Immutep (ASX:IMM) has announced a new clinical trial collaboration under which the Australian company's investigative LAG-3 immunotherapy, efti, will be studied with Merck and Pfizer's PBS-listed BAVENCIO (avelumab).
The Phase I INSIGHT-005 trial will study the combination in up to 30 patients with metastatic urothelial cancer.
“We are very pleased to be deepening our collaboration with Merck KGaA, Darmstadt, Germany and Pfizer through this new study in patients with urothelial cancer, the sixth most common cancer in the US, who are in need of treatment options,” said Immutep CEO Marc Voigt.
“INSIGHT-005 builds on the encouraging clinical efficacy and safety previously reported from the combination of efti and avelumab in various solid cancers, including deep and durable responses in patients with low or no PD-L1 expression and in indications that typically do not respond to immune checkpoint therapy."
The study will take place in Germany. The first patient is expected to be enrolled and dosed in the first half of the calendar year 2023, after completing the necessary ethics and regulatory steps.
BAVENCIO is a checkpoint inhibitor that works by targeting and blocking a protein called PD-L1 on the surface of certain immune cells, activating the cells to find and kill cancer cells.
Efti was previously evaluated in combination with BAVENCIO via the INSIGHT-004 study in patients with advanced solid cancers, including colorectal, pleural mesothelioma, squamous anal cell, cervical, and gastroesophageal carcinomas.
Under the Agreement, Immutep and Merck will jointly fund the INSIGHT-005 study.