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Immutep Limited

Wed, 1 September 2021, 10:00 pm

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

• Last 2^ndline 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 September2021 –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 2^ndline 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 (seeTable 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 24^thAugust 2021)

		Stage 1 (N) Actual / Target	Stage 2 (N) Actual / Target	Recruitment Status	Expansion Stage 3 Actual / Target
1	Part A (1st line NSCLC)	17/17	19/19	EXPANDED	43/74
2	Part B (2nd line NSCLC)	23/23	13/13	COMPLETE
3	Part C (2nd line HNSCC)	18/18	21/191	COMPLETE

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 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 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, Simon’s 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 Immutep’s website or on ClinicalTrials.gov (Identifier:
NCT03625323)