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

Immutep Limited 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 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.