GlobeNewswire Inc | Sep 1, 2021 08:00AM EDT

September 01, 2021

Sydney, Sept. 01, 2021 (GLOBE NEWSWIRE) --

-- Last 2nd line PD-1/PD-L1 refractory non-small cell lung cancer (NSCLC) patient has been enrolled and safely dosed, completing recruitment of Stage 2 of Part B -- Total of 154 patients out of up to 183 patients (84%) now participating in the expanded trial, with recruitment continuing for the expansion stage of Part A -- Further data expected to be reported in calendar year 2021 or early calendar year 2022

SYDNEY, AUSTRALIA 1 September 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 that the last patient has been enrolled and safely dosed in Stage 2 of Part B of its Phase II TACTI-002 study (also designated KEYNOTE-798). This completes the recruitment of 2nd line PD-1/PD-L1 refractory non-small cell lung cancer (NSCLC) patients into the trial.

Immutep expects to report further data from TACTI-002 at a scientific conference in calendar year 2021 or early calendar year 2022.

Patient recruitment is now complete for Parts B and C of TACTI-002 and continues to progress well for the expansion stage of Part A (see Table 1). A total of 154 patients out of up to 183 are now participating in TACTI-002 at currently 19 clinical sites across Australia, Europe, the UK and US.

Table 1 TACTI-002 Recruitment (as at 24th August 2021)

Stage 1 (N) Stage 2 (N) Recruitment Expansion Stage Actual / Actual / Status 3 Target Target Actual / TargetPart A (1st line 17/17 19/19 EXPANDED 43/74NSCLC)Part B (2nd line 23/23 13/13 COMPLETE NSCLC)Part C (2nd line 18/18 21/19^1 COMPLETE HNSCC)

The data presented for 2nd line PD-1/PD-L1 resistant NSCLC at the Society for Immunotherapy of Cancer (SITC) 35th Anniversary 2020 Annual Meeting as part of a late breaker poster looked encouraging, especially when compared to alternative treatment options. Based on the data, the DMC confirmed a positive risk-benefit-ratio in this very difficult to treat patient population with confirmed progression (i.e. two consecutive scans) and often low PD-L1 expression levels and recommended the opening of Stage 2 of this part in March 2021.About the TACT-002 TrialTACTI-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 MSDs KEYTRUDA (pembrolizumab) in up to 183 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, Simons two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in study centres across Australia, Europe, the UK and US.

Patients participate in one of the following: 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 and HNSCC. PD-L1 expression is typically reported in three groups for NSCLC: < 1%, 1-49% and 50% (Tumour Proportion Score or TPS) and in HNSCC: <1, 1-19 and 20 (Combined Positive Score or CPS). Patients with a high PD-L1 status are typically more responsive to anti-PD-1 therapy such as pembrolizumab, whereas those with low PD-L1 status are overall significantly less responsive.

More information about the trial can be found on Immuteps website or on ClinicalTrials.gov (Identifier:NCT03625323)

About Immutep

Further information can be found on the Companys 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

1 Two extra patients were treated as allowed under the trial protocol since 2 patients had dropped out due to Covid-19 prior to first post-baseline staging.