SPY443.91+0.73 0.16%
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IXIC15,047.70-4.55 -0.03%

Immutep Completes Recruitment of 2nd line PD-1/PD-L1 refractory NSCLC Patients in TACTI-002

Immutep Limited (NASDAQ: IMMP) 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...

Benzinga · 09/01/2021 05:27
Immutep Limited (NASDAQ:IMMP) 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-smallcell 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. 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. 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. Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000 ABN: 90 009 237 889 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)