Results From the C-144-01 Trial and Potential Impact on Clinical Practice
Source: Onc Live, February 2023
Transcript:
Amod Sarnaik, MD: The next abstract we would like to discuss is a multicenter, single-arm, phase 2 study involving TILs [tumor-infiltrating lymphocytes] in the treatment of advanced treatment-refractory melanoma. This was a study that was sponsored by Iovance [Biotherapeutics]. The study had 153 patients, so it’s the largest study of TILs in melanoma that we’re aware of. The patients were heavily pretreated with 3 median lines of prior therapy. The reported response rate was 31%.
All patients had metastatic melanoma that was refractory to PD-1 antibody-based therapy. And the median duration of response was not reached at a median follow-up of 36 months. The 12-month overall survival rate was 54%. And there was a plateau of the Kaplan-Meier curve very commonly seen with immunotherapy. The trial was a massive undertaking. It involved tumor harvest from around North America with centralized manufacturing.
The benefit of this study is it demonstrates the feasibility that we can harvest cells from patients at local cancer centers that do not have manufacturing capabilities of TIL on site. The tumor can be shipped centrally where manufacturing occurs and then shipped back to the originating center for patient treatment. This is convenient for the patient as they don’t have to travel as far. They can go to a regional cancer center that’s able to treat patients with the lymphodepletion, with TIL, and IL-2 [interleukin-2] as we discussed, but they don’t have to go all the way to a cancer center that has a manufacturing facility on site, which as you know can be quite expensive. The data from the study are being reviewed by the FDA, and we’re cautiously optimistic that we’ll get regulatory approval, but that’s still under scrutiny.