Immutep has entered into a partnership with MSD (known as Merck & Co. in the US and Canada) to assess the former’s eftilagimod alfa (efti) with Keytruda (pembrolizumab) and chemotherapy in the Phase 3 TACTI-004 trial in patients with metastatic non-small cell lung cancer (NSCLC).
In this connection, the parties have signed a clinical trial collaboration and supply agreement to evaluate the combination as first-line treatment for the disease.
Efti is a soluble LAG-3 protein and MHC Class 2 agonist. It is designed to stimulate both innate and adaptive immunity for cancer treatment.
The asset is currently being assessed for several types of solid tumours like NSCLC, head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer.
Efti has been granted fast track designation by the US Food and Drug Administration (FDA) as first-line of treatment for HNSCC and NSCLC.
The partnership between Immutep and MSD follows two prior collaborations for the TACTI-002 Phase 2 and TACTI-003 Phase 2b trials, which together treated more than 350 patients.
TACTI-004 will be a 1:1 randomised, double-blind, multinational, controlled clinical trial that will register around 750 NSCLC patients.
It will assess the investigational combination therapy against a standard-of-care combination of Keytruda, chemotherapy, and a placebo.
The trial will feature dual primary endpoints of progression-free and overall survival, with a predetermined futility boundary and a pre-planned interim analysis.
According to Immutep, the combination of efti with Keytruda is expected to enhance clinical outcomes for those who respond well and extend the therapy’s reach to a larger portion of the NSCLC population, irrespective of the PD-L1 expression levels.
Under the agreement, Immutep will oversee the registrational TACTI-004 study, while MSD will provide Keytruda.
This arrangement enables the parties to pursue marketing approval for the combination therapy and promote their compounds with appropriate label indications.
Besides, both entities retain the commercial rights to their respective compounds.
Immutep CEO Marc Voigt said: “We are eager to build upon the meaningful impact that immunotherapy has brought to patients with NSCLC, one of the largest cancer indications globally, and look for TACTI-004 to confirm the clinical benefits that have been achieved with efti in combination with Keytruda.”
