Merck Advances Pipeline with Tulisokibart Phase 3 Data and EU Nod for Keytruda-Padcev | iPharmaCenter

Merck has announced pivotal advancements across its pipeline, highlighting positive Phase 3 data for its ulcerative colitis candidate, tulisokibart, alongside a fresh European approval for its Keytruda-Padcev combination in bladder cancer.

Also read: CDSCO Approves AstraZeneca's Enhertu as New First-Line Combination for HER2-Positive Breast Cancer in India

Tulisokibart Hits Primary Target in Phase 3 Ulcerative Colitis Trial

Merck’s Phase 3 ATLAS-UC trial met its primary objective, demonstrating that tulisokibart (MK-7240) successfully induces clinical remission in patients with moderate-to-severe ulcerative colitis after 12 weeks. Evaluating the anti-TL1A monoclonal antibody against a placebo using the Modified Mayo Score, researchers also noted significant improvements in secondary endpoints. The drug achieved key benchmarks in clinical response, endoscopic healing, and combined histologic-endoscopic mucosal recovery.

Safety data mirrored earlier Phase 2 profiles, revealing no unexpected side effects. This milestone positions tulisokibart as the first TL1A-targeted antibody to clear a 12-week Phase 3 induction hurdle for this patient profile. Merck designed the therapy to interrupt immuno-fibrosis pathways that drive chronic tissue damage. The company is currently accelerating its broader clinical program, testing tulisokibart across seven indications including Crohn’s disease, rheumatoid arthritis, and systemic sclerosis-associated interstitial lung disease.

Also read: Japan Approves Sanofi’s Wayrilz for Chronic Immune Thrombocytopenia Treatment

EU Approves Keytruda-Padcev Combo for Bladder Cancer

Concurrently, the European Commission authorized pembrolizumab (Keytruda) combined with enfortumab vedotin (Padcev) as a perioperative treatment for adults with resectable, muscle-invasive bladder cancer (MIBC) who cannot tolerate cisplatin chemotherapy.

This decision establishes the regimen as the EU's first approved pairing of a PD-1 inhibitor and an antibody-drug conjugate for this patient population, spanning both pre-surgical (neoadjuvant) and post-surgical (adjuvant) phases.

Approval stems from the Phase 3 KEYNOTE-905 (EV-303) trial, a collaborative study with Pfizer and Astellas. The data revealed that the perioperative combination slashes the risk of event-free survival (EFS) events by roughly 60% and cuts mortality risk by approximately half compared to surgery alone.

Median EFS and overall survival figures remain immature as patients continue to outlive the benchmarks. Additionally, the combo induced a pathologic complete response in over half of the treated patients, compared to a single-digit success rate for the surgery-only cohort.

Also read: AbbVie to Acquire Apogee Therapeutics in $10.9 Billion Immunology Deal