KEY TAKEAWAYS
- The C-144-01 phase II trial aimed to present 4-year follow-up data from study C-144-01, focusing on treatment outcomes and response patterns of lifileucel.
- Lifileucel offered long-lasting survival benefits for heavily pretreated advanced melanoma patients, regardless of response type.
Many advanced melanoma patients stop responding to immunotherapy, leaving them with few options. Lifileucel, a single-dose cell therapy, offers hope, with early studies showing significant tumor shrinkage in this difficult-to-treat group.
Dr.Martin Wermke and his research team conducted a study that aimed to present the 4-year follow-up findings from study C-144-01, detailing the treatment outcomes and response patterns associated with lifileucel.
The multicohort open-label study focussed on the data from patients in Cohorts 2 and 4. Eligible patients underwent resection of at least one lesion (≥1.5 cm diameter) for the 22-day cryopreserved lifileucel manufacturing process.
The treatment protocol involved nonmyeloablative lymphodepletion (cyclophosphamide 60 mg/kg/d × 2d, fludarabine 25 mg/m2/d × 5d), followed by a single infusion of lifileucel and up to six doses of high-dose IL-2 (600,000 IU/kg).
About 153 patients were evaluated, with a median study follow-up of 48.1 months. The independent review committee assessed the overall response rate (ORR) by RECIST v1.1, which was 31.4%, and the median duration of response (DOR) was not reached. The 1-, 2-, 3-, and 4-year overall survival (OS) rates were 54.0%, 33.9%, 28.4%, and 21.9%, respectively.
Responders (n=48) had a median age of 55.0 years with a median of 3 prior lines of therapies. Clinically meaningful 4-year OS rates were observed across all response patterns (range, 37.2%–68.2%), with numerically higher OS rates in patients showing a deepened response. Treatment-emergent adverse events(TRAEs) were consistent with the known safety profiles of lymphodepletion and IL-2.
The results demonstrated enduring efficacy, resulting in sustained long-term survival benefits across various response patterns. The research was sponsored by Iovance Biotherapeutics, Inc.
Source: https://cslide.ctimeetingtech.com/immuno23hybrid/attendee/confcal/show/session/10
Clinical Trial: https://clinicaltrials.gov/study/NCT02360579
Wermke M. ‘’ Long-term efficacy and patterns of response of lifileucel tumor-infiltrating lymphocyte (TIL) cell therapy in patients with advanced melanoma: A 4-year analysis of the C-144-01 study.’’ Presented at: ESMO I-O 2023 (Presentation No. 119O).
