Immutep Limited announced that the first patient has been enrolled and safely dosed in the INSIGHT-005 Phase I trial. The investigator-initiated study jointly funded with Merck KGaA, Darmstadt, Germany, will evaluate eftilagimod alpha (?efti?) in combination with BAVENCIO® (avelumab) in up to 30 patients with metastatic urothelial carcinoma. This chemotherapy-free immuno-oncology (IO) combination has already shown promising signals of efficacy and a favorable safety profile in advanced solid tumors, including several IO insensitive indications, in the INSIGHT-004 Phase I trial.

Encouragingly, responses were achieved even in cancer patients with low and negative PD-L1 expression, who typically would not be expected to respond to anti-PD-(L)1 therapy. INSIGHT-005 looks to build on these clinical results and is focused on an area of high unmet need: metastatic urothelial carcinoma patients that are not eligible for platinum-based chemotherapy or progressing during or after platinum-based chemotherapy. The trial will assess the safety and efficacy of efti and avelumab, an anti PD-L1 monoclonal antibody owned by Merck KGaA, Darmstadt, Germany, that is widely recognized in international guidelines as the standard of care for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are progression-free following platinum-based chemotherapy.

INSIGHT-005 will be conducted by the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt and other German cancer centers, including Helios Klinikum Bad Saarow with Dr. Med. Daniel Pink, as part of the investigator-initiated INSIGHT platform for studies investigating efti in different combination treatments and routes of administration. INSIGHT currently consists of 5 different arms from stratums A to E (INSIGHT-005 is Stratum E).