1 June 2020
Immutep Limited (ASX: IMM; NASDAQ: IMMP) is pleased to report first interim data from its ongoing INSIGHT-004 Phase I clinical trial. The study is a phase I trial evaluating the combination of Immutep’s lead product candidate, eftilagimod alpha (“IMP321” or “efti”) with avelumab, a human anti-PD-L1 antibody, in 12 patients with solid cancers. Avelumab is co-developed and co-commercialized by Merck KGaA, Darmstadt, Germany and Pfizer Inc. The data was reported in a short talk poster presentation by Dr Thorsten O. Goetze, trial investigator, at the virtual event for the 2020 American Society of Clinical Oncology’s (ASCO) Annual Meeting. The poster presentation from Dr Goetze is available on the company’s website (click here).
INSIGHT-004 is the fourth arm of the investigator-initiated INSIGHT trial which is being conducted by the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt. 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 efti when given in combination with avelumab. Patients in cohort 1 receive 6mg doses of efti every two weeks with the standard dose of avelumab (800mg every two weeks), while patients in cohort 2 receive a higher dose of efti, 30mg, with avelumab.
INSIGHT-004 reached full recruitment in April 2020 and has recruited patients in different solid tumors, primarily with gastrointestinal indications. It is the first combination trial of an approved and marketed anti-PD-L1 drug and efti.
Prof Salah-Eddin Al-Batran, INSIGHT-004 trial investigator and Director of Oncology at IKF said: “It is good to see a number of patients are responding to the combination therapy of efti and avelumab, particularly as three patients in cohort 2 are still very early on in their treatment and haven’t yet been assessed. INSIGHT-004 is progressing well and we are pleased that efti continues to be safe and well tolerated by patients. These patients typically are heavily pretreated and do not have any good therapy options.”
Read the complete ASX announcement.