Lifileucel

A multicenter, multicohort, open-label trial (C-144-01 [NCT02360579]) evaluated the efficacy and safety of lifileucel in patients with unresectable or metastatic melanoma. The pivotal cohort (cohort 4) included 73 adult patients who had received prior anti–PD-1 therapy and, if BRAF V600 variant–positive, a BRAF inhibitor with or without a MEK inhibitor. Most patients had also received prior ipilimumab. All patients had an ECOG performance status of 0 or 1. Patients underwent nonmyeloablative lymphodepleting chemotherapy followed by a single infusion of lifileucel and subsequent high-dose IL-2. Tumors were resected and processed to manufacture the autologous TIL product prior to lymphodepletion. Efficacy was assessed according to objective response rate and duration of response.[36][Level of evidence B4]

A multicenter, multicohort, open-label trial (C-144-01 [NCT02360579]) evaluated the efficacy and safety of lifileucel in patients with unresectable or metastatic melanoma. The pivotal cohort (cohort 4) included 73 adult patients who had received prior anti–PD-1 therapy and, if BRAF V600 variant–positive, a BRAF inhibitor with or without a MEK inhibitor. Most patients had also received prior ipilimumab. All patients had an ECOG performance status of 0 or 1. Patients underwent nonmyeloablative lymphodepleting chemotherapy followed by a single infusion of lifileucel and subsequent high-dose IL-2. Tumors were resected and processed to manufacture the autologous TIL product prior to lymphodepletion. Efficacy was assessed according to objective response rate and duration of response.[36][Level of evidence B4]

At a median follow-up of 27.6 months. the objective response rate was 31.5% (95% CI, 21.1%–43.4%), including 4 complete responses and 19 partial responses. The median duration of response was not reached, and 44% of responses lasted 12 months or longer.[36]

A multicenter, multicohort, open-label trial (C-144-01 [NCT02360579]) evaluated the efficacy and safety of lifileucel in patients with unresectable or metastatic melanoma. The pivotal cohort (cohort 4) included 73 adult patients who had received prior anti–PD-1 therapy and, if BRAF V600 variant–positive, a BRAF inhibitor with or without a MEK inhibitor. Most patients had also received prior ipilimumab. All patients had an ECOG performance status of 0 or 1. Patients underwent nonmyeloablative lymphodepleting chemotherapy followed by a single infusion of lifileucel and subsequent high-dose IL-2. Tumors were resected and processed to manufacture the autologous TIL product prior to lymphodepletion. Efficacy was assessed according to objective response rate and duration of response.[36][Level of evidence B4]

In a supporting pooled efficacy set that included 153 patients, the objective response rate was 31.4% (95% CI, 24.1%–39.4%). The median duration of response was not reached, with 54.2% of responses maintained at 12 months.

A multicenter, multicohort, open-label trial (C-144-01 [NCT02360579]) evaluated the efficacy and safety of lifileucel in patients with unresectable or metastatic melanoma. The pivotal cohort (cohort 4) included 73 adult patients who had received prior anti–PD-1 therapy and, if BRAF V600 variant–positive, a BRAF inhibitor with or without a MEK inhibitor. Most patients had also received prior ipilimumab. All patients had an ECOG performance status of 0 or 1. Patients underwent nonmyeloablative lymphodepleting chemotherapy followed by a single infusion of lifileucel and subsequent high-dose IL-2. Tumors were resected and processed to manufacture the autologous TIL product prior to lymphodepletion. Efficacy was assessed according to objective response rate and duration of response.[36][Level of evidence B4]

In a subsequent analysis of the pooled efficacy cohort at a median follow-up of 48.1 months, the median OS was 13.9 months. The 3-year and 4-year OS rates were 28.4% and 21.9%, respectively.[37]

A multicenter, multicohort, open-label trial (C-144-01 [NCT02360579]) evaluated the efficacy and safety of lifileucel in patients with unresectable or metastatic melanoma. The pivotal cohort (cohort 4) included 73 adult patients who had received prior anti–PD-1 therapy and, if BRAF V600 variant–positive, a BRAF inhibitor with or without a MEK inhibitor. Most patients had also received prior ipilimumab. All patients had an ECOG performance status of 0 or 1. Patients underwent nonmyeloablative lymphodepleting chemotherapy followed by a single infusion of lifileucel and subsequent high-dose IL-2. Tumors were resected and processed to manufacture the autologous TIL product prior to lymphodepletion. Efficacy was assessed according to objective response rate and duration of response.[36][Level of evidence B4]

The most common grade 3 or higher adverse events were associated with lymphodepleting chemotherapy and IL-2 administration, including thrombocytopenia, anemia, febrile neutropenia, and hypotension.

A multicenter, multicohort, open-label trial (C-144-01 [NCT02360579]) evaluated the efficacy and safety of lifileucel in patients with unresectable or metastatic melanoma. The pivotal cohort (cohort 4) included 73 adult patients who had received prior anti–PD-1 therapy and, if BRAF V600 variant–positive, a BRAF inhibitor with or without a MEK inhibitor. Most patients had also received prior ipilimumab. All patients had an ECOG performance status of 0 or 1. Patients underwent nonmyeloablative lymphodepleting chemotherapy followed by a single infusion of lifileucel and subsequent high-dose IL-2. Tumors were resected and processed to manufacture the autologous TIL product prior to lymphodepletion. Efficacy was assessed according to objective response rate and duration of response.[36][Level of evidence B4]

Treatment-related mortality was not observed, although high-grade toxicities required inpatient monitoring and supportive care. This is an intense regimen that may only be offered at tertiary centers with experience in its administration.