Lilly vs. J&J in Crohn’s Disease: Phase III Results at ACG 2024

Eli Lilly and Johnson & Johnson are both pursuing expanded labels for their respective drugs Omvoh and Tremfya in the treatment of Crohn’s disease, following their initial approvals for managing ulcerative colitis. According to GlobalData, Tremfya is projected to achieve global sales of $7.8 billion by 2029.

Both companies presented promising data at the 2024 American College of Gastroenterology Annual Scientific Meeting, held in Philadelphia from October 25-30. Eli Lilly’s Omvoh and Johnson & Johnson’s Tremfya showed strong results in remission and response rates for Crohn’s disease patients in Phase III trials.

Johnson & Johnson shared results from its Phase III GRAVITI study, revealing that 56.1% of patients treated with a subcutaneous form of Tremfya achieved clinical remission at 12 weeks, compared to 21.4% in the placebo group. At this same period, endoscopic remission was seen in 41.3% of patients receiving Tremfya, versus 21.4% for those on placebo. At the 48-week mark, clinical remission rates improved to 60% for patients on a 100-mg maintenance dose of Tremfya every eight weeks, and to 66.1% for those on a 200-mg dose every four weeks. In contrast, only 17.1% of placebo recipients achieved clinical remission.

Esi Lamousé-Smith, the gastroenterology disease area lead at J&J Innovative Medicines, emphasized the potential of Tremfya to be the sole IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options for Crohn’s disease. If approved for this indication, Tremfya could provide a more convenient self-administration option for patients, starting from the beginning of their treatment.

GlobalData, an analytics firm, recently highlighted Tremfya’s potential to set a new standard in Crohn’s disease treatment, praising its patient-friendly administration profile. Sumaira Malik, an immunology analyst at GlobalData, pointed out that Tremfya’s positive clinical performance and unique dual-binding mechanism make it a stand-out option within its class. GlobalData forecasts Tremfya’s global sales to reach $7.8 billion by 2029.

In parallel, Eli Lilly released long-term data for Omvoh, demonstrating a 96% clinical response rate in Crohn’s disease patients as per the Crohn’s Disease Activity Index. Long-term results showed that 87% achieved clinical remission, with 76% showing an endoscopic response and 54% achieving endoscopic remission.

Additionally, Lilly presented follow-up data for Omvoh in moderate to severe ulcerative colitis, highlighting an 81% long-term clinical remission rate and an 82% long-term endoscopic remission rate. Furthermore, the data revealed that 72% of patients achieved mucosal healing, and 79% reached corticosteroid-free clinical remission.

Mark Genovese, Lilly’s senior vice president of immunology development, stated that Omvoh is unique as the first and only IL23p19 antagonist to report multi-year, long-term sustained efficacy data in both ulcerative colitis and Crohn’s disease.

Both companies are striving to expand the use of their respective drugs into Crohn’s disease. Johnson & Johnson filed a supplemental Biologics License Application for Tremfya in June 2024, supported by Phase III data from the GALAXI program, which indicated Tremfya had better endoscopic outcomes compared to Stelara, a blockbuster drug. Eli Lilly announced in May 2024 that it had filed for Omvoh’s expansion. Earlier this month, Lilly released data from the VIVID-1 trial, showing that Omvoh outperformed Stelara in histologic response.