Full Press Release Details
Immutep Successfully Completes Recruitment for Phase II TACTI-002 Study
of LAG-3 Therapy, Eftilagimod Alpha
SYDNEY, AUSTRALIA 19 November 2021 Immutep Limited (ASX: IMM; NASDAQ:
IMMP) ( Immutep or the Company ), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, announces the last patient has been
enrolled in the expansion stage of Part A of its Phase II TACTI-002 study (also designated KEYNOTE-798). The Company announced that the
TACTI-002 study has completed recruitment of patients across all cohorts.
A total of 185 patients are now
participating in TACTI-002 across Parts A, B, and C (see Table 1) at 20 clinical sites in Australia, Europe, and the US.1 Notably, recruitment into the
expansion stage of Part A was completed faster than anticipated, with all patients in this stage being recruited in under 12 months.
previously, further interim data from Part C (2nd line HNSCC) was presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2021, which took place from 10-14 November 2021. Further data from TACTI-002 (including from Part A) will be reported in the first half of calendar year 2022.
Immutep CEO, Marc Voigt commented: The completion of recruitment for our Phase II TACTI-002 trial marks
the achievement of a major milestone for Immutep. Our clinical team and partners have worked hard to continue the pace of patient enrolment and finished recruitment much earlier than originally anticipated, despite some challenging conditions
brought on by the COVID-19 pandemic. We are excited to be reporting further results from this trial in the coming months. We sincerely thank the patients and their families, and our various partners, for their
ongoing support of this important trial.
Table 1 TACTI-002 Recruitment (as at
| Stage 1 (N) Actual / Target | Stage 2 (N) Actual / Target | Expansion Stage Actual / Target | Recruitment Status | |||||||||||
| Part A (1 st line NSCLC) | 17/17 | 19/19 | 74/74 | 1 | COMPLETE | |||||||||
| Part B (2 nd line NSCLC) | 23/23 | 13/13 | COMPLETE | |||||||||||
| Part C (2 nd line HNSCC) | 18/18 | 21/19 | 2 | COMPLETE |
Level 12, 95 Pitt Street, Sydney NSW 2000
About the TACTI-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 eftilagimod alpha (efti) with MSD s KEYTRUDA (pembrolizumab) in
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 study centres across Australia, Europe, and the US.
Patients participate in one of the following:
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 and HNSCC.
More information about the trial can be found on Immutep s website or on ClinicalTrials.gov (Identifier: NCT03625323)
Immutep is a globally active biotechnology
company that is a leader in the development of LAG-3 related 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 soluble
LAG-3 fusion protein (LAG-3Ig), which is a first-in-class antigen presenting cell (APC)
activator being explored in cancer and infectious disease. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune disease.
Additional LAG-3 products, including antibodies for immune response modulation, are being developed by Immutep s
large pharmaceutical partners.
Further information can be found on the Company s website www.immutep.com or by contacting:
Australian Investors/Media:
+61 (0)406 759 268; cstrong@citadelmagnus.com
Level 12, 95 Pitt Street, Sydney NSW 2000
Tim McCarthy, LifeSci Advisors
915.2564; tim@lifesciadvisors.com
This announcement was authorised for release by the Board of Immutep Limited.
Level 12, 95 Pitt Street, Sydney NSW 2000