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


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

About the Phase 1 Trial of Eftilagimod Alpha in Advanced Stage Solid Tumors

Trial Name: An Explorative Phase I Study to Evaluate Feasibility and Safety of Intra-tumoral, Intra-peritoneal, and Subcutaneous Injection of IMP321 (Eftilagimod Alpha; LAG-3Ig Fusion Protein) Alone or in Combination for Advanced Stage Solid Tumors Identifier: NCT03252938

Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Recruitment Contact: Salah-Eddin Al-Batran, MD, 4969 7601 ext 4420, and Regina Eickhoff, PhD, 4969 7601 ext 4165,

Completion Date: June 30, 2024

The phase 1 INSIGHT-005 clinical trial (NCT03252938) will evaluate the use of eftilagimod alpha (IMP321) for patients with urothelial cancer (mUC).1

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

“We are very pleased to be deepening 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 are in need of treatment options,” said Marc Voigt, chief executive officer of Immutep Limited, in the press release. “INSIGHT-005 builds on the encouraging clinical efficacy and safety previously reported from the combination of [eftilagimod alpha] and avelumab in various solid cancers, including deep and durable responses in patients with low or no PD-L1 expression and in indications that typically do not respond to immune checkpoint therapy.”

The open-label, explorative, investigator-initiated, phase 1 INSIGHT-005 trial is assessing 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 trial will take place in Germany as a part of the investigator-initiated INSIGHT platform which is investigating different combinations of eftilagimod alpha with other agents for patients with metastatic solid tumors.

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

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

It is expected that the first patient will be enrolled and dosed in the trial at the start of 2023, after completing the necessary ethics and regulatory steps.

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

Findings from this trial showed the combination to elicit encouraging efficacy signals with a response rate of 41.7%. Avelumab administered at 800mg and eftilagimod alpha at 6mg in cohort 1 or 30 mg in cohort 2 was feasible and safe as no unexpected adverse events occurred. Signals of efficacy with the combination were seen with a disease control rate of 50.0%.

The INSIGHT-005 study aims to gain further data on the combination in patients with mUC. Further, investigators hope to increase target indications for combination approaches with eftilagimod alpha to exploit the full potential of the unique LAG-3 candidate.

Immutep enters into second clinical trial collaboration agreement with Merck KGaA, Darmstadt, Germany, and Pfizer for new combination study of its first-in-class LAG-3 candidate, eftilagimod alpha, and avelumab to treat urothelial cancer. News 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 INSIGHT platform trial: Advanced satery and efficacy data from stratum D evaluating feasibility and saefty of eftilagimod alpha (soluble LAG-3 protein) combined with avelumab in advanced stage solid tumors. Poster presented at the American Society of Clinical Oncology Annual Meeting; June 4-8, 2021.
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