On June 29, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported it has enrolled and safely dosed the last patient for stage 2 of Part A (1st line NSCLC) of its TACTI-002 Phase II study, completing recruitment for Part A (Press release, Immutep, JUN 29, 2020, View Source [SID1234561557]).
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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).
Immutep recently reported new data from TACTI-002 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Annual Meeting 2020, including results from stage 1 of Part A which showed an improving Progression Free Survival ("PFS") estimate of more than 9 months in patients with 1st line NSCLC.
The Company expects to report more mature data from TACTI-002 in H2 CY20.
TACTI-002 Recruitment Update
In total 81 patients out of up to 109 (74%) are already enrolled in the trial at 12 clinical sites across Australia, Europe, the UK and US. Recruitment is ongoing for Part B (second line NSCLC) and for stage 2 of Part C (2nd line HNSCC). Current recruitment numbers for each Part are below.
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, UK and Australia.
Patients participating in three parts:
Part A – First line Non-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 of PD-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% and ³50% (Tumour Proportion Score or TPS). Patients with a high PD-L1 status are typically more responsive to anti-PD-1 monotherapy such as pembrolizumab, whereas those with low PD-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 score ³1% (US) and ³50% (EU), reflecting 65% and 30% of all first line NSCLC patients, respectively.