Immutep Completes Recruitment for Part A of Phase II TACTI-002 Study

Monday, 29. June 2020 14:00
  • 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) --  Immutep Limited (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)17/1719/19COMPLETE
Part B (2nd line NSCLC)21/23-/13ONGOING
Part C (2nd line HNSCC)18/186/19ONGOING

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 www.immutep.com or by contacting:

Australian Investors/Media:
Catherine Strong, Citadel-MAGNUS
+61 (0)406 759 268; cstrong@citadelmagnus.com

U.S. Media:
Tim McCarthy, LifeSci Advisors
+1 (212) 915.2564; tim@lifesciadvisors.com

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