Behind the C-144-01 Study of Lifileucel in Melanoma
Theresa Medina, MD, discusses treatment with lifileucel in patients with advanced melanoma and the background of the C-144-01 study.
Theresa Medina, MD, associate professor of medicine-medical oncology at the University of Colorado Cancer Center, Anschutz Medical Campus, discusses treatment with lifileucel (Amtagvi) in patients with advanced melanoma and the background of the C-144-01 study (NCT02360579).
Lifileucel represents a significant advance as a personalized, one-time tumor-derived autologous T-cell immunotherapy. It is currently approved for the treatment of adult patients with unresectable or metastatic melanoma that has progressed following programmed cell death-1 (PD-1) blocking antibody and, if applicable, a BRAF inhibitor with or without a MEK inhibitor.
“The C-144-01 study was the first global, multicenter study looking at the use of what we call TIL, or tumor-infiltrating lymphocyte therapy, which actually has a really long history, but it was the first opportunity for multiple centers across the world to have access to this unique approach,” explains Medina in an interview with Targeted OncologyTM.
“It was a trial looking at patients who are refractory to standard therapies with immune checkpoint inhibitors and, when applicable, targeted therapies as a kind of additional line of therapy. It was the first study looking at, again, in the global setting, a cellular-based approach option for patients with solid tumors,” she adds.
C-144-01 is a phase 2, registrational, open-label, multicenter, multicohort trial that previously demonstrated compelling efficacy. Patients treated with lifileucel achieved an objective response rate (ORR) of 31.4% as assessed by an independent review committee.
The C-144-01 study enrolled patients with advanced melanoma who had progressed on prior immune checkpoint inhibitors and, where appropriate, targeted therapy. The treatment regimen involved nonmyeloablative lymphodepletion (cyclophosphamide and fludarabine) prior to a single infusion of cryopreserved lifileucel, followed by a short course of interleukin-2. Beyond ORR, key secondary end points of the trial were duration of response, overall survival, and safety.
“It was a modified intention-to-treat analysis with the patients that received lifileucel that were evaluated in that overall survival,” she says.
