23 April 2020
Immutep Limited, a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, announced that the last patient has been enrolled and safely dosed for the second cohort of the INSIGHT-004 Phase I clinical trial. This completes enrollment for the study.
The trial evaluates the combination of eftilagimod alpha (“efti” or “IMP321”), an antigen presenting cell activator, with a standard dose of avelumab, a human anti-PD-L1 antibody, in patients with advanced solid malignancies. Avelumab is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc. Initial results from the cohort of the INSIGHT-004 study are expected to be presented at a major medical conference in the second quarter of 2020.
Prof. Dr. Salah-Eddin Al-Batran, lead investigator of INSIGHT-004, commented: “We are pleased with the pace at which IKF was able to complete enrollment for the INSIGHT-004 study, especially considering the majority of the patients in the second Cohort were enrolled in just the past few weeks as the world continues to deal with the COVID-19 pandemic. We are excited by the opportunity to build on the data announced to date from the first cohort of the INSIGHT-004 study, as the second cohort offers a much higher dose, 30 mg, of efti to patients.”
The first cohort of six patients in the INSIGHT-004 study received a standard dose of avelumab and a 6 mg dose of efti with no new safety signals or dose limiting toxicities. The observed safety profile also aligns with the known safety profile of the monotherapies. Participants enrolled in the INSIGHT-004 trial are patients with late-stage cancer who have been heavily pre-treated for advanced, metastatic solid tumors. Typically, they have no other therapy options available.
INSIGHT-004 is the fourth arm of the INSIGHT trial which is being conducted by Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt, Germany (IKF). It is being conducted under Immutep’s collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer Inc., and is evaluating the safety, tolerability and recommended Phase II dose of Immutep’s lead immunotherapy product candidate efti when given in combination with avelumab in 12 patients with advanced solid malignancies.
Read the original media release.