Immutep Completes Recruitment for Part A of Phase II TACTI-002 Study
- Completes recruitment of patients with first line Non-Small Cell Lung Cancer (NSCLC)
- 81 patients out of up to 109 now participating across the trial, with recruitment continuing for Part B and stage 2 of Part C
- Further interim data from TACTI-002 expected throughout CY20
SYDNEY, Australia, June 29, 2020 (GLOBE NEWSWIRE) -- (ASX: IMM; NASDAQ: IMMP) ("Immutep” or “the Company”), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, is pleased to report 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.
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’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.
| Stage 1 (N) Actual/target | Stage 2 (N) Actual / target | ||
| Part A (1st line NSCLC) | 17/17 | 19/19 | COMPLETE |
| Part B (2nd line NSCLC) | 21/23 | -/13 | ONGOING |
| Part C (2nd line HNSCC) | 18/18 | 6/19 | ONGOING |
About the TACT-002 Trial
The TACTI-002 (Two ACTive Immunotherapies) 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 ≥50% (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 ≥1% (US) and ≥50% (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).
Further information can be found on the Company’s website or by contacting:
Australian Investors/Media:
Catherine Strong, Citadel-MAGNUS
+61 (0)406 759 268;
U.S. Media:
Tim McCarthy, LifeSci Advisors
+1 (212) 915.2564;
