anzutresgene autoleucel (IMA203) / Immatics - LARVOL DELTA

Response durability with anzutresgene autoleucel (anzu-cel), a PRAME-directed T-cell receptor (TCR) T-cell therapy, in advanced melanoma (ESMO 2026) - No abstract available

Metastases • Melanoma • Oncology • Solid Tumor • PRAME

Patient-level clinical response dynamics in advanced melanoma with anzutresgene autoleucel (anzu-cel), a PRAME-directed T-cell receptor (TCR) T-cell therapy. (ASCO 2026) - P3 | "Anzu-cel demonstrated favorable tolerability and induced clinically meaningful and durable responses. Exploratory analyses suggest that the CNS was not a common site for relapse. Future analyses will characterize response dynamics and progression patterns to better define scenarios in which progression following cPR remains clinically manageable, potentially supporting individualized decision-making regarding timing and necessity of subsequent systemic therapy."

Clinical • Metastases • Hemophagocytic lymphohistiocytosis • Immunology • Melanoma • Rare Diseases • Solid Tumor • HLA-A • IL2 • PRAME

Top advances of the year in autologous cellular therapy in melanoma and solid tumors. (PubMed, Cancer) - "Lifileucel, the first Food and Drug Administration-approved tumor-infiltrating lymphocyte (TIL) therapy for advanced melanoma, demonstrated durable efficacy in the 5-year analysis of the C-144-01 trial, with an objective response rate (ORR) of 31.4% and prolonged responses in a heavily pretreated population...Preferentially expressed antigen in melanoma (PRAME)-targeted T-cell receptor (TCR) T-cell therapy (anzu-cel, IMA203) showed promising activity in a phase 1 study, with ORR of approximately 50% in checkpoint inhibitor refractory melanoma, durable responses, and manageable toxicity, validating PRAME as a high value target across multiple tumor types...OBX-115, an IL-2 independent TIL platform expressing membrane-bound IL-15 regulated by acetazolamide, demonstrated early clinical activity with ORR of 67% in initial phase 1 data...Finally, afamitresgene autoleucel (afami-cel), a MAGE-A4 directed TCR-T therapy, showed durable efficacy in synovial sarcoma and expanding..."

Journal • Review • Melanoma • Oncology • Sarcoma • Solid Tumor • Synovial Sarcoma • IL15 • MAGEA4 • PRAME

SUPRAME: A phase 3 trial comparing IMA203, an engineered T-cell receptor expressing T cell therapy (TCR-T) vs investigator's choice in patients with previously treated advanced cutaneous melanoma. (ASCO 2025) - P3 | "Following lymphodepletion with cyclophosphamide (500 mg/m2 x 4 days) and fludarabine (30 mg/m2 x 4 days), 1-10x109 IMA203 TCR-T cells will be administered, followed by low-dose IL-2 (1mio IU daily x5 days, twice daily x5 days). Patients in the control arm will receive approved investigator's choice of standard treatment (nivolumab/relatlimab, nivolumab, ipilimumab, pembrolizumab, lifileucel (US), chemotherapy)...Secondary endpoints include OS, ORR, safety and patient-reported outcomes (EORTC QLQ-C30, EQ-5D-5L). The trial will enroll patients in the US and Europe."

Clinical • IO biomarker • Metastases • P3 data • Cutaneous Melanoma • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma • BRAF • HLA-A • PRAME

Efficacy and safety of IMA203, a PRAME-directed T-cell receptor (TCR) T-cell therapy, in patients with previously treated advanced or metastatic uveal melanoma from a phase I trial (ESMO 2025) - P1/2 | "UM with prior tebentafusp, measurable disease (RECIST 1.1) and ECOG PS 0-1. Tolerability was favorable. Further study in a larger UM cohort is warranted and planned."

Clinical • IO biomarker • Metastases • P1 data • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma • HLA-A • PRAME

Autologous T cell therapy for PRAME+ advanced solid tumors in HLA-A*02+ patients: a phase 1 trial. (PubMed, Nat Med) - P1 | "Overall, IMA203 showed promising anti-tumor activity in multiple solid tumors, including refractory melanoma. ClinicalTrials.gov identifier: NCT03686124 ."

IO biomarker • Journal • P1 data • Hematological Malignancies • Melanoma • Oncology • Sarcoma • Solid Tumor • HLA-A • PRAME

Phase 1 study results with PRAME-directed T-cell receptor (TCR) T-cell therapies in synovial sarcoma. (ASCO 2026) - P1/2 | "Results include 1 pt who received 3 sequential TCR T-cell therapies: the MAGE-A4-targeted afamitresgene-autoleucel (BOR: SD; PFS: 21.4 mos), PRAME-targeted anzu-cel (BOR: cPR; PFS: 24.4 mo), and IMA203CD8 (BOR: cPR; PFS ongoing at 24.4 mo). PRAME-directed TCR T-cell therapies exhibited a safety profile consistent with previous observations, and despite low doses, promising antitumor activity with durable responses that deepened over time in pts with SS. These results warrant further investigation."

P1 data • Sarcoma • Solid Tumor • Synovial Sarcoma • CD4 • CD8 • HLA-A • IL2 • MAGEA4 • PRAME

ACTengine IMA203 TCR-T targeting PRAME shows deep and durable anti-tumor activity in heavily pretreated solid cancer patients (SITC 2024) - P1 | "PFS and translational data will be presented at the conference. Conclusions IMA203 TCR-T was well tolerated and demonstrated deep and durable objective responses in heavily pretreated solid tumor patients, highlighting IMA203 as a novel and promising treatment option for melanoma and other solid cancers."

Clinical • Angiosarcoma • Breast Cancer • Lung Cancer • Melanoma • Mucosal Melanoma • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • Synovial Sarcoma • HLA-A • PRAME

Phase 1 clinical update of IMA203, an autologous TCR-T targeting PRAME in patients with PD1 refractory metastatic melanoma. (ASCO 2025) - P1, P3 | "IMA203 TCR-T was well tolerated and showed durable objective responses in patients with advanced melanoma. Given its promising risk/benefit profile and high PRAME prevalence in melanoma, a registration-directed Phase 3 trial (SUPRAME; NCT06743126) is underway to further evaluate its efficacy in patients with previously treated (2L) advanced cutaneous melanoma."

Clinical • Metastases • P1 data • Cutaneous Melanoma • Melanoma • Oncology • Ovarian Cancer • Sarcoma • Solid Tumor • Synovial Sarcoma • HLA-A • PD-1 • PRAME

Phase 3 trial, SUPRAME, for anzu-cel (IMA203) in previously treated, advanced melanoma (GlobeNewswire) - "Enrollment in SUPRAME, currently ongoing in North America and Europe, remains on track to complete required randomizations by year-end to support final analysis for the primary endpoint....Immatics intends to replace the previously planned interim and final PFS analyses with a single streamlined final analysis, now based on a lower prespecified number of PFS events while maintaining a robust power of 90% for the primary endpoint. At the same time, Immatics intends to increase the statistical power for the secondary endpoint of OS by enrolling approximately 90 additional patients, bringing the total trial size to approximately 450 patients."

Trial status • Cutaneous Melanoma

Second Quarter 2026 and Subsequent Company Progress: Anzu-cel (IMA203) PRAME Cell Therapy (GlobeNewswire) - "The Company expects to disclose topline data from the final PFS analysis in the first half of 2027, followed by a BLA submission in 2027. The Company continues to build the commercial infrastructure for the anticipated launch of anzu-cel after obtaining BLA approval."

FDA filing • Launch US • P3 data: top line • Cutaneous Melanoma

Immatics…announced three presentations at the European Society for Medical Oncology (ESMO) Congress 2026 (GlobeNewswire) - "The three presentations will include: (i) Phase 1b data from anzu-cel, the Company’s lead PRAME cell therapy, in metastatic cutaneous and uveal melanoma, focusing on predictors of durable response; (ii) Phase 1 data from IMA203CD8 PRAME cell therapy across multiple PRAME-positive solid tumors, including durability follow-up at clinically relevant dose levels in gynecologic cancers, supporting the broad applicability of IMA203CD8 across diverse tumor types; (iii) Phase 1b data from IMA402, the Company’s PRAME bispecific, at recommended Phase 2 dose (RP2D) range across multiple cancers, supporting continued development in expansion cohorts and combination approaches."

P1 data • Cutaneous Melanoma • Gynecologic Cancers • Uveal Melanoma

Immatics Presents Clinical Activity and Response Dynamics of Anzu-cel PRAME Cell Therapy at 2026 ASCO Annual Meeting (Yahoo Finance) - "Phase 3 SUPRAME trial remains on track as it advances toward BLA submission in 1H 2027...As of September 24, 2025, 33 heavily pretreated patients with metastatic (stage IV) melanoma received a one-time infusion of anzu-cel at the recommended Phase 2 dose (RP2D, 1 - 10x109 TCR T cells) in the Phase 1b dose expansion...Anzu-cel has maintained a manageable tolerability profile, which was consistent across patients with different melanoma subtypes...The PFS rate was 55% at six months and 37% at 12 months. The overall survival rate was 70% at 12 months and 46% at 24 months; 42% (14/33) of patients experienced a deep response (≥50% tumor reduction). In these patients, mPFS was 15.9 months at 39.6 months mFU."

FDA filing • P1 data • Cutaneous Melanoma • Melanoma • Mucosal Melanoma • Uveal Melanoma

SUPRAME: A Phase 3 trial evaluating anzutresgene autoleucel (anzu-cel, IMA203) PRAME-directed T-cell receptor T-cell therapy vs investigator's choice in previously treated advanced cutaneous melanoma (EADO 2026) - P1/2, P3 | "Patients in the control arm will receive nivolumab/relatlimab, nivolumab, ipilimumab, pembrolizumab, lifileucel (US), or chemotherapy. Secondary endpoints include OS, ORR, safety, and patient-reported outcomes. The trial is currently enrolling patients in the United States, Germany, the Netherlands, Germany, France, Canada, and the United Kingdom.Results N/AConclusions N/A"

IO biomarker • Metastases • P3 data • Cutaneous Melanoma • Eye Cancer • Hematological Disorders • Melanoma • Solid Tumor • Uveal Melanoma • BRAF • HLA-A • PRAME

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: Immatics US, Inc. | N=96 ➔ 360

Enrollment change • Cutaneous Melanoma • Melanoma • Oncology • Skin Cancer • Solid Tumor • BRAF

SUPRAME Phase 3 interim and final analysis for PRAME cell therapy, anzu-cel, expected to be triggered in 2026, advancing toward the Company’s first commercial launch planned in 2027. (Yahoo Finance) - "Phase 1 data readout with second-generation PRAME cell therapy, IMA203CD8, to be presented at the 2026 ASCO meeting, focusing on anti-tumor activity in gynecologic cancers...The Company is on track to complete Phase 1a dose escalation and determine the recommended Phase 2 dose (RP2D) in 2026....The Company continues to expect BLA submission in the first half of 2027..."

FDA filing • Launch US • P1 data • P3 data • Trial status • Cutaneous Melanoma • Gynecologic Cancers • Uveal Melanoma

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (clinicaltrials.gov) - P3 | N=96 | Recruiting | Sponsor: Immatics US, Inc.

New P3 trial • Cutaneous Melanoma • Melanoma • Oncology • Skin Cancer • Solid Tumor • BRAF

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (clinicaltrials.gov) - P3 | N=108 | Recruiting | Sponsor: Immatics US, Inc.

New P3 trial • Cutaneous Melanoma • Melanoma • Oncology • Skin Cancer • Solid Tumor • BRAF

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: Immatics US, Inc. | N=108 ➔ 360

Enrollment change • Cutaneous Melanoma • Melanoma • Oncology • Skin Cancer • Solid Tumor • BRAF

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (clinicaltrials.gov) - P3 | N=360 | Not yet recruiting | Sponsor: Immatics US, Inc.

New P3 trial • Cutaneous Melanoma • Melanoma • Oncology • Skin Cancer • Solid Tumor • BRAF

SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (clinicaltrials.gov) - P3 | N=360 | Recruiting | Sponsor: Immatics US, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cutaneous Melanoma • Melanoma • Oncology • Skin Cancer • Solid Tumor • BRAF

Efficacy and safety of IMA203, a PRAME-directed T-cell receptor (TCR) T-cell therapy, in patients with previously treated advanced or metastatic uveal melanoma from a Ph 1 trial (SMR 2025) - No abstract available

Clinical • Metastases • Eye Cancer • Melanoma • Oncology • Solid Tumor • Uveal Melanoma • PRAME

IMA203, a PRAME-directed T-cell receptor (TCR) T-cell therapy, demonstrated broad organ penetration in patients with heavily pretreated advanced or metastatic melanoma in a phase 1 trial (SMR 2025) - No abstract available

Clinical • Metastases • P1 data • Melanoma • Oncology • Solid Tumor • PRAME

Sequential Dosing of Next-Generation IMA203CD8 TCR-T-Cell Therapy Targeting PRAME in Combination with BRAF-/MEK-Inhibition in a Melanoma Patient with Progressive Disease - a Case Report (ASH 2024) - "Dexamethasone and Tocilizumab were initiated, which led to quick termination of ICANS but he had continuous high fever and intermittent oxygen dependency (CRS grade II), so that Anakinra was added alongside high-dose Dexamethasone and Tocilizumab on day +3. Additionally, as we could previously show with IMA203 TCR-T cells, IMA203CD8 TCR-T cells can be administered simultaneously with MAPKi and the combination is feasible, safe, and possibly beneficial. Although the individual contribution of the second IMA203CD8 infusion on the tumor response currently cannot be ultimately distinguished, longer follow-up and detailed assessment of the immune response will shed more light on the potential benefits of a delayed second infusion of T-cell therapies, as this novel approach could help increase anti-tumor activity of TCR- and CAR-T-cell therapies and enhance T-cell status potentially long-term with reduced T-cell exhaustion."

Case report • Clinical • Combination therapy • CNS Disorders • Melanoma • Oncology • Solid Tumor • IL2 • PRAME

Reactivation of Tebentafusp-Induced Skin Toxicity Following PRAME-Specific TCR-T Cell Therapy in Uveal Melanoma (DGHO 2025) - "We report a case of reactivated skin toxicity following PRAME-specific TCR-T therapy in a uveal melanoma patient previously treated with Tebentafusp.A 65-year-old male with metastatic uveal melanoma, refractory to multiple treatments including Tebentafusp, received an IMA203 TCR-T-cell product within compassionate use. This case highlights the importance of considering prior immune-related toxicities when managing solid tumor patients undergoing cellular therapies. Ongoing deep immunophenotyping of peripheral blood via spectral flow cytometry will be presented to further elucidate immune dynamics underlying both therapeutic response and immune-mediated toxicity"

IO biomarker • Dermatology • Eye Cancer • Immunology • Melanoma • Pruritus • Solid Tumor • Uveal Melanoma • PRAME