Immutep has signed a clinical trial collaboration and supply agreement with Merck to conduct a Phase II trial, examining the combination of eftilagimod alpha (efti or IMP321) with Keytruda (pembrolizumab) for the treatment of different types of solid tumours.
The proposed Two ACTive Immunotherapies (TACTI-002) trial is designed to analyse safety and efficacy of the efti and Keytruda combination in patients with non-small cell lung cancer (NSCLC), head and neck cancer, or ovarian cancer.
It will be a Simon two-stage study enrolling up to 120 patients across the three indications at various medical centres in Europe and the US.
The trial is expected to begin in the second half of this year.
Immutep CEO Marc Voigt said: “This clinical trial will evaluate a novel combination of two complementary immuno-oncology treatments in three cancer indications simultaneously, which could lead to more rapid drug development subject to successful outcomes.
“The data generated thus far from our ongoing TACTI-mel clinical trial has supported our hypothesis that there is a compelling therapeutic synergy in administering efti in combination with another immuno-oncology treatment.
“This new Phase II clinical trial significantly builds on the momentum we are delivering in the evaluation of efti in cancer, with two Phase I clinical trials and now two Phase II clinical trials in our programme for 2018.”
IMP321 is Immutep’s lead immunotherapy product candidate, while Keytruda is Merck’s anti-PD-1 therapy.
Last November, the European Patent Office allowed the use of IMP321 in combination with a chemotherapeutic agent for the treatment of cancer.