Core Insights - Immatics N.V. announced updated data from a Phase 1b trial of anzu-cel PRAME cell therapy for patients with metastatic uveal melanoma, highlighting its potential to improve treatment outcomes in this challenging patient population [1][3][4] Patient Population - The trial involved 16 patients with metastatic uveal melanoma, who received a one-time infusion of anzu-cel at a recommended Phase 2 dose of 1 to 10 billion total TCR T cells, with a median infused dose of approximately 4 billion TCR T cells [4][5] - Patients had a median of 2 lines of prior systemic treatments and a median target lesion sum diameter of 103 mm, with 81% having liver and extrahepatic metastasis [4] Anti-tumor Activity and Durability - The updated data showed a confirmed objective response rate (cORR) of 67% (10 out of 15 patients) and a disease control rate (DCR) of 88% (14 out of 16 patients) [6] - The median duration of response (mDOR) was 11 months, with a median progression-free survival (mPFS) of 8.5 months, and median overall survival (mOS) not reached at 14.3 months of follow-up [6][5] - Anti-tumor activity was observed across various metastases, including liver lesions, with a median shrinkage of 49.6% in liver target lesions [7][5] Safety Profile - Anzu-cel demonstrated a favorable tolerability profile, consistent with its overall safety profile, with the most frequent treatment-emergent adverse events being cytopenias associated with lymphodepletion [9][12] - Cytokine release syndrome (CRS) was mostly Grade 1 or 2, with no long-term CRS observed, and most cases resolved by day 14 [12][9] Development Path - Based on the promising clinical data, Immatics has initiated a Phase 2 cohort with approximately 30 patients planned, conducted at select centers in the U.S. and Germany [14] - Prospective PRAME testing is no longer required for inclusion in the clinical trial due to the high prevalence of PRAME expression in uveal melanoma [14] Company Overview - Immatics is a clinical-stage biopharmaceutical company focused on precision targeting of PRAME, with a broad pipeline that includes multiple product candidates and therapeutic modalities [16][18] - Anzu-cel is part of a larger strategy to develop therapies for various cancers expressing PRAME, with ongoing trials in both uveal and cutaneous melanoma [17][15]
Immatics Highlights Compelling Anti-Tumor Activity of Anzu-cel PRAME Cell Therapy in Metastatic Uveal Melanoma at the ESMO 2025 Presidential Symposium