First dose administered in Efti, BAVENCIO trial for metastatic urothelial cancer

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Immutep Limited, a pioneering clinical-stage biotechnology company specializing in LAG-3 immunotherapies, announced the enrollment and safe dosing of the first patient in the INSIGHT-005 Phase I trial in the fight against metastatic urothelial carcinoma.

In collaboration with Merck KGaA, Darmstadt, Germany, the investigator-initiated study will assess the efficacy and safety of eftilagimod alpha (efti) in combination with BAVENCIO (avelumab) in up to 30 patients facing metastatic urothelial carcinoma.

The chemotherapy-free immuno-oncology (IO) combination, previously showing promising signals of efficacy and a favourable safety profile in the INSIGHT-004 Phase I trial, is now poised to address a critical unmet need in patients ineligible for platinum-based chemotherapy.

According to the ASX-listed company, the INSIGHT-005 trial aims to build upon the success of the previous phase and is strategically focused on patients facing metastatic urothelial carcinoma, particularly those not eligible for platinum-based chemotherapy or progressing during or after such treatment.

Efti and avelumab have already demonstrated effectiveness in advanced solid tumours, even in cases with low or negative PD-L1 expression, where responses are typically challenging to achieve with anti-PD-(L)1 therapy.

Frédéric Triebel, M.D., PhD, chief scientific officer at Immutep, expressed optimism about the potential impact of this immunotherapy combination

“Immunotherapy has made great strides in improving clinical outcomes for patients with bladder cancer, including avelumab that has set a new standard of care for many metastatic urothelial carcinoma patients.”

He added, “We are pleased to commence patient enrollment in the INSIGHT-005 study that we hope will build upon this progress.”

The trial will be conducted by the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt and other German cancer centres, including Helios Klinikum Bad Saarow with Dr. Med. Daniel Pink.

The INSIGHT platform, dedicated to investigating efti in various combination treatments and routes of administration, currently consists of five different arms, with INSIGHT-005 falling under Stratum E.

Urothelial carcinoma, the most common type of bladder cancer, affects a significant number of individuals worldwide.

In 2023, it was estimated that there would be 82,290 new cases of bladder cancer and 16,710 deaths in the United States alone.