Australian immunotherapy company Immutep (ASX:IMM) has announced it has enrolled and safely dosed the last patient for stage two of Part A of its TACTI-002 Phase 2 trial.
The TACTI-002 (Two ACTive Immunotherapies) trial is being conducted in collaboration with US-based MSD. It is evaluating the combination of Immutep’s lead product candidate, eftilagimod alpha (efti) with MSD’s PBS-listed immunotherapy KEYTRUDA (pembrolizumab).
The trial is evaluating the combination of efti with KEYTRUDA in up to 109 patients with second-line head and neck squamous cell carcinoma or non-small cell lung cancer in the first and second line.
It is a Phase 2, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in up to 12 study centres across the U.S., Europe, UK and Australia. The company said 81 patients out of up to 109 are already enrolled in the trial
Immutep recently reported new data from TACTI-002 at the American Society of Clinical Oncology’s Annual Meeting 2020. This included results from the first stage of Part A that showed an improving progression-free survival (PFS) estimate of more than nine months in patients with non-small cell lung cancer (NSCLC).
The company said it expects to report more mature data from the TACTI-002 trial in the second half of 2020.
Patients are also being recruited in Part B (second-line NSCLC, PD-X refractory) and Part C (second-line Head and Neck Squamous Cell Carcinoma (HNSCC), PD-X naive).
TACTI-002 is an all-comer study in terms of PD-L1 status, which is a well-known predictive marker for response to KEYTURDA monotherapy. Patients with a high PD-L1 status are typically more responsive to anti-PD-1 monotherapy such as KEYTURDA.