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.
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