Benzinga | Jul 6, 2021 07:20AM EDT

Immutep Shares Are Trading Higher On Green Signal To Start Efti Combo Trial In First-Line Head & Neck Cancer

* Immutep Limited (NASDAQ:IMMP) has completed all the necessary steps with the FDA and has received institutional review board approval to commence its Phase 2b TACTI-003 trials in the U.S.

* Patient recruitment for the trial will begin in Q3 of 2021. It will evaluate the Company's lead product candidate, eftilagimod alpha (efti or IMP321), in combination with Merck Co & Inc's (NYSE:MRK) Keytruda (pembrolizumab) as first-line therapy in approximately 154 patients with Head and Neck Squamous Cell Carcinoma (HNSCC).

* The study will evaluate the safety and efficacy of efti plus pembrolizumab combo, compared to pembrolizumab alone in 1st line metastatic or recurrent HNSCC patients with PD-L1 positive tumors (cohort A), and determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumors (cohort B).

* About 130 patients will be in cohort A and up to 24 patients in cohort B.

* The primary endpoint of the study is the Overall Response Rate. Secondary endpoints include overall survival and Progression-Free Survival.

* Price Action: IMMP shares are up 8.46% at $4.23 during the premarket session on the last check Tuesday.