Full Press Release Details
IMMUTEP COMPLETES RECRUITMENT FOR STAGE 1 OF PART B IN TACTI-002 STUDY
SYDNEY, AUSTRALIA 18 August, 2020 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 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.
TACTI-002 Recruitment
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.
| Stage 1 (N) Actual/target | Stage 2 (N) Actual /target | Recruitment status | ||||
| Part A (1st line NSCLC) | 17/17 | 19/19 | COMPLETE | |||
| Part B (2nd line NSCLC) | 23/23 | -/13 | TBA | |||
| Part C (2nd line HNSCC) | 18/18 | 10/19 | ONGOING |
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.
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.
Level 12, 95 Pitt Street, Sydney NSW 2000
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).
a globally active biotechnology company that is a leader in the development of LAG-3 immunotherapies 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 the NASDAQ (IMMP) in the United States.
Immutep s current lead product candidate is eftilagimod alpha ( efti or IMP321 ), a soluble
LAG-3Ig fusion protein which is a first-in-class antigen presenting cell (APC) activator. Efti is currently in a Phase IIb
clinical trial known as AIPAC which is evaluating efti in combination with chemotherapy for the treatment of metastatic breast cancer (clinicaltrials.gov identifier NCT02614833); 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 as TACTI-002 to evaluate a combination of efti with KEYTRUDA (pembrolizumab) 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 as INSIGHT-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).
Further information can be found on the Company s website www.immutep.com or by
Australian Investors/Media:
Strong, Citadel-MAGNUS
+61 (0)406 759 268; cstrong@citadelmagnus.com
Tim McCarthy, LifeSci Advisors
+1 (212) 915.2564; tim@lifesciadvisors.com
announcement was authorised for release by the board of Immutep Limited.
Level 12, 95 Pitt Street, Sydney NSW 2000