Research will focus on eftilagimod alpha and avelumab for the treatment of urothelial cancer

Immutep – a company developing novel LAG-3 immunotherapies for cancer and autoimmune diseases – has announced a clinical trial partnership with Merck KGaA, Darmstadt, Germany and Pfizer. The collaboration involves a new phase 1 study – INSIGHT-005 – in patients with urothelial cancer.

The trial will be an investigator-initiated explorative, open-label study establishing the efficacy and safety of Immutep’s lead product candidate, eftilagimod (efti), in combination with avelumab (also known as Bavencio) in up to 30 patients with metastatic urothelial cancer.

It will take place in Germany and the first patient is expected to be enroled and dosed in 2023, after completing the necessary regulatory steps.

Under the agreement, Immutep and Merck KGaA, Darmstadt, Germany will both fund the INSIGHT-005 study. Meanwhile, it will be conducted by the Institute of Clinical Cancer Research, Krankenhaus Nordwest as part of the investigator-initiated INSIGHT platform for studies investigating efti in different combination treatments and routes of administration.

Immutep chief executive officer, Marc Voigt, reflected: “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.”

“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,” he concluded.

Efti was previously researched in combination with avelumab via the INSIGHT-004 study in patients with advanced solid cancers, including pleural mesothelioma, colorectal, squamous anal cell, cervical and gastroesophageal carcinomas. Immutep announced the final data from INSIGHT-004 in 2021, reporting encouraging efficacy signals from the combination with a response rate of 41.7%.

Urothelial cancer is a type of cancer in the bladder or urinary tract. In the US alone, it is estimated there will be 81,180 new cases of bladder cancer in 2022, while 17,100 people will die of the disease.