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Immutep Announces Improving Results from Stage I of Phase II TACTI-002 Study
SYDNEY, Australia, Sept. 18, 2020 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) announces new interim data from its ongoing Phase II TACTI-002 study. The data was presented in two poster presentations at the ESMO Virtual Congress 2020 on 17 September 2020 and relates to the cut-off date of 21 August 2020. The posters are available on Immutep’s website at https://www.immutep.com/investors-media/presentations.html TACTI-002 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 Immutep’s lead product candidate eftilagimod alpha (“efti” or “IMP321”) with MSD’s KEYTRUDA® (pembrolizumab) in up to 109 patients with 2nd line head and neck squamous cell carcinoma (HNSCC, Part C) or non-small cell lung cancer (NSCLC) in 1st and 2nd line (Parts A and B, respectively). Principal investigator, Dr Martin Forster, University College London Hospital, said: “We are very encouraged by the results in this patient group with resistant late stage Head & Neck Cancers where the likelihood of response to other treatments is small. The durability of responses and the two patients with a complete response are extremely promising signals and this combination should be further investigated.” Immutep CSO and CMO, Dr Frederic Triebel said: “The combination of efti and pembrolizumab is reporting encouraging progression free survival in patients with HNSCC and NSCLC, improving on the results from separate historical trials. For example, in comparable studies, HNSCC patients receiving pembrolizumab monotherapy had a PFS of 2.1 months, or 2.3 months if given chemotherapy1,2. This compares to a PFS of 4.3 months in HNSCC patients from the TACTI-002 trial, thus far. To have these very good and durable responses in both groups and without the use of chemotherapy is highly encouraging for efti.” Stage 1 of Part C (2nd line HNSCC, N=18):
Safety TACTI-002 Recruitment Update Recruitment details for each Part of the trial are shown below and are current as at 17 September 2020. At present, recruitment is ongoing for Stage 2 of Part C. Pending the Data Monitoring Committee’s recommendation, Immutep will consider opening Stage 2 of Part B for recruitment.
Next Results About the TACT-002 Trial The 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 Australia, Europe, the UK and US. Patients participating in three parts:
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. 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. Pembrolizumab monotherapy is registered in the US (regardless of PD-L1 expression) and EU (= 50% TPS score) for second line HNSCC patients. More information about the trial can be found on Immutep’s website or on ClinicalTrials.gov (Identifier: NCT03625323) Further information can be found on the Company’s website www.immutep.com or by contacting: Australian Investors/Media: Catherine Strong, Citadel-MAGNUS U.S. Media: ____________
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