Intensity Therapeutics' Sarcoma Trial INT230-6 Authorized to Continue by DMC
• Intensity Therapeutics' Phase 3 INVINCIBLE-3 study of INT230-6 in soft tissue sarcoma is authorized to continue without modifications after a Data Monitoring Committee review.
• The global, randomized trial compares intratumoral INT230-6 to standard-of-care chemotherapy in patients with leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma.
• INT230-6 showed a median overall survival of 21.3 months in Phase 1/2 data, compared to 6.7 months in a synthetic control, alongside increased T-cell activation and a favorable safety profile.
• The INVINCIBLE-3 study is actively recruiting across the US, Canada, and Europe, aiming to enroll 333 patients to evaluate overall survival and safety.
Keros Therapeutics Pauses Cibotercept Dosing in Higher Dose Arms of Phase 2 PAH Trial Due to Pericardial Effusion
• Keros Therapeutics halts dosing in the 3.0 mg/kg and 4.5 mg/kg arms of its Phase 2 TROPOS trial of cibotercept for pulmonary arterial hypertension (PAH) after detecting pericardial effusion.
• The decision follows a safety review and consultation with an independent Data Monitoring Committee; dosing continues in the 1.5 mg/kg arm.
• Keros is working with investigators and the FDA to understand the findings and expects to share topline data from all trial arms in Q2 2025.
• Despite this setback, Keros will continue safety and efficacy data collection for all treatment arms in the TROPOS trial.
Inventiva's Lanifibranor Maintains Positive Safety Profile in Phase 3 MASH Trial
• The Data Monitoring Committee (DMC) recommended the continuation of Inventiva's Phase 3 NATiV3 trial for MASH without protocol modification.
• The recommendation was based on unblinded safety data from over 1000 patients, including those treated for up to 72 weeks.
• The DMC's review confirmed the good safety and tolerability profile of lanifibranor in MASH patients.
• Lanifibranor is a pan-PPAR agonist being evaluated for its anti-fibrotic, anti-inflammatory, and metabolic benefits in MASH.
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