Anzu-cel shows favorable tolerability, strong anti-tumor activity in Phase 1b trial.

Anzu-cel, a one-time infusion, has shown favorable tolerability and strong anti-tumor activity in a Phase 1b trial for metastatic melanoma. The trial involved 33 heavily pretreated patients, with a 56% complete response rate, 12.1 months median duration of response, and 15.9 months median overall survival. A global, randomized Phase 3 trial, SUPRAME, is ongoing, with interim and final analyses expected in 2026.

Immatics N.V. (NASDAQ: IMTX) has reported favorable results for its PRAME cell therapy, anzu-cel (IMA203), in a Phase 1b trial for metastatic melanoma. The trial, which involved 33 heavily pretreated patients, demonstrated a 56% complete response rate (cORR), a median duration of response (mDOR) of 12.1 months, and a median overall survival (mOS) of 15.9 months [1].

The trial, presented at the 2025 ASCO Annual Meeting, further substantiates Immatics' global leadership in precision targeting of PRAME. The data showed favorable tolerability and promising clinical activity, with a median progression-free survival (mPFS) of 6.1 months and a median follow-up time (mFU) of 13.4 months [1].

Immatics is currently conducting a global, randomized, controlled Phase 3 trial, SUPRAME, to evaluate the efficacy, safety, and tolerability of anzu-cel PRAME cell therapy versus investigator's choice in patients with unresectable or metastatic cutaneous melanoma who have received prior treatment with a checkpoint inhibitor. The trial is designed as a well-controlled clinical trial evaluating anzu-cel as a monotherapy in a late-stage cutaneous melanoma patient population [1].

The primary endpoint for seeking full approval will be blinded independent central review (BICR)-assessed (RECIST v1.1) progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), safety, and patient-reported outcomes about quality of life. The interim and final data analyses will occur in 2026, with the Company on track for a planned Biologics License Application (BLA) submission in 1H 2027 and launch of anzu-cel in 2H 2027 [1].

References:
[1] https://www.marketscreener.com/news/immatics-announces-second-quarter-2025-financial-results-and-business-update-ce7c51dbdc89fe27