Falk Gastro Info 3/2025

Rubin DT et al, Lancet. 2025;405(10472):33-49

Guselkumab for the treatment of ulcerative colitis: In this phase 3 study in patients with moderate to severe ulcerative colitis (QUASAR), 23% achieved clinical remission after 12 weeks of treatment with the IL-23 antibody guselkumab compared to 8% with placebo. During maintenance therapy, 50% of patients treated with guselkumab achieved clinical remission after 44 weeks.

André T et al, Lancet. 2025;405(10476):383-395

Double is better – immunotherapy for metastatic microsatellite-instable colorectal cancer: In this phase 3 study in patients with the above-mentioned carcinomas (CheckMATE 8HW), combined treatment with nivolumab and ipilimumab led to superior progression-free survival in all lines of therapy compared to monotherapy with nivolumab.

Sangro B et al, Lancet. 2025;405(10474):216-232

Multimodal therapies for unresectable hepatocellular carcinoma: Several studies are currently evaluating drug therapies in combination with transarterial chemoembolization (TACE) for unresectable hepatocellular carcinoma. A large multicenter international phase 3 study shows the advantage of a combination therapy consisting of immunotherapy, antagonists against vascular endothelial growth factors (VEGF) and TACE compared with immunotherapy plus TACE or TACE without drug therapy.

Hou J et al, N Engl J Med. 2024;391(22):2098-2109

Efficacy of xalnesiran, a small-interfering RNA, with or without an immunomodulator in chronic hepatitis B virus (HBV) infection: Xalnesiran silences HBV transcription and has been studied as monotherapy and in combination with 2 immunomodulators. The primary end point was loss of HBV surface antigen. The highest response rates and most adverse events were observed after therapy with xalnesiran and pegylated interferon.

Hoeppner J et al, N Engl J Med. 2025;392(4):323-335

Multimodal therapy for resectable esophageal cancer: Perioperative chemotherapy with FLOT led to improved survival among patients with resectable esophageal adenocarcinoma as compared with preoperative chemoradiotherapy (including carboplatin and paclitaxel) in this phase 3 trial (ESOPEC).

Ferrante M et al, Lancet. 2024;404(10470):2423-2436

Mirikizumab for the treatment of Crohn's disease: In this phase 3 trial (VIVID-1) with a treat-through design, the IL-23 antibody mirikizumab achieved an endoscopic response in 38% and clinical remission in 45% after 12 and 52 weeks in patients with moderately to severely active Crohn's disease who had failed standard or biologic therapy.