Immatics Anzu-cel Phase 1b shows 56% ORR, 14.6m mDOR in melanoma
Immatics N.V. announced extended positive data from its Phase 1b clinical trial of anzu-cel (IMA203) PRAME TCR T-cell therapy for advanced melanoma. The one-time infusion demonstrated rapid, deep, and durable systemic anti-tumor activity in metastatic PD-1 relapsed cutaneous melanoma and metastatic uveal melanoma. Anzu-cel achieved a 56% confirmed Overall Response Rate (ORR), 14.6 months median Duration of Response (mDOR), 6.1 months median Progression-Free Survival (mPFS), and 16.2 months median Overall Survival (mOS) with a manageable tolerability profile. These findings reinforce the drug's effectiveness, keeping the Phase 3 SUPRAME trial on track for a Biologics License Application (BLA) submission in 1H 2027.
Key Highlights
- Anzu-cel Phase 1b trial showed 56% confirmed ORR (18/32 patients) in advanced melanoma.
- Median Duration of Response (mDOR) was 14.6 months (range 4.2, 38.2+).
- Median Progression-Free Survival (mPFS) was 6.1 months (range 1.4, 39.6+).
- Median Overall Survival (mOS) was 16.2 months (range 2.4, 39.6+).
- 42% (14/33) of patients experienced a deep response (>=50% tumor reduction).
- Phase 3 SUPRAME trial remains on track for BLA submission in 1H 2027.
- Safety profile was predictable and manageable, with mostly Grade 1/2 cytokine release syndrome (CRS).
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