On January 7, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported it has enrolled and safely dosed the last patient for stage 2 of Part C of its TACTI-002 Phase II study (Press release, Immutep, JAN 7, 2021, View Source [SID1234573696]).
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This completes recruitment for Part C of the trial which evaluates 2nd line HNSCC patients being treated with Immutep’s lead product candidate, eftilagimod alpha ("efti" or "IMP321") in combination with MSD’s KEYTRUDA (pembrolizumab).
Immutep reported encouraging interim data from TACTI-002 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 35th Anniversary 2020 Annual Meeting on 10 November 2020. The data from 2nd line HNSCC patients was very robust and forms an excellent basis for additional clinical development in this indication.
Also the recruitment of an additional 74 patients with 1st line NSCLC in accordance with the TACTI-002 collaboration trial expansion plans announced on November 19th, 2020, has commenced with now 4 patients newly recruited, adding to the 36 patients already enrolled prior to the expansion. In total 40 of 110 patients with 1st line NSCLC have now been recruited in Part A of TACTI-002.
The Company expects to report more data from TACTI-002 in the first half of CY 2021.
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 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.
More information about the trial can be found on Immutep’s website or on ClinicalTrials.gov (Identifier: NCT03625323).