Immutep, a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, 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 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 1H23.
 
Urothelial cancer is a type of cancer in the bladder or urinary tract. 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’s approved in more than 60 countries around the world as a monotherapy for first-line maintenance treatment for adult patients with advanced that has not progressed with first-line platinum-containing chemotherapy. Avelumab co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer.
 
Efti was previously evaluated in combination with avelumab via the INSIGHT-004 study in advanced solid cancers, including colorectal, pleural mesothelioma, squamous anal cell, cervical, and gastroesophageal carcinomas. Immutep announced final data from INSIGHT-004 reporting encouraging efficacy signals from the combination with a response rate of 41.7 percent according to RECIST 1.1.
 
Immutep and Merck KGaA 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).