About theTACT-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 ornon-small cell lung cancer in first and second line.
The trial is a Phase II, Simon’stwo-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.
Patients participating in three parts:
| | • | | Part A – First lineNon-Small Cell Lung Cancer (NSCLC),PD-X naive |
| | • | | Part B – Second line NSCLC,PD-X refractory |
| | • | | Part C – Second line Head and Neck Squamous Cell Carcinoma (HNSCC),PD-X naive |
TACTI-002 is an all comer study in terms ofPD-L1 status, a well-known predictive marker for response to pembrolizumab monotherapy especially in NSCLC.PD-L1 expression is typically reported in three groups for NSCLC: < 1%,1-49% and³50% (Tumour Proportion Score or TPS). Patients with a highPD-L1 status are typically more responsive toanti-PD-1 monotherapy such as pembrolizumab, whereas those with lowPD-L1 status are overall significantly less responsive. Pembrolizumab monotherapy is registered in the US and the EU for first-line NSCLC patients with a TPS score³1% (US) and³50% (EU), reflecting 65% and 30% of all first line NSCLC patients, respectively.
More information about the trial can be found on Immutep’s website or on ClinicalTrials.gov (Identifier: NCT03625323).
About Immutep
Immutep is a globally active biotechnology company that is a leader in the development of immunotherapeutic products for the treatment of cancer and autoimmune disease. Immutep is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders. Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.
Immutep’s current lead product candidate is eftilagimod alpha (“efti” or “IMP321”), a solubleLAG-3Ig fusion protein based on theLAG-3 immune control mechanism. This mechanism plays a vital role in the regulation of the T cell immune response. Efti is currently in a Phase IIb clinical trial as a chemoimmunotherapy for metastatic breast cancer termed AIPAC; a Phase II clinical trial being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada) referred to asTACTI-002 (Two ACTive Immunotherapies) to evaluate a combination of efti with KEYTRUDA® (or pembrolizumab, ananti-PD-1 therapy) in several different solid tumours (clinicaltrials.gov identifier NCT03625323); a Phase I clinical trial being conducted in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. referred to asINSIGHT-004 to evaluate a combination of efti with avelumab (clinical trials.gov identifier NCT03252938); and a Phase I combination therapy trial in metastatic melanoma termed TACTI-mel (clinicaltrials.gov identifier NCT02676869).
Immutep Limited,Level 12, 95 Pitt Street, Sydney NSW 2000
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