Australia's Immutep has signed a Clinical Trial Collaboration and Supply Agreement with Merck KGaA, Darmstadt, Germany and Pfizer for a new Phase I clinical study in patients with urothelial cancer, called INSIGHT-005.

INSIGHT-005 will be an investigator-initiated explorative, open-label study evaluating the safety and efficacy of Immutep’s lead product candidate, efti, in combination with avelumab (BAVENCIO) in up to 30 patients with metastatic urothelial cancer. The study will take place in Germany. The first patient is expected to be enrolled and dosed in H1 of calendar year 2023, after completing the necessary ethics and regulatory steps.

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 and an estimated 17,100 people will die of this disease. Avelumab 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.

It is approved in more than 60 countries around the world as a monotherapy for first-line maintenance treatment for adult patients with advanced urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy. Avelumab is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer. 

Under the Agreement, Immutep and Merck KGaA, Darmstadt, Germany will jointly fund the INSIGHT-005 study. It will be conducted by the Institute of Clinical Cancer Research, Krankenhaus Nordwest (IKF) as part of the investigator-initiated INSIGHT platform for studies investigating efti in different combination treatments and routes of administration. INSIGHT consists of 5 different arms from stratums A to E (INSIGHT-005 is Stratum E).