Dr Moser on the SUPRAME Trial of IMA203 in Pretreated Cutaneous Melanoma

"This is a registrational randomized study, so if this study were to be positive, showing that the progression-free survival for patients treated with IMA203 is better than that of the investigator's choice [of therapy], this would hopefully lead to FDA approval."

Justin Moser, MD, a medical oncologist at HonorHealth and associate clinical investigator at HonorHealth Research Institute, detailed the design and potential implications of the phase 3 SUPRAME trial (NCT06743126), a registrational study evaluating the efficacy, safety, and tolerability of the autologous T-cell receptor (TCR) therapy IMA203 in patients with previously treated advanced cutaneous melanoma.

This open-label, multicenter, randomized trial is enrolling patients with unresectable or metastatic cutaneous melanoma who have progressed on prior immune checkpoint inhibitor therapy, Moser began. All patients must be HLA-A*02:01 positive, have measurable disease per RECIST 1.1 criteria, ECOG performance status of 0 or 1, and adequate organ function. 

Following HLA testing and leukapheresis, patients are randomized to receive either IMA203 or investigator’s choice of standard therapy, which may include checkpoint inhibitors, lifileucel (Amtagvi) in the United States, or chemotherapy. Those assigned to the IMA203 arm will receive a lymphodepletion regimen consisting of fludarabine and cyclophosphamide, followed by a one-time infusion of IMA203 and subsequent low-dose IL-2. Patients will be stratified according to geography, baseline lactate dehydrogenase levels, and disease stage.

The trial’s primary end point is progression-free survival. Key secondary end points include overall survival, objective response rate, safety, and patient-reported quality of life. The trial is currently open to enrollment and is being conducted across approximately 50 sites in the United States and Europe.

According to Moser, the SUPRAME trial could change the treatment landscape for patients with refractory cutaneous melanoma who are HLA-A*02:01 positive. If positive, the trial could support FDA approval of IMA203, allowing it to be integrated as a new standard of care in this biomarker-defined population.