Anzu-cel (anzutresgene autoleucel, IMA203) (ACTengine) - (SUPRAME)

August 18, 2026: Immatics N.V. (NASDAQ: IMTX) reported that the Phase 3 SUPRAME trial of anzu-cel (anzutresgene autoleucel, IMA203) in previously treated advanced melanoma remains on track to complete required randomizations by year-end 2026. Because aggregate PFS events are occurring more slowly than modeled, and after FDA feedback, the company plans to replace interim and final PFS looks with a single streamlined final PFS analysis at a lower prespecified event count while maintaining 90% power; it will also add about 90 patients, increasing total enrollment to about 450, to strengthen OS power. Topline PFS data are expected in H1 2027, followed by a BLA submission in 2027.

For anzu-cel Phase 1b in metastatic melanoma, ASCO 2026 data showed 56% confirmed ORR, 14.6-month median DOR, 6.1-month median PFS, 16.2-month median OS, 70% 12-month OS, and 46% 24-month OS, with manageable tolerability; further analyses are planned for ESMO 2026.

IMA203CD8 Phase 1 ASCO 2026 data showed 63% ORR and 50% confirmed ORR in gynecologic cancers, with updated multi-tumor data planned for ESMO 2026.

IMA402 Phase 1b RP2D-range data are planned for ESMO 2026; the IMA402/IMA401 combination cohort in sqNSCLC is enrolling, with first data expected in 2027. Cash and financial assets were $448.2 million as of June 30, 2026, with runway projected into 2028.