Immutep reports efficacy data for TACTI-mel Phase 1 clinical study
Immutep Limited announced mature positive efficacy data from its TACTI-mel Phase I clinical study combining its lead product candidate, eftilagimod alpha with KEYTRUDA in metastatic melanoma. TACTI-mel evaluated the combination of efti with anti-PD-1 therapy KEYTRUDA in 24 patients with unresectable or metastatic melanoma. Patients participating in the trial had a very late stage of disease: 75% classified as M1c, 67% had lung metastasis, 50% had liver metastasis, 50% had elevated LDH and many had either a suboptimal response or disease progression with pembrolizumab treatment as a monotherapy. All patients received subcutaneous injections of efti every two weeks, with a treatment duration of up to either six or 12 months. TACTI-mel is a multi-centre, open label clinical trial involving four cohorts of six patients per cohort: Part A includes the first three cohorts testing different dosages of efti in combination with pembrolizumab, with efti treatment given for six months only and commencing at cycle five of pembrolizumab treatment. Part B includes the remaining cohort testing a 30mg dosage of efti given for 12 months in combination with pembrolizumab, starting at cycle 1, day 1 of pembrolizumab treatment. The primary endpoint of the trial is safety and tolerability, with the outcome to determine the recommended dose for a Phase II trial. The trial also evaluated efficacy through Overall Response Rate, tumour shrinkage and Disease Control Rate. Efti has a favourable safety profile in combination with pembrolizumab with no dose-limiting toxicities. The recommended dosage level for a Phase II trial is 30mg of efti, which is the dosage level currently used in the ongoing TACTI-002 Phase II trial. Deep and durable responses have been observed.