Core Insights - Immatics N.V. announced expanded data from the Phase 1b clinical trial of IMA203 PRAME cell therapy, showing a confirmed overall response rate (ORR) of 56% in heavily pretreated patients with metastatic melanoma [1][8][11] - The ongoing Phase 3 SUPRAME trial is evaluating IMA203 in patients with unresectable or metastatic cutaneous melanoma who have previously received checkpoint inhibitors [1][12][13] Phase 1b Trial Data - The trial included 33 heavily pretreated patients with a median of 2 prior systemic treatments, with a focus on cutaneous melanoma (n=14), uveal melanoma (n=16), and other subtypes [4][8] - The confirmed ORR was 56%, with a median duration of response (mDOR) of 12.1 months and a median progression-free survival (mPFS) of 6.1 months [8][9] - In the cutaneous melanoma subgroup, the confirmed ORR was 50%, with mDOR not reached and mPFS of 6.0 months [8][9] - The uveal melanoma subgroup showed a confirmed ORR of 67% and mDOR of 11.0 months [8][9] Safety and Tolerability - IMA203 maintained a favorable tolerability profile across 74 patients, with manageable treatment-emergent adverse events primarily related to lymphodepletion [5][6] - Cytokine release syndrome (CRS) was mostly Grades 1 and 2, with no long-term CRS observed [6][7] - Immune effector cell-associated neurotoxicity syndrome (ICANS) was infrequent and mostly mild [6][7] SUPRAME Phase 3 Trial Overview - The SUPRAME trial is a randomized, controlled study involving approximately 360 patients with unresectable or metastatic cutaneous melanoma [12][13] - The primary endpoint is progression-free survival (PFS) assessed by blinded independent central review [13] - Patient enrollment began in early 2025, with completion expected in 2026, and a Biologics License Application (BLA) is planned for submission in Q1 2027 [15] PRAME Target and Company Positioning - PRAME is expressed in over 50 cancers, and Immatics aims to establish a broad PRAME franchise with multiple indications and modalities [3][16] - The company is positioned as a global leader in precision targeting of PRAME, with IMA203 being a key product candidate [3][16][17]