Phase 1 INSIGHT-005 Study to Investigate Eftilagimod Alpha Plus Avelumab in mUC

The phase 1 INSIGHT-005 study will further evaluate the combination of eftilagimod alpha and avelumab in patients with metastatic urothelial cancer.

The phase 1 clinical study INSIGHT-005 (NCT03252938) will evaluate the use of eftilagimod alpha (IMP321) in patients with urothelial carcinoma (mUC).1

The start of the study builds on promising clinical data previously reported in the INSIGHT-004 study in patients with multiple solid tumors administered the combination of eftilagimod alpha and avelumab (Bavencio).

“We are very pleased to extend 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 United States, who require treatment options,” said Marc Voigt, Chief Executive Officer by Immutep Limited, in the press release. “INSIGHT-005 builds on the encouraging clinical efficacy and safety previously reported for the combination of [eftilagimod alpha] and avelumab in various solid cancers, including deep and durable responses in patients with little or no PD-L1 expression and in indications typically refractory to immune checkpoint therapy.”

The INSIGHT-005 Phase 1, open-label, exploratory, investigator-initiated study is evaluating the safety and efficacy of eftilagimod alpha in combination with avelumab as a treatment option for patients with mUC. Approximately 30 patients will be enrolled in this portion of the study.2

The study is being conducted in Germany as part of the investigator-initiated INSIGHT platform investigating different combinations of eftilagimod alpha with other drugs for patients with metastatic solid tumors.

Inclusion in INSIGHT-005 is open to male and female patients 18 years of age and older with an ECOG performance status of 0 or 1, adequate haematological, hepatic, renal, and coagulation functions, an expected survival time greater than 3 months, and resolution of associated toxicity with prior or ongoing therapy to grade 1-2, excluding alopecia and transaminases in liver metastases.

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The primary endpoint of the study is feasibility rate, with secondary endpoints of incidence and severity of adverse events, objective response rate, progression-free survival, overall survival, and immune response in whole blood and tumor tissue.

The first patient is expected to be enrolled and dosed in early 2023 after completing the necessary ethical and regulatory steps.

Previously, the INSIGHT-004 study evaluated eftilagimod alpha in combination with avelumab in patients with multiple advanced solid cancers, including colorectal, pleural mesothelioma, squamous cell, cervical and gastroesophageal cancer.3

The results of this study showed that the combination elicited encouraging signals of efficacy with a response rate of 41.7%. Administration of 800 mg avelumab and 6 mg eftilagimod alpha in cohort 1 or 30 mg in cohort 2 was feasible and safe with no unexpected side effects. Efficacy signals from the combination were observed with a disease control rate of 50.0%.

The INSIGHT-005 study aims to obtain further data on the combination in patients with mUC. In addition, researchers hope to increase the target indications for combination approaches with eftilagimod alpha to realize the full potential of the unique LAG-3 candidate.

Immutep signs a second clinical trial collaboration agreement with Merck KGaA, Darmstadt, Germany, and Pfizer for a new combination study of its lead LAG-3 candidate eftilagimod alpha and avelumab for the treatment of urothelial cancer. press release. Immutep Limited. November 29, 2022. Accessed December 1, 2022.
Feasibility and safety of IMP321 (eftilagimod alpha) for advanced-stage solid tumors. Updated November 15, 2022. Accessed December 1, 2022.
Goetze TO, Mueller DW, Rafiyan MR, et al. Phase 1 platform study INSIGHT: Advanced Stratum D Saterie and Efficacy Data to Assess the Feasibility and Safety of Eftilagimod alpha (soluble LAG-3 protein) in combination with avelumab in advanced-stage solid tumors. Poster Presented at the American Society of Clinical Oncology Annual Meeting; 4th-8th June 2021.