to placebo.
- In patients with prior TNF-inhibitor exposure, clinical remission results favored Zeposia over placebo, but findings were not significant at Week 10. A nominally statistically significant difference was observed for clinical response (p=0.008).
Maintenance Period (Week 52)
- At Week 52, highly statistically significant results were achieved for patients treated with Zeposia compared to placebo, including clinical response, endoscopic improvement, maintenance of remission, corticosteroid-free remission, mucosal healing and durable remission.
- Clinical remission and response improved with Zeposia regardless of previous TNF-inhibitor use at Week 52.
In the induction period, the most common treatment-emergent adverse events (TEAEs) for patients who received Zeposia versus placebo, respectively, were anemia (4.2% vs 5.6%), nasopharyngitis (3.5% vs 1.4%) and headache (3.3% vs 1.9%). In the maintenance period, the most common TEAEs for Zeposia versus placebo, respectively, were alanine aminotransferase increase (4.8% vs 0.4%; no serious events), and headache (3.5% vs 0.4%).
“These Zeposia True North results represent a meaningful achievement for patients living with ulcerative colitis, many of whom have an inadequate response or do not respond at all to currently available therapies,” said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb. “We look forward to working with health authorities to bring Zeposia to this patient population and remain committed to pursuing new scientific advances to help deliver transformational medicines for the gastroenterology community.”
Source: Company Press Release