Immatics reports 56% ORR and 16.2-month mOS in Phase 1b melanoma trial
IMTX•Immatics’ anzu-cel PRAME TCR therapy induced a 56% confirmed ORR with 14.6-month median duration of response, 6.1-month median progression-free survival and 16.2-month median overall survival in 33 heavily pretreated metastatic melanoma patients. Phase 3 SUPRAME remains on track for a BLA submission in first-half 2027.
1. Phase 1b Trial Design
The Phase 1b expansion enrolled 33 heavily pretreated metastatic melanoma patients, including cutaneous, uveal, mucosal and unknown primary subtypes, who received a one-time infusion of anzu-cel at the recommended Phase 2 dose of 1 to 10 billion TCR T cells following lymphodepletion.
2. Robust Anti-tumor Activity
Anzu-cel induced a 56% confirmed ORR, 64% overall ORR and 91% disease control rate across all melanoma subtypes, with median duration of response of 14.6 months, median progression-free survival of 6.1 months and median overall survival of 16.2 months at extended follow-up.
3. Manageable Safety Profile
Treatment-emergent adverse events were mostly expected lymphodepletion-related cytopenias, and cytokine release syndrome was predominantly Grade 1–2; immune effector cell-associated neurotoxicity syndrome was infrequent and mostly mild, with no long-term severe events.
4. Phase 3 SUPRAME Progress
Immatics is advancing the Phase 3 SUPRAME study to evaluate anzu-cel as monotherapy in advanced melanoma, with plans to file a biologics license application in the first half of 2027.
