18 August 2020
Immutep Limited is pleased to report it has enrolled and safely dosed the last patient for stage 1 of Part B of its TACTI-002 Phase II study, completing recruitment of stage 1 of Part B.
Based on the study’s Simon’s two-stage clinical trial design, safety and efficacy data will be provided to the Data Monitoring Committee (DMC) for its review and recommendation regarding opening recruitment into stage 2 of Part B once all patients have undergone at least one tumour imaging after treatment.
TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada) and is evaluating the combination of Immutep’s lead product candidate, eftilagimod alpha (“efti” or “IMP321”) with MSD’s KEYTRUDA® (pembrolizumab) in up to 109 patients with second line Head and Neck Squamous Cell Carcinoma (HNSCC) or NSCLC in first and second line.
Recruitment details for each Part of TACTI-002 are below. At present, recruitment is ongoing for Stage 2 of Part C. Pending the DMC’s recommendation, Immutep will consider opening stage 2 of Part B for recruitment. Read more in the complete media release.
About the TACT-002 Trial
TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada). The study is evaluating the combination of efti with MSD’s KEYTRUDA® (pembrolizumab) in up to 109 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.
The trial is a Phase II, 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 and Australia.
Read more in the complete media release.