On January 9, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, provides an update on its TACTI-002 and AIPAC studies for its lead product candidate, eftilagimod alpha ("efti" or "IMP321") (Press release, Immutep, JAN 9, 2020, View Source [SID1234552898]).
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TACTI-002 – Phase II study
The requisite number of predefined patient responses was observed in stage 1 of Part C. The decision by the DMC to recommend opening stage 2 recruitment follows its review of preliminary safety and efficacy data and is based on a predefined efficacy threshold.
This allows the Company to now proceed with the recruitment of an additional 19 patients, forming stage 2 of Part C of the study, having now also completed recruitment of the 18 HNSCC patients for stage 1. The staged approach to patient enrolment is based on the study’s Simon’s two-stage clinical trial design.
Stage 1 of Part A (first line Non-Small Cell Lung Cancer, NSCLC) was expanded in September 2019. Recruitment is ongoing for Part B (second line NSCLC) with 10 out of 23 patients now participating, and for stage 2 of Part A (first line NSCLC), where 4 out of 19 patients are now participating. The Company expects to report more mature data from TACTI-002 in Q1 CY20.
TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada).
Immutep CSO and CMO, Dr Frederic Triebel said: "The study is progressing well as the expansion of Part C to include 19 additional patients with second line HNSCC marks the second out of three parts of our TACTI-002 study to be expanded, having already observed the pre-determined number of partial responses in Parts A and C patients."
AIPAC – Phase IIb study in metastatic breast cancer
The Company continues to progress its AIPAC trial which evaluates efti in combination with chemotherapy in 227 metastatic breast cancer patients in a randomized, double blinded, placebo-controlled phase IIb clinical trial. The first progression-free survival read-out remains on track for Q1 CY20 and is expected to be reported in March 2020.
Immutep Limited, Level 12, 95 Pitt Street, Sydney NSW 2000
ABN: 90 009 237 889
About TACTI-002
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 (or pembrolizumab, an anti-PD-1 therapy) in up to 109 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 up to 13 study centres across the U.S., Europe and Australia.